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Group Counseling + Peer Support for Health-Related Stigma (HEARTS Trial)

N/A

Recruiting

Led By Rebecca Pearl, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Current or past thought disorder or psychosis, or unmanaged bipolar disorder

Unwilling or unable to complete study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 26

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new type of group counseling and peer support for patients dealing with the negative effects of health-related stigma. The goal is to help patients cope better with stigma, improve their mental

Who is the study for?

This trial is for adults over 18 with conditions like obesity, skin diseases, cancer (including those in remission), diabetes, or chronic pain who feel stigmatized because of their health. They must recognize this stigma and be able to attend virtual group meetings regularly for 6 months.

What is being tested?

The study tests a new counseling program called Healing HEARTS alongside peer support. It aims to help patients deal with the shame they might feel about their illness by talking in groups and supporting each other to improve mental health and life quality.

What are the potential side effects?

Since this trial involves counseling and peer support rather than medication, typical medical side effects are not expected. Participants may experience emotional discomfort discussing personal experiences related to stigma.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have a history of psychosis, thought disorders, or unmanaged bipolar disorder.

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I am unable or unwilling to follow the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Internalized Health-Related Stigma Scale at Week 12

Secondary study objectives

Change in 4-item Perceived Stress Scale score at Week 12

Change in 4-item Perceived Stress Scale score at Week 26

Change in CDC Healthy Days Core Measure at Week 12

+16 more

Other study objectives

Change in 6-Item Social Support Questionnaire scores at Week 12

Change in 6-Item Social Support Questionnaire scores at Week 26

Change in Brief COPE scores at Week 12

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Healing HEARTS InterventionExperimental Treatment1 Intervention

The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology.

Group II: Peer SupportActive Control1 Intervention

The peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology.

Group III: Waitlist ControlActive Control1 Intervention

The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention.

0 / 3Eligibility criteria met