RecruitingNot Applicable

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

China100 participantsStarted 2026-04-03

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Caregiver burden measured by the Zarit Burden Interview

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

Trial details

NCT IDNCT07734779

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

jue Chen

86 18017311203 chenjue2088@163.com

View on ClinicalTrials.gov More Anorexia Nervosa trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.