Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

NCT02054364 | Completed DMC

• 2 other identifiers: 1R34MH101281Grant Funding Number (NIH)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.

Conditions

Anorexia Nervosa

Keywords

Eating Disorder; Anorexia Nervosa; Eating Disorder Not Otherwise Specified; Maudsley; Family-Based Therapy; FBT; Family Therapy; Cognitive Remediation Therapy; CRT

Outcome Measures

Primary Outcomes (1)

• Full remission from AN (%MBW>95)

  Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)

  End of Treatment (6 months)

Study Arms (2)

FBT and CRT

EXPERIMENTAL

Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each)

Behavioral: FBT and CRT

FBT and art therapy

EXPERIMENTAL

Family-Based Treatment combined with art therapy (15 sessions of each)

Behavioral: FBT and art therapy

Interventions

FBT and CRT BEHAVIORAL

Also known as: Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT)

FBT and CRT

FBT and art therapy BEHAVIORAL

Also known as: Family-Based Treatment (FBT) combined with art therapy.

FBT and art therapy

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meets DSM-IV criteria for anorexia nervosa Lives with at least one English-speaking parent who is willing to participate Medically Stable Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English

You may not qualify if:

• Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Links

• Program information

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• James Lock, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (1)