Efficacy of psychoeducation in the treatment of unipolar depression
| ISRCTN | ISRCTN10760801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10760801 |
| Protocol serial number | N/A |
| Sponsor | Clinical Centre University of Sarajevo (Bosnia and Herzegovina) |
| Funder | European Union (EU) (Belgium) - Sixth Framework Programme (FP6): EVIDENCE (Strengthening Research Capacities and Evaluation of Mental Health Services in Bosnia and Herzegovina) (grant ref: INCO-CT-2007-043654 FP6) |
- Submission date
- 20/04/2009
- Registration date
- 30/04/2009
- Last edited
- 30/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alma Dzubur Kulenovic
Scientific
Scientific
Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina
| Phone | +387 (0)61 223 708 |
|---|---|
| almadz@epn.ba |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional opened multicentric randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of psychoeducation in the treatment of unipolar depression: a multicentric randomised controlled trial |
| Study objectives | Psychoeducation combined with treatment as usual leads to a greater reduction in depressive symptoms as measured by the Beck Depression Inventory (BDI) and Hamilton Depression Scale (HAM-D), and greater increase of subjective perception of the quality of life as measured by the Manchester Quality of Life Scale (MANSA) in subjects diagnosed with unipolar depression, than treatment as usual alone. |
| Ethics approval(s) | University Clinical Centre of Sarajevo Ethics Committee approved on the 21st March 2008 |
| Health condition(s) or problem(s) studied | Unipolar depression in adults |
| Intervention | The subjects in the experimental group will receive an 8-week course on psychoeducation based on Lewinsohn's Coping With Depression Course combined with treatment as usual (TAU). The subjects in the control group will receive TAU only. Assessments will be made with the use of standardised psychometric instruments: 1. International Neuropsychiatric Interview (MINI 5.00) 2. Mini Mental State Exam (MMSE) 3. Beck Depression Inventory (BDI) 4. Hamilton Depression Scale (HAM-D) 5. Manchester Quality of Life Scale (MANSA) 6. Socio-demographic questionnaire (specially designed for this study) Assessments will be performed before the intervention, after the intervention and in 6 and 12 months follow-up. The study will adhere with the methodology of a randomised controlled trial. |
| Intervention type | Other |
| Primary outcome measure(s) |
To assess possible changes in the total score on Beck Depression Inventory scale (BDI), and Hamilton Depression Scale (HAM-D), between the subjects who received psychoeducation and treatment as usual and the subjects who received only treatment as usual, after a 12 week course of psychoeducation, and in 9 months follow-up. |
| Key secondary outcome measure(s) |
1. To assess possible changes in the total score on Manchester Quality of Life Scale (MANSA) between the subjects who received psychoeducation and treatment as usual and the subjects who received only treatment as usual, after a 12 week course of psychoeducation and in 9 months follow-up |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Adult subjects aged 18 to 65 years, either sex 2. Diagnosis of unipolar depression (F 32.0-2, F 33.0-2) 3. Not due to a medical condition (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition [DSM IV] Axis V = 0) 4. No other Axis I co-morbid psychiatric disorder 5. Duration of symptoms not less than 3 months 6. Able to read and write (8 years formal education) 7. Subjects who sign the informed consent to participate in the study |
| Key exclusion criteria | 1. Refused to sign informed consent 2. Illiterate 3. Deaf or hearing impaired 4. Serious speech impairment or mutisim 5. Duration of symptoms less than three months 6. Symptoms of psychotic depression 7. History of a manic or hypo-manic episode 8. Cognitive impairment (mini Mental State Examination [MMSE] greater than or equal to 25) 9. Co-morbid anxiety disorder 10. Organic affective disorder 11. Depression caused by an underlying medical condition 12. Co-morbid personality disorder 13. Alcohol and preliminary alcohol screening (PAS) abuse and dependence 14. Subjects who are currently involved in other research 15. Pregnancy 16. Epilepsy 17. Subjects whose present condition requires psychiatric hospitalisation 18. Suicidality |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- Bosnia and Herzegovina
Study participating centre
Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina
71000
Bosnia and Herzegovina
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
