CBT + HIV Risk Reduction for Social Anxiety

(SC-RCT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining cognitive-behavioral therapy (CBT) with HIV risk reduction counseling can reduce social anxiety, substance use, and risky sexual behavior among men who have sex with men (MSM). Participants will receive either CBT with HIV counseling or applied relaxation, which helps with anxiety but not substance use or sexual risk. The trial seeks HIV-negative men who have experienced significant social anxiety, used substances before or during sex, and engaged in condomless anal sex without using PrEP in the last three months. This study could offer new methods to help MSM manage anxiety and reduce HIV risk. As an unphased trial, it provides participants the chance to contribute to innovative strategies for improving mental health and reducing HIV risk.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively treats anxiety and stress-related issues. CBT helps individuals change negative thoughts and feelings, reducing anxiety levels. Studies have found CBT to be safe and generally easy for patients to handle, with no specific reports of serious side effects, making it a safe option for treating social anxiety.

Similarly, Applied Relaxation (AR) manages anxiety by teaching individuals to relax their muscles and use these skills when anxious. Like CBT, AR has no history of causing significant side effects and is considered safe for treating anxiety.

Overall, both treatments in this trial are non-invasive and have strong safety records. Participants can feel confident that these therapies are safe and have been used successfully to treat anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Cognitive Behavioural Therapy (CBT) with HIV risk reduction strategies specifically tailored for individuals with social anxiety, which is quite unique. Most standard treatments for social anxiety focus solely on reducing anxiety symptoms, often through medications like SSRIs or traditional CBT, and don't address the link between social anxiety, substance use, and HIV risk. This trial stands out because it incorporates a comprehensive approach, aiming to not only alleviate social anxiety through cognitive restructuring and exposure but also to directly reduce HIV risk by considering sexual history, promoting safer practices, and discussing the potential use of PrEP. The hope is that by tackling these interconnected issues simultaneously, participants can achieve more holistic and sustainable improvements in their mental and physical health.

What evidence suggests that this trial's treatments could be effective for reducing social anxiety and HIV risk?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, effectively reduces social anxiety and risky sexual behaviors. Studies indicate that CBT can lead to a 50% decrease in risky sexual activities, such as having anal sex without a condom, and can also help lower social anxiety. These positive effects often continue to improve even a year after treatment. In this trial, participants may receive CBT, which combines techniques to reduce anxiety with strategies to manage these risks, making it a promising option for reducing HIV risk among men who have sex with men (MSM). Meanwhile, Applied Relaxation, another treatment arm in this trial, effectively treats social anxiety but does not specifically address substance use or behaviors that increase the risk of HIV. ^{1 2 6 7 8}

Who Is on the Research Team?

Trevor A Hart, Ph.D, CPsych

Principal Investigator

Toronto Metropolitan University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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