ACT for HIV-Positive Men (ACT for HIV)

Evaluation of the Effectiveness of Acceptance and Commitment Therapy for General Mental Health Concerns in HIV-Positive Men

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.

Study Overview

• Status: Terminated
• Conditions: Stress; Anxiety; Mental Disorder; Distress-based Psychopathology
• Intervention / Treatment: Behavioral: Acceptance and commitment therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and commitment therapy; Trial of acceptance and commitment therapy for hiv-positive men.	Behavioral: Acceptance and commitment therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Alliance Scale	Measure of patient and therapist alliance	Administered immediately after final intervention session (8th/final session; each session is 1 hour)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Nicholas Borgogna, PhD, University of Alabama at Birmingham; Principal Investigator: Drew Whittington, MS, MA, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 16, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anxiety Disorders; Mental Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: IRB-300013506; Start-up (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Dataset will be shared with requesting researchers
• IPD Sharing Time Frame: When results are published
• IPD Sharing Access Criteria: Requesting researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No