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Teletherapy Treatments for Anorexia Nervosa
N/A
Recruiting
Led By Ann Haynos, PhD
Research Sponsored by Virginia Commonwealth 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 to end of treatment (week 24)
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how two treatments for Anorexia Nervosa (AN) can help individuals discharged from higher-level care. 80 participants will receive 24 weeks of PAT-AN or PBT therapy through teletherapy. Measures will be taken to assess treatment effectiveness, mental health, and other outcomes.
Who is the study for?
This trial is for adults over 18 with Anorexia Nervosa who are transitioning from intensive treatment to outpatient care or have done so within the last 3 months. They must be willing to participate in weekly assessments, speak English, and have access to a smartphone or computer. Those with medical instability, overlapping therapy content, pregnancy, substance use disorders, or primary psychotic/bipolar-I disorder cannot join.
What is being tested?
The study compares two remote therapies for Anorexia Nervosa after intensive treatment: Positive Affect Treatment (PAT-AN) and Psychoeducational and Behavioral Therapy (PBT). Participants will receive one of these treatments via teletherapy for 24 weeks starting within three months post-discharge.
What are the potential side effects?
Since this trial involves psychological therapies rather than medications, side effects may include emotional discomfort or distress during sessions. However, specific side effects will depend on individual experiences with the therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of treatment (week 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (week 24)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Body Mass Index (BMI) from Baseline to End of Treatment
Change in Eating Disorder Symptoms
Secondary study objectives
Change in Anxiety Symptoms
Change in Depressive Symptoms
Change in Suicidal Ideation
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: Positive Affect Treatment for Anorexia Nervosa (PAT-AN):Experimental Treatment1 Intervention
Group II: Psychoeducational and Behavioral Therapy (PBT):Active Control1 Intervention
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,888,408 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,826 Total Patients Enrolled
55 Trials studying Eating Disorders
23,567 Patients Enrolled for Eating Disorders
Ann Haynos, PhDPrincipal InvestigatorPrincipal Investigator
2 Previous Clinical Trials
112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to do weekly check-ins and allow my therapy sessions to be recorded.I was recently discharged from a higher-level care facility to outpatient care.I have been diagnosed with anorexia or atypical anorexia.I am too ill to be cared for at home.I have access to a smartphone or computer for remote therapy.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Positive Affect Treatment for Anorexia Nervosa (PAT-AN):
- Group 2: Psychoeducational and Behavioral Therapy (PBT):
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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