Smart Technology for Anorexia Nervosa Recovery

Anorexia Nervosa Clinical Trial

— STAR  

Official title:

Smart Technology for Anorexia Nervosa Recovery: A Pilot Intervention for the Post-Acute Treatment of Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190926
• Other study ID #: STUDY00141926
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of Kansas
• Contact: Kelsie Forbush, PhD
• Phone: 7858646525
• Email: kforbush[@]ku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

AN is the third leading cause of chronic illness in adolescents and, if left untreated, can lead to major organ damage, structural and functional brain changes, and early-onset osteopenia and osteoporosis. Although family-based interventions are efficacious for up to 75% of adolescents with AN, approximately 30% will relapse after recovery. There is a critical need to optimize treatments and prevent post-discharge relapse following acute treatment to improve outcomes for adolescents with AN. To address this critical need, the investigative team developed a suite of digital tools that advance the science of assessment, risk prediction, and clinical-decision support for use in the post-acute treatment window, called "Smart Treatment for Anorexia Recovery (STAR)." STAR uses cutting-edge assessment technology to shorten test administration and machine-learning to predict likelihood of recovery. This information is then provided back to the clinician via an easy-to-use clinical-decision support tool to alert the clinician when user-entered data suggests the patient is not progressing.

In the current clinical trial, the investigators will expand STAR to test an adaptive mHealth intervention delivered in the post-discharge window. The investigators' hypothesis is that a transdiagnostic assessment and clinical-decision support tool delivered within the STAR suite will optimize face-to-face clinical service and the addition of an adaptive mobile-health (mHealth) intervention will improve outpatient treatment response and reduce relapse in adolescents discharged from intensive treatment for AN. The investigators' previous work supports the hypothesis. Specifically, the investigators' past studies provide robust support for the predictive validity and clinical utility of the investigators' assessment tool for predicting ED-related psychiatric impairment and recovery. However, the number of items across the paper-based assessment tool is 144, which is overly long for routine use. To overcome this challenge, the investigators developed a mobile phone app that uses computerized adaptive testing to reduce assessment length by up to 50% while retaining the reliability and validity of the original paper-and-pencil measure. The investigators propose to leverage this innovation to optimize both face-to-face and mHealth treatment for AN. The objectives are to: 1) develop the mHealth intervention (with clinician and stakeholder input) and 2) establish feasibility, acceptability, and preliminary effect size of the mHealth intervention using both clinician and patient data. To accomplish these objectives, the investigators will employ a computerized adaptive test coupled with machine learning algorithms, delivered within the app to signal clinicians when their clients are at-risk for poor outcomes and relapse. Specific aims include: 1) adapt the existing clinical tool to provide therapist support modules and patient mHealth messages; 2) conduct a preliminary randomized controlled trial (RCT) of the integrated assessment and mHealth intervention tool; 3) test preliminary mechanisms that lead to changes in AN symptoms.

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 hypotheses in two conditions: 1) STAR app and 2) PACT app. In both conditions, participants must be working with an individual outpatient therapist.

Given there is a scarcity of specialty care for AN following acute treatment, yet 95% of adolescents have smartphones, the proposed research is innovative and significant because it has the future potential to reduce relapse and optimize existing community-delivered interventions for AN over the post-acute treatment window.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Kansas, Wakarusa Research Facility	Lawrence	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas	Children's Mercy Hospital Kansas City, Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Therapist Treatment Fidelity	The investigators will adapt clinician-rated checklists adapted from past research to identify which components of the Unified Protocol were used by therapists as a treatment fidelity check.	Weekly during the 12-week intervention period
Other	Clinical Utility	The investigators will administer the Clinical Utility Rating Form (CURF), to assess utility of STAR. Questions ask about utility of assessment information and modules for formulating a treatment plan, anticipating treatment difficulties, clinical communication, etc.	12-week
Other	Discharge Decisions	At baseline and end-of-treatment, clinicians will be asked to provide information about their discharge decision (e.g., transition to higher or lower level-of-care, discontinuation due to improvement, and discontinuation against medical advice). From randomization until discharge or end of 12-week period, whichever is first.	12-week
Primary	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	Change in Categorical Recovery Status	Responses from the Eating Disorder Diagnostic Survey (EDDS) will calculate categorical recovery status for anorexia nervosa (excellent, good, marginal, poor) based on definitions from Bardone-Cone et al. (2010). Baseline recovery status will allow the investigators to assess initial recovery status following acute treatment for anorexia nervosa.	Baseline, 12-week, and 3- and 6-month follow-ups
Secondary	Change in Mood and Anxiety Symptoms	The Mood and Anxiety Symptoms Questionnaire (MASQ) was designed to measure dimensions of mood and anxiety relevant to the Unified Protocol (General Distress, Anxiety, and Positive Affect). The investigators will use the MASQ to assess changes in internalizing symptoms over the course of treatment.	Baseline, 12-week, and 3- and 6-month follow-ups
Secondary	Change in Eating Disorder Symptom Severity	The investigators will use the total number of eating-disorder symptoms from the Eating Disorder Diagnostic Survey (EDDS) as an indicator of eating-disorder symptom severity.	Baseline, 12-week, and 3- and 6-month follow-ups
Secondary	Change in Psychiatric Impairment	Psychiatric and psychosocial impairment questionnaires will include the Clinical Impairment Assessment (CIA), which measures psychosocial impairment secondary to eating-disorder features and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).	Baseline, 12-week, and 3- and 6-month follow-ups
Secondary	Change in Parent-Reported Mealtime Behaviors	Parents will complete the Meals in Our Households (MOH) to measure: Structure of Family Meals; Parental Concern about Child's Diet; Spousal Stress Related to Mealtime Behaviors (if relevant); and Problematic Child Mealtime Behaviors.	Baseline, 12-week, and 3- and 6-month follow-ups
Secondary	Change in Emotion Avoidance	The Brief Experiential Avoidance Questionnaire (BEAQ) will assess unwillingness to remain in contact with distressing emotions, thoughts, memories, and physical sensations. The investigators will use the BEAQ to test whether changes in emotion avoidance leads to changes in eating-disorder behaviors.	Baseline and 12-week intervention (weekly)
Secondary	Change in Eating-Disorder Behaviors	The investigators will use an ad-hoc checklist within the app to measure eating-disorder behaviors (e.g., binge eating, purging, etc.)	Daily during the 12-week intervention period
Secondary	Change in Patient Skill Utilization	Skill utilization will be assessed via a daily in-app checklist for patients (including an option to report "none").	Daily during the 12-week intervention period