Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa

NCT07734779 | Recruiting DMC

• 1 other identifier: 2026-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Anorexia nervosa (AN) is a severe psychiatric disorder characterized by a chronic and relapsing course. Caregivers of individuals with AN often experience substantial caregiving burden, emotional distress, and impairment in family functioning due to their ongoing responsibilities in meal supervision, treatment support, and symptom management. Despite the critical role of caregivers in treatment and recovery, evidence-based interventions specifically targeting caregiver burden remain limited in China. This study aims to develop and evaluate an online intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) for caregivers of individuals with AN. FBT emphasizes empowering caregivers to support nutritional rehabilitation and recovery, whereas DBT provides skills in emotion regulation, validation, and effective communication. The integration of these approaches may help caregivers reduce distress, improve caregiving skills, and enhance family functioning. This study will employ a randomized controlled trial design. A total of 80 primary caregivers of individuals with AN will be recruited and randomly assigned to either an online FBT-DBT intervention group or an online supportive psychological intervention group. Both interventions will be delivered in a group format over 12 weeks. Assessments will be conducted at baseline, 4 weeks, 8 weeks, post-intervention (12 weeks), and at 1-month and 3-month follow-up. The primary outcome will be caregiver burden. Secondary outcomes will include psychological distress, negative emotional experiences, and the impact of eating disorder symptoms on the family. The study aims to determine the effectiveness of the online FBT-DBT intervention in reducing caregiver burden and psychological distress and to evaluate whether it provides greater benefits than supportive psychological intervention. Findings may contribute to the development of accessible and evidence-based caregiver interventions for families affected by AN in China.

Conditions

Anorexia Nervosa; Caregiver Burden

Outcome Measures

Primary Outcomes (1)

• Caregiver burden measured by the Zarit Burden Interview

  Caregiver burden assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater caregiver burden.

  Baseline, 4 weeks, 8 weeks, 12 weeks(1-month follow-up), 16 weeks, and 24 weeks(3-month follow-up)

Study Arms (2)

Online FBT-DBT Caregiver Intervention

EXPERIMENTAL

Participants receive a 12-week online group intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) skills for caregivers of individuals with anorexia nervosa.

Behavioral: Online FBT-DBT Intervention; Behavioral: Online Supportive Psychological Intervention

Online Supportive Psychological Intervention

ACTIVE COMPARATOR

Participants receive a 12-week online supportive psychological intervention delivered in a group format.

Behavioral: Online FBT-DBT Intervention; Behavioral: Online Supportive Psychological Intervention

Interventions

Online FBT-DBT Intervention BEHAVIORAL

A 12-week online caregiver intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) principles and skills.

Online FBT-DBT Caregiver Intervention; Online Supportive Psychological Intervention

Online Supportive Psychological Intervention BEHAVIORAL

A 12-week online supportive psychological intervention delivered in a group format.

Online FBT-DBT Caregiver Intervention; Online Supportive Psychological Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caregiver of an individual diagnosed with anorexia nervosa (AN) by a qualified clinician.
• The individual with AN is between 10 and 18 years of age. The individual with AN does not have a severe comorbid physical illness or severe psychiatric disorder.
• The caregiver lives in the same household as the individual with AN. The caregiver has at least a primary school level of education and is able to complete study procedures and questionnaires.
• All participating caregivers from the same family are willing to participate in the intervention and assessment procedures.
• Able and willing to provide informed consent.

You may not qualify if:

• Currently providing care for another family member with a chronic physical illness or psychiatric disorder.
• Current or past history of a severe physical illness or severe psychiatric disorder that would interfere with study participation.
• Severe emotional instability, active self-harm or suicidal behavior, psychotic symptoms, or other psychiatric conditions requiring immediate clinical intervention.
• Unable or unwilling to participate in the intervention or assessment procedures.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Caregiver Burden

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• jue Chen

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

jue Chen

CONTACT

86 18017311203; chenjue2088@163.com

lei Zhang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Participants will be randomly assigned to either an online Family-Based Treatment (FBT) combined with Dialectical Behavior Therapy (DBT) caregiver intervention group or an online supportive psychological intervention group. Both interventions will be delivered over 12 weeks in a group format, with assessments conducted at baseline, during treatment, post-intervention, and follow-up.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)