UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062235 |
|---|---|
| Receipt number | R000071215 |
| Scientific Title | Effectiveness of Brief Cognitive Behavioral Therapy Delivered by General Practitioners for Somatic Symptom Disorder |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/14 23:41:36 |
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Basic information
Public title
Brief Cognitive Behavioral Therapy for Patients with Somatic Symptom Disorder in General Practice
Acronym
SSD-CBT Study
Scientific Title
Effectiveness of Brief Cognitive Behavioral Therapy Delivered by General Practitioners for Somatic Symptom Disorder
Scientific Title:Acronym
SSD-CBT Study
Region
| Japan |
Condition
Condition
Somatic Symptom Disorder
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of brief cognitive behavioral therapy (CBT) delivered by general practitioners during outpatient care for patients with somatic symptom disorder (SSD), to develop practical tools such as a handbook for delivering CBT in SSD care, and to examine the feasibility of applying these tools in real-world clinical settings. Specifically, this study aims to evaluate symptom improvement resulting from brief CBT delivered by general practitioners to patients with SSD, to develop practical support tools such as a handbook for delivering CBT for patients with SSD in outpatient settings, and to examine barriers and facilitators among general practitioners in order to assess the applicability of the developed tools to real-world clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the severity of somatic symptoms before and after the intervention, assessed using the Patient Health Questionnaire-15 (PHQ-15).The assessment time points are before the intervention, 6 months after the intervention, and 12 months after the intervention.
Key secondary outcomes
Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9): baseline, 6 months, and 12 months after the intervention.
Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7): baseline, 6 months, and 12 months after the intervention.
Health-related quality of life assessed by the 36-Item Short Form Health Survey (SF-36): baseline and 12 months after the intervention.
Barriers and facilitators to cognitive behavioral therapy (CBT) implementation: qualitative patient interviews.
Handbook usability and areas for improvement: qualitative patient interviews.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
In the usual care group, patients with somatic symptom disorder or persistent somatic symptoms will receive routine outpatient care. The content, interval, and number of consultations will be determined according to each patient's condition and the physician's clinical judgment. This group will be used as a historical control without the brief handbook-based psychological intervention.
Interventions/Control_2
In the handbook-assisted care group, general practitioners will provide a brief psychological intervention using a handbook during routine outpatient consultations for patients with somatic symptom disorder or persistent somatic symptoms. The program incorporates elements of cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness. The intervention will consist of three sessions, each lasting approximately 15 minutes. If necessary, the physician will first confirm the program purpose, procedure, safety considerations, and the patient's agreement to participate. The sessions will include reviewing symptoms, impact on daily life, mood, personal values, and a 3-month short-term goal; introducing body scan practice; planning and reviewing behavioral experiments; and discussing coping strategies. Patients will complete homework such as body scan practice and behavioral experiments between sessions.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(a) Aged 18 years or older and able to communicate sufficiently in Japanese.
(b) Able to provide written informed consent to participate in the study.
(c) Assessed by the attending physician in clinical practice as having somatic symptom disorder (SSD) or suspected SSD, and meeting the following diagnostic concept used in this study:
A. At least one of the following:
(1) Disproportionate and persistent thoughts about the seriousness of one's symptoms.
(2) Persistently high level of anxiety about health or symptoms.
(3) Excessive time and energy devoted to these symptoms or health concerns.
B. Although any one somatic symptom need not be continuously present, the state of being symptomatic has persisted for at least 3 months.
Key exclusion criteria
(a) Those with the following psychiatric disorders or conditions: depressive disorders, bipolar disorder, suicidal tendency, eating disorders, substance use disorders, acute psychosis, brain injury, personality disorders, or similar conditions.
(b) Those who pose a risk of harm to others or themselves, or who require urgent medical care.
(c) Those who have received inpatient psychiatric treatment within the past 5 years or psychotherapy for SSD within the past 2 years.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Ishikawa |
Organization
Jichi Medical University
Division name
Division of General Internal Medicine
Zip code
329-0498
Address
3311-1 Yakushizi, Shimotsuke-City, Tochigi
TEL
+81-285-58-7498
yuishi@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Ishikawa |
Organization
Jichi Medical University
Division name
Division of General Internal Medicine
Zip code
329-0498
Address
3311-1 Yakushizi, Shimotsuke-City, Tochigi
TEL
+81-285-58-7498
Homepage URL
https://nrid.nii.ac.jp/ja/nrid/1000060406080/
yuishi@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushizi, Shimotsuke-City, Tochigi
Tel
0285-44-2111
rinri@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071215
