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WellbeingT2CNCT07524309

Self-Help Plus Pilot Study, Colombia: Train2Care

A study testing Self help plus in people with Wellbeing, run by George Washington University at 1 site in Colombia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This project will strengthen local capacity for mental health care in high-need settings in Colombia by culturally and linguistically adapting the Self-Help+ intervention and delivering participatory, supervised training. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Wellbeing
What is being tested?
Self help plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteColombia
Study dates
15 Jun 2026to 31 Oct 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years old and living in the study area

Who cannot join

  • Current risk of self-harm or suicide that requires a higher level of care
  • Significant cognitive impairment that would interfere with the ability to participate in the intervention or provide informed consent
  • Severe mental health conditions requiring specialized care (for example, psychosis)
  • Severe substance use or substance use disorders that would interfere with participation or require specialized treatment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Colombia1 site

  • Universidad Catolica del Oriente

    Rionegro, Antioquia

Other trials in Colombia

About this study

Official title: Self-Help Plus Pilot Study, Colombia: Training to Care: Global Mental Health With a Territorial Approach

This project will strengthen local capacity for mental health care in high-need settings in Colombia by culturally and linguistically adapting the Self-Help+ intervention and delivering participatory, supervised training. Local community leaders will be trained to implement Self Help+ for their own well-being and to train others in their communities. The project will deliver a structured program with hands-on practice, ongoing technical support, and participatory evaluation of psychosocial outcomes and sustainability.

Read the detailed description

The main goal of the project is to strengthen the mental health capacity of individuals living in low-income settings and community-based, public, and private organizations in Eastern Antioquia, Colombia, by culturally adapting the Self-Help+ intervention and piloting a participatory training program with key community actors, laying the groundwork for future scale-up and sustainability. The following are the objectives of the study:

  • Culturally and linguistically adapt Self-Help+ to the local context of communities in Eastern Antioquia, Colombia
  • Co-design a pilot training program on Self-Help+ delivery with key community actors using participatory methods
  • Implement the pilot training program on Self-Help+ with the selected community actors using participatory approaches
  • Conduct a preliminary mixed-methods evaluation of acceptability, feasibility, and early psychosocial outcome indicators
  • Systematize implementation data to support knowledge sharing and ongoing technical monitoring of the strategies in critical contexts.
Conditions
Wellbeing
Being tested
Self help plus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self help plusOther

    Self-Help Plus is the World Health Organization's 5-session stress management course for large groups of up to 30 people. It is delivered by supervised, non-specialist facilitators who complete a short training course and use pre-recorded audio and an illustrated guide to teach stress management skills. The course is suitable for adults who experiences stress, wherever they live and whatever their circumstances.

Study groups in NCT07524309
Study groupRoleWhat they receive
Self Help Plus interventionActive comparatorThe Self Help Plus intervention is a five-session mental health support delivered to groups of up to 30 people. The Self-Help Plus supports the well-being of individuals facing adversity. This intervention is based on acceptance and commitment therapy and includes developing practical skills in grounding and present moment attention, mindful awareness, cognitive defusion, and valueclarification.
Receives: Other: Self help plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wellbeing - patient-defined mental health problems and functioning

    Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes.

    Measured: Baseline

  2. Wellbeing - patient-defined mental health problems and functioning

    Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes.

    Measured: Immediately after the intervention

  3. Wellbeing - patient-defined mental health problems and functioning

    Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes.

    Measured: 3 months follow-up

  4. WHO-5 Well-being Index

    The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being.

    Measured: Baseline

  5. WHO-5 Well-being Index

    The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being.

    Measured: Immediately after the intervention

  6. WHO-5 Well-being Index

    The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being.

    Measured: 3 months follow-up

Secondary outcomes (6)

  1. Depression symptom severity

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms.

    Measured: Baseline

  2. Depression symptom severity

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms.

    Measured: Immediately after the intervention

  3. Depression symptom severity

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms.

    Measured: 3 months follow-up

  4. Generalized anxiety symptom severity

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms.

    Measured: Baseline

  5. Generalized anxiety symptom severity

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms.

    Measured: Immediately after the intervention

  6. Generalized anxiety symptom severity

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms.

    Measured: 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start15 Jun 2026
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524309
Sponsor's protocol ID
NCR267175
Acronym
T2C
Status last verified
Oct 2026
First submitted
23 Feb 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Self Help Plus (SH+): a group-based stress management course for adults. Generic field-trial version 1.0, 2021. Geneva: World Health Organization; 2021 (Series on low-intensity psychological interventions, No. 5). Licence: CC BY-NC-SA 3.0 IGO.

  • The Self-Help Plus (SH+) training manual: for training facilitators to deliver the SH+ course. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.

  • Singla DR, Lawson A, Kohrt BA, Jung JW, Meng Z, Ratjen C, Zahedi N, Dennis CL, Patel V. Implementation and Effectiveness of Nonspecialist-Delivered Interventions for Perinatal Mental Health in High-Income Countries: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 May 1;78(5):498-509. doi: 10.1001/jamapsychiatry.2020.4556.

    PubMed 33533904

  • Patel V, Saxena S, Lund C, Thornicroft G, Baingana F, Bolton P, Chisholm D, Collins PY, Cooper JL, Eaton J, Herrman H, Herzallah MM, Huang Y, Jordans MJD, Kleinman A, Medina-Mora ME, Morgan E, Niaz U, Omigbodun O, Prince M, Rahman A, Saraceno B, Sarkar BK, De Silva M, Singh I, Stein DJ, Sunkel C, UnUtzer J. The Lancet Commission on global mental health and sustainable development. Lancet. 2018 Oct 27;392(10157):1553-1598. doi: 10.1016/S0140-6736(18)31612-X. Epub 2018 Oct 9. No abstract available.

    PubMed 30314863

  • Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up of treatment of depression and anxiety - Authors' reply. Lancet Psychiatry. 2016 Jul;3(7):603-4. doi: 10.1016/S2215-0366(16)30131-6. No abstract available.

    PubMed 27371983

Questions about this trial

What is this clinical trial studying?

A study testing Self help plus in people with Wellbeing, run by George Washington University at 1 site in Colombia.

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 1 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 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 Colombia. 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?

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?

Wellbeing - patient-defined mental health problems and functioning (time frame: Baseline). The study lists 6 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 NCT07524309, which also lists 5 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 5 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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