Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility 7
研究概览
简要总结
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.
详细描述
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. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •pregnant or nursing
- •in care and on ART for <6 months
- •history of- or positive assessment for- bipolar or psychotic disorder.
研究组 & 干预措施
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.
干预措施: Problem Solving Therapy (Behavioral)
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.
干预措施: Problem Solving Therapy (Behavioral)
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.
干预措施: Change My Story (Other)
结局指标
主要结局
Feasibility 7
时间窗: 3 months
Proportion in need for additional data bundles
Feasibility 6
时间窗: 3 months
Proportion of users requiring mobile phone replacement due to loss or theft
Engagement
时间窗: 3 months
The percentage of recommended problem solving therapy sessions attended.
Patient Satisfaction with Interventionn
时间窗: 3 months
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.
Feasibility 1
时间窗: 3 months
Weiner's feasibility of an intervention (FIM). Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Feasibility 2
时间窗: 3 months
Proportion of consented patients enrolled
Feasibility 3
时间窗: 3 months
Proportion of game play sessions interrupted by technical problems
Feasibility 4
时间窗: 3 months
Proportion of users requiring mobile phone (at baseline) or requiring a replacement phone (due to loss or theft)
Feasibility 5
时间窗: Baseline
Proportion of users requiring mobile phone
Acceptability 1
时间窗: Once
Weiner's acceptability of an intervention. Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Acceptability 2
时间窗: up to 3 months
Number of minutes of total game play per month
Acceptability 3
时间窗: up to 3 months
Number of days of total game play per month
Acceptability 4
时间窗: 3 months
Percentage of recommended game play minutes completed
Acceptability 5
时间窗: 3 months
Proportion of narratives completed assessed from aggregated game play metrics
Feasibility 7
时间窗: 3 months
Proportion in need for additional data bundles
Acceptability 1
时间窗: Once
Weiner's acceptability of an intervention. Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Acceptability 2
时间窗: up to 3 months
Number of minutes of total game play per month
Acceptability 3
时间窗: up to 3 months
Number of days of total game play per month
Acceptability 4
时间窗: 3 months
Percentage of recommended game play minutes completed
Acceptability 5
时间窗: 3 months
Proportion of narratives completed assessed from aggregated game play metrics
Engagement
时间窗: 3 months
The percentage of recommended problem solving therapy sessions attended.
Feasibility 1
时间窗: 3 months
Weiner's feasibility of an intervention (FIM). Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Feasibility 2
时间窗: 3 months
Proportion of consented patients enrolled
Feasibility 3
时间窗: 3 months
Proportion of game play sessions interrupted by technical problems
Feasibility 4
时间窗: 3 months
Proportion of users requiring mobile phone (at baseline) or requiring a replacement phone (due to loss or theft)
Feasibility 5
时间窗: Baseline
Proportion of users requiring mobile phone
Feasibility 6
时间窗: 3 months
Proportion of users requiring mobile phone replacement due to loss or theft
次要结局
- Viral suppression(3 and 6 months)
- Remission of depression.(3 and 6 months)
- Remission of psychological distress.(3 and 6 months)
- ART adherence(3 and 6 months)
研究者
Aimalohi Ahonkhai
Associate Physician in Medicine
Massachusetts General Hospital