Health Trials

Change My Story Task Shifted Mental Health Intervention

ConditionsHivDepressionPsychological Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-29
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

pregnant or nursing

in care and on ART for <6 months

history of- or positive assessment for- bipolar or psychotic disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Change My Story

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: PST aloneActive comparator 1 intervention
Group B: PST with Change My StoryExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Engagement

The percentage of recommended problem solving therapy sessions attended.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months
4

Feasibility 2

Proportion of consented patients enrolled

Time frame
3 months

Secondary outcomes

1

Remission of depression.

Patient health questionnaire-9. For this research, a PHQ-9 score \< 6 will be considered in remission.

Time frame
3 and 6 months
2

Remission of psychological distress.

Self reporting questionnaire-20. For this research, a SRQ-20 \< 5 will be considered in remission.

Time frame
3 and 6 months
3

ART adherence

Based on % pharmacy refill

Time frame
3 and 6 months
4

Viral suppression

VL \< 200 copies/mL

Time frame
3 to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

University of Ibadan

Collaborator

Source ClinicalTrials.gov
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