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Psychotherapy for depression in children and adolescents

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

(1) Primary objective: to examine effectiveness of psychotherapy in comparison with non‐treatment, waiting‐list control or treatment as usual in the treatment of depression in children and adolescents
(2) Secondary objective: to examine adverse effects of psychotherapy in comparison with non‐treatment, waiting‐list control or treatment as usual in the treatment of depression in children and adolescents
(3) To examine cost‐effectiveness of structured psychotherapy in comparison with non‐treatment, waiting‐list control or treatment as usual in the treatment of depression in children and adolescents

Background

Depression ranks as one of the most disabling diseases worldwide, as measured by its impact on Quality of Life (QOL) (WHO 2004). The three month prevalence of minor or major depressive disorders amongst children and adolescents is around 2.2% (Costello 2003), and over 9% of adolescents have been found to have moderate to severe depressive symptoms (Rushton 2002). The predicted cumulative prevalence of any depressive disorder between the ages of 9 and 16 is around 9.5% (Costello 2003).

In spite of its high prevalence in the community, depression is under‐recognised in children and adolescents, even in medical settings, because the presentation of symptoms in children is different from depression in adults; depressed children and adolescents are more likely to show an irritable mood, rather than the sad mood that features in depressed adults. Some symptoms that are commonly recognized as "depressive", but are not formally part of DSM criteria for major depressive disorder (MDD) in adults, such as somatic complaints, social withdrawal, and hopelessness, are very common in children and adolescents with major depression (Ryan 1987). Gathering a history of depression may be problematic as children and adolescents often have more difficulty in giving a precise description of their thoughts and feelings (Lagges 2003).

The average length of a major depressive episode in children and adolescents has been estimated at six to seven months (Birmaher 1996). Although its course is similar to adult depression, it may have a more severe effect on children or adolescents because of the impact upon their academic and social development. Furthermore, adolescents and young adults with a history of childhood maltreatment have been reported to be three times more likely to become depressed or suicidal in adult life (Brown 1999).

Two broad categories of treatment have been used to treat children and adolescents with depression ; one is pharmacotherapy, with antidepressants such as tricyclic antidepressants (TCAs) and serotonin selective reuptake inhibitors (SSRIs), and the other is psychotherapy.

TCAs are of unlikely benefit in the treatment of depression in pre pubertal children (Hazell 1995; Hazell 2002). SSRIs had been believed to be associated with less adverse effects, and on the basis of a small number of positive trials were recommended as the preferred pharmacological treatment for depression in children and adolescents (Lagges 2003; Emslie 2000; Renaud 1999; Walter 1996; Michael 2002; DeVane 1996). However, recently, medical committees, including the UK Committee on Safety of Medicines (CSM), The Royal College of Psychiatrists' (RCPsych) Faculty of Child and Adolescent Psychiatry and The US Food and Drug Administration (FDA), warned that all SSRIs (except fluoxetine) should not be used to treat depression in those under aged 18, because of the possibility that they may increase the risk of suicide (Meek 2004). Moreover, the most recent systematic review reported that published data suggested favourable risk‐benefit profiles for some SSRIs, but addition of unpublished data had indicated that risks could outweigh benefits of these drugs (except fluoxetine) in treatment for depression in children and young people (Whittington 2004). Consequently, clinicians may now be less inclined to prescribe either type of antidepressants to children and adolescents suffering from depression.

Approximately three quarters of children and adolescents treated for depression are reported to have received some form of psychotherapy, although approximately one third of patients underwent only one or two treatment visits during the course of the survey year in a developed country (Olfson 2003).

A number of structured psychosocial treatments are administered for depression in children and adolescents, such as cognitive‐behavioural therapy (CBT), which has been commonly used for adult patients with depression. Other types of psychotherapies include behavioural therapy, cognitive therapy (including bibliotherapy), interpersonal therapy, problem‐solving therapy, play therapy and psychodynamic therapy. Each has been used as an additional or alternative treatment to so‐called 'treatment as usual' (TAU).

Some randomised controlled trials (RCTs) have examined the efficacy of psychotherapy, although they have not reached one strong conclusion. For instance, CBT was compared favourably with a non‐focused intervention after 3.5‐month acute phase treatment for children with depression (Vostanis 1996). However, another RCT reported that CBT offered no significant advantage to that of non‐directive counselling, which is considered as a form of TAU, in the short term or at one year follow‐up (Ward 2000).

There have been few systematic reviews for depression in children and adolescents, and evidence of effectiveness of psychotherapy remains unclear. Most of the published reviews on this topic are characterised by the fact that they did not focus on any head‐to‐head comparisons, but just compared the effect size of each treatment (Michael 2002; Weisz 1987; Weisz 1995). However, it has been demonstrated and well acknowledged that adjusted indirect comparisons usually but not always agree with the results of head‐to‐head randomised trials (Bucher 1997; Song 2003). One systematic review focusing on CBT (Harrington 1998) seems to be sophisticated in terms of doing head‐to‐head analyses and giving a consideration to sources of bias, but only six studies were included in this review and it is now somewhat outdated. Another recent review also focused on CBT (Compton 2004) but limited itself to English studies, and no meta‐analytic analyses were conducted.

For these reasons, better‐designed systematic reviews are urgently needed in this area. Although systematic reviews dealing with several comparisons between categories of psychotherapy (e.g. CBT versus inter‐personal psychotherapy) are needed to establish evidence for the purpose of improving clinical practice, effectiveness of psychotherapy against control conditions should be examined as a matter of first priority. The present review therefore focuses on effectiveness of psychotherapy compared with non‐treatment, waiting‐list control or treatment as usual.

Objectives

(1) Primary objective: to examine effectiveness of psychotherapy in comparison with non‐treatment, waiting‐list control or treatment as usual in the treatment of depression in children and adolescents
(2) Secondary objective: to examine adverse effects of psychotherapy in comparison with non‐treatment, waiting‐list control or treatment as usual in the treatment of depression in children and adolescents
(3) To examine cost‐effectiveness of structured psychotherapy in comparison with non‐treatment, waiting‐list control or treatment as usual in the treatment of depression in children and adolescents

Methods

Criteria for considering studies for this review

Types of studies

Any relevant randomised controlled trials. Quasi‐randomised trials, such as those using alternate days of the week for allocating, will be excluded. For trials using a crossover design, we will only use the first active treatment phase for our analysis.

Types of participants

Children or adolescents should be between the age of 6 and 18 years when they initially participated in the primary studies. In terms of diagnostic criteria, it seems ideal that only one kind of criteria such as DSM‐IV or ICD‐10 is used in order to diagnose only one status of depression such as major depression, for the purpose of reducing clinical heterogeneity. However, it is likely that it could lead us to miss a lot of important information from clinical settings, as some children who do not satisfy the typical major depression criteria but suffer from depressive symptoms, can also have serious functional deterioration in social and educational situations. Therefore, we will apply the following broad criteria to identify the participants in our study. We will examine its effect in a sensitivity analysis later by means of adhering to strict diagnostic criteria for major depression (see below).
(1) Major depression as diagnosed according to standardised criteria (e.g. Feighner criteria, Research Diagnostic Criteria, DSM‐III, DSM‐III‐R, DSM‐IV or ICD‐10)
(2) Minor depression or dysthymia as diagnosed according to standardised criteria (e.g. Feighner criteria, Research Diagnostic Criteria, DSM‐III, DSM‐III‐R, DSM‐IV or ICD‐10)
(3) Depressive status, defined as scoring above a certain cutoff on a screening questionnaire according to the original authors' definition. Children or adolescents with a diagnosis of adjustment disorder with depressed mood may be classified in this category. Examples of screening questionnaires are: Children's Depression Inventory (CDI) (Kovacs 1985), Beck depression inventory (BDI) (Beck 1987), Center for Epidemiologic Study Depression Scale (CES‐D) (Radloff 1977), Revised Children's Depression Rating Scale (CDRS‐R) (Poznanski 1984) or Hamilton Rating Scale for Depression (HRSD) (Hamilton 1960).

Children or adolescents whose primary psychiatric diagnosis is one of the following will be excluded; mental retardation, learning disorder, motor skill disorder, communication disorder, pervasive development disorder, attention‐deficit and disruptive disorder, tic disorder, substance‐related disorder, schizophrenia, anxiety disorder, factitious disorder or dissociative disorder. The reason for this is that the effectiveness of psychotherapy might be affected by these comorbidities.

Children or adolescents with comorbid physical or mental disorders that were not a primary diagnosis will be included, but the effect of their inclusion will be examined in a sensitivity analysis.

Types of interventions

Trials will be included if they compared psychotherapy against either of the control conditions listed below.
For psychotherapy, CBT, behavioural therapy, cognitive therapy, interpersonal therapy, problem‐solving therapy, play therapy, supportive therapy or psychodynamic therapy will be included regardless of their frequency and duration if they were fully structured and manualized. Family therapy for depression is being covered by another Cochrane review (in preparation). Counselling may be excluded because it is rarely structured or manualised.

The psychotherapy will be deemed:

  • "CBT" when it used some kind of cognitive restructuring training and promoted behavioural change

  • "behavioural therapy" when it used some kind of behavioural training and thus promoted cognitive change. It may include relaxation therapy, biofeedback or social skills training.

  • "cognitive therapy" when it used some kind of cognitive restructuring training but did not promote behavioural changes apparently

  • "interpersonal therapy" when it focused on the participants' social relationships and current evaluation of these relationships

  • "problem‐solving therapy" when it focused on the problems participants are currently facing and on helping them find solutions to those problems

  • "play therapy" when it used techniques to engage participants in recreational activities to help them cope with their problems and fears

  • "supportive therapy" when it employed non‐judgmental advice, attention, and sympathy

  • "psychodynamic therapy" when it referred to a technique designed to help a person understand the origin and nature of long standing problems including psychological trauma

If sufficient numbers of studies are detected, we will conduct a subgroup analysis by type of psychotherapy, because it seems probable that the effects of each type of psychotherapy are different from each other.

With regard to control condition, non‐treatment, waiting‐list control or treatment as usual will be included. TAU is not considered to be structured psychotherapy but may have some treatment effects, whereas both non‐treatment and waiting list control do not have any active treatment effects. Thus we will do a sensitivity analysis by limiting to TAU for the purpose of investigating its effects as a control condition.

Although studies where any psychotropic agent was regularly used at all of the arms in the primary report will be included, the effect of concomitant use of psychotropic agent will be examined in a sensitivity analysis, because effects of psychotherapy might be affected by psychotropic agents.

Types of outcome measures

A1. Short‐term, i.e. during the acute phase treatment
(1) The primary outcome of short‐term efficacy will be the relative risk of "response". Examples include "remission" diagnosed according to operationalized criteria, or "response" such as substantial overall improvement from baseline as defined by the original investigators (e.g. more than a 50% reduction on a depression continuous measure), "marked" improvement according to the Clinical Global Impression (CGI) Change Scale, "no or minimal" symptom according to the CGI Severity Scale, HRSD score ≤ 9 or BDI score ≤ 10. On studies where no clinical global status was reported on the primary report, we will employ the depression severity scale to provide the number of participants with "remission" such as a 50% or greater reduction from baseline in the scale.
(2) Secondary outcomes will include standardised weighted mean differences in continuous depression severity scales, as measured for example by HRSD, BDI, CDI, etc. Measures assessed by blind assessors will be preferentially exploited in a study where more than two measures on depression severity were used.
(3) Standardised weighted mean differences in global judgment, global severity, general anxiety, and social functioning on continuous scales
(4) Quality of life, as measured for example by SF‐36, SF‐12, etc.
(5) Participants' satisfaction with treatment
(6) Economic costs

A2. Long‐term
After the acute phase treatment, we will examine the naturalistic follow‐up, if data are available, in order to examine the possible delayed or preventive effects of psychotherapy against future worsening or recurrence. If some participants took further treatments including continuous treatment, booster sessions or any other psychotherapies or antidepressants during this follow‐up period, we will include them in the analysis. However, the number of participants who did not take further treatments will be utilised as a proxy measure of long‐term efficacy of the acute phase interventions. In this analysis, on studies where continuous or maintenance treatment or booster sessions were planned in advance on the protocol of these primary reports, participants will not be counted as those who took further treatment because additional treatments did not derive from worsening of their depressive symptoms. Studies where participants were randomized again to either maintenance treatment or not will be excluded.
(1) The primary outcome in the long‐term will be defined as the relative risk of successful outcome, e.g. remission throughout follow‐up defined similarly to the acute phase measurement
(2) The secondary outcome will be standardized weighted mean differences in continuous depression‐severity scales
(3) Global judgment on continuous scales. Examples would be Clinical Global Impression Severity Scale (1 to 7), Clinical Global Impression Change Scale (1 to 7).
(4) Quality of life
(5) Number of participants who did not take further treatment during naturalistic follow‐up
(6) Participants' satisfaction
(7) Economic costs

B. Adverse effects
Adverse effects are considered to be difficult to discern in terms of worsening depressive symptoms, but some harmful effects have been reported to emerge during treatment phase, such as panic attacks (TADS Team 2004)
(1) Total number of dropouts for any reason as a proxy measure of treatment acceptability both in the acute and in the long term
(2) Number of dropouts due to adverse effects both in the acute and in the long terms
(3) Number of participants experiencing at least one adverse effect both in the acute and in the long term

Search methods for identification of studies

(1) Electronic search of CCDAN REGISTERS
We will search the Cochrane Collaboration Depression, Anxiety and Neurosis Registers (CCDAN REGISTERS) in December 2004. This comprehensive register is updated regularly adding the results on searches of The Cochrane Library, MEDLINE (1966‐), EMBASE (1980‐), CINAHL (1982‐), PsycINFO (1974‐), PSYNDEX (1977‐) and LILACS (1982‐1999) and handsearches of major psychiatric, medical journals and conference proceedings. It contains more than 24,000 records on trials comparing treatment options within the scope of the CCDAN.
Moreover, the register is being coded continuously with respect to characteristics of studies such as the kind of interventions and their concomitant use, by looking through the full article of relevant studies manually. The studies already coded are being stored in CCDANCTR‐Studies (Table 1), and the others in CCDANCTR‐References (Table 2). Therefore, we will search the relevant studies in these registers.

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Table 1. Search terms for CCDANCTR‐Studies

CCDANCTR study terms

Main Diagnostic Criteria = "Depress*"
Trial Design = "RCT"
Participant Age = "Child*" OR "Adolescen*"
Interventions = "Psychotherap*"

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Table 2. Search terms for CCDANCTR‐References

CCDANCTR Ref terms

Free text = (adolescen* OR child* OR jubenile* OR infan* OR youth*) and (depress* OR dysthymi* OR adjustment disorder*) and (psychotherap* OR behavio* OR family therap* OR cognitive OR interpersonal OR relaxation OR problem solving OR bibliotherap* OR play therap* OR physical reinforcement OR operant OR consultation OR biofeedback OR social skill OR parent training OR discussion group OR insight oriented OR client centered OR counsel* OR exercise OR supportive OR massag* OR contract* OR insight*OR paradox* OR psychoanalys OR pscyhodrama OR role?playing OR transactional OR primary control OR secondary control) and (untreated OR attention OR waiting OR treatment as usual OR TAU OR primary care OR general practitioner care OR non?focus* OR non?directive OR non?treatment) and (comparative study OR controlled OR randomi?ed)

(2) Complementary electronic search
We will undertake a search of the following electronic databases:
MEDLINE (1966 to December Week 2 2004) (Table 3)
EMBASE (1980 to December Week 2 2004) (Table 4)
PsycINFO (1974 to December Week 2 2004) (Table 5)
The Cochrane Central Register of Controlled Trials (CENTRAL) (Table 6)

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Table 3. Search terms for MEDLINE (1966 to December Week 2 2004)

MEDLINE search terms

1. exp adolescent/
2. exp child/
3. adolescen$.tw
4. child$.tw
5. juvenile$.tw
6. infan$.tw
7. pre?adolescen$.tw
8. youth$.tw
9. or/1‐8
10. exp depressive disorder/
11. exp depression/
12. depress$.tw
13. minor depressi$.tw
14. dysthymi$.tw
15. exp adjustment disorders/
16. adjustment disorder$.tw
17. or/10‐16
18. exp psychotherapy/
19. behavio?r therap$.tw
20. family therap$.tw
21. cognitive therap$.tw
22. interpersonal.tw
23. psychotherap$.tw
24. relaxation$.tw
25. problem solving.tw
26. bibliotherap$.tw
27. play therap$.tw
28. plaything$.tw
29. physical reinforcement$.tw
30. operant$.tw
31. consultation$.tw
32. reinforcement$.tw
33. biofeedback$.tw
34. social skill$.tw
35. cognitive?behavio?ral.tw
36. parent training$.tw
37. behavio$.tw
38. cognitive therap$.tw
39. discussion group.tw
40. insight oriented.tw
41. client centered.tw
42. counsel$.tw
43. exercise.tw
44. supportive.tw
45. massag$.tw
46. contract$.tw
47. insight$.tw
48. paradox$.tw
49. psychoanalys$.tw
50. pscyhodrama.tw
51. roleplaying.tw
52. transactional.tw
53. primary control.tw
54. secondary control.tw
55. or/18‐54
56. untreated.tw
57. attention control.tw
58. attention placebo.tw
59. waiting?list.tw
60. treatment?as?usual.tw
61. primary?care.tw
62. general practitioner care.tw
63. non?focus$.tw
64. non?directive.tw
65. non?treatment$.tw
66. or/56‐65
67. exp comparative study/
68. exp controlled clinical trials/
69. controlled$.tw
70. randomi?ed$.tw
71. clinical trial$.tw
72. or/67‐71
73. 9 and 17 and 55 and 66 and 72

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Table 4. Search terms for EMBASE (1980 to December Week 2 2004)

EMBASE search terms

1. exp adolescent/
2. exp child/
3. exp adolescence/
4. exp childhood/
5. adolescen$.mp
6. child$.mp
7. juvenile$.mp
8. infan$.mp
9. pre?adolescen$.mp
10. youth$.mp
11. #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10
12. exp Depression/
13. exp Adjustment Disorder/
14. exp affective neurosis/
15. exp major affective disorder/
16. exp minor affective disorder/
17. exp anxiety neurosis/
18. exp dysthymia/
19. depress$.mp
20. minor depressi$.mp
21. dysthymi$.mp
22. adjustment disorder$.mp
23. #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22
24. exp psychotherapy/
25. behavio?r therap$.mp
26. family therap$.mp
27. cognitive therap$.mp
28. interpersonal.mp
29. psychotherap$.mp
30. relaxation$.mp
31. problem solving.mp
32. bibliotherap$.mp
33. play therap$.mp
34. plaything$.mp
35. physical reinforcement$.mp
36. operant$.mp
37. consultation$.mp
38. reinforcement$.mp
39. biofeedback$.mp
40. social skill$.mp
41. cognitive?behavio?ral.mp
42. parent training$.mp
43. behavio$.mp
44. cognitive therap$.mp
45. discussion group.mp
46. insight oriented.mp
47. client centered.mp
48. counsel$.mp
49. exercise.mp
50. supportive.mp
51. massag$.mp
52. contract$.mp
53. insight$.mp
54. paradox$.mp
55. psychoanalys$.mp
56. pscyhodrama.mp
57. roleplaying.mp
58. transactional.mp
59. primary control.mp
60. secondary control.mp
61. #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51 or #52 or #53 or #54 or #55 or #56 or #57 or #58 or #59 or #60
62. untreated.mp
63. attention control.mp
64. attention placebo.mp
65. waiting?list.mp
66. treatment?as?usual.mp
67. primary?care.mp
68. general practitioner care.mp
69. non?focus$.mp
70. non?directive.mp
71. non?treatment$.mp
72. #62 or #63 or #64 or #65 or #66 or #67 or #68 or #69 or #70 or #71
73. controlled$.mp
74. random$.mp
75. clinical?trial$.mp
76. compar$.mp
77. placebo$.mp
78. doubl$.mp
79. bilind$.mp
80. #73 or #74 or #75 or #76 or #77 or #78 or #79
81. #11 and #23 and #61 and #72 and #80

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Table 5. Search terms for PsycINFO (1974 to December Week 2 2004)

PsychINFO terms

1. adolescen$.mp
2. child$.mp
3. juvenile$.mp
4. infan$.mp
5. pre?adolescen$.mp
6. youth$.mp
7. #1 or #2 or #3 or #4 or #5 or #6
8. exp major depression/
9. exp "depression (emotion)"/
10. exp Adjustment Disorders/
11. depress$.mp
12. minor depressi$.mp
13. dysthymi$.mp
14. adjustment disorder$.mp
15. #8 or #9 or #10 or #11 or #12 or #13 or #14
16. exp PSYCHOTHERAPY/
17. behavio?r therap$.mp
18. family therap$.mp
19. cognitive therap$.mp
20. interpersonal.mp
21. psychotherap$.mp
22. relaxation$.mp
23. problem solving.mp
24. bibliotherap$.mp
25. play therap$.mp
26. plaything$.mp
27. physical reinforcement$.mp
28. operant$.mp
29. consultation$.mp
30. reinforcement$.mp
31. biofeedback$.mp
32. social skill$.mp
33. cognitive?behavio?ral.mp
34. parent training$.mp
35. behavio$.mp
36. cognitive therap$.mp
37. discussion group.mp
38. insight oriented.mp
39. client centered.mp
40. counsel$.mp
41. exercise.mp
42. supportive.mp
43. massag$.mp
44. contract$.mp
45. insight$.mp
46. paradox$.mp
47. psychoanalys$.mp
48. pscyhodrama.mp
49. roleplaying.mp
50. transactional.mp
51. primary control.mp
52. secondary control.mp
53. #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51 or #52
54. untreated.mp
55. attention control.mp
56. attention placebo.mp
57. waiting?list.mp
58. treatment?as?usual.mp
59. primary?care.mp
60. general practitioner care.mp
61. non?focus$.mp
62. non?directive.mp
63. non?treatment$.mp
64. #54 or #55 or #56 or #57 or #58 or #59 or #60 or #61 #62 or #63
65. controlled$.mp
66. random$.mp
67. clinical?trial$.mp
68. compar$.mp
69. placebo$.mp
70. doubl$.mp
71. bilind$.mp
72. #65 or #65 or #66 or #67 or #68 or #69 or #70 or #71
73. #7 and #15 and #53 and #64 and #72

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Table 6. Search terms for The Cochrane Central Register of Controlled Trials (CENTRAL)

CENTRAL search terms

Free text = (adolescen* OR child* OR jubenile* OR infan* OR youth*) and (depress* OR dysthymi* OR adjustment disorder*) and (psychotherap* OR behavio* OR family therap* OR cognitive OR interpersonal OR relaxation OR problem solving OR bibliotherap* OR play therap* OR physical reinforcement OR operant OR consultation OR biofeedback OR social skill OR parent training OR discussion group OR insight oriented OR client centered OR counsel* OR exercise OR supportive OR massag* OR contract* OR insight*OR paradox* OR psychoanalys OR pscyhodrama OR role?playing OR transactional OR primary control OR secondary control) and (untreated OR attention OR waiting OR treatment as usual OR TAU OR primary care OR general practitioner care OR non?focus* OR non?directive OR non?treatment) and (comparative study OR controlled OR randomi?ed) NOT sr‐depressn

(3) Reference search
We will inspect the references of all selected studies for more published reports and citations of unpublished research.
In addition, we will check relevant review papers.

(4) SciSearch
All the selected studies will be sought as a citation in the SciSearch in order to identify more studies.

(5) Personal communication
To ensure all RCTs are being identified, we will contact the authors of the trials included, those of significant papers and other experts in the field.

Data collection and analysis

(1) Selection of trials
Two reviewers (NW and TAF) will examine titles and abstracts of references identified by the electronic search strategies described above in order to see if the study is likely to be relevant. Full articles of all the studies identified by either of the two reviewers will be then obtained and inspected by the same two reviewers for trials meeting the following broad and simple criteria:
(a) Randomised trial;
(b) Major depression, minor depression or dysthymia as diagnosed by operationalized criteria; or inclusion criteria for the primary study contain any depressive status assessed with a depression severity measure;
(c) Any psychotherapy versus non‐treatment, waiting‐list control, or treatment as usual
Although some studies may use 'attention placebo' as the control condition, studies will be included only when the content of 'attention placebo' is similar to TAU as described in 'Types of intervention'.
The inter‐rater reliability of the two raters will be calculated. Any disagreement will be resolved by consensus between the two reviewers and, if need be, with another reviewer. All the candidate papers will then be subjected to the next stage of study selection according to the strict eligibility criteria.
Two independent reviewers (NW and TAF) will examine the strict eligibility of these trials. The inter‐rater reliability of these eligibility criteria will be calculated. Any disagreement will be resolved by consensus between the two reviewers and, if need be, with other reviewers. The references of other relevant review papers will be checked by NW and TAF. All of these studies will be subjected to SciSearch in order to identify more recent reports.

(2) Quality assessment
Three independent reviewers (NW, VH and RC) will assess the methodological quality of the selected studies.
The criteria for the quality assessment are based on the recommendations of the Cochrane Collaboration Handbook. The Handbook is characterised to urge reviewers to consider the following two points in terms of the quality assessment;
(a) Quality of allocation concealment in randomisation to treatment conditions. There is empirical evidence that poor quality of randomisation can produce biased results (Chalmers 1983; Moher 1998; Schulz 1995).
(b) Quality of assessors' blinding. It is often difficult to keep both participants and clinicians blind to their treatment group in psychotherapy trials. In these trials, we need blind assessors for outcome measurement in order to minimize detection bias. A self‐report questionnaire can be a "blind" measurement, only when the participants were kept blind to the allocated treatment, for example, by credible attention placebo. There is some evidence to suggest that trials that did not describe themselves "double‐blind" yield biased results (Coldiz 1989; Schulz 1995).
Taking these two points into consideration, the overall quality of the trials will be scored according to important elements of design and conduct. Study quality will be examined using 23 criteria (Churchill 2001), and each item will be scored between 0 and 2 with a maximum total score of 46. The total point of each study will be utilized in sensitivity analyses for the purpose of looking at robustness of the findings. In addition, we will employ a quality rating scale for quality of conduction studies especially on psychotherapy (Foa 1997). Although this rating scale has seven items and most of them appear to overlap with the 23‐item criteria, we will use it in a sensitivity analysis in order to examine robustness of the results.
The inter‐rater reliability of the total score of study quality assessment will be examined with ANOVA ICC. Any disagreement will be resolved by consensus between the two raters and, if need be, with another reviewer.
In addition to these methodological qualities of the selected trials, we will assess the type and adequacy of the psychotherapy according to the following two criteria.
(1) First, we will determine, regardless of the designation by the original investigators, to which category of psychotherapy (CBT, behavioural therapy, cognitive therapy, interpersonal therapy, problem‐solving therapy, play therapy or psychodynamic therapy) it belonged, according to the definitions described "Types of intervention" section.
(2) Secondly, we will determine if the administered psychotherapy had demonstrable quality in each study.
A: when the conduct of psychotherapy was examined by a third reviewer through audiotapes etc, and when the authors gave sufficiently detailed description of the therapy procedure
B: when the study fulfills either of the two conditions as stated above; and
C: when none of these applied.

(3) Data extraction
Three reviewers (NW, VH and RC) will independently extract data from the original reports using data extraction forms. Although we will define primary outcomes as dichotomous data ("response or remission" or not), for studies where exact numbers of participants with response were not presented in the original reports but only their means and standard deviations of continuous global depression scales, we will impute the number of responders by using a validated statistical method (Furukawa 2005) in order to conduct intention‐to‐treat (ITT) analyses as described below. Any disagreement will be resolved by consensus between the two or, where necessary, between all reviewers.

(4) Data synthesis
Data will be entered into Review Manager 4.2 by NW twice using the duplicate data entry facility.
For dichotomous outcomes, we will calculate the relative risks and their 95% confidence intervals using the random effects model, because the random effects model RR has been shown to be favourable in clinical interpretability and external generalisability than fixed effect models and odds ratios or risk differences (Furukawa 2002). Heterogeneity between studies will be assessed by the Q statistic, I‐squared test and by visual inspection of the results. When heterogeneity is found to be significant, sources will be investigated.
We will use two levels of ITT analyses in terms of dichotomous data. Dropouts will be always included in this analysis. In the first analysis, when dropouts were excluded from any assessment in the original studies (for example, those who never returned for assessment after randomisation), they will be considered non‐responders both in the active psychotherapy group and in the control group.
In the second, more stringent analysis (ITT analyses based on worst case scenario), all the dropouts will be considered non‐responders in the active treatment group but as responders in the control group. It will help readers see how robust the results of the present review are.
For continuous outcomes, the standardized weighted mean difference (SMD) will be calculated using the random effects model. Scores from continuous outcomes will not be analyzed on an ITT basis. This approach is not feasible as studies perform only LOCF or endpoint analyses. Continuous outcomes will therefore be analyzed on an endpoint basis, including only participants with a final assessment or with a last observation carried forward to the final assessment.

(5) Subgroup analyses
Subgroup analyses should be performed and interpreted with caution because multiple analyses will lead to false positive conclusions (Oxman 1992). However, we will perform the following subgroups analyses, where possible.
(a) For each type of psychotherapy separately (CBT, behavioural therapy, cognitive therapy, interpersonal therapy, problem‐solving therapy, play therapy, supportive therapy or psychodynamic therapy)
(b) For the age of participants (e.g. 6 to 12 years or older according to when children and adolescents were included in the study), because the effects of psychotherapy may vary from age to age due to childrens' developing cognitive functions.
(c) For the severity of depression (e.g. mild, moderate or severe), defined by the authors of the original studies

(6) Funnel plot analysis and sensitivity analyses
We will perform funnel plot analyses to check for publication bias.
The following sensitivity analyses are planned a priori. By limiting the studies to be included to those of higher quality we will examine if the results change and intend to check for the robustness of the observed findings.
(a) By limiting studies to those that employed standardised criteria for major depression (e.g. Feighner criteria, Research Diagnostic Criteria, DSM‐III, DSM‐III‐R, DSM‐IV or ICD‐10)
(b) By excluding studies with comorbid physical or mental disorders that were not a primary diagnosis (if possible, excluding only participants that had comorbid diagnosis)
(c) By limiting studies where the status of the control group was treatment as usual
(d) By limiting studies to those that did not allow concomitant use of psychotropic agents
(e) By limiting studies where the administered psychotherapy had a demonstrative quality rates as A or B according to the above criteria in the Quality Assessment section
(f) By limiting studies to those where study quality is assessed as "high" by using 23‐item quality rating scale (Churchill 2001), namely total score of 20 or more
(g) By limiting studies to those satisfying all the items in the 7‐item quality rating scale (Foa 1997)

Table 1. Search terms for CCDANCTR‐Studies

CCDANCTR study terms

Main Diagnostic Criteria = "Depress*"
Trial Design = "RCT"
Participant Age = "Child*" OR "Adolescen*"
Interventions = "Psychotherap*"

Figuras y tablas -
Table 1. Search terms for CCDANCTR‐Studies
Table 2. Search terms for CCDANCTR‐References

CCDANCTR Ref terms

Free text = (adolescen* OR child* OR jubenile* OR infan* OR youth*) and (depress* OR dysthymi* OR adjustment disorder*) and (psychotherap* OR behavio* OR family therap* OR cognitive OR interpersonal OR relaxation OR problem solving OR bibliotherap* OR play therap* OR physical reinforcement OR operant OR consultation OR biofeedback OR social skill OR parent training OR discussion group OR insight oriented OR client centered OR counsel* OR exercise OR supportive OR massag* OR contract* OR insight*OR paradox* OR psychoanalys OR pscyhodrama OR role?playing OR transactional OR primary control OR secondary control) and (untreated OR attention OR waiting OR treatment as usual OR TAU OR primary care OR general practitioner care OR non?focus* OR non?directive OR non?treatment) and (comparative study OR controlled OR randomi?ed)

Figuras y tablas -
Table 2. Search terms for CCDANCTR‐References
Table 3. Search terms for MEDLINE (1966 to December Week 2 2004)

MEDLINE search terms

1. exp adolescent/
2. exp child/
3. adolescen$.tw
4. child$.tw
5. juvenile$.tw
6. infan$.tw
7. pre?adolescen$.tw
8. youth$.tw
9. or/1‐8
10. exp depressive disorder/
11. exp depression/
12. depress$.tw
13. minor depressi$.tw
14. dysthymi$.tw
15. exp adjustment disorders/
16. adjustment disorder$.tw
17. or/10‐16
18. exp psychotherapy/
19. behavio?r therap$.tw
20. family therap$.tw
21. cognitive therap$.tw
22. interpersonal.tw
23. psychotherap$.tw
24. relaxation$.tw
25. problem solving.tw
26. bibliotherap$.tw
27. play therap$.tw
28. plaything$.tw
29. physical reinforcement$.tw
30. operant$.tw
31. consultation$.tw
32. reinforcement$.tw
33. biofeedback$.tw
34. social skill$.tw
35. cognitive?behavio?ral.tw
36. parent training$.tw
37. behavio$.tw
38. cognitive therap$.tw
39. discussion group.tw
40. insight oriented.tw
41. client centered.tw
42. counsel$.tw
43. exercise.tw
44. supportive.tw
45. massag$.tw
46. contract$.tw
47. insight$.tw
48. paradox$.tw
49. psychoanalys$.tw
50. pscyhodrama.tw
51. roleplaying.tw
52. transactional.tw
53. primary control.tw
54. secondary control.tw
55. or/18‐54
56. untreated.tw
57. attention control.tw
58. attention placebo.tw
59. waiting?list.tw
60. treatment?as?usual.tw
61. primary?care.tw
62. general practitioner care.tw
63. non?focus$.tw
64. non?directive.tw
65. non?treatment$.tw
66. or/56‐65
67. exp comparative study/
68. exp controlled clinical trials/
69. controlled$.tw
70. randomi?ed$.tw
71. clinical trial$.tw
72. or/67‐71
73. 9 and 17 and 55 and 66 and 72

Figuras y tablas -
Table 3. Search terms for MEDLINE (1966 to December Week 2 2004)
Table 4. Search terms for EMBASE (1980 to December Week 2 2004)

EMBASE search terms

1. exp adolescent/
2. exp child/
3. exp adolescence/
4. exp childhood/
5. adolescen$.mp
6. child$.mp
7. juvenile$.mp
8. infan$.mp
9. pre?adolescen$.mp
10. youth$.mp
11. #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10
12. exp Depression/
13. exp Adjustment Disorder/
14. exp affective neurosis/
15. exp major affective disorder/
16. exp minor affective disorder/
17. exp anxiety neurosis/
18. exp dysthymia/
19. depress$.mp
20. minor depressi$.mp
21. dysthymi$.mp
22. adjustment disorder$.mp
23. #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22
24. exp psychotherapy/
25. behavio?r therap$.mp
26. family therap$.mp
27. cognitive therap$.mp
28. interpersonal.mp
29. psychotherap$.mp
30. relaxation$.mp
31. problem solving.mp
32. bibliotherap$.mp
33. play therap$.mp
34. plaything$.mp
35. physical reinforcement$.mp
36. operant$.mp
37. consultation$.mp
38. reinforcement$.mp
39. biofeedback$.mp
40. social skill$.mp
41. cognitive?behavio?ral.mp
42. parent training$.mp
43. behavio$.mp
44. cognitive therap$.mp
45. discussion group.mp
46. insight oriented.mp
47. client centered.mp
48. counsel$.mp
49. exercise.mp
50. supportive.mp
51. massag$.mp
52. contract$.mp
53. insight$.mp
54. paradox$.mp
55. psychoanalys$.mp
56. pscyhodrama.mp
57. roleplaying.mp
58. transactional.mp
59. primary control.mp
60. secondary control.mp
61. #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51 or #52 or #53 or #54 or #55 or #56 or #57 or #58 or #59 or #60
62. untreated.mp
63. attention control.mp
64. attention placebo.mp
65. waiting?list.mp
66. treatment?as?usual.mp
67. primary?care.mp
68. general practitioner care.mp
69. non?focus$.mp
70. non?directive.mp
71. non?treatment$.mp
72. #62 or #63 or #64 or #65 or #66 or #67 or #68 or #69 or #70 or #71
73. controlled$.mp
74. random$.mp
75. clinical?trial$.mp
76. compar$.mp
77. placebo$.mp
78. doubl$.mp
79. bilind$.mp
80. #73 or #74 or #75 or #76 or #77 or #78 or #79
81. #11 and #23 and #61 and #72 and #80

Figuras y tablas -
Table 4. Search terms for EMBASE (1980 to December Week 2 2004)
Table 5. Search terms for PsycINFO (1974 to December Week 2 2004)

PsychINFO terms

1. adolescen$.mp
2. child$.mp
3. juvenile$.mp
4. infan$.mp
5. pre?adolescen$.mp
6. youth$.mp
7. #1 or #2 or #3 or #4 or #5 or #6
8. exp major depression/
9. exp "depression (emotion)"/
10. exp Adjustment Disorders/
11. depress$.mp
12. minor depressi$.mp
13. dysthymi$.mp
14. adjustment disorder$.mp
15. #8 or #9 or #10 or #11 or #12 or #13 or #14
16. exp PSYCHOTHERAPY/
17. behavio?r therap$.mp
18. family therap$.mp
19. cognitive therap$.mp
20. interpersonal.mp
21. psychotherap$.mp
22. relaxation$.mp
23. problem solving.mp
24. bibliotherap$.mp
25. play therap$.mp
26. plaything$.mp
27. physical reinforcement$.mp
28. operant$.mp
29. consultation$.mp
30. reinforcement$.mp
31. biofeedback$.mp
32. social skill$.mp
33. cognitive?behavio?ral.mp
34. parent training$.mp
35. behavio$.mp
36. cognitive therap$.mp
37. discussion group.mp
38. insight oriented.mp
39. client centered.mp
40. counsel$.mp
41. exercise.mp
42. supportive.mp
43. massag$.mp
44. contract$.mp
45. insight$.mp
46. paradox$.mp
47. psychoanalys$.mp
48. pscyhodrama.mp
49. roleplaying.mp
50. transactional.mp
51. primary control.mp
52. secondary control.mp
53. #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51 or #52
54. untreated.mp
55. attention control.mp
56. attention placebo.mp
57. waiting?list.mp
58. treatment?as?usual.mp
59. primary?care.mp
60. general practitioner care.mp
61. non?focus$.mp
62. non?directive.mp
63. non?treatment$.mp
64. #54 or #55 or #56 or #57 or #58 or #59 or #60 or #61 #62 or #63
65. controlled$.mp
66. random$.mp
67. clinical?trial$.mp
68. compar$.mp
69. placebo$.mp
70. doubl$.mp
71. bilind$.mp
72. #65 or #65 or #66 or #67 or #68 or #69 or #70 or #71
73. #7 and #15 and #53 and #64 and #72

Figuras y tablas -
Table 5. Search terms for PsycINFO (1974 to December Week 2 2004)
Table 6. Search terms for The Cochrane Central Register of Controlled Trials (CENTRAL)

CENTRAL search terms

Free text = (adolescen* OR child* OR jubenile* OR infan* OR youth*) and (depress* OR dysthymi* OR adjustment disorder*) and (psychotherap* OR behavio* OR family therap* OR cognitive OR interpersonal OR relaxation OR problem solving OR bibliotherap* OR play therap* OR physical reinforcement OR operant OR consultation OR biofeedback OR social skill OR parent training OR discussion group OR insight oriented OR client centered OR counsel* OR exercise OR supportive OR massag* OR contract* OR insight*OR paradox* OR psychoanalys OR pscyhodrama OR role?playing OR transactional OR primary control OR secondary control) and (untreated OR attention OR waiting OR treatment as usual OR TAU OR primary care OR general practitioner care OR non?focus* OR non?directive OR non?treatment) and (comparative study OR controlled OR randomi?ed) NOT sr‐depressn

Figuras y tablas -
Table 6. Search terms for The Cochrane Central Register of Controlled Trials (CENTRAL)