Smart Technology for Anorexia Nervosa Recovery
STAR
1 other identifier
interventional
90
1 country
1
Brief Summary
Anorexia nervosa (AN) has the highest mortality rate of any mental illness, with a typical onset in adolescence. Although family-based interventions are efficacious for up to 75 percent of adolescents with AN, approximately 30 percent will relapse after recovery. There is a critical need to improve treatments and prevent post-discharge relapse following acute treatment to improve outcomes for adolescents with AN. To address this critical need, the investigators developed an adaptive smart-phone based therapy support tool for teens with AN, called Smart Treatment for Anorexia Recovery (STAR). STAR is for adolescents between the ages of 13-21 who recently received acute treatment for AN (e.g., inpatient, residential, intensive outpatient, or day hospital) who are currently working with an outpatient therapist. STAR incorporates elements from the Unified Protocol and Acceptance and Commitment Therapy to target emotion avoidance, which the investigators hypothesize will lead to reductions in eating-disorder behaviors. The investigators will compare STAR to Present-focused Anorexia Nervosa Coping Treatment (PACT), which focuses on current life stressors and problems. The investigators' hypothesis is that STAR will improve outpatient treatment response and reduce relapse in adolescents discharged from intensive treatment for AN. The investigators will evaluate their hypotheses in two conditions: 1) STAR app and 2) PACT app. In both conditions, participants must be working with an individual outpatient therapist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedStudy Start
First participant enrolled
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 11, 2023
July 1, 2023
1.1 years
December 8, 2021
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body Mass Index Z-Scores (BMI-z)
Therapists, caregivers, or primary care physicians will provide weight and height measurements each week to calculate BMI-z.
Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups
Secondary Outcomes (8)
Change in Categorical Recovery Status
Baseline, 12-week, and 3- and 6-month follow-ups
Change in Mood and Anxiety Symptoms
Baseline, 12-week, and 3- and 6-month follow-ups
Change in Eating Disorder Symptom Severity
Baseline, 12-week, and 3- and 6-month follow-ups
Change in Psychiatric Impairment
Baseline, 12-week, and 3- and 6-month follow-ups
Change in Parent-Reported Mealtime Behaviors
Baseline, 12-week, and 3- and 6-month follow-ups
- +3 more secondary outcomes
Other Outcomes (3)
Change in Therapist Treatment Fidelity
Weekly during the 12-week intervention period
Clinical Utility
12-week
Discharge Decisions
12-week
Study Arms (2)
Smart Treatment for Anorexia Nervosa Recovery (STAR) app
EXPERIMENTALSTAR incorporates elements from the Unified Protocol and Acceptance and Commitment Therapy to reduce emotion avoidance and improve disordered-eating behaviors and negative emotions. Participants will complete 1-2 weekly modules in STAR for 12 weeks. During this time, participants will continue working with their outpatient therapist. Outcome and target engagement measures will be assessed daily or weekly within the STAR app. Participants will complete additional measures of outcome and target engagement at 3-months and 6-months after treatment. Parents will be asked to complete outcome measures at baseline, 12 weeks, 3-months, and 6-months.
Present-focused Anorexia Nervosa Coping Treatment (PACT) app
PLACEBO COMPARATORPACT is an adapted form of Present-Centered Therapy and focuses on daily life stressors, problems, and concerns that may impact AN. Participants will complete 1 weekly module in Weeks 1, 2, and 12 and complete a Daily Diary of life stressors thereafter for 9 weeks. During this time, participants will continue working with their outpatient therapist. Outcome and target engagement measures will be assessed daily or weekly within the PACT app. Participants will complete additional measures of outcome and target engagement at 3-months and 6-months after treatment. Parents will be asked to complete outcome measures at baseline, 12 weeks, 3-months, and 6-months.
Interventions
Adolescents will use their smartphone to access short 5-10 minute "modules" that teach them about the function of emotions, ways to regulate challenging emotions, and strategies to improve negative thinking, mood, and reduce eating-disorder symptoms. Module content will include text, images, videos, and interactive questions and quizzes.
Adolescents will use their smartphone to access two brief psychoeducational modules that teach about the common symptoms of AN, common reactions and problems associated with AN, and goals for treatment. Starting in Week 3, adolescents will complete a Daily Diary that will ask them to record life stressors, challenges, and problems, which will serve as a launching point for discussion with their outpatient therapist.
Eligibility Criteria
You may qualify if:
- Age 13 to 21
- Able to read and speak fluent English
- Access to a smartphone
- Received acute treatment for anorexia nervosa or atypical anorexia nervosa \[residential, inpatient, partial hospitalization (PHP), or intensive outpatient program (IOP)\] within the past three months
- Currently receiving weekly outpatient treatment (or planning to start outpatient treatment) for current anorexia nervosa/atypical anorexia nervosa, or past anorexia nervosa/atypical anorexia nervosa (e.g., anorexia nervosa in partial remission).
You may not qualify if:
- Uncorrected visual impairments that would prevent smartphone use
- Intellectual or developmental disability
- Medical condition that affects appetite or weight (e.g., thyroid disorder, diabetes, cancer, pregnancy)
- Current psychotic disorder or substance use disorder
- BMI-z \< 14 or lab abnormalities indicating medical instability
- Unwillingness for data to be shared with outpatient therapist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansaslead
- Children's Mercy Hospital Kansas Citycollaborator
- Purdue Universitycollaborator
Study Sites (1)
University of Kansas, Wakarusa Research Facility
Lawrence, Kansas, 66045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelsie Forbush, PhD
University of Kansas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
January 13, 2022
Study Start
May 8, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
July 11, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be released in a timely fashion in waves as soon as the main study findings are published. Data will remain available in perpetuity.
- Access Criteria
- Investigators interested in using the data will be required to contact the PI to provide a brief description of the intended use. Although investigators will be able to design and analyze the data as they choose, such documentation will prevent duplication of research and provide a greater level of protection of intellectual property. These instructions will be included in a peer-reviewed publication that describes the study design.
De-identified data collected from this study will be made publicly available. The investigators will restrict any data that may reveal subjects' identities (e.g., geographical location). To protect subjects' privacy, publicly-available data will not contain any personally identifying or private health information (PHI). Consent forms will describe the data sharing plan so that participants are informed of how their data will be handled. Prior to the release of data, the investigators will require that a local privacy officer certify that all datasets contain no PHI. The investigators will also require that individuals requesting data sign a Letter of Agreement.