RISE+: Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05314088

Collaborator

National Institute on Aging (NIA) (NIH)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.

Condition or Disease	Intervention/Treatment	Phase
Resilience HIV-1-infection Stress, Psychological	Behavioral: RISE+ Behavioral: Stress Reduction Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RISE+ Resilience Intervention Participants in the intervention group will come to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention will be facilitated by a trained research assistant but as in the pilot study, he/she will be minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants will be given handouts with summaries of the program material. We will gather qualitative and quantitative feedback on the intervention at the one-month posttest.	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.
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. As with the intervention group, participants in the control group will come to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement will be the same as the intervention group (e.g., the research assistant will explain computer activities and games but will otherwise not interact with the participant).	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.

Arm

Intervention/Treatment

Experimental: RISE+ Resilience Intervention

Participants in the intervention group will come to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention will be facilitated by a trained research assistant but as in the pilot study, he/she will be minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants will be given handouts with summaries of the program material. We will gather qualitative and quantitative feedback on the intervention at the one-month posttest.

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.

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. As with the intervention group, participants in the control group will come to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement will be the same as the intervention group (e.g., the research assistant will explain computer activities and games but will otherwise not interact with the participant).

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.

Outcome Measures

Primary Outcome Measures

resilience resources [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.
stress reactivity [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.

Secondary Outcome Measures

health related quality of life [3 months after intervention]
Medical Outcomes Study HIV Health Survey
depressive symptoms [3 months after intervention]
Centers for Epidemiological Studies Depression Scale
HIV medication adherence [3 months after intervention]
Visual Analogue Scale ART adherence
HIV Treatment Management Abilities [3 months after intervention]
HIV Treatment Adherence Self-Efficacy Scale
HIV Viral Load [3 months after intervention]
HIV plasma viral load (copies per mL of plasma) extracted from medical records

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

current UAB HIV Clinic patient
age 50+
have a recent history (within the past 12 months) of suboptimal HIV management, defined as having either ≥one record of detectable viral load or ≥one missed clinic visit without prior cancellation/reschedule

Exclusion Criteria:

neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham
National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pariya L. Fazeli, PhD, Associate Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05314088

Other Study ID Numbers:

1R21AG076377-01A1

First Posted:

Apr 6, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress, Psychological

Study Results

No Results Posted as of Jun 27, 2022