UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007552 |
|---|---|
| Receipt number | R000008920 |
| Scientific Title | A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for social anxiety disorder refractory to initial SSRI treatment |
| Date of disclosure of the study information | 2012/03/30 |
| Last modified on | 2021/12/09 14:03:39 |
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Basic information
Public title
A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for social anxiety disorder refractory to initial SSRI treatment
Acronym
CBT for SAD refractory to SSRI- Effectiveness of CBT adjunct usual care
Scientific Title
A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for social anxiety disorder refractory to initial SSRI treatment
Scientific Title:Acronym
CBT for SAD refractory to SSRI- Effectiveness of CBT adjunct usual care
Region
| Japan |
Condition
Condition
Social Anxiety Disorder, Social Phobia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of cognitive behavioral therapy as an adjunct to usual care when compared to usual care alone in patients with social anxiety disorder refractory to initial SSRI treatment.
Basic objectives2
Others
Basic objectives -Others
To examine long-term and cost effectiveness of cognitive behavioral therapy as an adjunct to usual care when compared to usual care alone in patients with social anxiety disorder refractory to initial SSRI treatment for one year. As for usual care-alone group, we monitor outcomes only first 16 weeks, and following course were simulated.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Liebowtz Social Anxiety Scale: LSAS (assessor-rated)
Key secondary outcomes
Social Phobia and Anxiety Inventory: SPAI
Beck Depression Inventory: BDI
Clinical Global Impression-Severity: CGI-S
Clinical Global Impression-Improvement: CGI-I
Seehan Disability Scale: SDS
World Health Organization Quality of Life: WHOQOL
Euro QOL-5 Dimensions: EQ-5D
fMRI (exploratory outcome)
<For long-term outcome>
Liebowtz Social Anxiety Scale: LSAS (Self-reported)
Patient Health Questionnaire-9: PHQ-9
Generalized Anxiety Disorder-7: GAD-7
Euro QOL-5 Dimensions: EQ-5D
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cognitive behavioral therapy
Interventions/Control_2
usual care only
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of social anxiety Disorder refractory to initial SSRI treatment (Taking antidepressant treatment and had done so for at least 12 weeks at an adequate dose while remaining at least moderately ill (LSAS > 50).
Aged 18 to 75 years
Key exclusion criteria
psychosis, major depression, bipolar, active suicidality, organic brain disorder, substance abuse or dependence, antisocial personality disorder, other severe mental / physical condition
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
esearch Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Yoshinaga |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
Homepage URL
yoshinaga.n@hospital.chiba-u.jp
Sponsor or person
Institute
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Ministry of Health and Labor
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Psychiatry, Chiba University
National Institute of Radiological Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
Tel
+81432227171
chibacrc@mac.com
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
千葉大学医学部附属病院、千葉大学医学研究院、放射線医学総合研究所（千葉県） Chiba university hospital, Graduate School of Medicine Chiba University, National Institute of Radiological Sciences (Chiba)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
http://bmjopen.bmj.com/content/3/2/e002242.full
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/27230862
Number of participants that the trial has enrolled
Results
This study aimed to examine the effectiveness of cognitive behavioral therapy (CBT) as an adjunct to usual care (UC) when compared to UC alone in SAD patients who remain symptomatic following antidepressant treatment. Patients were randomly allocated to CBT + UC (n=21) or UC-alone (n=21) group. After 16 weeks, the mean reduction in the Liebowitz Social Anxiety Scale from baseline for CBT + UC and UC-alone was -40.87 and 0.68, respectively; between-group difference was -41.55 (-53.68 to -29.42, p<0.0001). Response rates were 85.7% and 10.0% for CBT + UC and UC-alone, respectively (p<0.0001); the corresponding remission rates were 47.6% and 0.0%, respectively (p=0.0005). Significant differences were also found in favor of CBT + UC for social anxiety symptoms, depressive symptoms, and functional impairment. Our results suggest that in SAD patients who have been ineffectively-treated with antidepressant, CBT is an effective treatment adjunct to UC over 16 weeks in reducing social anxiety and related symptoms.
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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data on long-term effectiveness, cost-effectiveness, and exploratory outcome (fMRI) will be analyzed and reported elsewhere.
Management information
Registered date
| 2012 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008920
