- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06574074
Improving Help-seeking for Depression Care in Nepal
Optimizing a Community-based Intervention to Improve Help-seeking for Depression Care in Morang District of Nepal
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bagmati
-
Kathmandu, Bagmati, Nepal, 44600
- Transcultural Psychosocial Organization (TPO) Nepal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Factor-1
Participants allocated to this will receive full version of the Gain Life intervention
|
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.
|
|
Other: Factor-2
Participants allocated to this will receive a few components of the Gain Life intervention that include information on depression, available treatments, and stigma reduction
|
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.
|
|
Other: Factor-3
Participants allocated to this will receive only a few components of Gain Life intervention including information on depression, available treatments, and life transformation experiences
|
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.
|
|
Other: Factor-4
Participants allocated to this will receive only information on depression, and available treatments components of the Gain Life intervention
|
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.
|
|
Other: Factor-5
Participants allocated to this will receive three components of the Gain Life intervention that include information on depression, stigma reduction and life transformation experiences
|
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.
|
|
Other: Factor-6
Participants allocated to this will receive information on depression and stigma reduction components of the Gain Life intervention
|
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.
|
|
Other: Factor-7
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
|
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.
|
|
Other: Factor-8
Participants allocated to this will receive only the information on depression component of the Gain Life intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
In one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment adherence for depression
Time Frame: In three month
|
The secondary outcome of the study is "treatment adherence for depression defined by the proportion of people who continue treatment for three months".
|
In three month
|
|
Change in knowledge, attitude and perception
Time Frame: In three months
|
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.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.
|
In three months
|
|
Change in symptom severity of depression
Time Frame: In three month
|
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
|
In three month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WTMOST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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