Change My Story Task Shifted Mental Health Intervention

NCT06389565 | Recruiting DMC

• 1 other identifier: 2024p000857
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Depression; Psychological Distress

Outcome Measures

Primary Outcomes (14)

• Engagement

  The percentage of recommended problem solving therapy sessions attended.

  3 months

• Patient Satisfaction with Interventionn

  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 Outcomes (4)

• Remission of depression.

  3 and 6 months

• Remission of psychological distress.

  3 and 6 months

• ART adherence

  3 and 6 months

• Viral suppression

  3 and 6 months

Study Arms (2)

PST alone

ACTIVE COMPARATOR

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

PST with Change My Story

EXPERIMENTAL

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; Other: Change My Story

Interventions

Problem Solving Therapy BEHAVIORAL

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.

PST alone; PST with Change My Story

Change My Story OTHER

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.

PST with Change My Story

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Ibadan: collaborator

Study Sites (1)

University of Ibadan

Ibadan, Oyo State, Nigeria

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Aima a Ahonkhai, MD

CONTACT

617-726-3906; AAHONKHAI@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician in Medicine

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 29, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-06

Locations

NG (1)