Pilot Randomized Clinical Trial of Change My Story

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389565
• Other study ID #: 2024p000857
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Aima a Ahonkhai, MD
• Phone: 617-726-3906
• Email: AAHONKHAI[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Hiv
• Psychological Distress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Ibadan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement	The percentage of recommended problem solving therapy sessions attended.	3 months
Primary	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
Primary	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
Primary	Feasibility 2	Proportion of consented patients enrolled	3 months
Primary	Feasibility 3	Proportion of game play sessions interrupted by technical problems	3 months
Primary	Feasibility 4	Proportion of users requiring mobile phone (at baseline) or requiring a replacement phone (due to loss or theft)	3 months
Primary	Feasibility 5	Proportion of users requiring mobile phone	Baseline
Primary	Feasibility 6	Proportion of users requiring mobile phone replacement due to loss or theft	3 months
Primary	Feasibility 7	Proportion in need for additional data bundles	3 months
Primary	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
Primary	Acceptability 2	Number of minutes of total game play per month	up to 3 months
Primary	Acceptability 3	Number of days of total game play per month	up to 3 months
Primary	Acceptability 4	Percentage of recommended game play minutes completed	3 months
Primary	Acceptability 5	Proportion of narratives completed assessed from aggregated game play metrics	3 months
Secondary	Remission of depression.	Patient health questionnaire-9. For this research, a PHQ-9 score < 6 will be considered in remission.	3 and 6 months
Secondary	Remission of psychological distress.	Self reporting questionnaire-20. For this research, a SRQ-20 < 5 will be considered in remission.	3 and 6 months
Secondary	ART adherence	Based on % pharmacy refill	3 and 6 months
Secondary	Viral suppression	VL < 200 copies/mL	3 and 6 months