RecruitingNot ApplicableNCT07734779

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

A Randomized Controlled Trial of an Online Family-Based Treatment (FBT) Combined With Dialectical Behavior Therapy (DBT) Intervention Versus Online Supportive Psychological Intervention for Reducing Caregiver Burden Among Caregivers of Individuals With Anorexia Nervosa


Sponsor

Shanghai Mental Health Center

Enrollment

100 participants

Start Date

Apr 3, 2026

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Online FBT-DBT Intervention and a behavioral approach called Online Supportive Psychological Intervention for people with anorexia nervosa and caregiver burden. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALOnline FBT-DBT Intervention

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

BEHAVIORALOnline Supportive Psychological Intervention

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


Locations(1)

Shanghai Mental Health Center

Shanghai, China

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NCT07734779


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