Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

University of Pittsburgh

Status: Active, not recruiting

Conditions: Eating Disorders; Anorexia Nervosa

Treatments: Behavioral: Integrative family therapy; Behavioral: Family-based treatment (FBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05184556

R34MH123589 (U.S. NIH Grant/Contract)

STUDY22040112

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

Family-based treatment

Experimental group

Description:

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

Treatment:

Behavioral: Family-based treatment (FBT)

Integrative family therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Integrative family therapy