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

Primary Purpose

Anorexia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Affect Treatment for Anorexia Nervosa (PAT-AN):
Psychoeducational and Behavioral Therapy (PBT)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > or = 18 years old Ability to read and speak in English DSM-5 diagnosis of AN or atypical AN at admission to higher-level care In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months Current BMI > or = 18.5 kg/m2 (or will be by time of discharge) BMI increase of > or = 0.5 kg/m2 while in higher-level care Ability to designate and sign a release of information for a primary physical or mental health provider for study duration Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration Access to a smartphone and/or computer permitting engagement in remote therapy and assessment. Exclusion Criteria: Medical instability for outpatient care; Pregnancy Lifetime DSM-5 primary psychotic or bipolar-I disorder Current DSM-5 substance use disorder Enrollment in outpatient therapy with highly overlapping content to PAT-AN

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Affect Treatment for Anorexia Nervosa (PAT-AN):

Psychoeducational and Behavioral Therapy (PBT):

Arm Description

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI) from Baseline to End of Treatment
Objective height will be captured through guided measurement at baseline. Objective weight will be measured throughout on a blind smartscale, which will transfer weight data directly to the research team by wireless internet without providing an outward display of weight to participants. Participants will have a smartscale shipped to their home. They will measure their weight at baseline and following treatment on the scale in standard street clothes (no outer garments or shoes) while on a video call with research staff.
Change in Eating Disorder Symptoms
The Eating Disorder Examination (EDE) is an investigator-based interview assessing eating disorder psychopathology that will be used as the primary measure of eating disorder symptoms. The EDE has extensive psychometric data to support its reliability and validity. The EDE comprises four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Each question is scored by the interviewer based on frequency over the past month from 0 (symptom not present) to 6 (symptom present every day). Each subscale score is the average of all items in the subscale, while global EDE score is the average of the four subscale scores. Higher EDE scores indicate greater severity and frequency of eating disorder symptoms.

Secondary Outcome Measures

Change in Depressive Symptoms
The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess depressive symptom severity. The depression subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 depression subscale range from 0 to 21, with higher scores indicating greater depressive symptom severity.
Change in Anxiety Symptoms
The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess anxiety symptom severity. The anxiety subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 anxiety subscale range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in Suicidal Ideation
The Columbia - Suicide Severity Rating Scale (C-SSRS) is an interview-based measure assessing the presence and intensity of suicidal ideation and the presence of suicidal behavior. The C-SSRS will be used to determine if treatment impacts suicidal ideation. Intensity of suicidal ideation is rated from 0-5, with higher scores indicating more severe suicidal ideation.

Full Information

First Posted
February 28, 2023
Last Updated
July 21, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05799872
Brief Title
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Official Title
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive Affect Treatment for Anorexia Nervosa (PAT-AN):
Arm Type
Experimental
Arm Title
Psychoeducational and Behavioral Therapy (PBT):
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Positive Affect Treatment for Anorexia Nervosa (PAT-AN):
Intervention Description
PAT-AN is an adaptation of the cognitive-behavioral outpatient individual therapy for anhedonia (17, 68). The overarching aim of PAT-AN is to enhance reward sensitivity (reward anticipation, experiencing, and learning) to non-eating disorder experiences and to decrease or replace reward sensitivity to weight-loss experiences (26). PAT-AN includes 6 sequential modules, each designated to target specific reward sensitivity disturbances (26, 68). Homework and experiential practice during sessions are essential components of PAT-AN, and participants are provided a workbook to assist with this practice. During each session, collaborative homework review is followed by skill development and homework assignments.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational and Behavioral Therapy (PBT)
Intervention Description
The comparison treatment is modeled off of educational and behavioral interventions used in prior clinical trials for AN and common elements of standard behavioral eating disorder treatments. The treatment is structured to parallel the modular format of PAT-AN.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI) from Baseline to End of Treatment
Description
Objective height will be captured through guided measurement at baseline. Objective weight will be measured throughout on a blind smartscale, which will transfer weight data directly to the research team by wireless internet without providing an outward display of weight to participants. Participants will have a smartscale shipped to their home. They will measure their weight at baseline and following treatment on the scale in standard street clothes (no outer garments or shoes) while on a video call with research staff.
Time Frame
Baseline to End of treatment (week 24)
Title
Change in Eating Disorder Symptoms
Description
The Eating Disorder Examination (EDE) is an investigator-based interview assessing eating disorder psychopathology that will be used as the primary measure of eating disorder symptoms. The EDE has extensive psychometric data to support its reliability and validity. The EDE comprises four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Each question is scored by the interviewer based on frequency over the past month from 0 (symptom not present) to 6 (symptom present every day). Each subscale score is the average of all items in the subscale, while global EDE score is the average of the four subscale scores. Higher EDE scores indicate greater severity and frequency of eating disorder symptoms.
Time Frame
Baseline to End of treatment (week 24)
Secondary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess depressive symptom severity. The depression subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 depression subscale range from 0 to 21, with higher scores indicating greater depressive symptom severity.
Time Frame
Baseline to End of treatment (week 24)
Title
Change in Anxiety Symptoms
Description
The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess anxiety symptom severity. The anxiety subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 anxiety subscale range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time Frame
Baseline to End of treatment (week 24)
Title
Change in Suicidal Ideation
Description
The Columbia - Suicide Severity Rating Scale (C-SSRS) is an interview-based measure assessing the presence and intensity of suicidal ideation and the presence of suicidal behavior. The C-SSRS will be used to determine if treatment impacts suicidal ideation. Intensity of suicidal ideation is rated from 0-5, with higher scores indicating more severe suicidal ideation.
Time Frame
Baseline to End of treatment (week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > or = 18 years old Ability to read and speak in English DSM-5 diagnosis of AN or atypical AN at admission to higher-level care In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months Current BMI > or = 18.5 kg/m2 (or will be by time of discharge) BMI increase of > or = 0.5 kg/m2 while in higher-level care Ability to designate and sign a release of information for a primary physical or mental health provider for study duration Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration Access to a smartphone and/or computer permitting engagement in remote therapy and assessment. Exclusion Criteria: Medical instability for outpatient care; Pregnancy Lifetime DSM-5 primary psychotic or bipolar-I disorder Current DSM-5 substance use disorder Enrollment in outpatient therapy with highly overlapping content to PAT-AN
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kira Venables
Phone
(804)828-2658
Email
venableskg@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Haynos, PhD
Phone
(804)828-1193
Email
haynosa@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Haynos, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final dataset will include information from self-report questionnaires, clinician-guided interviews, physical assessments, ecological momentary assessment, and neurocognitive tasks. Data will be de-identified and consistent with NDA regulations. Data will be shared via the National Database for Clinical Trials Related to Mental Illness (NDCT) in the NIMH Data Archive (NDA). Established by NIMH, and supported by other Institutes of NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing. All data will be collected from subjects who have broadly consented to share their data for research use or who have consented to share their data for research, with data use limitations. All de-identified data resulting from this project will be submitted to the NDA at the item level and subject level along with appropriate supporting documentation to enable efficient use of the data.
IPD Sharing Time Frame
Descriptive/raw research data will be made available for access to other researchers within four (4) months after submission.

Learn more about this trial

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

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