RECRUITING

Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.

Official Title

Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa

Quick Facts

Study Start:2023-12-06
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05799872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> or = 18 years old
  2. 2. Ability to read and speak in English
  3. 3. DSM-5 diagnosis of AN or atypical AN at admission to higher-level care
  4. 4. In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months
  5. 5. Current BMI \> or = 18.5 kg/m2 (or will be by time of discharge)
  6. 6. BMI increase of \> or = 0.5 kg/m2 while in higher-level care
  7. 7. Ability to designate and sign a release of information for a primary physical or mental health provider for study duration
  8. 8. Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration
  9. 9. Access to a smartphone and/or computer permitting engagement in remote therapy and assessment.
  1. 1. Medical instability for outpatient care;
  2. 2. Pregnancy
  3. 3. Lifetime DSM-5 primary psychotic or bipolar-I disorder
  4. 4. Current DSM-5 substance use disorder
  5. 5. Enrollment in outpatient therapy with highly overlapping content to PAT-AN

Contacts and Locations

Study Contact

Kira Venables
CONTACT
(804)828-2658
venableskg@vcu.edu
Ann Haynos, PhD
CONTACT
(804)828-1193
haynosa@vcu.edu

Principal Investigator

Ann Haynos, PhD
PRINCIPAL_INVESTIGATOR
Principal Investigator

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Ann Haynos, PhD, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2025-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anorexia Nervosa