cognitive behaviolral familly therapy for chronic pain

JRCT ID: jRCT1030200356

Registered date:09/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: somatic symptom disorder with predominant pain
• Date of first enrollment: 09/02/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Remote family cognitive behavioral therapy (CBFT) using a video conferencing system will be conducted for 10 consecutive weeks in addition to regular medical care. CFBT follows the program and participates with the family.

Outcome(s)

• Primary Outcome: BPI total score from session1 to session10

Secondary Outcome

Change of score from session 1 to session16 and to 3 month follow-up.
BPI pain severity and pain interference
EuroQol 5 Dimension (EQ-5D-5L)
Pain Catastrophizing Scale (PCS)
Pain Disability Assessment Scale (PDAS)
Beck Depression Inventory 2 (BDI 2)
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder-7 (GAD-7)
WHO QOL 26
Client Satisfaction Questionnaire (CSQ-8)
Injustice Experience Questionnaire chronic (IEQ-chr)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Meet the diagnostic criteria for "physical symptoms (pain is the main symptom)" in DSM-5
2) 18 years of age or older at the time of obtaining consent.
3)One or more reports of interference with daily life due to patient's pain from a family member living together.
4) To practice cognitive-behavioral therapy once a week (10 times in total) with their family (living together in principle).
5) Continuing regular treatment for chronic pain and not be planed to started new drug therapy.
6) Have internet environment at home and can perform online treatment.

Exclude criteria

Those who meet any of the following conditions are not eligible.
1) Have neurocognitive disorder group, psychotic disorder, bipolar disorder, substance-related disorder and other serious mental disorders in DSM-5.
2) cancer pain.
3) Mental developmental delay, neurocognitive impairment (dementia) , autism spectrum disorder.
4) Have serious progressive physical illness.
5) judged to be inappropriate for conducting this examination safely by the investigator or the psychiatrist.
6) Have pain proceedings or compensation issues

Related Information

• Primary Sponsor: Shimizu Eiji
• Secondary Sponsor: Taguchi Kayoko,Ministry of Education, Culture, Sports, Science and Technology