Trials / Completed
CompletedNCT05314088
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.
Detailed description
A two-group RCT will enroll 100 older (aged 50+) people living with HIV (PLHIV), who will be recruited from the UAB HIV outpatient clinic. Eligible participants will complete a baseline assessment including a 14-day experience sampling method (ESM) protocol, and then be randomized to either the intervention group (n=50) or an attention-matched control group (n=50). We will block randomize groups based on race, sex, and self-reported resilience (Connor Davidson Resilience Scale). If differences are found between groups on influential variables (e.g., SES), such factors will be controlled in analyses and exploratory aim analyses will examine treatment moderators (e.g., sex, race). Both groups will return for four weekly two-hour group visits, followed by a one-month post intervention assessment (including qualitative and quantitative feedback) and a second ESM protocol. A three-month follow-up (comparable to baseline) will assess health outcomes. A blinded research assistant will conduct follow-ups. Our Primary Aims will use ESM via text messaging, and focus on intervention effects on the use of resilience resources following times when stressors are reported and whether such increases drive improved affective stress reactivity and recovery (Aim 1). Our secondary aim will examine effects on health outcomes at three months. Our exploratory aim will examine moderators of treatment response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | RISE+ | The intervention includes psychoeducational videos and written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. |
| BEHAVIORAL | Stress Reduction Control | Placebo Comparator: Stress Reduction Control Control participants will complete an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games. |
Timeline
- Start date
- 2023-02-03
- Primary completion
- 2025-05-31
- Completion
- 2025-05-31
- First posted
- 2022-04-06
- Last updated
- 2025-09-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05314088. Inclusion in this directory is not an endorsement.