CBT + HIV Risk Reduction for Social Anxiety

(SC-RCT Trial)

Recruiting at 1 trial location

Overseen By Jane Cao

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Ryerson University

Must not be taking: PrEP

Disqualifiers: PrEP, Disabilities, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 14 weeks

176 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications to join the trial?

The trial does not require you to stop taking your current medications, but if you change your medication or dose during the study, your data won't be included in the main analysis.

What data supports the effectiveness of the treatment Applied Relaxation, Applied Relaxation Therapy, Cognitive Behavioural Therapy, CBT, Cognitive Behavioral Therapy for social anxiety?

Research shows that Cognitive Behavioral Therapy (CBT), including group therapy formats, is effective in reducing social anxiety symptoms and improving quality of life. Studies have demonstrated significant improvements in social anxiety and life interference, both in research settings and community clinics, indicating that CBT is a reliable treatment for social anxiety. ^{1 2 3 4 5}

Is CBT safe for people with HIV and anxiety?

Cognitive Behavioral Therapy (CBT) has been shown to be generally safe for people with HIV and anxiety, as it is a psychological treatment that does not involve medication and focuses on changing thought patterns to improve mental health. ^{6 7 8 9 10}

How does the CBT + HIV Risk Reduction treatment for social anxiety differ from other treatments?

This treatment is unique because it combines Cognitive Behavioral Therapy (CBT), which is effective in reducing anxiety and improving medication adherence, with HIV risk reduction strategies, specifically targeting social anxiety in people living with HIV. Unlike standard anxiety treatments, this approach addresses both psychological and behavioral aspects related to HIV, aiming to improve overall quality of life and health outcomes. ^{6 7 10 11 12}

Research Team

Trevor A Hart, Ph.D, CPsych

Principal Investigator

Toronto Metropolitan University

Eligibility Criteria

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.

Inclusion Criteria

I've had unprotected sex with a potentially HIV-positive partner and used substances before or during sex in the last 3 months.

I am a man aged 18 or older.

I will inform the study team if I start any new mental health treatments or change my medication.

Exclusion Criteria

I am not currently taking PrEP for HIV prevention.

Persons will be excluded if 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

Participants need to score within 1 SD of the clinical mean (M = 67.2) for social anxiety disorder on the Liebowitz Social Anxiety Scale

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of cognitive-behavioural therapy with HIV risk reduction counselling or 12 sessions of applied relaxation

14 weeks

12 sessions (teletherapy)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of social anxiety, substance use, and sexual risk behaviour

6 months

3 visits (virtual)

Treatment Details

Interventions

• Applied Relaxation
• Cognitive Behavioural Therapy

Trial Overview 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.

Participant Groups

Group I: Cognitive Behavioural Therapy Experimental Treatment 1 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 Relaxation Active Control 1 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.

Who Is Running the Clinical Trial?

Ryerson University

Lead Sponsor

Trials

77

Recruited

7,800+

Toronto Metropolitan University

Lead Sponsor

Trials

95

Recruited

19,300+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Findings from Research

Cognitive Behavioural Group Therapy (CBGT) for social phobia was effective in reducing symptoms and life interference in both research (71 patients) and community clinic settings (94 patients), demonstrating its efficacy across different environments.

Despite community patients starting with more severe symptoms and additional challenges, the degree of improvement in social anxiety was similar to that of patients in the research unit, indicating that CBGT can be successfully implemented in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural group therapy for social phobia: evidence of transportability to community clinics. McEvoy, PM., Nathan, P., Rapee, RM., et al.[2018]

Brief cognitive behavior group therapy (bCBGT) significantly improved symptoms of social anxiety disorder (SAD) in a study of 50 medical students, showing large effect sizes at both post-treatment and two-month follow-up assessments.

bCBGT was found to be statistically superior to a credible placebo therapy (psychoeducational-supportive therapy) in reducing social anxiety symptoms, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief cognitive behavior group therapy for social anxiety among medical students: A randomized placebo-controlled trial. Samantaray, NN., Nath, B., Behera, N., et al.[2021]

Cognitive behavioural group therapy (CBGT) for social phobia was effective in a community mental health clinic, with 153 patients showing significant reductions in social anxiety and depression after attending seven sessions.

More than half of the participants who completed the treatment experienced reliable improvement, and one-third achieved clinically significant change on key measures, indicating that CBGT can be a valuable intervention for social phobia in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioural group therapy for social phobia in a community clinic: a benchmarking study. McEvoy, PM.[2022]

Cognitive-behavioral therapy (CBT) is the most researched non-drug treatment for social anxiety disorder, showing significant effectiveness in improving symptoms and quality of life based on numerous studies.

The article reviews various CBT methods and their efficacy over both short and long-term periods, highlighting the potential benefits of combining CBT with medication for enhanced treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for social anxiety disorder: current status and future directions. Heimberg, RG.[2019]

Social phobia affects about 13% of adults in the U.S. and is a chronic condition that typically requires intervention for significant improvement, highlighting the need for effective long-term treatments.

Cognitive-behavioral group therapy (CBGT), which combines exposure and cognitive restructuring, has shown lasting efficacy, with patients maintaining improvements even five years post-treatment, although the exact components that contribute to its effectiveness remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social phobia. Longitudinal course and long-term outcome of cognitive-behavioral treatment. Juster, HR., Heimberg, RG.[2018]

A systematic review of 39 studies on anxiety in HIV-positive individuals found that 48% of the interventions were effective in reducing anxiety, with psychological therapies, particularly cognitive behavioral therapy, showing greater efficacy than pharmacological treatments.

The majority of studies were conducted in North America and predominantly involved men, highlighting a significant gap in research on women, children, and individuals from developing countries, as well as a need for standardized anxiety measurement in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions for anxiety in people with HIV. Clucas, C., Sibley, E., Harding, R., et al.[2022]

The HIV/Anxiety Management-Reduction Treatment (HAMRT) is a six-session cognitive-behavioral therapy designed to reduce anxiety symptoms in people living with HIV/AIDS, and it has shown effectiveness in decreasing anxiety, depression, and negative feelings in three case studies.

HAMRT also improved medication adherence and quality of life for participants, highlighting its potential as a valuable intervention for enhancing overall well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Integrated Cognitive-Behavioral Therapy for Anxiety and Medication Adherence Among Persons Living With HIV/AIDS. Brandt, CP., Paulus, DJ., Garza, M., et al.[2020]

In a study of 422 HIV-positive individuals, 17.3% reported experiencing anxiety and fear, highlighting the prevalence of these symptoms in this population.

Self-care strategies were commonly employed to manage anxiety and fear, with distraction activities (25%) and talking to others (21%) being the most frequently used methods, indicating the importance of social support and coping mechanisms in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care management of anxiety and fear in HIV disease. Kemppainen, JK., Holzemer, WL., Nokes, K., et al.[2015]

In a study involving 45 HIV-positive men divided into three groups, both group stress management training and cognitive-behavioral therapy (CBT) effectively reduced levels of depression, anxiety, and perceived stress.

Group stress management training was found to be more effective than CBT in decreasing these mental health issues among the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Training of Stress Management vs. Group Cognitive-Behavioral Therapy in Reducing Depression, Anxiety and Perceived Stress Among HIV-Positive Men. Hemmati Sabet, A., Khalatbari, J., Abbas Ghorbani, M., et al.[2021]

A systematic review of 40 studies involving 24,111 patients with AIDS found that the overall prevalence of anxiety among these patients is 25%, indicating a significant mental health concern that needs to be addressed.

The study revealed that anxiety prevalence is highest in South America at 38% and lowest in Africa at 19%, suggesting that geographical and socio-economic factors may influence mental health outcomes in AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The worldwide prevalence of anxiety in acquired immune deficiency syndrome patients: A systematic review and meta-analysis. Rahmati, J., Ahmadi, S., Rezaei, S., et al.[2021]

A behavioral stress-management program significantly improved anxiety, mood, self-esteem, and T-cell counts in HIV-positive men with low T-cell counts (below 400) after 20 biweekly sessions.

The improvements were maintained one month after treatment, suggesting that stress management could be an important part of care for individuals with HIV, as it may help support immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a behavioral stress-management program on anxiety, mood, self-esteem, and T-cell count in HIV positive men. Taylor, DN.[2009]

In a study involving 35 individuals living with HIV/AIDS, cognitive-behavioral therapy (CBT) for anxiety led to significant reductions in anxiety sensitivity, which is a key factor in maintaining anxiety and depression.

The reductions in anxiety sensitivity were directly linked to improvements in anxiety and depressive symptoms, as well as overall quality of life, highlighting the importance of targeting anxiety sensitivity in treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectory of change in anxiety sensitivity in relation to anxiety, depression, and quality of life among persons living with HIV/AIDS following transdiagnostic cognitive-behavioral therapy. Paulus, DJ., Brandt, CP., Lemaire, C., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural group therapy for social phobia: evidence of transportability to community clinics. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Brief cognitive behavior group therapy for social anxiety among medical students: A randomized placebo-controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioural group therapy for social phobia in a community clinic: a benchmarking study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for social anxiety disorder: current status and future directions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Social phobia. Longitudinal course and long-term outcome of cognitive-behavioral treatment. [2018]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of interventions for anxiety in people with HIV. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Novel Integrated Cognitive-Behavioral Therapy for Anxiety and Medication Adherence Among Persons Living With HIV/AIDS. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Self-care management of anxiety and fear in HIV disease. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Group Training of Stress Management vs. Group Cognitive-Behavioral Therapy in Reducing Depression, Anxiety and Perceived Stress Among HIV-Positive Men. [2021]

10. Iran pubmed.ncbi.nlm.nih.gov

The worldwide prevalence of anxiety in acquired immune deficiency syndrome patients: A systematic review and meta-analysis. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of a behavioral stress-management program on anxiety, mood, self-esteem, and T-cell count in HIV positive men. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Trajectory of change in anxiety sensitivity in relation to anxiety, depression, and quality of life among persons living with HIV/AIDS following transdiagnostic cognitive-behavioral therapy. [2021]