Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
NCT05563649 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-06-26
Summary
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
Conditions
- Anorexia Nervosa
Interventions
- BEHAVIORAL
-
Online Guided Self-Help-Family-based Treatment
GSH-FBT consists of 10 20-minute sessions for parents only over 9 months. Sessions follow an online curriculum of 65 short videos: 62 with an expert clinician instructing parents on the principles of FBT, and 3 reflections from an adolescent who recovered from AN and completed FBT. Each lecture series contains an introduction orienting the viewer to the videos, 5-9 short videos (\< 7 minutes each), and assigned reading from the parent education manual Help Your Teenager Beat an Eating Disorder. Three lectures include additional resources for parents (e.g., Academy of Eating Disorder (AED) Medical Management Guidelines). Homework assignments are included with some lectures (e.g., strategies to help the child eat during meals, practice making calorically dense meals). In line with GSH approaches, coach-therapists direct parents, to watch or re-watch specific video content contained in the online learning material related to their questions rather than direct behavioral change.
- BEHAVIORAL
-
FBT via Videoconferencing
15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-17
- Primary Completion
- 2027-07-31
- Completion
- 2027-10-01
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
NCT02139462 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa
NCT00149786 ·Status: COMPLETED ·Phase: PHASE1
-
Adaptive Treatment for Adolescent Anorexia Nervosa
NCT03097874 ·Status: COMPLETED ·Phase: NA
-
Parent Emotion Coaching for Anorexia Nervosa
NCT04421989 ·Status: COMPLETED ·Phase: NA
-
Finding Treatments for Eating Disorders
NCT05249140 ·Status: UNKNOWN ·Phase: NA
-
Smart Technology for Anorexia Nervosa Recovery
NCT05190926 ·Status: UNKNOWN ·Phase: NA
-
Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family Based and Metacognitive Approach
NCT06139770 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
NCT02054364 ·Status: COMPLETED ·Phase: NA
-
Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa
NCT06097247 ·Status: ACTIVE_NOT_RECRUITING
-
Comparing the Effectiveness of Three Types of Therapy for the Treatment of Anorexia Nervosa in Adolescents
NCT00183586 ·Status: COMPLETED ·Phase: PHASE2
-
Helping HAND: Healing Anorexia Nervosa Digitally
NCT05499676 ·Status: COMPLETED ·Phase: NA
-
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
NCT02252822 ·Status: COMPLETED ·Phase: NA
-
Family Therapy and Anorexia Nervosa : Which is the Best Approach?
NCT03350594 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)
NCT06597305 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Open Trial of Family-Based Treatment for Anorexia Nervosa
NCT00417521 ·Status: COMPLETED ·Phase: NA
-
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
NCT00418977 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.
NCT05418075 ·Status: UNKNOWN ·Phase: NA
-
Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa Controlled Trial
NCT05362981 ·Status: UNKNOWN ·Phase: NA
-
Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa
NCT01274416 ·Status: COMPLETED ·Phase: NA
-
Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
NCT05763849 ·Status: RECRUITING ·Phase: NA
-
Treatment Outcome in Eating Disorders
NCT03599921 ·Status: COMPLETED
-
Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
NCT05184556 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT
NCT05017831 ·Status: COMPLETED ·Phase: NA
-
Family Treatment for Adolescents With Anorexia Nervosa
NCT01280799 ·Status: COMPLETED ·Phase: PHASE1
-
The Efficacy of Readiness and Motivation Therapy in Individuals With Anorexia Nervosa and Bulimia Nervosa
NCT00220662 ·Status: UNKNOWN ·Phase: PHASE3