Help-Seeking BehaviorNCT06574074
Improving Help-seeking for Depression Care in Nepal
A study testing Gain-Life (Give informAtIoN to transform Life) in people with Help-Seeking Behavior and Depression, run by Transcultural Psychosocial Organization Nepal at 1 site in Nepal.
Trial summary
Depression is a serious public health concern worldwide due to its high prevalence rate and significant emotional and financial burden on individuals, their families, and society. There is a substantial gap between the number of people in need of treatment for depression and those who actually receive it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Help-Seeking Behavior, Depression
- What is being tested?
- Gain-Life (Give informAtIoN to transform Life)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteNepal
- Study dates
- 15 Jul 2024to 30 Nov 2024
- 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
- being an adult aged 18 or older residing in Kanepokhari Rural Municipality or Patharisanischare Municipality,
- those detected through the CIDT
- providing consent for participation
- being proficient in speaking and understanding Nepali
Who cannot join
- people with already receiving mental health services
- having severe mental illness]
- participants below the age of 18 years,
- participants outside of Kanepokhari and Pathari-sanischare Municipality
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Transcultural Psychosocial Organization (TPO) Nepal
Kathmandu, Bagmati, 44600
About this study
Official title: Optimizing a Community-based Intervention to Improve Help-seeking for Depression Care in Morang District of Nepal
Depression is a serious public health concern worldwide due to its high prevalence rate and significant emotional and financial burden on individuals, their families, and society. There is a substantial gap between the number of people in need of treatment for depression and those who actually receive it. The recent World Health Organization (WHO) World Mental Health Survey revealed that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries did not receive any treatment in the past 12 months. This study aims to evaluate a community-based intervention to address demand-side barriers by improving mental health literacy, dispelling myths and misconceptions about depression, changing negative attitudes towards depression care, and promoting help-seeking behavior.
Read the detailed description
It is estimated that more than 300 million people worldwide are experiencing depression, which is about 4.4% of the world's population. Despite the availability of evidence-based treatment, it is reported that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries received no treatment in the past 12 months. Among people who receive treatment for depression, only one out of 27 persons receive minimally adequate treatment in low- and middle-income countries (LMICs). Despite being the major contributor to the overall global burden of disease, depression receives less or no health priority in many LMICs, where more than 80% of people with depression reside.
This study will take place in two municipalities in Morang district, eastern Nepal. Female Community Health Volunteers will administer the intervention to individuals identified with depression using the locally developed and validated Community Informant Detection Tool (CIDT). Participants who receive the intervention will be followed up after one month to evaluate their help-seeking behavior (primary outcome) and after three months to assess treatment adherence, a secondary objective of the study. The study will assess the effects and interactions of four intervention components (information on depression, available treatments, stigma and myths, and life transformation experiences) on the primary outcome of help-seeking behavior and secondary outcomes such as treatment adherence. The severity of depression symptoms will be assessed using the validated PHQ-9, and knowledge and attitudes toward depression will be evaluated to assess mediation effects.
- Conditions
- Help-Seeking Behavior, Depression
- Being tested
- Gain-Life (Give informAtIoN to transform Life)
- Keywords
- Depression, Help-seeking behaviour, Demand side barriers, Stigma, Nepal
- Medical subject headings
- Help-Seeking Behavior, Depression, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gain-Life (Give informAtIoN to transform Life)Behavioural
The Gain Life intervention comprises four components: (i) information about depression, (ii) awareness of available services, (iii) stigma reduction through dispelling myths and facts about depression, and (iv) a life transformation story. The first module aims to raise awareness about depression, with a particular focus on its causes, manifestations, and the potential negative consequences of untreated depression. The second component includes the types of services offered, costs, distance to service providers, and operating hours. The third component address stigma and misconceptions surrounding depression by addressing the root causes of stigma, dispelling myths, and providing accurate information about depression. The final module of the Gain Life intervention features recovery stories of individuals who have overcome depression. This module includes two 8-minute video stories of individuals who successfully recovered from depression.
| Study group | Role | What they receive |
|---|---|---|
| Factor-1 | Other | Participants allocated to this will receive full version of the Gain Life intervention Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-2 | Other | Participants allocated to this will receive a few components of the Gain Life intervention that include information on depression, available treatments, and stigma reduction Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-3 | Other | Participants allocated to this will receive only a few components of Gain Life intervention including information on depression, available treatments, and life transformation experiences Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-4 | Other | Participants allocated to this will receive only information on depression, and available treatments components of the Gain Life intervention Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-5 | Other | Participants allocated to this will receive three components of the Gain Life intervention that include information on depression, stigma reduction and life transformation experiences Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-6 | Other | Participants allocated to this will receive information on depression and stigma reduction components of the Gain Life intervention Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-7 | Other | Participants allocated to this will receive a selected components of the Gain Life intervention such as information on depression, available treatments and life transformation experiences Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
| Factor-8 | Other | Participants allocated to this will receive only the information on depression component of the Gain Life intervention Receives: Behavioral: Gain-Life (Give informAtIoN to transform Life) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in help-seeking behaviour for depression care
The primary outcome of this study is "change in help-seeking behavior for depression care, defined by the proportion of participants who receive treatment from a health provider".
Measured: In one month
Secondary outcomes (3)
Treatment adherence for depression
The secondary outcome of the study is "treatment adherence for depression defined by the proportion of people who continue treatment for three months".
Measured: In three month
Change in symptom severity of depression
The secondary outcome of the study is change in symptom severity of depression assessed by patient health questionnaire (PHQ-9). The total score of PHQ9 can range from 0 to 27, with higher scores indicating greater severity of depression
Measured: In three month
Change in knowledge, attitude and perception
The secondary outcome of this study is to measure changes in knowledge, attitudes, and perceptions related to depression using a questionnaire developed based on the intervention content. The results will be presented based on the number of correct responses (yes and no) for each item of each scale separately. Number of greater \"Yes\" response indicates greater knowledge in depression, and positive attitude in help-seeking.
Measured: In three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start15 Jul 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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 Help-Seeking BehaviorStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The unit of randomization will be study participants who are identified with depression by FCHVs. Each participant will be randomized into one of eight groups using a computer-generated random number.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcultural Psychosocial Organization Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574074
- Sponsor's protocol ID
- WTMOST
- Status last verified
- Sep 2024
- First submitted
- 4 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No many researchers involved in the study so the data will only be shared within the research team
Publications
Luitel NP, Kohrt BA, Lamichhane B, Bhardwaj A, Gautam K, Jordans MJ. Optimizing a community-based intervention to improve help-seeking for depression care: study protocol for a randomized factorial trial. Trials. 2025 Aug 16;26(1):293. doi: 10.1186/s13063-025-09014-2.
PubMed 40819070
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Community-based Intervention to Improve Help-seeking for Depression Care in Morang District of Nepal
- ClinicalTrials.gov ID
- NCT06574074
- Acronym / sponsor ID
- WTMOST
- Conditions
- Help-Seeking Behavior, Depression
- Keywords
- Depression, Help-seeking behaviour, Demand side barriers, Stigma, Nepal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Transcultural Psychosocial Organization NepalUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 27 Aug 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.
Depression is a serious public health concern worldwide due to its high prevalence rate and significant emotional and financial burden on individuals, their families, and society. There is a substantial gap between the number of people in need of treatment for depression and those who actually receive it. The recent World Health Organization (WHO) World Mental Health Survey revealed that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries did not receive any treatment in the past 12 months. This study aims to evaluate a community-based intervention to address demand-side barriers by improving mental health literacy, dispelling myths and misconceptions about depression, changing negative attitudes towards depression care, and promoting help-seeking behavior.
Detailed description
It is estimated that more than 300 million people worldwide are experiencing depression, which is about 4.4% of the world's population. Despite the availability of evidence-based treatment, it is reported that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries received no treatment in the past 12 months. Among people who receive treatment for depression, only one out of 27 persons receive minimally adequate treatment in low- and middle-income countries (LMICs). Despite being the major contributor to the overall global burden of disease, depression receives less or no health priority in many LMICs, where more than 80% of people with depression reside.
This study will take place in two municipalities in Morang district, eastern Nepal. Female Community Health Volunteers will administer the intervention to individuals identified with depression using the locally developed and validated Community Informant Detection Tool (CIDT). Participants who receive the intervention will be followed up after one month to evaluate their help-seeking behavior (primary outcome) and after three months to assess treatment adherence, a secondary objective of the study. The study will assess the effects and interactions of four intervention components (information on depression, available treatments, stigma and myths, and life transformation experiences) on the primary outcome of help-seeking behavior and secondary outcomes such as treatment adherence. The severity of depression symptoms will be assessed using the validated PHQ-9, and knowledge and attitudes toward depression will be evaluated to assess mediation effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- The unit of randomization will be study participants who are identified with depression by FCHVs. Each participant will be randomized into one of eight groups using a computer-generated random number.
| Arm | Type | Receives |
|---|---|---|
| Factor-1 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive full version of the Gain Life intervention |
| Factor-2 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive a few components of the Gain Life intervention that include information on depression, available treatments, and stigma reduction |
| Factor-3 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive only a few components of Gain Life intervention including information on depression, available treatments, and life transformation experiences |
| Factor-4 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive only information on depression, and available treatments components of the Gain Life intervention |
| Factor-5 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive three components of the Gain Life intervention that include information on depression, stigma reduction and life transformation experiences |
| Factor-6 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive information on depression and stigma reduction components of the Gain Life intervention |
| Factor-7 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive a selected components of the Gain Life intervention such as information on depression, available treatments and life transformation experiences |
| Factor-8 | Other | Behavioral: Gain-Life (Give informAtIoN to transform Life)Participants allocated to this will receive only the information on depression component of the Gain Life intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being an adult aged 18 or older residing in Kanepokhari Rural Municipality or Patharisanischare Municipality,
- those detected through the CIDT
- providing consent for participation
- being proficient in speaking and understanding Nepali
Key exclusion criteria (4 listed)
- people with already receiving mental health services
- having severe mental illness]
- participants below the age of 18 years,
- participants outside of Kanepokhari and Pathari-sanischare Municipality
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 |
|---|---|---|
| Gain-Life (Give informAtIoN to transform Life)The Gain Life intervention comprises four components: (i) information about depression, (ii) awareness of available services, (iii) stigma reduction through dispelling myths and facts about depression, and (iv) a life transformation story. The first module aims to raise awareness about depression, with a particular focus on its causes, manifestations, and the potential negative consequences of untreated depression. The second component includes the types of services offered, costs, distance to service providers, and operating hours. The third component address stigma and misconceptions surrounding depression by addressing the root causes of stigma, dispelling myths, and providing accurate information about depression. The final module of the Gain Life intervention features recovery stories of individuals who have overcome depression. This module includes two 8-minute video stories of individuals who successfully recovered from depression. | Behavioural | Factor-1, Factor-2, Factor-3, Factor-4, Factor-5, Factor-6, Factor-7, Factor-8 |
Primary outcome
Change in help-seeking behaviour for depression care
Time frame: In one month
The primary outcome of this study is "change in help-seeking behavior for depression care, defined by the proportion of participants who receive treatment from a health provider".
3 secondary outcomes
Treatment adherence for depression
Time frame: In three month
Change in symptom severity of depression
Time frame: In three month
Change in knowledge, attitude and perception
Time frame: In three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40819070Luitel NP, Kohrt BA, Lamichhane B, Bhardwaj A, Gautam K, Jordans MJ. Optimizing a community-based intervention to improve help-seeking for depression care: study protocol for a randomized factorial trial. Trials. 2025 Aug 16;26(1):293. doi: 10.1186/s13063-025-09014-2.
- Individual participant dataSharing planned: No. No many researchers involved in the study so the data will only be shared within the research team
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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 Gain-Life (Give informAtIoN to transform Life) in people with Help-Seeking Behavior and Depression, run by Transcultural Psychosocial Organization Nepal at 1 site in Nepal.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Nepal. 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?
Results are not available in the source record.
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?
Change in help-seeking behaviour for depression care (time frame: In one month). 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 NCT06574074, 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 19 Sep 2024.