DepressionNCT06295250
ASHA Bangladesh--An Integrated Intervention to Address Poverty and Depression
A study testing Manualized Group Based Psychotherapy and Poverty Alleviation in people with Depression and Economic Vulnerability, run by University of Massachusetts, Worcester at 1 site in Bangladesh.
Trial summary
The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Economic Vulnerability, Anxiety
- What is being tested?
- Manualized Group Based Psychotherapy and Poverty Alleviation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45
- Meets criteria for Economic Vulnerability as measured by: household income <= 15000 Taka per month; food insufficiency in household over previous six months; OR owning <= 10 decimals of land
- Family willingness to participate in the program
- Basic literacy as measured by ability to read a simple sentence;
- A score >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline
Who cannot join
- Pregnancy at screen;
- Cognitive or physical impairment precluding participation
- Plans to relocate or to travel for > 1 month during 18 M period.
- Household debt greater than 70,000 Taka
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Disease Research
Dhaka, Dhaka Division
Fahmida Tofail, MBBS, PhD, ftofail@icddrb.org
About this study
Official title: ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women
The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question[s] it aims to answer are whether adding poverty alleviation to depression treatment in an integrated intervention: 1) improves depression outcomes at 6 months post baseline as measured by changes in the PHQ-9 from baseline--compared to depression treatment alone; 2) reduces the chance of relapse (PHQ-9 >=5) at 18 months among patients who remitted (PHQ-9<5) at six months--compared to depression treatment alone; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention--compared to depression treatment alone. Other outcomes that will be studied include economic vulnerability and psychosocial variables such as anxiety, culturally specific symptoms, quality of life, and function. Participants in both arms will participate in research interviews at 6,12 and 18 months. The project also includes a mixed methods implementation evaluation. Quantitative implementation outcomes to be examined include adoption/uptake; retention in the intervention, and fidelity of intervention delivery. A qualitative process evaluation will include interviews with 80 study participants and approximately 40 staff members, including research staff, agricultural officers, and interventionist staff.
- Conditions
- Depression, Economic Vulnerability, Anxiety, Culture Specific Symptoms
- Being tested
- Manualized Group Based Psychotherapy, Poverty Alleviation
- Keywords
- Depression treatment, Cash Transfer, Problem Management Plus, Poverty Alleviation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manualized Group Based PsychotherapyBehavioural
Participants in the control group will receive a 10-session 6-month manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: 1) problem solving; 2) increasing social support; 3) behavioral activation; and 4) relaxation through deep breathing. The intervention is delivered by trained non professional peers.
Poverty AlleviationOther
In addition to the psychotherapy intervention described above, participants in the experimental group will receive a poverty alleviation intervention adapted from the well-known Graduation Program--a poverty alleviation intervention widely used in low income countries. The poverty alleviation intervention includes a) 4 sessions of financial literacy education; b) savings accounts; c) consumption support equal to the cost of 1kg of rice per day for six months; d) productive asset transfer of 3 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building.
| Study group | Role | What they receive |
|---|---|---|
| Depression Treatment (DT) | Active comparator | Participants in the control group will receive: 1) 6-sessions of a manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: problem solving; increasing social support; behavioral activation; and relaxation through deep breathing; 2) 4 support group meetings. The intervention is delivered by trained non professional peers. Receives: Behavioral: Manualized Group Based Psychotherapy |
| Integrated Intervention | Experimental | The experimental arm includes 2 elements:
1. The 6-ssesion psychotherapy intervention described above.
2. A poverty alleviation intervention that includes a) 4 sessions of financial literacy education; b) savings accounts; c) consumption support equal to the cost of 1kg of rice per day for six months; d) productive asset transfer of 3 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building. Receives: Behavioral: Manualized Group Based Psychotherapy; Other: Poverty Alleviation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive symptoms at 6 Months
Change in Symptoms from Baseline to 6 months post baseline, as measured by the Patient Health Questionnaire, a 9 item questionnaire designed to assess depressive symptoms. The minimum score is 0; the maximum score is 27.
Measured: 6 Months
Secondary outcomes (7)
18-Month Relapse
Relapse is defined as a score of Patient Health Questionnaire>= 5 among participants who achieved remission at Time 2: 6 months. To assess relapse, at each data collection point (6, 12, and 18 month) the investigators will ask participants about the experience of depressive symptoms at any time since the previous data collection point. Data collection will focus on 18 month relapse, or the presence of relapse at any time since Time 2.
Measured: 18 months
Depression at 12 and 18 months
Changes between PHQ-9 and Baseline at other time points: 12 and 18 months
Measured: 12 and 18 months
Economic vulnerability Index
A composite index of economic vulnerability including a variety of indicators such as income, debt, and food insecurity.
Measured: Baseline, 12, and 18 Months
Anxiety
Anxiety symptoms as measured on the General Anxiety Disorder scale - a seven item questionnaire with scores from 0-21. Higher scores indicate more anxiety.
Measured: Baseline, 6 Months, 12 Months, and 18 Months
Function
Function and disability as measured by the World Health Organization Disability Assessment Schedule, a 12 item questionnaire that is scored from 12-60 with higher scores indicating greater disability.
Measured: Baseline, 6 Months, 12 Months, and 18 Months
Change in Quality of Life
Quality of life measure that includes five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression, scored from 0-100 with higher scores indicating better quality of life.
Measured: Baseline, 6 Months, 12 Months, and 18 Months
Tension Scale
A questionnaire that measures both psychological symptoms as well as somatic cultural symptoms: a 39 item instrument measured from 0-3 with a minimum score of 0 and a maximum score of 117 with higher scores indicating higher levels of distress.
Measured: Baseline, 6 Months, 12 Months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (163)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Georgetown University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alison Karasz, University of Massachusetts, Worcester
- Investigators
- Alison Karasz, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295250
- Sponsor's protocol ID
- STUDY00001114
- Other IDs
- 7R01MH127577
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will create a deidentified dataset and it is our intention that these data be readily accessible and used. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes. All such data requests will be approved though by the investigative team, including the International Center for Diarrhoeal Disease Research (ICDDRB), to help ensure ethical use of the data.
Publications
Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003 Dec;64(12):1465-75. doi: 10.4088/jcp.v64n1211.
PubMed 14728109Kessler RC, Akiskal HS, Ames M, Birnbaum H, Greenberg P, Hirschfeld RM, Jin R, Merikangas KR, Simon GE, Wang PS. Prevalence and effects of mood disorders on work performance in a nationally representative sample of U.S. workers. Am J Psychiatry. 2006 Sep;163(9):1561-8. doi: 10.1176/ajp.2006.163.9.1561.
PubMed 16946181Heflin CM, Iceland J. Poverty, Material Hardship and Depression. Soc Sci Q. 2009 Dec 1;90(5):1051-1071. doi: 10.1111/j.1540-6237.2009.00645.x.
PubMed 25530634Haushofer J, Fehr E. On the psychology of poverty. Science. 2014 May 23;344(6186):862-7. doi: 10.1126/science.1232491.
PubMed 24855262Patel V, Araya R, de Lima M, Ludermir A, Todd C. Women, poverty and common mental disorders in four restructuring societies. Soc Sci Med. 1999 Dec;49(11):1461-71. doi: 10.1016/s0277-9536(99)00208-7.
PubMed 10515629Lerman S. The syndemogenesis of depression Concepts and examples. depression. 2018.
Lund C, De Silva M, Plagerson S, Cooper S, Chisholm D, Das J, Knapp M, Patel V. Poverty and mental disorders: breaking the cycle in low-income and middle-income countries. Lancet. 2011 Oct 22;378(9801):1502-14. doi: 10.1016/S0140-6736(11)60754-X. Epub 2011 Oct 16.
PubMed 22008425Lund C, Breen A, Flisher AJ, Kakuma R, Corrigall J, Joska JA, Swartz L, Patel V. Poverty and common mental disorders in low and middle income countries: A systematic review. Soc Sci Med. 2010 Aug;71(3):517-528. doi: 10.1016/j.socscimed.2010.04.027. Epub 2010 May 12.
PubMed 20621748Program UND. Human development report 2019: Beyond income, beyond averages, beyond today: Inequalities in human development in the 21st century. 2019.
Buckshee K. Impact of roles of women on health in India. Int J Gynaecol Obstet. 1997 Jul;58(1):35-42. doi: 10.1016/s0020-7292(97)02887-7.
PubMed 9253664Jambunathan J. Sociocultural factors in depression in Asian Indian women. Health Care Women Int. 1992 Jul-Sep;13(3):261-70. doi: 10.1080/07399339209516001.
PubMed 1399866Rani M, Bonu S. Rural Indian women's care-seeking behavior and choice of provider for gynecological symptoms. Stud Fam Plann. 2003 Sep;34(3):173-85. doi: 10.1111/j.1728-4465.2003.00173.x.
PubMed 14558320Rodrigues M, Patel V, Jaswal S, de Souza N. Listening to mothers: qualitative studies on motherhood and depression from Goa, India. Soc Sci Med. 2003 Nov;57(10):1797-806. doi: 10.1016/s0277-9536(03)00062-5.
PubMed 14499506Ullrich HE. A study of change and depression among Havik Brahmin women in a south Indian village. Cult Med Psychiatry. 1987 Sep;11(3):261-87. doi: 10.1007/BF00048516.
PubMed 3677776Karasz A. Marriage, Depression and Illness: Sociosomatic Models in a South Asian Immigrant Community. Psychology and Developing Societies. 2005;17(2):161-180.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women
- ClinicalTrials.gov ID
- NCT06295250
- Acronym / sponsor ID
- STUDY00001114
- Conditions
- Depression, Economic Vulnerability, Anxiety, Culture Specific Symptoms
- Keywords
- Depression treatment, Cash Transfer, Problem Management Plus, Poverty Alleviation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Georgetown University, National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2024 (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 randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question[s] it aims to answer are whether adding poverty alleviation to depression treatment in an integrated intervention: 1) improves depression outcomes at 6 months post baseline as measured by changes in the PHQ-9 from baseline--compared to depression treatment alone; 2) reduces the chance of relapse (PHQ-9 >=5) at 18 months among patients who remitted (PHQ-9<5) at six months--compared to depression treatment alone; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention--compared to depression treatment alone. Other outcomes that will be studied include economic vulnerability and psychosocial variables such as anxiety, culturally specific symptoms, quality of life, and function. Participants in both arms will participate in research interviews at 6,12 and 18 months. The project also includes a mixed methods implementation evaluation. Quantitative implementation outcomes to be examined include adoption/uptake; retention in the intervention, and fidelity of intervention delivery. A qualitative process evaluation will include interviews with 80 study participants and approximately 40 staff members, including research staff, agricultural officers, and interventionist staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression Treatment (DT) | Active comparator | Behavioral: Manualized Group Based PsychotherapyParticipants in the control group will receive: 1) 6-sessions of a manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: problem solving; increasing social support; behavioral activation; and relaxation through deep breathing; 2) 4 support group meetings. The intervention is delivered by trained non professional peers. |
| Integrated Intervention | Experimental | Behavioral: Manualized Group Based Psychotherapy, Other: Poverty AlleviationThe experimental arm includes 2 elements: 1. The 6-ssesion psychotherapy intervention described above. 2. A poverty alleviation intervention that includes a) 4 sessions of financial literacy education; b) savings accounts; c) consumption support equal to the cost of 1kg of rice per day for six months; d) productive asset transfer of 3 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-45
- Meets criteria for Economic Vulnerability as measured by: household income <= 15000 Taka per month; food insufficiency in household over previous six months; OR owning <= 10 decimals of land
- Family willingness to participate in the program
- Basic literacy as measured by ability to read a simple sentence;
- A score >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline
Key exclusion criteria (4 listed)
- Pregnancy at screen;
- Cognitive or physical impairment precluding participation
- Plans to relocate or to travel for > 1 month during 18 M period.
- Household debt greater than 70,000 Taka
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 |
|---|---|---|
| Manualized Group Based PsychotherapyParticipants in the control group will receive a 10-session 6-month manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: 1) problem solving; 2) increasing social support; 3) behavioral activation; and 4) relaxation through deep breathing. The intervention is delivered by trained non professional peers. | Behavioural | Depression Treatment (DT), Integrated Intervention |
| Poverty AlleviationIn addition to the psychotherapy intervention described above, participants in the experimental group will receive a poverty alleviation intervention adapted from the well-known Graduation Program--a poverty alleviation intervention widely used in low income countries. The poverty alleviation intervention includes a) 4 sessions of financial literacy education; b) savings accounts; c) consumption support equal to the cost of 1kg of rice per day for six months; d) productive asset transfer of 3 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building. | Other | Integrated Intervention |
Primary outcome
Change in Depressive symptoms at 6 Months
Time frame: 6 Months
Change in Symptoms from Baseline to 6 months post baseline, as measured by the Patient Health Questionnaire, a 9 item questionnaire designed to assess depressive symptoms. The minimum score is 0; the maximum score is 27.
7 secondary outcomes
18-Month Relapse
Time frame: 18 months
Depression at 12 and 18 months
Time frame: 12 and 18 months
Economic vulnerability Index
Time frame: Baseline, 12, and 18 Months
Anxiety
Time frame: Baseline, 6 Months, 12 Months, and 18 Months
Function
Time frame: Baseline, 6 Months, 12 Months, and 18 Months
Change in Quality of Life
Time frame: Baseline, 6 Months, 12 Months, and 18 Months
Tension Scale
Time frame: Baseline, 6 Months, 12 Months, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 14728109Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003 Dec;64(12):1465-75. doi: 10.4088/jcp.v64n1211.
- Background: PubMed 16946181Kessler RC, Akiskal HS, Ames M, Birnbaum H, Greenberg P, Hirschfeld RM, Jin R, Merikangas KR, Simon GE, Wang PS. Prevalence and effects of mood disorders on work performance in a nationally representative sample of U.S. workers. Am J Psychiatry. 2006 Sep;163(9):1561-8. doi: 10.1176/ajp.2006.163.9.1561.
- Background: PubMed 25530634Heflin CM, Iceland J. Poverty, Material Hardship and Depression. Soc Sci Q. 2009 Dec 1;90(5):1051-1071. doi: 10.1111/j.1540-6237.2009.00645.x.
- Background: PubMed 24855262Haushofer J, Fehr E. On the psychology of poverty. Science. 2014 May 23;344(6186):862-7. doi: 10.1126/science.1232491.
- Background: PubMed 10515629Patel V, Araya R, de Lima M, Ludermir A, Todd C. Women, poverty and common mental disorders in four restructuring societies. Soc Sci Med. 1999 Dec;49(11):1461-71. doi: 10.1016/s0277-9536(99)00208-7.
- BackgroundLerman S. The syndemogenesis of depression Concepts and examples. depression. 2018.
- Background: PubMed 22008425Lund C, De Silva M, Plagerson S, Cooper S, Chisholm D, Das J, Knapp M, Patel V. Poverty and mental disorders: breaking the cycle in low-income and middle-income countries. Lancet. 2011 Oct 22;378(9801):1502-14. doi: 10.1016/S0140-6736(11)60754-X. Epub 2011 Oct 16.
- Background: PubMed 20621748Lund C, Breen A, Flisher AJ, Kakuma R, Corrigall J, Joska JA, Swartz L, Patel V. Poverty and common mental disorders in low and middle income countries: A systematic review. Soc Sci Med. 2010 Aug;71(3):517-528. doi: 10.1016/j.socscimed.2010.04.027. Epub 2010 May 12.
- BackgroundProgram UND. Human development report 2019: Beyond income, beyond averages, beyond today: Inequalities in human development in the 21st century. 2019.
- Background: PubMed 9253664Buckshee K. Impact of roles of women on health in India. Int J Gynaecol Obstet. 1997 Jul;58(1):35-42. doi: 10.1016/s0020-7292(97)02887-7.
- Background: PubMed 1399866Jambunathan J. Sociocultural factors in depression in Asian Indian women. Health Care Women Int. 1992 Jul-Sep;13(3):261-70. doi: 10.1080/07399339209516001.
- Background: PubMed 14558320Rani M, Bonu S. Rural Indian women's care-seeking behavior and choice of provider for gynecological symptoms. Stud Fam Plann. 2003 Sep;34(3):173-85. doi: 10.1111/j.1728-4465.2003.00173.x.
- Individual participant dataSharing planned: Yes. We will create a deidentified dataset and it is our intention that these data be readily accessible and used. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes. All such data requests will be approved though by the investigative team, including the International Center for Diarrhoeal Disease Research (ICDDRB), to help ensure ethical use of the data.
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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.
Alison Karasz, PhD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manualized Group Based Psychotherapy and Poverty Alleviation in people with Depression and Economic Vulnerability, run by University of Massachusetts, Worcester at 1 site in Bangladesh.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 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 Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Karasz, PhD (3478435652, alison.karasz@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive symptoms at 6 Months (time frame: 6 Months). 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 NCT06295250, which also lists 163 linked publications.
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 15 Jun 2026.