StressACT for HIVNCT06625437
ACT for HIV-Positive Men
A study testing Acceptance and commitment therapy in people with Stress and Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress, Anxiety, Mental Disorder
- What is being tested?
- Acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- identify as a man
- be at least 18 years old
- has been diagnosed with HIV by a healthcare professional
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Anxiety, Mental Disorder, Distress-based Psychopathology
- Being tested
- Acceptance and commitment therapy
- Medical subject headings
- Anxiety Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy | Experimental | Trial of acceptance and commitment therapy for hiv-positive men. Receives: Behavioral: Acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 Screener
Measure of depressive symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Internalized homophobia scale
Measure of internalized homophobia
Measured: 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
Measured: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Life Quality Scale
Measure of life quality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
PSYFLEX
Measure of psychological flexibility
Measured: 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
Measure of patient and therapist alliance
Measured: Administered immediately after final intervention session (8th/final session; each session is 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start15 Jan 2025
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Why it stopped: Insufficient administrative resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post design with single group of participants who will each receive the treatment
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas C. Borgogna, University of Alabama at Birmingham
- Investigators
- Nicholas Borgogna, PhD, Principal investigator, University of Alabama at BirminghamDrew Whittington, MS, MA, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625437
- Sponsor's protocol ID
- IRB-300013506
- Other IDs
- Start-up
- Acronym
- ACT for HIV
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset will be shared with requesting researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Acceptance and Commitment Therapy for General Mental Health Concerns in HIV-Positive Men
- ClinicalTrials.gov ID
- NCT06625437
- Acronym / sponsor ID
- ACT for HIV / IRB-300013506
- Conditions
- Stress, Anxiety, Mental Disorder, Distress-based Psychopathology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient administrative resources.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post design with single group of participants who will each receive the treatment
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy | Experimental | Behavioral: Acceptance and commitment therapyTrial of acceptance and commitment therapy for hiv-positive men. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- identify as a man
- be at least 18 years old
- has been diagnosed with HIV by a healthcare professional
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyAcceptance 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 | Behavioural | Acceptance and commitment therapy |
Primary outcome
Patient Health Questionnaire-9 Screener
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of depressive symptoms
PTSD Checklist-5
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of post-traumatic stress symptoms
Yale-Brown Obsessive Compulsive Scale
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of obsessive-compulsive disorder symptoms
Alcohol Use Disorders Identification Test
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of alcohol use
HIV stigma scale
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of facets of stigma experienced by individuals with HIV
Internalized homophobia scale
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of internalized homophobia
Brief pornography screen
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of concerning pornography use
Life Quality Scale
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of life quality
Experiential Avoidance Rating Scale
Time frame: 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)
Measure of experiential avoidance
National Institute of Drug Abuse Modified Alcohol, Smoking, and Substance Involvement Screening Test
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of drug use
High risk sexual behaviors
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
* Frequency of sex with penetration * Frequency of condom use * Frequency of oral sex * Frequency of sexual partners
Generalized Anxiety Disorder-7 Screener
Time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of anxiety symptoms
PSYFLEX
Time frame: 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)
Measure of psychological flexibility
1 secondary outcome
Therapeutic Alliance Scale
Time frame: Administered immediately after final intervention session (8th/final session; each session is 1 hour)
Results and safety
The study was stopped early (reason given: Insufficient administrative resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Dataset will be shared with requesting researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Borgogna, PhD principal investigator
University of Alabama at Birmingham
Drew Whittington, MS, MA principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy in people with Stress and Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient administrative resources.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 Screener (time frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.