ACT for HIV-Positive Men

NCT06625437 | Terminated

• 2 other identifiers: IRB-300013506Start-up
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men.

Conditions

Stress; Anxiety; Mental Disorder; Distress-based Psychopathology

Outcome Measures

Primary Outcomes (13)

• Patient Health Questionnaire-9 Screener

  Measure of depressive symptoms

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• PTSD Checklist-5

  Measure of post-traumatic stress symptoms

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Yale-Brown Obsessive Compulsive Scale

  Measure of obsessive-compulsive disorder symptoms

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Alcohol Use Disorders Identification Test

  Measure of alcohol use

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• HIV stigma scale

  Measure of facets of stigma experienced by individuals with HIV

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Internalized homophobia scale

  Measure of internalized homophobia

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Brief pornography screen

  Measure of concerning pornography use

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Life Quality Scale

  Measure of life quality

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Experiential Avoidance Rating Scale

  Measure of experiential avoidance

  Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)

• National Institute of Drug Abuse Modified Alcohol, Smoking, and Substance Involvement Screening Test

  Measure of drug use

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• High risk sexual behaviors

  * Frequency of sex with penetration * Frequency of condom use * Frequency of oral sex * Frequency of sexual partners

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• Generalized Anxiety Disorder-7 Screener

  Measure of anxiety symptoms

  Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)

• PSYFLEX

  Measure of psychological flexibility

  Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)

Secondary Outcomes (1)

• Therapeutic Alliance Scale

  Administered immediately after final intervention session (8th/final session; each session is 1 hour)

Study Arms (1)

Acceptance and commitment therapy

EXPERIMENTAL

Trial of acceptance and commitment therapy for hiv-positive men.

Behavioral: Acceptance and commitment therapy

Interventions

Acceptance and commitment therapy BEHAVIORAL

Acceptance and commitment therapy is a psychotherapy focused at increasing psychological flexibility and an individual\'s engagement in valued activities rather than focusing solely or primarily on reducing psychiatric symptoms

Acceptance and commitment therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• identify as a man
• be at least 18 years old
• has been diagnosed with HIV by a healthcare professional

You may not qualify if:

• has engaged in self-harm within the last three months
• has attempted suicide within the last year
• has had an active plan to attempt suicide within the last 30 days
• is currently diagnosed with any eating disorder
• has experienced hallucinations or delusions within the last 30 days
• has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Mental Disorders

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicholas Borgogna, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Drew Whittington, MS, MA

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pre-post design with single group of participants who will each receive the treatment

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 3, 2024
• Study Start: January 15, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: When results are published
• Access Criteria: Requesting researchers

Locations

US (1)