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CBT + HIV Risk Reduction for Social Anxiety (SC-RCT Trial)

N/A

Recruiting

Led By Trevor A Hart, Ph.D, CPsych

Research Sponsored by Ryerson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must self-identify as a man (including trans* men who self-identify as men) and be aged 18 or older

Be older than 18 years old

Must not have

Participants taking PrEP will be excluded from participating. This excludes individuals on daily PrEP dosing, with no more than 3 doses missed per week at the time of exposure and on-demand dosing at the time of the exposure, including at least one dose before and after exposure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 14 weeks, 3- and 6- month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will provide the first efficacy data for a novel and innovative HIV prevention intervention for MSM that combines the most empirically supported treatment for social anxiety disorder, cognitive-behavioural therapy, with HIV risk reduction counselling.

Who is the study for?

This trial is for HIV-negative gay, bisexual, and other men who have sex with men (MSM) over 18 years old. Participants must experience social anxiety, engage in condomless anal sex without PrEP with partners of unknown or positive HIV status, and use substances before or during sexual activity.

What is being tested?

The study tests a new intervention combining cognitive-behavioural therapy (CBT) with HIV risk reduction counselling against applied relaxation to treat social anxiety disorder and reduce substance use and HIV risk behaviors in MSM.

What are the potential side effects?

While not explicitly listed, side effects may include discomfort from discussing personal issues during CBT sessions or relaxation exercises. There could also be emotional distress related to confronting anxiety-provoking situations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking PrEP for HIV prevention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 14 weeks, 3- and 6- month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 14 weeks, 3- and 6- month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 14 weeks, 3- and 6- month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Condomless Anal Sex with partners of unknown or HIV-positive status, without participant use of PrEP, based on response at 6 months (yes/no).

Secondary study objectives

Hepatitis Viruses

Qualitative Exit Interview

Self-report measures

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioural TherapyExperimental Treatment1 Intervention

In sessions 1-2, the participant's sexual history and goals regarding social anxiety reduction and HIV risk reduction will be discussed, including reducing CAS, and considering use of PrEP to reduce HIV risk. In sessions 3-4, the role of social anxiety and substances in social avoidance and HIV risk will be discussed, and a fear hierarchy of the participant's social fears will be created. In sessions 5-7, cognitive restructuring and coping skills for anxiety reduction will be discussed. In sessions 8-9, participants will face their fears via exposures to feared situations using their new cognitive coping skills. In sessions 10-11, exposures are continued with a focus on (a) situations higher in the fear hierarchy and (b) the role of substance use as a barrier to personal goals. In session 12, relapse prevention and goals for progress regarding social anxiety, substance use, and HIV risk reduction beyond the end of therapy will be discussed.

Group II: Applied RelaxationActive Control1 Intervention

In AR, patients are trained in progressive muscle relaxation, and then taught to practice using relaxation when facing feared situations, as a new coping response. AR involves noticing early signs of anxiety, learning relaxation skills, and applying relaxation at the first sign of anxiety. This therapy is chosen because it does not involve the cognitive and exposure focused techniques that are used in the experimental condition. Reviews of psychological treatments show that AR does not statistically differ from cognitive restructuring with exposure in its effects on social anxiety. However, AR is an appropriate control arm for the present study because it is credible and can be time-matched to CBT, but has no theoretical or empirical support for substance use management or HIV risk behaviour reduction, the latter of which is the primary outcome of the present study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioural Therapy

2002

Completed Phase 3

~4030

0 / 2Eligibility criteria met