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App-based Cognitive Behavioral Therapy Intervention for Fibromyalgia

App-based Cognitive Behavioral Therapy Intervention for Fibromyalgia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084320
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

Interventional group:the intervention group will receive 8 weeks of app-based CBT-P treatment
control group:The waitlist control group will receive a 30-minute session of health education and exercise guidance specifically for fibromyalgia.

Sponsors

The first medical center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70 years. 2. Meets the revised 2016 American College of Rheumatology (ACR) diagnostic criteria for Fibromyalgia (FM). 3. Has not taken any FM treatment medications (such as duloxetine, pregabalin, milnacipran, amitriptyline, or other anti-anxiety and antidepressant medications) or has been on a stable dose of such medications for at least 3 months. 4. Serum C-reactive protein (CRP) level 42 on the revised Fibromyalgia Impact Questionnaire (FIQ-R) screening. 6. Scores = 4 on the Brief Pain Inventory (BPI) assessing average pain over the past 24 hours. 7. Able to read, write, and converse in Chinese, and independently proficient in using a smartphone App for communication. 8. Capable of independent mobility. 9. Agrees to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Currently involved in a workers' compensation or insurance claim process. 2. Daily oral intake of opioid medications at a morphine-equivalent dose of = 10 mg. 3. Diagnosed with major diseases such as inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis), connective tissue diseases, malignancies, or uncontrolled endocrine disorders, confirmed by necessary laboratory and imaging studies. 4. Diagnosed with severe mental illness or at high risk of self-harm (e.g., suicidal ideation), requiring urgent intervention. 5. Currently undergoing other non-pharmacological psychosomatic interventions. 6. Pregnancy.

Design outcomes

Primary

MeasureTime frame
The Revised Fibromyalgia Impact Questionnaire(FIQR);The Revised Fibromyalgia Impact Questionnaire(FIQR);The Revised Fibromyalgia Impact Questionnaire(FIQR);The Revised Fibromyalgia Impact Questionnaire(FIQR);Brief Pain Inventory(BPI);Brief Pain Inventory(BPI);Brief Pain Inventory(BPI);Brief Pain Inventory(BPI);The Depression Anxiety Stress Scale(DASS);The Depression Anxiety Stress Scale(DASS);The Depression Anxiety Stress Scale(DASS);The Depression Anxiety Stress Scale(DASS);pain self-efficacy questionnaire(PSEQ);pain self-efficacy questionnaire(PSEQ);pain self-efficacy questionnaire(PSEQ);pain self-efficacy questionnaire(PSEQ);pain catastrophizing scale(PCS);pain catastrophizing scale(PCS);pain catastrophizing scale(PCS);pain catastrophizing scale(PCS);

Countries

China

Contacts

Public ContactLiang Dongfeng

The first medical center of PLA General Hospital

liangdongfeng301@foxmail.com+86 135 2072 9402

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026