NCT06574074

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

August 4, 2024

Last Update Submit

September 2, 2024

Conditions

Keywords

DepressionHelp-seeking behaviourDemand side barriersStigmaNepal

Outcome Measures

Primary Outcomes (1)

  • 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".

    In one month

Secondary Outcomes (3)

  • Treatment adherence for depression

    In three month

  • Change in symptom severity of depression

    In three month

  • Change in knowledge, attitude and perception

    In three months

Study Arms (8)

Factor-1

OTHER

Participants allocated to this will receive full version of the Gain Life intervention

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

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

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

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

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

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

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

Behavioral: Gain-Life (Give informAtIoN to transform Life)

Interventions

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.

Factor-1Factor-2Factor-3Factor-4Factor-5Factor-6Factor-7Factor-8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transcultural Psychosocial Organization (TPO) Nepal

Kathmandu, Bagmati, 44600, Nepal

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Help-Seeking BehaviorDepressionSocial Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data collectors will be blinded to the allocation of the participants to different groups.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 27, 2024

Study Start

July 15, 2024

Primary Completion

November 1, 2024

Study Completion

November 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

No many researchers involved in the study so the data will only be shared within the research team

Locations