← Back to Search

Baseline and HRVB group for Psychological Distress

N/A

Waitlist Available

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (t1), 2 weeks after (t2)

Awards & highlights

No Placebo-Only Group

Summary

The goal of this clinical trial study is to test the heart rate variability biofeedback training in female college students with eating disorders and compare the results between intervention and control group. The main questions it aims to answer are: * How does heart rate variability biofeedback (HRVB) training impact behaviors related to eating disorders (EDs) and the perceived stress associated with these behaviors? * What difference are observed in the quality of life and stress responses between individuals trained in HRVB protocol and those in the wait list condition? * Does HRVB training enhance heart resilience and improve the ability to cope with psychosocial stressors in young women with eating disorders, compared to those in the wait list condition? Participants will be asked to do the following steps: * Baseline heart rate variability assessment and completion of the baseline questionnaire * HRVB training session and two weeks of at-home HRVB practice-10 minutes daily, (intervention group) * Post-intervention questionnaire completion and heart rate variability assessment * Optional interview (for intervention group) and HRVB training session (for control group) Researchers will compare the results of intervention group with control group to see if the participants improve in levels of emotional health, quality of life, and resilience.

Eligible Conditions

Binge Eating Disorder
Binge eating disorder
Eating disorder
Psychological Distress
Emotion Regulation
Autonomic Nervous System
Anorexia nervosa
Heart Rate Variability

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t1), 2 weeks after (t2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (t1), 2 weeks after (t2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1), 2 weeks after (t2) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks

Secondary study objectives

Change from baseline on Brief Resilience Scale (BRS)

Change from baseline on Eating Disorder Examination Questionnaire

Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks

+2 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

Group I: Baseline and HRVB waitlistExperimental Treatment2 Interventions

In-person baseline surveys (using paper and pen surveys) before the random assignment to HRVB waitlist group. After the baseline data collection, for two weeks, they will be provided educational material regarding education materials and coping with stress and they will be encouraged to read them during the two weeks. At the end of the two-week period, participants will be scheduled for a final in-person session including T2 survey and HRV assessment. They will be also provided HRVB training session at T2.

Group II: Baseline and HRVB groupExperimental Treatment2 Interventions

In-person baseline surveys (using paper and pen survey) before the random assignment to HRVB arm. This group will receive a standardized HeartMath© Inner balance device and HRV biofeedback training session at the start of the two-week intervention period. They will be asked to attend one-on-one 30-minute HRVB training session and asked to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period. Participants will receive a weekly email notification and reminder phone call to complete their at-home practice of HRVB.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Educational materials

2014

Completed Phase 3

~2520

Baseline survey

2024

N/A

~30