Back to resultsIMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion (IMPRESS)
Primary Purpose
Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Community Intervention
Healthy Activity Program (HAP)
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
(A) Contact Coverage Outcome Inclusion Criteria Adults (>18 years) Residing in the clusters included in the trial Speak English or one of the local languages (Konkani, Marathi, Hindi) Exclusion Criteria Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention Patients who present to the health centre for emergency medical attention Patients with active psychotic symptoms (B) Effectiveness Coverage Outcome Inclusion Criteria Adults (>18 years); Residing in the clusters included in the trial Speak English or one of the local languages (Konkani, Marathi, Hindi). Screen positive for moderately severe or severe depression (total score >15) on the Patient Health Questionnaire-9 items (PHQ-9) Intend to reside in the trial clusters for at least 3 months (to enhance the likelihood of completion of treatment) Exclusion Criteria Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention Patients who present to the health centre for emergency medical attention Patients with active psychotic symptoms Patients who do not have access to a mobile phone as that will be needed for communicating with the counsellors and Sangathis, for example, to follow-up if the patient misses an appointment.
Sites / Locations
- Sangath
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Community Model
Facility Model
Arm Description
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
The HAP, a manualized and evidence-based psychological treatment based on behavioural activation, will be delivered by existing healthcare workers (called counsellors from here onwards) within the health centres who will be trained to deliver the HAP.
Outcomes
Primary Outcome Measures
Contact coverage
Patient Health Questionnaire 9 items (PHQ-9) score >4. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Effectiveness coverage
Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Secondary Outcome Measures
Sustained effectiveness
Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Remission
Patient Health Questionnaire 9 items (PHQ-9 score) score <10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Remission
Patient Health Questionnaire 9 items (PHQ-9 score) score <10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Response to treatment
>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Response to treatment
>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Client Service Receipt Inventory
Out-of-pocket costs for receiving care and the related non-medical costs
WHO Disability Assessment Schedule (WHODAS 2.0)
Standardized disability scores used to estimate Quality Adjusted Life Years (QALYs). The 12-item WHODAS 2.0 score ranges from 12 to 60, where higher scores indicate higher disability or loss of function.
Depression awareness
Awareness about depression. This will be a bespoke tool developed for our trial and will have questions to assess awareness related to depression based on the information disseminated in our community intervention and higher scores will indicate greater awareness.
Perceived social support
Perception of social support received. This will be a bespoke tool developed for our trial and will have questions to assess perceived support related to support provided by community volunteers in our community intervention and higher scores will indicate greater awareness.
Treatment completion
Met treatment goals or completed the maximum number of sessions or were referred to mental health specialists
Behavioral activation
Level of behavioral activation measured using PREMIUM Abbreviated Activation Scale. This is a five-item scale, originally developed based on the Behavioural Activation for Depression Scale. It includes five self-reported indicators and the total score can range from 0 to 25. Higher scores indicate greater level of behavioural activation such as engagement with a variety of activities, and associated pleasure and mastery.
Full Information
NCT ID
NCT05890222
First Posted
May 12, 2023
Last Updated
July 25, 2023
Sponsor
Sangath
Collaborators
London School of Hygiene and Tropical Medicine, Harvard Medical School (HMS and HSDM), Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT05890222
Brief Title
IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
Acronym
IMPRESS
Official Title
IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sangath
Collaborators
London School of Hygiene and Tropical Medicine, Harvard Medical School (HMS and HSDM), Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Community Model
Arm Type
Experimental
Arm Description
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
Arm Title
Facility Model
Arm Type
Active Comparator
Arm Description
The HAP, a manualized and evidence-based psychological treatment based on behavioural activation, will be delivered by existing healthcare workers (called counsellors from here onwards) within the health centres who will be trained to deliver the HAP.
Intervention Type
Behavioral
Intervention Name(s)
Community Intervention
Intervention Description
Community intervention strategies will be delivered by community volunteers (called Sangathis - which means companion in Konkani, one of the local languages) to i) enhance demand for the HAP treatment and ii) promote engagement with, and completion of, the HAP treatment. The community intervention is co-produced with local community members and includes strategies such as activities to increase awareness about depression (community meetings, street plays and health camps), and dissemination of psycho-educational materials (i.e., leaflets and posters), identify people with possible depression in the community, and facilitate access to HAP in the health centres. Additionally, the Sangathis will coordinate continuing care of people receiving HAP, through home visits to encourage behavioural activation, homework completion and following up with the counsellor, and engaging family members to support the patient in achieving treatment goals.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Activity Program (HAP)
Intervention Description
HAP includes the following strategies: psychoeducation, behavioural assessment, activity monitoring, activity structuring and scheduling, activation of social networks, and problem-solving. HAP will be delivered in an individual format. It entails three phases of treatment, delivered over six to eight sessions, each lasting up to 40 minutes, with the sessions being at weekly intervals. Sessions will be delivered face-to-face, at the health centre where the counsellors already work.
Primary Outcome Measure Information:
Title
Contact coverage
Description
Patient Health Questionnaire 9 items (PHQ-9) score >4. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Three months post recruitment
Title
Effectiveness coverage
Description
Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Three months post recruitment
Secondary Outcome Measure Information:
Title
Sustained effectiveness
Description
Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Six months post recruitment
Title
Remission
Description
Patient Health Questionnaire 9 items (PHQ-9 score) score <10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Three months post recruitment
Title
Remission
Description
Patient Health Questionnaire 9 items (PHQ-9 score) score <10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Six months post recruitment
Title
Response to treatment
Description
>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Three months post recruitment
Title
Response to treatment
Description
>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Time Frame
Six months post recruitment
Title
Client Service Receipt Inventory
Description
Out-of-pocket costs for receiving care and the related non-medical costs
Time Frame
Baseline, 3- and 6- months post recruitment
Title
WHO Disability Assessment Schedule (WHODAS 2.0)
Description
Standardized disability scores used to estimate Quality Adjusted Life Years (QALYs). The 12-item WHODAS 2.0 score ranges from 12 to 60, where higher scores indicate higher disability or loss of function.
Time Frame
3- and 6- months post recruitment
Title
Depression awareness
Description
Awareness about depression. This will be a bespoke tool developed for our trial and will have questions to assess awareness related to depression based on the information disseminated in our community intervention and higher scores will indicate greater awareness.
Time Frame
Baseline, 6 and 12 months of implementation
Title
Perceived social support
Description
Perception of social support received. This will be a bespoke tool developed for our trial and will have questions to assess perceived support related to support provided by community volunteers in our community intervention and higher scores will indicate greater awareness.
Time Frame
Baseline, 3- and 6- months post recruitment
Title
Treatment completion
Description
Met treatment goals or completed the maximum number of sessions or were referred to mental health specialists
Time Frame
Across 12 months of implementation
Title
Behavioral activation
Description
Level of behavioral activation measured using PREMIUM Abbreviated Activation Scale. This is a five-item scale, originally developed based on the Behavioural Activation for Depression Scale. It includes five self-reported indicators and the total score can range from 0 to 25. Higher scores indicate greater level of behavioural activation such as engagement with a variety of activities, and associated pleasure and mastery.
Time Frame
Baseline, 3- and 6- months post recruitment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
(A) Contact Coverage Outcome
Inclusion Criteria
Adults (>18 years)
Residing in the clusters included in the trial
Speak English or one of the local languages (Konkani, Marathi, Hindi)
Exclusion Criteria
Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
Patients who present to the health centre for emergency medical attention
Patients with active psychotic symptoms
(B) Effectiveness Coverage Outcome
Inclusion Criteria
Adults (>18 years);
Residing in the clusters included in the trial
Speak English or one of the local languages (Konkani, Marathi, Hindi).
Screen positive for moderately severe or severe depression (total score >15) on the Patient Health Questionnaire-9 items (PHQ-9)
Intend to reside in the trial clusters for at least 3 months (to enhance the likelihood of completion of treatment)
Exclusion Criteria
Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
Patients who present to the health centre for emergency medical attention
Patients with active psychotic symptoms
Patients who do not have access to a mobile phone as that will be needed for communicating with the counsellors and Sangathis, for example, to follow-up if the patient misses an appointment.
Facility Information:
Facility Name
Sangath
City
Goa
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
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