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Smart Technology for Anorexia Nervosa (STAR Trial)

N/A
Recruiting
Led By Kelsie Forbush, PhD
Research Sponsored by University of Kansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received acute treatment for anorexia nervosa [residential, inpatient, partial hospitalization (PHP), or intensive outpatient program (IOP)] within the past two months
Age 13 to 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12-week, and 3- and 6-month follow-ups
Awards & highlights

Summary

This trial will test whether a new smart-phone based therapy tool can help improve outcomes for adolescents with anorexia nervosa.

Who is the study for?
This trial is for teens aged 13-18 who have recently undergone acute treatment for anorexia nervosa and are currently seeing a therapist. They must be able to read and speak English fluently, have access to a smartphone, and not have any medical conditions affecting appetite or weight, severe visual impairments, psychotic disorders, substance use disorders, or intellectual disabilities.
What is being tested?
The study tests two smartphone-based therapy support tools: STAR (Smart Treatment for Anorexia Recovery) which targets emotion avoidance using the Unified Protocol and Acceptance Commitment Therapy; versus PACT (Present-focused Anorexia Nervosa Coping Treatment), focusing on current life stressors. The goal is to see if these can improve treatment response and reduce relapse after intensive care.
What are the potential side effects?
As this trial involves psychological interventions through apps rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when confronting eating disorder behaviors or stressors during the therapeutic process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had recent treatment for anorexia nervosa.
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I am between 13 and 18 years old.
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I am currently in or planning to start outpatient treatment for anorexia nervosa.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12-week, and 3- and 6-month follow-ups
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12-week, and 3- and 6-month follow-ups for reporting.

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 Z-Scores (BMI-z)
Secondary study objectives
Change in Categorical Recovery Status
Change in Eating Disorder Symptom Severity
Change in Eating-Disorder Behaviors
+5 more
Other study objectives
Change in Therapist Treatment Fidelity
Clinical Utility
Discharge Decisions

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Smart Treatment for Anorexia Nervosa Recovery (STAR) appExperimental Treatment1 Intervention
STAR 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.
Group II: Present-focused Anorexia Nervosa Coping Treatment (PACT) appPlacebo Group1 Intervention
PACT 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.

Find a Location

Who is running the clinical trial?

University of KansasLead Sponsor
150 Previous Clinical Trials
326,629 Total Patients Enrolled
Children's Mercy Hospital Kansas CityOTHER
251 Previous Clinical Trials
930,350 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
60 Patients Enrolled for Anorexia Nervosa
Purdue UniversityOTHER
228 Previous Clinical Trials
72,780 Total Patients Enrolled

Media Library

Present-focused Anorexia Nervosa Coping Treatment (PACT) Clinical Trial Eligibility Overview. Trial Name: NCT05190926 — N/A
Anorexia Nervosa Research Study Groups: Present-focused Anorexia Nervosa Coping Treatment (PACT) app, Smart Treatment for Anorexia Nervosa Recovery (STAR) app
Anorexia Nervosa Clinical Trial 2023: Present-focused Anorexia Nervosa Coping Treatment (PACT) Highlights & Side Effects. Trial Name: NCT05190926 — N/A
Present-focused Anorexia Nervosa Coping Treatment (PACT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190926 — N/A
~39 spots leftby Sep 2025
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