A clinical trial to study the effect of psychoeducation along with treatment as usual in patients with late life depression.

Active, not recruiting

Conditions: Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (3) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features,

Registration Number: CTRI/2019/05/018956

Lead Sponsor: KING GEORGES MEDICAL UNIVERSITY

Brief Summary: This study is a randomised, parallel group, placebo controlled trial to see the effect of psychoeducation along with treatment as usual on short-term outcome in 154 patients with depression aged 60 years and above. It is a single centred study to be conducted in the Department of Geriatric Mental Health, King Georgeâ€™s Medical University, Lucknow, Uttar Pradesh, India. The intervention is that psychoeducation video will be shown to the case group and the control group will be shown placebo-psychoeducation video. The primary outcome is that psychoeducation will improve depression in the case group patients at 4 weeks. Since there will be improvement in depression, hence the scores of Hamilton Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS) will also lower down.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 154

Inclusion Criteria

1Patients aged 60 years and above 2Patients giving the informed consent 3Patients scoring 24 and above in the Hindi Mental Status Examination (HMSE) 4Patients with first episode of depression and no previously diagnosed psychiatric disorder 5Patients who have been clinically diagnosed with depression 6Patientsâ€™ diagnosis will be confirmed on Mini International Neuropsychiatric Interview 6.0 (MINI 6.0).

Exclusion Criteria

1 Patients having any severe medical illness 2 Patients with hearing impairment or language problem or any other issue which is can be serious impediment to the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychoeducation will improve outcome in case group patients with late life depression.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Giving psychoeducation will lower down the scores of Hamilton Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS) in case group patients.	4 weeks

Trial Locations

Locations (1): KING GEROGES MEDICAL UNIVERSITY
🇮🇳
Lucknow, UTTAR PRADESH, India
KING GEROGES MEDICAL UNIVERSITY
🇮🇳Lucknow, UTTAR PRADESH, India
DR SHRIKANT SRIVASTAVA
Principal investigator
9621373167
shrikantsrivastava@kgmcindia.edu