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Cochrane Database of Systematic Reviews Protocol - Intervention

Music therapy for depression

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Abstract

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

1. To identify randomised controlled trials and controlled clinical trials examining the efficacy of music therapy in reducing the symptoms of clinical depression as defined by the authors

2. To compare efficacy of music therapy with standard care (as defined by the authors) or with other therapies

3. To compare efficacy of different forms of music therapy

Background

Global impact of depression
Depression is a common problem, affecting about 121 million people world‐wide. Depressive disorder is characterised by a marked lowering of self‐esteem and feelings of worthlessness and guilt. A persistent low mood leads to changes in appetite, sleep pattern and overall functioning. Symptoms further include anhedonia, fatigue and impaired concentration. (ICD 10) At its worst, depression can lead to suicide, which is associated with the loss of 1 million lives per year. Depression is projected to become the leading cause of disability and the second leading contributor to the global burden of disease by the year 2020. It occurs in persons of all genders, ages, and backgrounds (WHO 2001). The huge personal and economic impact of depression implies a need for systematic reviews of the evidence for efficacy for all current treatment modalities.

Treatments for depression
Depression is widely assumed to be effectively treated with a combination of pharmacological and talking therapies. Both tricyclic antidepressants and the more recent selective serotonin reuptake inhibitors (SSRIs) have been found to be effective in treating depression (Paykel 1992; Edwards 1992). However, in a recent Cochrane Review, Moncrieff 2003 found small differences between anti‐depressant medications and active placebos with the lowest effects found in inpatient trials. A variety of talking therapies have also been found to be helpful in treating depression and two systematic reviews are currently in progress comparing psychological and pharmacological treatments (Churchill 2003 a; Churchill 2003 b).

Depression is also one of the most common reasons for the use of complementary and alternative therapies (Ernst 1998). The reasons for this are complex and vary according to client group. They may entail a lack of satisfaction with conventional treatments, and/or a wish to avoid side‐effects from medication or the stigma attached to seeking talking therapy. In the case of music therapy, people may feel more able to access this medium as listening to or playing music in other contexts has been felt by the individual to be beneficial. Music therapy might also be indicated for populations who have difficulties in using words, such as those with a learning or physical disability. Music therapy might also be used where non‐directive talking therapies are considered inappropriate, for example where depression is secondary to a psychotic illness or severe personality disorder.

Music therapy
Although music has been used for the purpose of improving health throughout the history of mankind (Horden 2000), it was not until the middle of the 20th century that music therapy was developed and instituted as a clinical method. Music therapy began to be used by US government programmes in the 1940s, and in Europe two decades later (Bunt 1994). It is now a state registered profession in some countries (UK and USA) and is used extensively in many types of treatment and rehabilitation facilities from psychiatric hospitals to hospices to private practices on all continents (Maranto 1993). Music therapy has been defined as "a systematic process of intervention wherein the therapist helps the client to promote health, using musical experiences and the relationships that develop through them as dynamic forces of change."

Music therapy models are based on different theoretical backgrounds, such as psychodynamic, humanistic, and behavioural, but also educational theories. The techniques used in music therapy can be broadly classified as Active, when clients re‐create, improvise or compose music, and Receptive, when clients listen to music. (Bruscia 1998). Often, a combination of different techniques is used in the same therapy. The choice of approach tends to be based upon the client's needs, the therapist's training and the context (Drieschner 2001; Wigram 2002).

In most approaches, clinical music therapy offers a therapeutic relationship in which the client can experience himself differently either by making music or by listening to it with the therapist. In Active approaches, the therapist is a trained musician and uses clinical improvisation techniques to stimulate or guide or respond to the client who may use his/her voice or any musical instrument of choice within his/her capability (such as marimba, gong, cymbal, drums, guitar, harp, piano). Clients may also bring songs written by them or others, or pre‐composed music to play with the therapist. Active forms of music therapy also aim to offer the client a way of experiencing and exploring new ways of relating.

Receptive forms frequently involve an adjunctive activity performed whilst listening to live or recorded music, such as relaxation, meditation, movement, drawing, reminiscing etc. Aims in this sort of music therapy might include reducing stress, soothing pain, or energising the body. In a psychodynamic approach, listening to songs might help access feelings which the client can then work through verbally. For older adults, it might facilitate structured reminiscence or life review (Bruscia 1991).

Music therapy can be carried out in the long‐term (for example more than 3 years), medium term or short term. Intensity of treatment also varies from daily to weekly to monthly treatment. Patients might be seen in groups or individually, they may drop in to an open group (for example in a psychiatric ward setting) or have been referred and assessed by the music therapist before being placed in individual treatment or a closed group. Music therapy may be carried out by a trained therapist or a trainee therapist on placement. There are still a number of untrained practitioners who call their practice music therapy, and due to the relative newness of music therapy as a profession and the lack of evidence available, these will be included in this review. To be classified as well‐defined music therapy, there should also be a coherent theoretical framework underpinning the intervention.

Need for a review of the evidence
Proponents of music therapy have suggested that it may be particularly beneficial for people who experience mental distress (e.g. Hadsell 1974; Benenzon 1981). For example, one observational study concluded that music therapy may have beneficial effects for people experiencing depression (Reinhardt 1982), a finding which was subsequently supported by a small randomised control trial of music therapy vs waiting list control among older adults with depressive disorders (Hanser 1994). However, a preliminary scan of the few systematic attempts at experimental research in this field highlights a number of difficulties. In particular, all RCTs have suffered from small sample sizes, making outcomes difficult to gauge accurately. In addition, client groups are often heterogeneous (Radulovic 1997) and as mentioned above, types of music therapy vary enormously. However, as music therapy is being sought and accessed for the treatment of depression as a complement or alternative to pharmacological or other psychological therapies, there is a need for a systematic review of the evidence available to support its use with this client group.

There is also a case for comparing different music therapy approaches although this is difficult given the overlap of techniques used in all approaches. This is justified where the treatments are strikingly opposing, for example if we were to compare long‐term individual psychotherapeutic improvisation and short‐term large‐group exercising to music.

Objectives

1. To identify randomised controlled trials and controlled clinical trials examining the efficacy of music therapy in reducing the symptoms of clinical depression as defined by the authors

2. To compare efficacy of music therapy with standard care (as defined by the authors) or with other therapies

3. To compare efficacy of different forms of music therapy

Methods

Criteria for considering studies for this review

Types of studies

All randomised controlled and all controlled clinical trials, published and unpublished, involving depressed patients, which compare any form of music therapy treatment with any form of standard care, undertaken in any country will be eligible for entry.

Types of participants

The review will include studies of men and women, whether in or out patients with clinical depression using any diagnostic criteria. These might be defined according to the ICD or DSM or Research Diagnostic Criteria. They may also or alternatively be defined as scoring above a cut‐off score of a selfrating depression questionnaire or as scoring above a cut‐off score on a clinician rated instrument (the cut‐off scores as used by the authors of the studies will be used).

Where no formal diagnosis has been received, subjects will be analysed separately.

Types of interventions

The review will include all studies in which any form of music therapy has been compared with any form of standard care, as defined by the authors, or with other psychological or pharmacological therapies or where one form of music therapy has been compared with another (for example Active versus Receptive approaches).
Music therapy will usually be provided by a certificated professional. Trials involving trainees on formal music therapy training programmes will be included and summarised separately as will those by music therapists without formal training.

The intervention should comprise the following features to be classified as music therapy:
1. Sessions are carried out within a structured therapeutic framework
2. There is some kind of musical interaction between therapist and patient or between therapist and members of a group (e.g. improvisation, other forms of musical expression, listening to music)
3. The aim is to improve health status
4. The main therapeutic change agent could be described as i) the music, ii) the relationship or iii) the talking which stems from the music

Types of outcome measures

The most likely outcome measure used in this review will be:
1. Decrease in symptoms of depression. This is usually measured by a range of scales, for example self‐rating scales such as the Beck Depression Inventory (Beck 1961) and the clinician‐rated scales, such as the Hamilton Rating Scales for Depression (HRSD). (Hamilton 1960)

Other important outcomes are:
2. Survival
3. Improvement of day‐to‐day functioning / ability to (return to) work
4. Increased happiness / ability to experience pleasure
5. Ability to maintain satisfying relationships
6. Improved self‐esteem
7. Improved quality of life
8. Economic outcomes ‐ cost efficiency of treatment

Where more than one measure per outcome and study has been used, preference will be given to measures made using validated instruments. Rating scales may be administered by the patient, his significant other, or by an independent observer who may or may not be blinded. Ratings by the therapist who conducted the therapy will not be included.

Outcome will have been measured at the end of the treatment period (short‐term: up to 20 sessions; long‐term: more than 20 sessions) and then at any point at follow up.

Search methods for identification of studies

1.ELECTRONIC SEARCHES
Study identification is in accordance with Cochrane Depression, Anxiety and Neurosis Review Group (CCDAN) search strategy and will include the following:

i) The CCDAN Controlled Trials Register ‐Studies will be searched using the following terms,

Intervention = "Music Therapy" and Diagnosis = (depress* or dysthymi*)

For the remaining databases, the following terms will be used:
#1 = RANDOM*
#2 = (SINGL* or DOUBL* or TRIPL* or TREBL*) near (BLIND* or MASK*)
#3 = CROSSOVER
#4 = CROSS‐OVER
#5 = VERSUS
#6 = VS
#7 = PLACEBO*
#8 = #1 or #2 or #3 or #4 or #5 or #6 or #7
#9 = Music
#10 = #8 and #9

The remaining databases will be:
ii) Cochrane Central register fo Controlled Trials (CENTRAL)
iii) The Science Citation Index
iv) The specialist music therapy research database on www.musictherapyworld.net
v) Institute of music therapy, University of Witten‐Herdecke info CD Roms 1, 2 and 3 containing collected papers, doctoral theses etc
vi) Medline, Embase, Psyclit, and Psyndex

vii) The internet will also be searched using general search engines e.g. Google.com

2) HAND SEARCHES
i) The relevant specialist journals will be hand searched for all dates:
British Journal of Music Therapy,
Journal of Music Therapy,
Nordic Journal of Music Therapy,
Music Therapy Perspectives,
Canadian Journal of Music Therapy,
Musiktherapeutische Umschau,
Music Therapy,
Australian Journal of Music Therapy,
La Revue de Musicotherapie,
The Arts in Medicine / The International Journal of the Arts in Medicine (if retrievable),
The Arts in Psychotherapy

ii) Reference lists of all included studies

iii) International Music Therapy Research Register

3) Personal Communication.
We will contact professional bodies, email discussion lists and the authors of included studies for information on unpublished material.

Data collection and analysis

SELECTION OF STUDIES
The full article of studies identified as above will be inspected by the principal reviewer (AMT). All articles will be re‐inspected by CG and the level of inter‐rater reliability for trial selection will be checked and any disagreements will be resolved by discussion.

QUALITY ASSESSMENT OF TRIALS
The assessment of methodological quality will be done according to the Cochrane Collaboration Handbook. The CCDAN Quality Rating will be used as a descriptive tool (Moncrieff 2001)

DATA EXTRACTION
Data from selected trials will be extracted independently by two reviewers (AMT and CG) using a standardised extraction sheet, and entered on Review Managaer software. Any disagreements will be discussed by the reviewers and clarification from the authors and arbitration will be sought when necessary.

Author
Year of publication
Setting (country, in vs outpatient etc)
Ethics (sponsor was ethics approval obtained?)
Type of Study (ie single centre / multicentre, crossover, parallel group, placebo‐controlled)
Intention‐to‐treat analysis (including power calculation, withdrawals/dropouts/ losses top follow up described)
Definition of inclusion/exclusion criteria
Pre/Post‐hoc defined subgroups
Compliance measured (including method)
Participants (including diagnosis, criteria, baseline characteristics, demographics)
Treatment (all adjunctive, concomitant and permitted treatments)
Outcome parameters (deaths, scales, adverse effects)
No of participants
Type of music therapy
Intensity of sessions
Duration
Individual or group sessions
Therapist's training
Therapist's post‐qualifying experience
Monitoring of adherence of music therapy paradigm/protocol

Missing information will be obtained from investigators where possible.

DATA ANALYSIS
Differences between treatment and control groups will be calculated and pooled estimates calculated using both fixed and random models. Initially a fixed effects model will be used for the analysis. A formal test of heterogeneity will be undertaken for each analysis and the value of Chi square estimated. Where significant heterogeneity is identified, and this cannot be explained by a moderator variable, a random effects model will be used.

The following treatment comparisons will be made (if studies and data are available). Where data cannot be pooled and therefore no meta‐analysis is possible, these will be summarised in text form.
1. Music therapy versus standard care

2. Music therapy versus other therapies (psychological or pharmacological)

3. Different forms of music therapy (individual vs. group, active vs. receptive, short‐term vs. long‐term therapy)

The main outcome in the trials for this review is likely to be symptom levels (depression levels) measured by rating scales, at treatment‐end and/or follow‐up, presented either as continuous or dichotomous outcomes (significant clinical improvement versus no significant clinical improvement). Depression will be measured using any rating scale

Drop‐outs from treatment will be assumed to be treatment failures unless expressly stated otherwise by the trialists. Treatment discontinuation will be treated as a proxy measure for tolerability and examined in relation to stated outcomes.

Baseline means of the groups in a study might differ, especially in non‐randomised studies and small‐sample studies; therefore, change scores (differences between baseline and treatment‐end or follow‐up will also be examined (if data are available).

Dichotomous outcomes will be summarised using odds ratios (OR); continuous outcomes will be summarised as weighted mean differences (WMD) where all results are from the same scale, and as standardised mean differences (SMD) where results from different scales are combined. 95% confidence intervals will be calculated for each effect estimate.

The effects of clinical heterogeneity will be examined according to:

Duration of treatment/follow‐up

Population (ie age, gender, length of syndrome history, comborbidity)

Setting (individual vs. group, active vs. receptive)

Where such heterogeneity is identified, the results of subgroups will be presented separately.

The presence of a publication bias will be examined using a funnel plot.

The influence of study quality will be examined using a sensitivity analysis where the results including and excluding lower‐quality studies are compared.