Rsecue in cogunitive behavioral family therapy

JRCT ID: jRCT1030210244

Registered date:16/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: somatic symtom disorder with predominant pain
• Date of first enrollment: 18/06/2021
• Target sample size: 15
• 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 by patients
1. BPI pain severity and pain interference
2. EuroQol 5 Dimension (EQ-5D-5L)
3. Pain Catastrophizing Scale (PCS)
4. Pain Disability Assessment Scale (PDAS)
5. Beck Depression Inventory 2 (BDI 2)
6. Patient Health Questionnaire-9 (PHQ-9)
7. Generalized Anxiety Disorder-7 (GAD-7)
8. WHO QOL 26
9. Client Satisfaction Questionnaire (CSQ-8)
10. Injustice Experience Questionnaire chronic (IEQ-chr)
Change of score from session 1 to session16 by family
1. BPI pain severity and pain interference. The assessment about patient.
2. Pain Disability Assessment Scale (PDAS).The assessment about patient.
3. WHO QOL 26
4. Client Satisfaction Questionnaire (CSQ-8)

Key inclusion & exclusion criteria

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

Include criteria

Patients that participated as treatment as usual in RCT (jRCT1030200356) set to target.
1) Meet the diagnostic criteria for "physical sympt
oms (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 lif
e 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 tog
ether in principle).
5) Continuing regular treatment for chronic pain a
nd 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 ar
e not eligible.
1) Have neurocognitive disorder group, psychotic
disorder, bipolar disorder, substance-related disor
der and other serious mental disorders in DSM-5.
2) cancer pain.
3) Mental developmental delay, neurocognitive im
pairment (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 psych
iatrist.
6) Have pain proceedings or compensation issues

Related Information

• Primary Sponsor: Shimizu Eiji
• Secondary Sponsor: Taguchi Kayoko
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology
• Secondary ID(s): Nil known