Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

• ClinicalTrials.gov Identifier: NCT05563649
• Recruitment Status: Recruiting
• First Posted: October 3, 2022
• Last Update Posted: January 26, 2023
• Sponsor: Stanford University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): James Dale Lock, Stanford University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anorexia Nervosa	Behavioral: Online Guided Self-Help-Family-based Treatment; Behavioral: FBT via Videoconferencing	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
• Estimated Study Start Date: January 19, 2023
• Estimated Primary Completion Date: July 31, 2027
• Estimated Study Completion Date: October 1, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Online Guided Self-Help-Family-based Treatment (GSH-FBT); GSH-FBT consists of 10 20-minute parent-only sessions over 9 months. The guidance portion is manualized and will be delivered by a clinician familiar with both the online modules and FBT, who acts as a "coach." Sessions follow an online curriculum containing a total of 65 short videos. Each lecture series is comprised of a written 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. In line with GSH approaches, coaches direct parents to watch or re-watch specific videos contained in the online platform related to their questions.	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.; Other Name: GSH-FBT
Active Comparator: FBT via Videoconferencing (FBT-V); 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.	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.; Other Name: FBT-V

Outcome Measures

Primary Outcome Measures :

1. Ratio of therapist hours to %EBW change [ Time Frame: Assessed from baseline through end of treatment (EOT) ]
   The investigators will compare GSH-FBT and FBT-V groups at EOT in terms of the change in %EBW from baseline divided by total therapist time utilized. Estimated Body Weight (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents. Total therapist time utilized will be collected based on video records of actual sessions spent with participants.

Secondary Outcome Measures :

1. Eating Disorder Examination (EDE) [ Time Frame: Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up ]
   The EDE is a standardized investigator-based interview that measures the severity of the characteristic psychopathology of eating disorders. The psychometric properties of the EDE are sound and validated in diverse samples. It takes about 1 hour to complete.
2. Beck Depression Inventory (BDI) [ Time Frame: These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up) ]
   The BDI is a measure with sound psychometric properties and was validated on a diverse sample. It has been used in numerous studies of adolescent depression. This measure also includes questions about suicidal ideation and intent and will be used to assess suicide during the study. These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points. It takes about 10 minutes to complete.
3. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline, sessions 2, 4, 6, 8, and EOT ]
   The BAI is a 21-item questionnaire about anxiety that has sound psychometric properties and was validated on a diverse sample. Assessments will be collected at baseline, sessions 2, 4, 6, 8, and EOT.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Participants are 12-18 years of age
2. Participants live with a family (some families may contain only one parent)
3. Family members fluently speak and read English and have access to a computer with internet
4. Participants meet DSM-5 criteria for AN (both subtypes)
5. EBW between 75% and 88%
6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
7. Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.

Exclusion Criteria:

Current psychotic illness or mental retardation or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; currently taking medication for co-morbid disorders that cannot be safely discontinued or current dose has not been maintained for a minimum of 2 months; and inability of the participant and/or family to speak and understand English.

Contacts and Locations

Contacts

Contact: Hazal Y Gurcan, B.A.; 6507239182; familytreatment@stanford.edu

Locations

United States, California

Stanford University; Recruiting

Stanford, California, United States, 94305

Contact: Hazal Y Gurcan, B.A. 650-723-9182 familytreatment@stanford.edu

Principal Investigator: James D Lock, MD, PhD

Sub-Investigator: Brittany E Matheson, PhD

Canada, Ontario

McMaster University; Not yet recruiting

Hamilton, Ontario, Canada

Contact: Sadaf Sami, MD, CCRA samis2@mcmaster.ca

Sponsors and Collaborators

Stanford University

National Institute of Mental Health (NIMH)

More Information

• Responsible Party: James Dale Lock, Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents, Stanford University
• ClinicalTrials.gov Identifier: NCT05563649
• Other Study ID Numbers: 67295; R01MH130388 ( U.S. NIH Grant/Contract )
• First Posted: October 3, 2022
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anorexia; Anorexia Nervosa; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders