Anorexia NervosaSTARNCT05190926
Smart Technology for Anorexia Nervosa Recovery
A study testing Smart-Treatment for Anorexia Nervosa Recovery (STAR) and Present-focused Anorexia Nervosa Coping Treatment (PACT) in people with Anorexia Nervosa, run by University of Kansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Smart-Treatment for Anorexia Nervosa Recovery (STAR) and Present-focused Anorexia Nervosa Coping Treatment (PACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas, Wakarusa Research Facility
Lawrence, Kansas, 66045
Anjali Sharma, B.A., 785-864-8830, arsharma@ku.edu
Emily Like, B.A., 785-864-8830, emilylike@ku.edu
About this study
Official title: Smart Technology for Anorexia Nervosa Recovery: A Pilot Intervention for the Post-Acute Treatment of Anorexia Nervosa
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.
Read the detailed 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Smart-Treatment for Anorexia Nervosa Recovery (STAR), Present-focused Anorexia Nervosa Coping Treatment (PACT)
- Keywords
- Anorexia Nervosa, Adolescents, Smartphone, Therapy Support Tools
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-Treatment for Anorexia Nervosa Recovery (STAR)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Treatment for Anorexia Nervosa Recovery (STAR) app | Experimental | 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. Receives: Behavioral: Smart-Treatment for Anorexia Nervosa Recovery (STAR) |
| Present-focused Anorexia Nervosa Coping Treatment (PACT) app | Placebo comparator | 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. Receives: Behavioral: Present-focused Anorexia Nervosa Coping Treatment (PACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups
Secondary outcomes (8)
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.
Measured: Baseline, 12-week, and 3- and 6-month follow-ups
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.
Measured: Baseline, 12-week, and 3- and 6-month follow-ups
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.
Measured: Baseline, 12-week, and 3- and 6-month follow-ups
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).
Measured: Baseline, 12-week, and 3- and 6-month follow-ups
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.
Measured: Baseline, 12-week, and 3- and 6-month follow-ups
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.
Measured: Baseline and 12-week intervention (weekly)
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.)
Measured: Daily during the 12-week intervention period
Change in Patient Skill Utilization
Skill utilization will be assessed via a daily in-app checklist for patients (including an option to report "none").
Measured: Daily during the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start8 May 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City, Purdue University
- Responsible party
- Sponsor
- Investigators
- Kelsie Forbush, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190926
- Sponsor's protocol ID
- STUDY00141926
- Acronym
- STAR
- Status last verified
- Jul 2023
- First submitted
- 8 Dec 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Technology for Anorexia Nervosa Recovery: A Pilot Intervention for the Post-Acute Treatment of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05190926
- Acronym / sponsor ID
- STAR / STUDY00141926
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Adolescents, Smartphone, Therapy Support Tools
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City, Purdue University
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Treatment for Anorexia Nervosa Recovery (STAR) app | Experimental | Behavioral: Smart-Treatment for Anorexia Nervosa Recovery (STAR)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. |
| Present-focused Anorexia Nervosa Coping Treatment (PACT) app | Placebo comparator | Behavioral: Present-focused Anorexia Nervosa Coping Treatment (PACT)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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Smart Treatment for Anorexia Nervosa Recovery (STAR) app |
| 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. | Behavioural | Present-focused Anorexia Nervosa Coping Treatment (PACT) app |
Primary outcome
Change in Body Mass Index Z-Scores (BMI-z)
Time frame: Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups
Therapists, caregivers, or primary care physicians will provide weight and height measurements each week to calculate BMI-z.
8 secondary outcomes
Change in Categorical Recovery Status
Time frame: Baseline, 12-week, and 3- and 6-month follow-ups
Change in Mood and Anxiety Symptoms
Time frame: Baseline, 12-week, and 3- and 6-month follow-ups
Change in Eating Disorder Symptom Severity
Time frame: Baseline, 12-week, and 3- and 6-month follow-ups
Change in Psychiatric Impairment
Time frame: Baseline, 12-week, and 3- and 6-month follow-ups
Change in Parent-Reported Mealtime Behaviors
Time frame: Baseline, 12-week, and 3- and 6-month follow-ups
Change in Emotion Avoidance
Time frame: Baseline and 12-week intervention (weekly)
Change in Eating-Disorder Behaviors
Time frame: Daily during the 12-week intervention period
Change in Patient Skill Utilization
Time frame: Daily during the 12-week intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelsie Forbush, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart-Treatment for Anorexia Nervosa Recovery (STAR) and Present-focused Anorexia Nervosa Coping Treatment (PACT) in people with Anorexia Nervosa, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelsie Forbush, PhD (7858646525, kforbush@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.