Change My Story Task Shifted Mental Health Intervention

Официальное название

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

Обзор

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.

Подробное описание

Young people living with HIV (Y-PLWH) have poor adherence to antiretroviral therapy and engagement in HIV care, making HIV the leading cause of death for African adolescents. Depression and psychological distress are much more common among Y-PLWH than in the general population, and are associated with significantly worse adherence to care and treatment when compared to Y-PLWH without these co-morbid conditions. Thus, untreated depression and severe psychological distress are important contributors to poor HIV outcomes in this population. Nigeria is home to the 4th largest HIV population globally and 10% of Y-PLWH, but mental health screening is not routinely conducted in this setting, and less than 10% of those diagnosed have access to evidence-based care. Despite this treatment gap, few interventions have targeted the mental health needs of Y-PLWH in Africa. The World Health Organization recommends that caregivers of Y-PLWH adopt youth-friendly strategies and incorporate psychosocial services to meet their needs, and that task shifting to non-specialized health workers be used to overcome the dearth of trained professionals in low and middle-income countries. Task-shifted problem Solving Therapy (PST) has been effectively used to treat both depression and psychological distress using a task-shifted approach. However, PST is an intensive strategy (typically 6-15 weekly sessions) often delivered in-person and poor completion rates are associated with less effectiveness. Mobile health technologies may be uniquely suited to surmount some of the obstacles for effective A theory-grounded game, Change My Story, has been developed which allows players navigate difficult experiences based on drivers of psychological distress and interact with a virtual environment this research aims to 1) conduct a hybrid implementation-effectiveness pilot RCT for 80 Y-PLWH with depression or psychological distress, and compare feasibility, acceptability, engagement, satisfaction and preliminary effectiveness among individuals receiving PST alone or PST with Change My Story, and 2) use the Consolidated Framework for Implementation Research (CFIR) to assess factors influencing engagement, acceptability, and satisfaction along with facilitators and barriers to implementation delivery.

Вмешательства

• Поведенческое Problem 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.
• Другое Change 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.

Первичные конечные точки

• Engagement [Срок оценки: 3 months]
• Patient Satisfaction with Interventionn [Срок оценки: 3 months]
• Feasibility 1 [Срок оценки: 3 months]
• Feasibility 2 [Срок оценки: 3 months]
• Feasibility 3 [Срок оценки: 3 months]
• Feasibility 4 [Срок оценки: 3 months]
• Feasibility 5 [Срок оценки: Baseline]
• Feasibility 6 [Срок оценки: 3 months]
• Feasibility 7 [Срок оценки: 3 months]
• Acceptability 1 [Срок оценки: Once]

Вторичные конечные точки (4)

• Remission of depression. [Срок оценки: 3 and 6 months]
• Remission of psychological distress. [Срок оценки: 3 and 6 months]
• ART adherence [Срок оценки: 3 and 6 months]
• Viral suppression [Срок оценки: 3 to 6 months]

Критерии участия

Критерии включения

• HIV-positive
• age 16-29 years
• self-reported proficiency in reading and understanding English.
• PHQ9 score of 9-17 and impairment in functioning (consistent with clinical depression)

Критерии исключения

• pregnant or nursing
• in care and on ART for <6 months
• history of- or positive assessment for- bipolar or psychotic disorder.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Nigeria · 1 центр

• University of Ibadan — Ibadan

Публикации

• Eliazer C, Omotosho T, Kuti KM, Pierce LJ, Gray D, Audet CM, Awolude O, Gureje O, Oladeji B, Ahonkhai AA. A Mobile Game Intervention for Young Persons Living With HIV and Depression in Nigeria: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Dec 3;14:e74199. doi: 10.2196/74199. PMID 41337738

Идентификаторы

NCT: NCT06389565 · 2024p000857

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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