Holley Mears Building
Birmingham, Alabama, 35294, United States
NCT Number: NCT05314088
This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: immediately following the 4 week intervention
we will use daily text messaging after the intervention to assess use of resilience resources following stressors. Participants will be texted daily to ask if they experienced a stressor (YES/NO) and then they respond on a 5 pt Likert scale on their levels of 7 resilience resources: hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores will be a total average score and individual average scores for each resource.
Time frame: immediately following the 4 week intervention
we will use daily text messaging after the intervention to assess use of stress reactivity following stressors. Participants will be texted daily to ask if they experienced a stressor (YES/NO) and then they respond on a Visual Analog Scale of their positive and negative affect. Their are 10 items for positive affect and 10 for negative affect. Total average positive and negative affect scores will be used.
Time frame: 3 months after intervention
Medical Outcomes Study HIV Health Survey
Time frame: 3 months after intervention
Centers for Epidemiological Studies Depression Scale
Time frame: 3 months after intervention
Visual Analogue Scale ART adherence
Time frame: 3 months after intervention
HIV Treatment Adherence Self-Efficacy Scale
Time frame: 3 months after intervention
HIV plasma viral load (copies per mL of plasma) extracted from medical records
University of Alabama at Birmingham
Other
Acronym: RISE+
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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