RecruitingNot ApplicableNCT06389565

Change My Story Task Shifted Mental Health Intervention

Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression

Sponsor

Massachusetts General Hospital

Enrollment

80 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Psychological Distress Depression HIV

Summary

Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.

Eligibility

Min Age: 16 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study tests an adapted digital mental health program called Change My Story to help young HIV-positive people (ages 16–24) who are experiencing depression. The program uses structured exercises delivered through technology to help improve mood and day-to-day functioning. **You may be eligible if...** - You are between 16 and 24 years old and HIV-positive - You have moderate depression symptoms (PHQ-9 score of 8–17) that are affecting your daily life - You have been in HIV care and on antiretroviral treatment for at least 6 months - You read and understand English **You may NOT be eligible if...** - You are pregnant or nursing - You have been in HIV care for less than 6 months - You have a history of bipolar disorder or psychotic disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALProblem Solving Therapy

Problem solving therapy (PST) is a cognitive-behavioral therapy (CBT)-based intervention that uses seven basic steps to teach problem solving orientation and skills to equip individuals to manage the impact of stressful life events on their mental health.

OTHERChange My Story

Change My Story is a narrative game with a choose-your-own-adventure format in which players navigate emotionally difficult experiences along with the character(s) and interact with the virtual environment to choose a narrative path toward the story's conclusion. It will used to address important obstacles in the mental health treatment gap for Y-PLWH.

Locations(1)

University of Ibadan

Ibadan, Oyo State, Nigeria

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NCT06389565

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