Change My Story Task Shifted Mental Health Intervention

Mass General Brigham

Status: Enrolling

Conditions: Depression; Hiv; Psychological Distress

Treatments: Behavioral: Problem Solving Therapy; Other: Change My Story

Study type: Interventional

Funder types: Other

Identifiers

NCT06389565

2024p000857

Details and patient eligibility

About

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.

Full description

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 -- a concern further magnified during the current COVID-19 climate. 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-positive
• age 16-24 years
• self-reported proficiency in reading and understanding English.
• PHQ9 score of 8-17 and impairment in functioning (consistent with clinical depression)

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

PST alone

Active Comparator group

Description:

Patients randomized to PST alone will receive PST delivered using a stepped-care approach. Subsequent care will be determined based on participant PHQ-9 score at the week 6 evaluation. All participants who do not achieve remission (PHQ-9 \<12) after completion of the additional six-week therapy sessions, will be required to have a referral to either the general MD or psychiatrist at the clinic to determine need for pharmacologic treatment or additional intervention based on local clinical practice guidelines. During each PST session, the HIV counselor will ask the participant structured questions to identify those at risk of suicide, or with adverse reactions to prescribed antidepressants. Participants who indicate suicidality (plan/attempt) during PST sessions, or ongoing refractory disease (at reassessment points) will require immediate consultation by the psychiatry clinic.

Treatment:

Behavioral: Problem Solving Therapy

PST with Change My Story

Experimental group

Description:

In addition to all activities described in the PST alone arm, at enrollment, participants in the arm with Change My Story, will download the game onto their phones, receive instructions about the game and receive recommendations on how to play the game (at least one narrative for one of the three characters) each week within 48 hours of the PST session. Participants will be encouraged to set a weekly reminder alarm for their game play session. Participants will have an opportunity to explore the game at will according to these loose parameters prior to the first PST session.

Treatment:

Other: Change My Story

Behavioral: Problem Solving Therapy