NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1030210244

Registered date:16/08/2021

Rsecue in cogunitive behavioral family therapy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedsomatic symtom disorder with predominant pain
Date of first enrollment18/06/2021
Target sample size15
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeBPI total score from session1 to session10
Secondary OutcomeChange 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 maximumNot applicable
GenderBoth
Include criteriaPatients 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 criteriaThose 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

Contact

Public contact
Name Kayoko Taguchi
Address 1-8-1 Inohana Chuo-ku Chiba city Chiba Chiba Japan 260-8677
Telephone +81-43-226-2027
E-mail k.taguchi@chiba-u.jp
Affiliation Chiba University
Scientific contact
Name Eiji Shimizu
Address 1-8-1 Inohana Chuo-ku Chiba city Chiba Chiba Japan 260-8677
Telephone +81-43-226-2027
E-mail eiji@faculty.chiba-u.jp
Affiliation Chiba University