An interventional study of Online FBT-DBT Intervention and Online Supportive Psychological Intervention in Anorexia Nervosa and Caregiver Burden, sponsored by Shanghai Mental Health Center. Recruiting at 1 site in China. Open to participants aged 10 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Supportive care
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.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 100 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Online FBT-DBT Intervention · Behavioral: Online Supportive Psychological Intervention
Participants receive a 12-week online supportive psychological intervention delivered in a group format.
Behavioral: Online FBT-DBT Intervention · Behavioral: Online Supportive Psychological Intervention
A 12-week online caregiver intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) principles and skills.
A 12-week online supportive psychological intervention delivered in a group format.
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)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 7 months is below that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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