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

Sponsor
Shanghai Mental Health Center
Study ID
NCT07734779
Status
Recruiting
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Conditions

  • Anorexia Nervosa
  • Caregiver Burden

Eligibility Criteria

Sex
ALL
Age
10 Years - 20 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Apr 3, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2026
Completion
Jan 20, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Online FBT-DBT Caregiver Intervention
    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.
  • Active Comparator: Online Supportive Psychological Intervention
    Participants receive a 12-week online supportive psychological intervention delivered in a group format.

Primary Outcome Measure

Caregiver burden measured by the Zarit Burden Interview [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks(1-month follow-up), 16 weeks, and 24 weeks(3-month follow-up) ]

Central Contacts

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