The Effect of Culturally Adapted CBT-based Guided Self Help in Depressed Patients With Myocardial Infarction
1 other identifier
interventional
140
1 country
1
Brief Summary
This is a randomized controlled assessor-blind clinical trial comparing CaCBT based guided self-help (using a manual titled Khushi Aur Khatoon) against treatment as usual (TAU)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedFirst Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2020
CompletedNovember 8, 2022
November 1, 2022
5 months
April 13, 2020
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Anxiety and Depression Scale-Depression Subscale (HAD-D)
Change in the score of the Hospital Anxiety and Depression Scale (HADS) from baseline to end of therapy. The total score is the sum of the 7 items, ranging from 0-21. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of depression.
9-12 weeks (end of therapy)
Secondary Outcomes (3)
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
9-12 weeks (end of therapy)
Bradford Somatic Inventory (BSI)
9-12 weeks (end of therapy)
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
9-12 weeks (end of therapy)
Study Arms (2)
Intervention
EXPERIMENTALThis group will receive CaCBT based guided self-help using the manual (Khushi Aur Khatoon) as an intervention in addition to treatment as usual
Control
NO INTERVENTIONThis group will receive treatment as usual
Interventions
CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
Eligibility Criteria
You may qualify if:
- Diagnosis of Myocardial Infarction
- Score 8 or more on HADS
- Fulfilling criteria of Major Depressive Disorder using DSM-V
You may not qualify if:
- Participants with use of alcohol or drugs
- Significant cognitive impairment (intellectual disability or dementia)
- Active psychosis
- Participants who have received CBT during the previous 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Punjab Institute of Cardiology
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Farooq Naeem, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof of Psychiatry & Director Research
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 15, 2020
Study Start
October 22, 2019
Primary Completion
March 15, 2020
Study Completion
April 25, 2020
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share