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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

STAR Trial 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.Check my eligibility

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.See study design

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.

STAR Trial 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.

STAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12-week, and 3- and 6-month follow-ups

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Body Mass Index Z-Scores (BMI-z)

Secondary outcome measures

Change in Categorical Recovery Status

Change in Eating Disorder Symptom Severity

Change in Eating-Disorder Behaviors

+5 more

Other outcome measures

Change in Therapist Treatment Fidelity

Clinical Utility

Discharge Decisions

STAR 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of KansasLead Sponsor

147 Previous Clinical Trials

325,771 Total Patients Enrolled

Children's Mercy Hospital Kansas CityOTHER

245 Previous Clinical Trials

935,709 Total Patients Enrolled

1 Trials studying Anorexia Nervosa

60 Patients Enrolled for Anorexia Nervosa

Purdue UniversityOTHER

224 Previous Clinical Trials

72,674 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open recruitment period for individuals to join this research?

"As viewed on clinicaltrials.gov, the study is no longer searching for participants after its initial post date of February 28th 2023 and last recorded update of November 16th 2022. However, 77 other medical trials remain open to recruit patients at this time."

Answered by AI

Who qualifies for enrolment in this medical experiment?

"This trial is open to 129 adolescents between the ages of 13 and 18 who are suffering from anorexia nervosa. Eligible participants must be able to converse in English fluently, possess a smartphone, have recently undergone acute treatment for their condition (residential care, inpatient etc.), as well as receive weekly outpatient therapy or plan on starting it soon."

Answered by AI

Is there an age restriction for participation in the trial?

"The stipulations for this medical trial necessitate that interested parties must be between the ages of 13-18. Additionally, 38 studies are available to people below 18 years and 33 studies are accessible to those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smart Technology for Anorexia Nervosa Recovery

2023. "Smart Technology for Anorexia Nervosa Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190926.

All > Anorexia Nervosa