Anorexia Nervosa, Eating Disorders
Conditions
Brief 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. 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.
Interventions
BEHAVIORALFamily-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.
BEHAVIORALIntegrative family therapy
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.
Sponsors
University of Pittsburgh
National Institute of Mental Health (NIMH)
Lifespan
Rhode Island College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index percentile | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abbreviated Acceptability Rating Profile | Up to 32-weeks post randomization | 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. |
| Therapy Suitability and Patient Expectancy | Up to 32-weeks post randomization | 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. |
| Acceptability, Appropriateness, and Feasibility of Intervention Measure | Up to 3 years | 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. |
| Client Satisfaction Questionnaire | Up to 32-weeks post randomization | 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. |
| Multi-theoretical List of Therapeutic Interventions | Up to 32-weeks post randomization | 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. |
| Therapeutic Technique Scale | Up to 3 years | 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. |
| Engagement | Up to 3 years | Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit. |
| Enrollment | Up to 3 years | Percentage of potentially eligible families who ultimately enroll in the treatment. |
| Attendance | Up to 32-weeks post randomization | Number of therapy sessions completed. |
| Completion | Up to 32-weeks post randomization | Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea B Goldschmidt, Ph.D.
The University of Pittsburgh
Outcome results
None listed