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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007552
Receipt No. 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 2017/11/15

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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

<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
Middle name
Last name Eiji Shimizu
Organization Graduate School of Medicine Chiba University
Division name esearch Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Yoshinaga
Organization Graduate School of Medicine Chiba University
Division name Department of Cognitive Behavioral Physiology
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Homepage URL
Email yoshinaga.n@hospital.chiba-u.jp

Sponsor
Institute Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University
Institute
Department

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
Address
Tel
Email

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
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 of long-term and cost effectiveness will be analyzed and reported elsewhere.

Management information
Registered date
2012 Year 03 Month 22 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008920

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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