What side effects are associated with this type of intervention?

Coping skills interventions like AFFIRM, which are similar to cognitive-behavioral therapy (CBT) and other psychotherapies, generally have minimal physical side effects. However, participants may experience emotional discomfort as they confront and discuss distressing thoughts and experiences. Some individuals might feel increased anxiety or stress during the initial stages of therapy. It is important for facilitators to provide a supportive environment to help manage these emotional responses.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of mental health issues, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, which are commonly used to treat depression and anxiety disorders. Additionally, cognitive-behavioral therapy (CBT) is a widely recognized non-pharmacological treatment that focuses on coping skills and behavioral changes, similar to the AFFIRM intervention. While AFFIRM itself is a psychosocial intervention and not a medication, it complements pharmacotherapy by addressing the psychosocial aspects of mental health through education and rehearsal.

What other types of research exist?

Promising alternatives to AFFIRM for mental health issues include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in psychological well-being and sleep-related quality of life. 2) Biofeedback-assisted relaxation training, which has been effective in reducing pain and stress in various patient populations. 3) Mindfulness-Based Stress Reduction (MBSR), which uses meditation practices to enhance self-regulation and stress management. 4) Mobile well-being apps, which have demonstrated potential in maintaining clinical improvements for anxiety and depression.

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Coping Skills Intervention for Mental Health in Sexual and Gender Minority Youth (AFFIRM Trial)

N/A

Waitlist Available

Led By Shelley L Craig, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

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

Must have

Aged 14 to 29 years at time of screening

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests AFFIRM, a group program for LGBTQ+ youth. It uses CBT techniques to help them manage stress, change negative thoughts, and build supportive social networks.

Who is the study for?

This trial is for young individuals aged 14 to 29 who identify as part of the sexual and/or gender minority community, can communicate fluently in English, and are interested in an intervention called AFFIRM. It's not suitable for those needing more intensive therapy or currently in crisis with a high risk of suicidality.

What is being tested?

AFFIRM, an 8-session group program designed to help reduce sexual risks and mental distress by affirming sexual and gender identities through education and role-play exercises. The study spans five years using a stepped wedge design where participants receive the intervention at different times.

What are the potential side effects?

As AFFIRM is a coping skills educational intervention rather than a medical treatment, it does not have physical side effects like drugs do. However, discussing sensitive topics might cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 14 and 29 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability - participant satisfaction with group sessions

Feasibility - participant attendance at group sessions

Secondary study objectives

Intervention fidelity - how closely facilitators adhere to intervention model

Other study objectives

Abstinence Self-Efficacy Scale

Change in Adult Hope Scale

Change in Beck Depression Inventory-II

+10 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: AFFIRMExperimental Treatment1 Intervention

AFFIRM is an 8-session psychoeducational weekly group intervention

Group II: Waitlisted controlActive Control1 Intervention

Waitlisted control

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Coping skills interventions, such as the AFFIRM program, work by teaching patients practical skills to manage their emotions and behaviors through education and rehearsal. These treatments involve cognitive restructuring to change negative thought patterns and behavioral rehearsal to practice new skills in a supportive environment. This approach is crucial for mental health patients as it equips them with effective tools to handle stressors, thereby reducing psychosocial distress and enhancing overall well-being.

A Brief Mindfulness-Based Cognitive Therapy (MBCT) Intervention as a Population-Level Strategy for Anxiety and Depression.Solution Focused Brief Therapy Telemental Health Suicide Intervention.Psychotherapy for Borderline Personality Disorder: Progress and Remaining Challenges.