DepressionIMPRESSNCT05890222
IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
A study testing Community Intervention and Healthy Activity Program (HAP) in people with Depression, run by Sangath at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Community Intervention and Healthy Activity Program (HAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18 years)
- Residing in the clusters included in the trial
- Speak English or one of the local languages (Konkani, Marathi, Hindi)
- 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 >14) on the Patient Health Questionnaire-9 items (PHQ-9)
Who cannot join
- 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
- Effectiveness Coverage Outcome
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression
- Being tested
- Community Intervention, Healthy Activity Program (HAP)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community InterventionBehavioural
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.
Healthy Activity Program (HAP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Model | Experimental | In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers. Receives: Behavioral: Community Intervention; Behavioral: Healthy Activity Program (HAP) |
| Facility Model | Active comparator | 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. Receives: Behavioral: Healthy Activity Program (HAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During recruitment
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.
Measured: Three months post recruitment
Secondary outcomes (14)
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.
Measured: Six months post recruitment
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.
Measured: Three months post recruitment
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.
Measured: Six months post recruitment
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.
Measured: Three months post recruitment
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.
Measured: Six months post recruitment
Client Service Receipt Inventory
Out-of-pocket costs for receiving care and the related non-medical costs
Measured: 3- and 6- months post recruitment
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.
Measured: Baseline, 3- and 6- months post recruitment
Survey form for collecting costs of receiving HAP intervention to patients
Out-of-pocket costs for receiving HAP intervention (e.g. time loss, travel)
Measured: 3 months post recruitment
Inventory form for collecting system-level economic costs of delivering interventions
System-level costs: Economic costs in WHO six building blocks for delivering the interventions
Measured: Monthly, through study completion up to approximately 12 months
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.
Measured: Baseline, 6, 12 and 18 months of implementation
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 support.
Measured: 3- and 6- months post recruitment
Multidimensional Scale of Perceived Social Support (MSPSS)
12 item short instrument designed to measure an individual's perception of support from 3 sources: family, friends and a significant other. Minimum score 12 and maximum 84
Measured: Baseline, 3- and 6-months post-recruitment
Treatment completion
Met treatment goals or completed the maximum number of sessions or were referred to mental health specialists
Measured: Across 12 months of implementation
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 20. Higher scores indicate greater level of behavioural activation such as engagement with a variety of activities, and associated pleasure and mastery.
Measured: Baseline, 3- and 6- months post recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Nov 2023
- Primary completion18 Nov 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangath
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Harvard Medical School (HMS and HSDM), Centre for Addiction and Mental Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890222
- Sponsor's protocol ID
- SAN_IMPRESS_2023
- Acronym
- IMPRESS
- Status last verified
- Jun 2026
- First submitted
- 12 May 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nadkarni A, Gandhi Y, Fernandes L, Mirchandani K, Kamat S, Weiss HA, Singla DR, Velleman R, Lu C, Bhatia U, Biswal B, Sequeira M, D'souza E, Raikar K, Patel V. Effectiveness and cost-effectiveness of a community intervention in enhancing access to care and improving clinical outcomes for depression: a protocol for a cluster randomised controlled trial in India. Trials. 2024 Aug 28;25(1):569. doi: 10.1186/s13063-024-08236-0.
PubMed 39198915
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
- ClinicalTrials.gov ID
- NCT05890222
- Acronym / sponsor ID
- IMPRESS / SAN_IMPRESS_2023
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- SangathUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Harvard Medical School (HMS and HSDM), Centre for Addiction and Mental Health
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Model | Experimental | Behavioral: Community Intervention, Behavioral: Healthy Activity Program (HAP)In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers. |
| Facility Model | Active comparator | Behavioral: Healthy Activity Program (HAP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (>18 years)
- Residing in the clusters included in the trial
- Speak English or one of the local languages (Konkani, Marathi, Hindi)
- Adults (>18 years);
- Residing in the clusters included in the trial
Key exclusion criteria (7 listed)
- 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
- Effectiveness Coverage Outcome
- Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community InterventionCommunity 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. | Behavioural | Community Model |
| Healthy Activity Program (HAP)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. | Behavioural | Community Model, Facility Model |
Primary outcome
Contact coverage
Time frame: During recruitment
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
Time frame: Three months post recruitment
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.
14 secondary outcomes
Sustained effectiveness
Time frame: Six months post recruitment
Remission
Time frame: Three months post recruitment
Remission
Time frame: Six months post recruitment
Response to treatment
Time frame: Three months post recruitment
Response to treatment
Time frame: Six months post recruitment
Client Service Receipt Inventory
Time frame: 3- and 6- months post recruitment
WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: Baseline, 3- and 6- months post recruitment
Survey form for collecting costs of receiving HAP intervention to patients
Time frame: 3 months post recruitment
Inventory form for collecting system-level economic costs of delivering interventions
Time frame: Monthly, through study completion up to approximately 12 months
Depression awareness
Time frame: Baseline, 6, 12 and 18 months of implementation
Perceived social support
Time frame: 3- and 6- months post recruitment
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline, 3- and 6-months post-recruitment
Treatment completion
Time frame: Across 12 months of implementation
Behavioral activation
Time frame: Baseline, 3- and 6- months post recruitment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 39198915Nadkarni A, Gandhi Y, Fernandes L, Mirchandani K, Kamat S, Weiss HA, Singla DR, Velleman R, Lu C, Bhatia U, Biswal B, Sequeira M, D'souza E, Raikar K, Patel V. Effectiveness and cost-effectiveness of a community intervention in enhancing access to care and improving clinical outcomes for depression: a protocol for a cluster randomised controlled trial in India. Trials. 2024 Aug 28;25(1):569. doi: 10.1186/s13063-024-08236-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Intervention and Healthy Activity Program (HAP) in people with Depression, run by Sangath at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact coverage (time frame: During recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05890222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.