What side effects are associated with this type of intervention?

Behavioral modification and support treatments, such as cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and psychoeducation, generally have minimal physical side effects. However, they can sometimes cause emotional discomfort as patients work through challenging thoughts and feelings. The time commitment and effort required for these therapies can also be burdensome for some individuals. Overall, these treatments are considered safe and effective for improving quality of life.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at enhancing quality of life, particularly those involving behavioral modification and support. Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) are notable examples that have been widely recognized for their efficacy in treating conditions like depression and anxiety, which significantly impact quality of life. These therapies focus on changing negative thought patterns and behaviors, thereby improving mental health and overall well-being. While specific FDA approvals for group-based behavioral interventions like the Horizons Program are limited, the principles of CBT and MBCT are foundational in many approved therapeutic approaches aimed at improving quality of life.

What other types of research exist?

Promising novel alternatives to the Horizons Program for enhancing quality of life in patients include: 1) Distress Tolerance (DT) treatment incorporating exposure-based and acceptance-based approaches, particularly for patients initiating buprenorphine. 2) Internet-delivered acceptance-based behavior therapy for generalized anxiety disorder, which has shown significant within-group improvement and high client satisfaction. 3) Psilocybin-assisted psychotherapy, which has demonstrated sustained reductions in psychiatric and existential distress in patients with life-threatening conditions. These alternatives have shown feasibility and potential clinical benefits in pilot studies and ongoing trials.

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Group Therapy for Graft-versus-Host Disease

N/A

Waitlist Available

Led By Lara Traeger, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Have moderate to severe chronic graft versus host disease

Currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-intervention) to 10-week follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a group therapy program can improve quality of life for people with GvHD.

Who is the study for?

This trial is for patients who had a stem cell transplant and are now dealing with moderate to severe chronic graft-versus-host disease. They must be getting care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program and able to join group sessions in English or Spanish. Pregnant women, prisoners, or those with conditions that affect understanding or participation are excluded.

What is being tested?

The Horizons Program, a group-based behavioral intervention designed to improve life quality for patients suffering from chronic graft-versus-host disease after stem cell transplantation, is being tested for its practicality.

What are the potential side effects?

Since this study focuses on a behavioral intervention rather than medication, traditional side effects like you'd see with drugs aren't expected. However, participants may experience emotional discomfort discussing their condition.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have moderate to severe chronic graft versus host disease.

Select...

I am currently a patient at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program.

Select...

I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-intervention) to 10-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-intervention) to 10-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-intervention) to 10-week follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participant attendance

Percentage of participant enrollment

Percentage of participant retention

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Horizons GroupExperimental Treatment1 Intervention

Participants will receive the Horizons Group intervention for up to 8 weeks.

0 / 3Eligibility 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

Common treatments aimed at improving Quality of Life, such as those studied in the Horizons Program, include cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and group-based behavioral interventions. These therapies function by helping patients develop effective coping mechanisms, reduce stress, and improve emotional regulation. This is essential for Quality of Life patients as it enhances their ability to manage symptoms, boosts mood, and overall well-being, thereby significantly improving their daily functioning and life satisfaction.

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