Psychosocial interventions for depression in dialysis patients
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effectiveness of psychosocial interventions in treating depression in patients with end stage renal disease undergoing dialysis. Psychosocial interventions can be defined as those interventions that do not have a widely accepted physical basis of action (treatments that are not medications or ECT, for example cognitive‐behavioural therapy).
Background
Dialysis patients are at increased risk for developing depression. Psychodynamically, depression has been linked to loss (Levenson 1991; Kimmel 1993; Finkelstein 2000). End‐stage renal disease patient have experienced multiple losses, including loss of kidney function, occupational function, and status within family, mobility and physical function and capacity, and cognitive abilities (Kimmel 1993; Kimmel 2001). They also suffer from diminished sexual desire and function (Kimmel 1993; Finkelstein 2000; Kimmel 2001).
Depression is the most common psychological problem in patients undergoing haemodialysis (Levenson 1991; Kimmel 1993; Finkelstein 2000). The diagnosis of depression in dialysis patients is confounded by the fact that several symptoms of uraemia such as anorexia, lethargy, psychomotor retardation or agitation, sleep apnoea and arthropathy mimic somatic components of depression (Streltzer 1983; Kimmel 2002). Studies have shown that at least 25% of patients on haemodialysis and 30% of patients on peritoneal dialysis are depressed (Kimmel 1995; Juergenson 1996; Kimmel 1996).
Depression can adversely affect the physical well being of dialysis patients in several ways. Depressed dialysis patients have been show to have poor compliance with dialysis prescriptions (Kimmel 1995; Kaveh 2001) and fluid restriction (Everett 1993). Depressed patients on peritoneal dialysis have been shown to have higher complication rates with peritonitis (Juergenson 1996). Dialysis patients are more likely to commit suicide than the general population (Abram 1971; Haenel 1980). Studies have shown that depression has been associated with increased mortality in dialysis patients (Ziarnik 1977; Peterson 1991; Lopes 2002). In fact the effect of depression on chronic haemodialysis patient survival is of the same order of magnitude as medical risk factors (Kimmel 2000). The risk of hospitalisation is increased in patients with depression (Lopes 2002). Among patients aged 65 and over, rates of hospitalisation for depression as a primary diagnosis in the renal failure population was significantly greater than in patients with ischaemic heart disease, cerebrovascular disease and peptic ulcer disease (Kimmel 1998). The quality of life of dialysis patients has been shown to correlate more strongly with depression than with dialysis adequacy measures (Steele 1996; Martin 2000 ). Depression thus affects dialysis patients, physically, mentally and socially.
Depression in dialysis patients has important consequences for health care system planning. The treatment of complications as a result of depression in the dialysis population has cost implications in terms of drugs, hospitalisation and, where needed, additional dialysis sessions. The increased rates of hospitalisation creates pressure on the bed‐state in the hospital making it important to plan and create more hospital beds adding to the costs of treating dialysis patients.
Chronic dialysis treatment requires regular attendance at a dialysis unit or constant maintenance of peritoneal exchanges. Such intrusive therapy may be difficult for patients with co‐existent psychiatric disorders. Non‐compliance with treatment will worsen uraemia, which may be diagnosed as dementia or organic mental syndrome. Depression and end‐stage renal disease (ESRD) form a vicious cycle, each one making the other worse. Compound (or double) depression, the condition in which depression is co‐existent with another psychiatric and medical illness is more refractory to treatment and associated with worsened morbidity and mortality (Kimmel 2002). Almost a quarter of dialysed patients hospitalised with a psychiatric disorder have more than one mental illness, suggesting they may be resistant to therapy and have risk of potentially poorer outcomes (Kimmel 1998). The treatment of dialysis patients with co‐existent depression is therefore a challenge.
Psychosocial interventions have several advantages. Patients undergoing psychosocial therapies are spared of the side effects associated with drugs and electro‐convulsive therapy (ECT). Hospital haemodialysis patients can have their treatment sessions on their dialysis days so that they need not come separately for them and thereby minimising interruption of their social life. The specialised, intensive treatment required by dialysis patients means that non‐physical treatments for depression need assessing for efficacy and feasibility in renal settings.
Objectives
To assess the effectiveness of psychosocial interventions in treating depression in patients with end stage renal disease undergoing dialysis. Psychosocial interventions can be defined as those interventions that do not have a widely accepted physical basis of action (treatments that are not medications or ECT, for example cognitive‐behavioural therapy).
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) in which psychosocial intervention is compared with a control group (receiving a control psychosocial or supportive treatment or no treatment) in the treatment of depression in dialysis patients. Quasi‐randomised trials will be excluded. Studies comparing psychosocial interventions with drugs or ECT will be excluded, they will however be identified and considered for a separate review.
Types of participants
INCLUSION CRITERIA
‐ Patients of all ages, undergoing dialysis (either haemo‐ or peritoneal) for ESRD and diagnosed to have depression. Sub‐group analysis of children, adolescents and elderly will not be performed routinely as the numbers of trials/patients are likely to be limited. However the age‐groups within trials will be considered if heterogeneity needs exploration.
‐ Interventions are included whether they are targeted at individual patients or groups of patients.
EXCLUSION CRITERIA
‐ Studies dealing only with patients having bipolar disorder will be excluded.
Types of interventions
‐ Treatment of depression with any psychosocial interventions such as exercise training, counselling, intercessory prayer, cognitive and behavioural therapies. This list however, is not exhaustive.
‐ The duration of treatment, length of each treatment session, number of sessions, skill of the therapist (background, profession and specific training), concomitant medication and previous treatment will be recorded.
Types of outcome measures
‐ Improvement in mental state (whatever measure used),
‐ All‐cause hospitalisation. We will also analyse hospitalisation according to whether it is related primarily to depression or to a medical problem.
‐ Mortality
‐ Suicides or suicide attempts
‐ Compliance with dialysis treatment
‐ Quality of life
‐ Adverse events potentially attributable to the intervention or control treatment
‐ Number of withdrawals from dialysis treatment
‐ Number of withdrawals from the treatment interventions for depression
Search methods for identification of studies
Published and unpublished studies of randomised controlled trials identified from Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and article reference lists. All the databases will be searched on OVID. (Additional Table 1 ‐ Electronic search strategies)
The search strategy will be conducted by KSR and SW.
| Database searched | Search strategy |
| MEDLINE (1966 ‐ present) | 1 controlled clinical trial.pt. |
| EMBASE (1980 ‐ present) | 1 Randomized Controlled Trial/ |
| American College of Physicians database | 1 [dialysis/ or electrodialysis/ or equilibrium dialysis/ or exp hemodialysis/ or home dialysis/] |
| Cochrane Central Register of Controlled Trials (CENTRAL) ‐ on OVID | 1 renal replacement therapy/ |
| PsycINFO (1872‐present) | 1 (clinical trial or empirical study or followup study or prospective study or treatment outcome study).fc. |
1) MEDLINE (1966‐present)
2) EMBASE (1980‐ present)
3) American College of Physicians database
4) Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects
5) PsycINFO (1872‐present)
6) Authors of studies identified as potentially eligible for inclusion will be contacted both to clarify missing data or methodological details and to ask for additional published or unpublished studies.
7) Studies presented in conference proceedings will be included. No additional search strategy to identify these will be used.
8) Reference lists of previous reviews (including systematic reviews) and previous trials will be included
9) Expert members of the Cochrane Renal Group including the Trials Search Coordinator will be contacted for references of studies not yet identified by the search process.
10) Papers in languages other than English will be included and translation facilities within the Cochrane Collaboration will be used when needed.
11) No additional hand‐searching will be undertaken.
12) Duplicate Publications: The most recently published version will be used. Where relevant outcomes are only published in earlier versions their data will be included. There, source will be highlighted. Any discrepancy between published versions will be highlighted.
Data collection and analysis
All titles and abstracts will be independently assessed by KSR and CD. Full papers will be obtained for those studies that might fulfil the inclusion criteria. KSR and CD will independently assess these studies to determine if they fulfilled the inclusion criteria. Disagreement will be resolved by discussion or if necessary the decision of a third reviewer (AMM).
STUDY QUALITY
KSR and CD according to Cochrane Handbook for RCTs will perform assessment of study quality independently. The quality items to be assessed are allocation concealment, intention to treat analysis, completeness of follow up and blinding of investigators, subjects and outcomes assessment.
DATA EXTRACTION
KSR and CD will data extract independently. Data extraction will be done using the Cochrane Renal Group prescribed data extraction form. Discrepancies will be resolved by discussion with AMM. Letters will be sent to authors to clarify missing or unclear data.
Information will be collected on participant characteristics (number, age and sex), duration on dialysis, whether they were on the transplant list or not, criteria used to diagnose depression,the duration of treatment, length of each treatment session, number of sessions, skill of the therapist (background, profession and specific training), concomitant medication and previous treatment will be recorded. Data will be double entered into RevMan.
QUALITY CHECKLIST
Allocation Concealment
Adequate ‐ Randomisation method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study Unclear ‐ Randomisation stated but no information on method used is available
Inadequate ‐ Method of randomisation used such as alternate medical record numbers or unsealed envelopes; any information in the study that indicated that investigators or participants could influence intervention group
Blinding
Blinding of investigators: Yes/No/not stated
Blinding of participants: Yes/No/not stated
Blinding of outcome assessor: Yes/No/not stated
Blinding of data analysis: Yes/No/not stated
In trials where no placebo is used, or where the intervention and comparison arms use drugs with different dosing schedules then unless otherwise clarified both the investigators and the participants will be considered non‐blinded.
Though the blinding of investigators, participants and outcome assessors for psychosocial interventions maybe very difficult, the above will still be recorded.
Intention‐to‐treat analysis
Yes: Specifically reported by authors that intention‐to‐treat analysis (ITT) was undertaken and this was confirmed on study assessment., or not stated but evident from study assessment that ITT was undertaken.
Unclear. Reported but unable to confirm on study assessment, or not reported and unable to confirm by study assessment.
No: Lack of intention‐to‐treat analysis confirmed on study assessment (Patients who were randomised were not included in the analysis because they did not receive the study intervention, they withdrew from the study or were not included because of protocol violation) regardless of whether ITT reported or not.
Completeness of follow‐up
The percentage of participants for whom data was complete at defined study end‐point where interim analyses are reported 'not stated' will be recorded
We will not use a summary scoring system to assess study quality.
STATISTICAL ASSESSEMENT
KSR and CD will enter data separately. For dichotomous data relative risk (RR) will be used with 95% confidence intervals (CI) and for continuous data weighted mean difference (WMD) will be used. Data will be pooled using the random effects model but the fixed effects model will also be analysed to ensure robustness of the model chosen and susceptibility to outliers. Heterogeneity will be analysed using the Chi‐squared test with an p of 0.05 used for statistical significance.
Plausible explanations for variations in treatment effect will be explored using sub‐group analysis based on study quality, populations and interventions.
If sufficient RCTs are found analysis for publication bias will be made using the funnel plot method.
| Database searched | Search strategy |
| MEDLINE (1966 ‐ present) | 1 controlled clinical trial.pt. |
| EMBASE (1980 ‐ present) | 1 Randomized Controlled Trial/ |
| American College of Physicians database | 1 [dialysis/ or electrodialysis/ or equilibrium dialysis/ or exp hemodialysis/ or home dialysis/] |
| Cochrane Central Register of Controlled Trials (CENTRAL) ‐ on OVID | 1 renal replacement therapy/ |
| PsycINFO (1872‐present) | 1 (clinical trial or empirical study or followup study or prospective study or treatment outcome study).fc. |
