Recruiting

Anorexia Nervosa

Sponsor:

University of Kansas

Code:

NCT05190926

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Smart-Treatment for Anorexia Nervosa Recovery (STAR)

Present-focused Anorexia Nervosa Coping Treatment (PACT)

Study Details

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.

Conditions

Anorexia Nervosa

Study ID

NCT05190926

Start date

May 8, 2023

Status verified date

Jul, 2023

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smart Treatment for Anorexia Nervosa Recovery (STAR) app

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.

placebo comparator: Present-focused Anorexia Nervosa Coping Treatment (PACT) app

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.

Interventions

Smart-Treatment for Anorexia Nervosa Recovery (STAR)

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.

Present-focused Anorexia Nervosa Coping Treatment (PACT)

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.

Primary outcome measure

  • Change in Body Mass Index Z-Scores (BMI-z) [ Time Frame: Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups ]

Central Contacts and Locations

Central contacts

Kelsie Forbush, PhD

7858646525kforbush@ku.edu

Locations

University of Kansas, Wakarusa Research Facility

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

More Information

Sponsor

University of Kansas

Last update posted

Jul 11, 2023

Last verified

Jul, 2023

Keywords

  • Anorexia Nervosa
  • Adolescents
  • Smartphone
  • Therapy Support Tools

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas on 2023-07-11.