Anorexia NervosaNCT05184556
Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
A study testing Family-based treatment (FBT) and Integrative family therapy in people with Anorexia Nervosa and Eating Disorders, run by University of Pittsburgh at 2 sites in United States.
Trial summary
This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Eating Disorders
- What is being tested?
- Family-based treatment (FBT) and Integrative family therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2022to 30 Apr 2026
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
- Currently living at home with caregivers who are willing to engage in family treatment.
- Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment.
- If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
- Available for follow-up.
Who cannot join
- Associated physical illness that necessitates hospitalization.
- Psychotic illness/other mental illness requiring hospitalization.
- Current dependence on drugs or alcohol.
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight.
- Concurrent involvement in other psychological treatment for an eating disorder.
- Developmental delay that would preclude participation in the intervention.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gateway Healthcare
Pawtucket, Rhode Island, 02860
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome
Read the detailed description
Participants (adolescents with AN-spectrum and their parents) are asked to complete study assessments at 5 time points: baseline and 6-, 12-, 24-, and 32-weeks after starting treatment. The 32-week time point was added approximately a year into the study, at the suggestion of the Program Officer. The research team noted that some families are still in treatment at the time of the 24-week assessment, so these data do not capture post-treatment thoughts and behaviors. To better assess post-treatment outcomes, a 32-week assessment was added to protocol.
- Conditions
- Anorexia Nervosa, Eating Disorders
- Being tested
- Family-based treatment (FBT), Integrative family therapy
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based treatment (FBT)Behavioural
FBT is a structured behavioral treatment focused on empowering caregivers to take charge of the adolescent's eating behavior and return him/her to a normative weight and developmental trajectory. FBT involves three consecutive phases: 1) caregivers are fully in control of the adolescent's eating; 2) control of eating is gradually returned to the adolescent; and 3) developmental issues are explored. In the current study, FBT is adapted for delivery in the home setting in the following ways: intensified dose of treatment (2-6 hours of therapy per week over 10 - 32 weeks); use of clinician as an additional support to the family; multiple family meals in the home and community; sociocultural tailoring; and inclusion of supplemental individual work with the adolescent to improve emotion regulation/distress tolerance.
Integrative family therapyBehavioural
The integrated family therapy approach includes psychoeducation, supportive family therapy, and elements of cognitive-behavioral interventions. Families may be referred for additional nutritional counseling and prescribed a meal plan as indicated. Typical strategies include educating families on the presentation and prognosis of adolescent AN; identifying dysfunctional family structures/alliances and communication patterns; using reflective listening to engage and validate family members; challenging maladaptive beliefs about eating and weight; and supporting families in developing strategies for management of both general and eating disorder-specific distress. Treatment is generally non-directive.
| Study group | Role | What they receive |
|---|---|---|
| Family-based treatment | Experimental | Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care Receives: Behavioral: Family-based treatment (FBT) |
| Integrative family therapy | Active comparator | Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care Receives: Behavioral: Integrative family therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index percentile
Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.
Measured: Up to 32-weeks post randomization
Eating Disorder Examination
The Eating Disorder Examination will be used to diagnose anorexia nervosa, and assess eating disorder behaviors, attitudes, and cognitions. Items are scored from 0-7 and averaged to create subscales reflecting restraint, eating concerns, shape concerns, weight concerns, and global eating-related psychopathology. Higher scores indicate more severe eating disorder symptoms.
Measured: Up to 32-weeks post randomization
Secondary outcomes (10)
Abbreviated Acceptability Rating Profile
The Abbreviated Acceptability Rating Profile is an 8-item questionnaire that assesses acceptability of treatment from both parent and child viewpoints on a 6-point Likert scale. Higher scores reflect greater levels of treatment acceptability.
Measured: Up to 32-weeks post randomization
Therapy Suitability and Patient Expectancy
The Therapy Suitability and Patient Expectancy is used to assess patients' and caregivers' perceptions of treatment suitability and expected improvement with treatment from 0 (not at all) to 10 (extremely) using 2 items. Higher scores reflect more positive expectations from treatment.
Measured: Up to 32-weeks post randomization
Acceptability, Appropriateness, and Feasibility of Intervention Measure
The Acceptability, Appropriateness, and Feasibility of Intervention Measure is a 31-item survey comprising three subscales (acceptability, appropriateness, and feasibility) that will assess clinician perspectives of treatment. Higher scores reflect greater perceived acceptability, appropriateness, and feasibility.
Measured: Up to 3 years
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire-8 is an 8-item questionnaire that assesses satisfaction with treatment on a 4-point Likert scale, with higher scores indicating higher treatment satisfaction.
Measured: Up to 32-weeks post randomization
Multi-theoretical List of Therapeutic Interventions
The Multi-theoretical List of Therapeutic Interventions assesses different therapeutic techniques occurring across different forms of psychotherapy. The MULTI-60 comprises 8 subscales representing 8 primary therapeutic orientations, including cognitive-behavioral and dialectic-behavioral therapy. Items are rated from 1-5, with higher scores indicating that a given technique is more typical of the overall treatment approach.
Measured: Up to 32-weeks post randomization
Therapeutic Technique Scale
The Therapeutic Technique Scale assesses clinician implementation of 17 therapeutic techniques to measure treatment fidelity. Items are rated from 0-5, with higher scores indicating a greater level of skill in implementing each therapeutic technique in therapy sessions.
Measured: Up to 3 years
Engagement
Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit.
Measured: Up to 3 years
Enrollment
Percentage of potentially eligible families who ultimately enroll in the treatment.
Measured: Up to 3 years
Attendance
Number of therapy sessions completed.
Measured: Up to 32-weeks post randomization
Completion
Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely.
Measured: Up to 32-weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Aug 2022
- Primary completion30 Mar 2026
- Study completion30 Apr 2026
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.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Lifespan, Rhode Island College
- Responsible party
- Principal investigator, Andrea Goldschmidt, University of Pittsburgh
- Investigators
- Andrea B Goldschmidt, Ph.D., Principal investigator, The University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184556
- Sponsor's protocol ID
- STUDY22040112
- Other IDs
- R34MH123589
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data from participants will be shared with the broader scientific community through the NIMH Data Archive and the National Database for Clinical Trials related to Mental Illness. Data will be de-identified and harmonized to a common standard. Data will include all adolescent-, caregiver-, and clinician-level variables reflecting eating- and weight-related outcomes, implementation metrics, and treatment mechanisms, and will be accompanied by a data dictionary describing the variables, data structure, and any relevant coding/re-coding schemes. Data will be uploaded at least every six months for the duration of the study. All informed consent/assent documents will include a discussion of how data will be shared with the Data Archive and the research community.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
- ClinicalTrials.gov ID
- NCT05184556
- Acronym / sponsor ID
- STUDY22040112
- Conditions
- Anorexia Nervosa, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Lifespan, Rhode Island College
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 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.
This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome
Detailed description
Participants (adolescents with AN-spectrum and their parents) are asked to complete study assessments at 5 time points: baseline and 6-, 12-, 24-, and 32-weeks after starting treatment. The 32-week time point was added approximately a year into the study, at the suggestion of the Program Officer. The research team noted that some families are still in treatment at the time of the 24-week assessment, so these data do not capture post-treatment thoughts and behaviors. To better assess post-treatment outcomes, a 32-week assessment was added to protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based treatment | Experimental | Behavioral: Family-based treatment (FBT)Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care |
| Integrative family therapy | Active comparator | Behavioral: Integrative family therapyFamilies will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
- Currently living at home with caregivers who are willing to engage in family treatment.
- Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment.
- If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
- Available for follow-up.
Key exclusion criteria (6 listed)
- Associated physical illness that necessitates hospitalization.
- Psychotic illness/other mental illness requiring hospitalization.
- Current dependence on drugs or alcohol.
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight.
- Concurrent involvement in other psychological treatment for an eating disorder.
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 |
|---|---|---|
| Family-based treatment (FBT)FBT is a structured behavioral treatment focused on empowering caregivers to take charge of the adolescent's eating behavior and return him/her to a normative weight and developmental trajectory. FBT involves three consecutive phases: 1) caregivers are fully in control of the adolescent's eating; 2) control of eating is gradually returned to the adolescent; and 3) developmental issues are explored. In the current study, FBT is adapted for delivery in the home setting in the following ways: intensified dose of treatment (2-6 hours of therapy per week over 10 - 32 weeks); use of clinician as an additional support to the family; multiple family meals in the home and community; sociocultural tailoring; and inclusion of supplemental individual work with the adolescent to improve emotion regulation/distress tolerance. | Behavioural | Family-based treatment |
| Integrative family therapyThe integrated family therapy approach includes psychoeducation, supportive family therapy, and elements of cognitive-behavioral interventions. Families may be referred for additional nutritional counseling and prescribed a meal plan as indicated. Typical strategies include educating families on the presentation and prognosis of adolescent AN; identifying dysfunctional family structures/alliances and communication patterns; using reflective listening to engage and validate family members; challenging maladaptive beliefs about eating and weight; and supporting families in developing strategies for management of both general and eating disorder-specific distress. Treatment is generally non-directive. | Behavioural | Integrative family therapy |
Primary outcome
Body mass index percentile
Time frame: Up to 32-weeks post randomization
Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.
Eating Disorder Examination
Time frame: Up to 32-weeks post randomization
The Eating Disorder Examination will be used to diagnose anorexia nervosa, and assess eating disorder behaviors, attitudes, and cognitions. Items are scored from 0-7 and averaged to create subscales reflecting restraint, eating concerns, shape concerns, weight concerns, and global eating-related psychopathology. Higher scores indicate more severe eating disorder symptoms.
10 secondary outcomes
Abbreviated Acceptability Rating Profile
Time frame: Up to 32-weeks post randomization
Therapy Suitability and Patient Expectancy
Time frame: Up to 32-weeks post randomization
Acceptability, Appropriateness, and Feasibility of Intervention Measure
Time frame: Up to 3 years
Client Satisfaction Questionnaire
Time frame: Up to 32-weeks post randomization
Multi-theoretical List of Therapeutic Interventions
Time frame: Up to 32-weeks post randomization
Therapeutic Technique Scale
Time frame: Up to 3 years
Engagement
Time frame: Up to 3 years
Enrollment
Time frame: Up to 3 years
Attendance
Time frame: Up to 32-weeks post randomization
Completion
Time frame: Up to 32-weeks post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Research data from participants will be shared with the broader scientific community through the NIMH Data Archive and the National Database for Clinical Trials related to Mental Illness. Data will be de-identified and harmonized to a common standard. Data will include all adolescent-, caregiver-, and clinician-level variables reflecting eating- and weight-related outcomes, implementation metrics, and treatment mechanisms, and will be accompanied by a data dictionary describing the variables, data structure, and any relevant coding/re-coding schemes. Data will be uploaded at least every six months for the duration of the study. All informed consent/assent documents will include a discussion of how data will be shared with the Data Archive and the research community.
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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.
Andrea B Goldschmidt, Ph.D. principal investigator
The University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based treatment (FBT) and Integrative family therapy in people with Anorexia Nervosa and Eating Disorders, run by University of Pittsburgh at 2 sites 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: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index percentile (time frame: Up to 32-weeks post randomization). The study lists 2 primary outcomes in all. 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 3 Jun 2026.