Condition category
Mental and Behavioural Disorders
Date applied
20/04/2009
Date assigned
30/04/2009
Last edited
30/04/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alma Dzubur Kulenovic

ORCID ID

Contact details

Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina
+387 (0)61 223 708
almadz@epn.ba

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of psychoeducation in the treatment of unipolar depression: a multicentric randomised controlled trial

Acronym

Study hypothesis

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

University Clinical Centre of Sarajevo Ethics Committee approved on the 21st March 2008

Study design

Interventional opened multicentric randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Only available to recruiting centres

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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
2. To assess possible differences in types of mental health services received between the two groups in 9 months follow-up

Overall trial start date

01/05/2009

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/05/2009

Recruitment end date

01/05/2010

Locations

Countries of recruitment

Bosnia and Herzegovina

Trial participating centre

Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina

Sponsor information

Organisation

Clinical Centre University of Sarajevo (Bosnia and Herzegovina)

Sponsor details

Psychiatric Clinic
Bolnicka 25
Sarajevo
71000
Bosnia and Herzegovina
+387 (0)61 223 708
psihijatrija@bih.net.ba

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes