Sexual Confidence: CBT for Social Anxiety Disorder With HIV Risk Reduction Counselling for HIV-negative gbMSM

NCT04381559 | Unknown DMC

• 1 other identifier: 2020-100
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Given the continued high human immunodeficiency virus (HIV) prevalence rates among gay, bisexual, and other men who have sex with men (MSM) in North American cities, there is a critical need for HIV prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal and performance situations, is a reliable risk factor for condomless anal sex (CAS) among MSM. Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM. As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide the first efficacy data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and therapies to reduce social anxiety. The investigators propose to test the efficacy of a novel integrated HIV prevention intervention that combines the most empirically supported treatment for social anxiety disorder, cognitive-behavioural therapy, with HIV risk reduction counselling in order to simultaneously treat social anxiety disorder, substance use disorders, and HIV sexual risk behaviour. This study will be a randomized controlled trial comparing the study intervention relative to applied relaxation, a behavioural intervention that is efficacious in treating social anxiety disorder but that does not address substance use problems or HIV sexual risk behaviours. For this trial, 176 participants will be randomized to either 12 sessions of cognitive-behavioural therapy with HIV risk reduction counselling or 12 sessions of applied relaxation. Participants will be eligible for the trial if they are HIV-negative, report clinically significant symptoms of social anxiety disorder, substance use 2 hours before or during sexual activity, and CAS without the use of pre-exposure prophylaxis (PrEP) with a male partner who was not known to be HIV-negative. PrEP is a biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV.126 The present intervention, if found to be efficacious, is innovative in that mental health clinicians will be able to not only extend empirically supported therapies tested primarily with heterosexual populations to MSM, but they will also be able to prevent HIV through empirically supported psychotherapy practice.

Conditions

Social Anxiety; Sexual Risk; HIV

Keywords

MSM, social anxiety, HIV, sexual risk

Outcome Measures

Primary Outcomes (1)

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

  Participants will indicate frequency of and number of sexual partners for 1) insertive and receptive anal sex and vaginal or frontal sex both with and without a condom, in the past 3 months. For each of these 3 sexual behaviours, we will ask whether the sexual behaviour was with partners who were HIV-positive, HIV-negative, or of unknown serostatus. Participants will also be asked if they had insertive or receptive CAS or condomless vaginal or frontal sex with their last sex partner, as well as the HIV status of the person with whom they last had CAS or condomless vaginal or frontal sex. A draft of this measure is included in the "Questionnaire" document.

  6-months follow-up

Secondary Outcomes (6)

• Social Anxiety Measures

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

• The Structured Clinical Interview for DSM-5 Disorders (SCID-5)

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

• Self-report measures

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

• Yale Adherence & Competence Scale-II Cognitive Behavioural Therapy Scales

  3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks

• 11.5 Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis

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

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioural Therapy

Applied Relaxation

ACTIVE COMPARATOR

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.

Behavioral: Applied Relaxation

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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.

Cognitive Behavioural Therapy

Applied Relaxation BEHAVIORAL

12 sessions of AR will serve as our second, control arm. 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.86 AR involves noticing early signs of anxiety, learning relaxation skills, and applying relaxation at the first sign of anxiety.87 This therapy is chosen because it does not involve the cognitive and exposure focused techniques that are used in the experimental condition.88 Reviews of psychological treatments show that AR does not statistically differ from cognitive restructuring with exposure in its effects on social anxiety.87 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.

Applied Relaxation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gay and bisexual men and other men who have sex with men (including trans men)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must report engaging in CAS sex without PrEP with a man of HIV-positive or unknown HIV status within the last 3 months and report using substances within 2 hours before and/or during sexual activities. Participants must self-identify as a man (including trans\* men who self-identify as men), and be aged 18 or older.
• To minimize bias, participants will be asked to report to the research study clinician in case they decide to engage in other psychotherapies outside of the study protocol or decide to change their psychoactive medication or dose for the duration of their participation in the study. Participants who participate in outside psychotherapies or who change their medication regimens will still be permitted to conclude the therapy, but their data will not be included in the RCT analyses.

You may not qualify if:

• As mentioned previously, participants taking PrEP will be excluded from participating. This excludes individuals 1) on daily PrEP dosing, with no more then 3 doses missed per week at the time of exposure and 2) on-demand dosing at the time of the exposure, including at least one dose before and after exposure. Participants need to score within 1 SD of the clinical mean (M = 67.2) for social anxiety disorder on the Liebowitz Social Anxiety Scale.
• Persons will be excluded if our assessors/counsellors find that a participant's ability to respond to study measures is compromised by mental or physical disabilities or inability to speak and understand English.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• University of British Columbia: collaborator
• Unity Health Toronto: collaborator

Study Sites (1)

Toronto Metropolitan University

Toronto, Ontario, M5B 1Y3, Canada

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Trevor A Hart, Ph.D, CPsych

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Cao

CONTACT

4169795000; hivprevmanager@torontomu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Counsellors cannot be blinded as they are providing treatment, however assessors will be blinded to treatment condition. Participants will not be provided with details on the treatment condition to which they were not assigned to minimize the possibility that participant beliefs about which condition is better will impact outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Our proposed research is a single blind, two arm randomized trial. Participants will be randomly assigned to the CBT or Applied Relaxation (AR) arm. Participants will be randomly assigned to CBT, the experimental arm, or the AR arm, which serves as the control condition. Both arms are active treatment conditions; however, we hypothesize that the Sexual Confidence CBT arm will have a significantly larger effect on sexual risk behaviour than the AR arm as AR does not discuss or address substance use, sexual risk reduction, or sexual behaviour.

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 11, 2020
• Study Start: December 15, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 30, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)