UMIN-CTR Clinical Trial

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
Email	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
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	Chiba University Hospital Clinical Research Center
Address	1-8-1 Inohana, Chuouku, Chiba, Japan
Tel	+81432227171
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008920