Pilot Randomized Clinical Trial of Change My Story

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Hiv; Psychological Distress
• Intervention / Treatment: Behavioral: Problem Solving Therapy; Other: Change My Story

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aima a Ahonkhai, MD; Phone Number: 617-726-3906; Email: AAHONKHAI@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PST alone; 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.	Behavioral: 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.
Experimental: PST with Change My Story; 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.	Behavioral: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	The percentage of recommended problem solving therapy sessions attended.	3 months
Satisfaction	Based on an adapted version of the client satisfaction questionnaire (CSQ-8). Total scores range from 8 to 32, with the higher number indicating greater satisfaction.	3 months
Feasibility 1	Weiner's feasibility of an intervention (FIM). Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.	3 months
Feasibility 2	Proportion of consented patients enrolled	3 months
Feasibility 3	Proportion of game play sessions interrupted by technical problems	3 months
Feasibility 4	Proportion of users requiring mobile phone (at baseline) or requiring a replacement phone (due to loss or theft)	3 months
Feasibility 5	Proportion of users requiring mobile phone	Baseline
Feasibility 6	Proportion of users requiring mobile phone replacement due to loss or theft	3 months
Feasibility 7	Proportion in need for additional data bundles	3 months
Acceptability 1	Weiner's acceptability of an intervention. Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.	Once
Acceptability 2	Number of minutes of total game play per month	up to 3 months
Acceptability 3	Number of days of total game play per month	up to 3 months
Acceptability 4	Percentage of recommended game play minutes completed	3 months
Acceptability 5	Proportion of narratives completed assessed from aggregated game play metrics	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission of depression.	Patient health questionnaire-9. For this research, a PHQ-9 score < 6 will be considered in remission.	3 and 6 months
Remission of psychological distress.	Self reporting questionnaire-20. For this research, a SRQ-20 < 5 will be considered in remission.	3 and 6 months
ART adherence	Based on % pharmacy refill	3 and 6 months
Viral suppression	VL < 200 copies/mL	3 and 6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: University of Ibadan

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2024p000857

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No