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

NCT07734779 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Mental Health Center

Phase

Not applicable

Started

2026-04-03

Last updated

2026-08-25

Condition(s) studied

Anorexia NervosaCaregiver Burden

Investigational drug(s) / intervention(s)

Online FBT-DBT InterventionOnline Supportive Psychological Intervention

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

Online Supportive Psychological Intervention: A 12-week online supportive psychological intervention delivered in a group format.

Study 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.

Eligibility

Sex

ALL

Min age

10 Years

Max age

20 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Primary caregiver of an individual diagnosed with anorexia nervosa (AN) by a qualified clinician. The individual with AN is between 10 and 20 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Caregiver burden measured by the Zarit Burden Interview — Baseline, 4 weeks, 8 weeks, 12 weeks(1-month follow-up), 16 weeks, and 24 weeks(3-month follow-up)
Caregiver burden assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater caregiver burden.

Trial sites (1)

Facility	City	Region	Status
Shanghai Mental Health Center	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07734779 on ClinicalTrials.gov ↗ ← All trials in China