Anorexia NervosaNCT07734779
Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa
A study testing Online FBT-DBT Intervention and Online Supportive Psychological Intervention in people with Anorexia Nervosa and Caregiver Burden, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Caregiver Burden
- What is being tested?
- Online FBT-DBT Intervention and Online Supportive Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Currently providing care for another family member with a chronic physical illness or psychiatric disorder.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
lei Zhang contact
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
shanghai mental health center, 86 021 34773308, smhcirb@163.com
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Anorexia Nervosa, Caregiver Burden
- Being tested
- Online FBT-DBT Intervention, Online Supportive Psychological Intervention
- Medical subject headings
- Anorexia Nervosa, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online FBT-DBT InterventionBehavioural
A 12-week online caregiver intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) principles and skills.
Online Supportive Psychological InterventionBehavioural
A 12-week online supportive psychological intervention delivered in a group format.
| Study group | Role | What they receive |
|---|---|---|
| Online FBT-DBT Caregiver Intervention | Experimental | 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. Receives: Behavioral: Online FBT-DBT Intervention; Behavioral: Online Supportive Psychological Intervention |
| Online Supportive Psychological Intervention | Active comparator | Participants receive a 12-week online supportive psychological intervention delivered in a group format. Receives: Behavioral: Online FBT-DBT Intervention; Behavioral: Online Supportive Psychological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden measured by the Zarit Burden Interview
Caregiver burden assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater caregiver burden.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks(1-month follow-up), 16 weeks, and 24 weeks(3-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start3 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an online Family-Based Treatment (FBT) combined with Dialectical Behavior Therapy (DBT) caregiver intervention group or an online supportive psychological intervention group. Both interventions will be delivered over 12 weeks in a group format, with assessments conducted at baseline, during treatment, post-intervention, and follow-up.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue CHEN, Shanghai Mental Health Center
- Investigators
- jue Chen, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734779
- Sponsor's protocol ID
- 2026-21
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07734779
- Acronym / sponsor ID
- 2026-21
- Conditions
- Anorexia Nervosa, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an online Family-Based Treatment (FBT) combined with Dialectical Behavior Therapy (DBT) caregiver intervention group or an online supportive psychological intervention group. Both interventions will be delivered over 12 weeks in a group format, with assessments conducted at baseline, during treatment, post-intervention, and follow-up.
| Arm | Type | Receives |
|---|---|---|
| Online FBT-DBT Caregiver Intervention | Experimental | Behavioral: Online FBT-DBT Intervention, Behavioral: Online Supportive Psychological InterventionParticipants 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. |
| Online Supportive Psychological Intervention | Active comparator | Behavioral: Online FBT-DBT Intervention, Behavioral: Online Supportive Psychological InterventionParticipants receive a 12-week online supportive psychological intervention delivered in a group format. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Currently providing care for another family member with a chronic physical illness or psychiatric disorder.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online FBT-DBT InterventionA 12-week online caregiver intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) principles and skills. | Behavioural | Online FBT-DBT Caregiver Intervention, Online Supportive Psychological Intervention |
| Online Supportive Psychological InterventionA 12-week online supportive psychological intervention delivered in a group format. | Behavioural | Online FBT-DBT Caregiver Intervention, Online Supportive Psychological Intervention |
Primary outcome
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)
Caregiver burden assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater caregiver burden.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lei Zhang contact
jue Chen study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online FBT-DBT Intervention and Online Supportive Psychological Intervention in people with Anorexia Nervosa and Caregiver Burden, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jue Chen (86 18017311203, chenjue2088@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.