Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Body Image Distress in Head and Neck Cancer Survivors (BRIGHT Trial)

Saint Louis, MO

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Age > 18 years on the day of informed consent

No planned significant HNC ablative or reconstructive surgery during the study intervention or follow-up period

Must not have

Pre-existing, ongoing CBT services for other disorders and unwillingness to discontinue prior therapy for the duration of the proposed trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not a brief video tele-cognitive behavioral therapy intervention (BRIGHT) is more effective than a manualized tele-supportive care intervention (Attention Control) in reducing body image distress (BID) for head and neck cancer (HNC) survivors. The primary endpoint is the IMAGE-HN, a validated patient-reported outcome measure of HNC-related BID.

See full description

Who is the study for?

This trial is for adults over 18 who've had curative surgery for head and neck cancer within the last year, are now cancer-free, and experience significant body image distress. They must not be planning major surgeries during the study and should not have severe psychiatric issues or ongoing cognitive behavioral therapy.Check my eligibility

What is being tested?

The BRIGHT clinical trial tests a video tele-cognitive behavioral therapy against an Attention Control supportive care intervention to see which better helps with body image distress in head and neck cancer survivors.See study design

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects are minimal. However, participants may experience emotional discomfort or increased awareness of their body image concerns.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18 years old.

show original

Select...

I don't have any major head or neck surgery planned during the study.

show original

Select...

I am currently free of cancer.

show original

Select...

I had surgery aimed at curing my cancer, with or without additional treatments or reconstruction.

show original

Select...

I have a confirmed diagnosis of squamous cell carcinoma.

show original

Exclusion Criteria

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

Select...

I am currently in CBT for another condition and do not want to stop it for this trial.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

IMAGE-HN

Secondary study objectives

Automatic Thoughts Questionnaire

Feeling suicidal (finding)

Body Image Coping Strategies Inventory (BICSI)

+6 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: BRIGHTExperimental Treatment1 Intervention

BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.

Group II: Attention ControlActive Control1 Intervention

The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BRIGHT

2020

N/A

~60

0 / 6Eligibility criteria met