Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALRISE+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.
BEHAVIORALStress Reduction ControlPlacebo 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.