Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-20
SponsorShanghai Mental Health Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Primary caregiver of an individual diagnosed with anorexia nervosa (AN) by a qualified clinician.
Disqualifiers
Currently providing care for another family member with a chronic physical illness or psychiatric disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
Online FBT-DBT Intervention
BehavioralA 12-week online caregiver intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) principles and skills.
Online Supportive Psychological Intervention
BehavioralA 12-week online supportive psychological intervention delivered in a group format.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Online FBT-DBT Caregiver InterventionExperimental treatment 2 interventions
Group B: Online Supportive Psychological InterventionActive comparator 2 interventions
Trial outcomes
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.
Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks(1-month follow-up), 16 weeks, and 24 weeks(3-month follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov