Anorexia Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 20
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
jue Chen
chenjue2088@163.com
86 18017311203
Backup
lei Zhang
Time Frame
Start Date: 2026-04-03
Estimated Completion Date: 2027-01-20
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov