UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and feasibility study of the cognitive behavioral therapy for complicated grief in Japanese clinical setting
Title of the study (Brief title)	An open label pilot study of the cognitive behavioral therapy for complicated grief
Region	Japan

Condition
Condition	Complicated grief
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness and feasibility of cognitive behavioral therapy for complicated grief in Japanese clinical setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Inventory of Complicated Grief (ICG) 2. Response rate(responder status: score of 2 or lower on the CGI-I or ICG improvement of at least 2SDs above baseline mean)
Key secondary outcomes	1. Mini-International Neuropsychiatric Interview (M.I.N.I.) 2. Structured Clinical Interview for Complicated Grief (SCI-CG) 3. Prolonged Grief Disorder Scale (PG-13) 4. Grief Related Avoidance Questionnaire (GRAQ) 5. Beck Depression Inventory-2 (BDI-2) 6. State-Trait Anxiety Inventory (STAI) 7. Impact of Event Scale-Revised (IES-R) 8. Posttraumatic Cognition Inventory (PTCI) 9. Pittsburg Sleep Quality Index (PSQI) 10. Connor-Davidson Resilience Scale (CD-RISC) 11. MOS 36-Item Short-Form Health Survey (SF-36) 12. Social Support Questionnaire short form (SSQ-6) 13.Positive and Negative Affect Schedule Scale(PANAS)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cognitive Behavioral Therapy for Complicated Grief (once a week, 16 sessions)
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Complicated grief as the most important clinical problem 2. More than 30 score of Inventory of Complicated Greif 3. 13 months and over after the death of loved one 4. Stable antidepressant medication for a minimum of 3 months, with at least 6 weeks at the same dose. 5. Those who can give a written informed consent 6. Those who can visit to hospital once a week 7. Native Japanese speaker
Key exclusion criteria	1. Comorbidity of psychotic disorders, bipolar disorder, alcohol/drug dependence or abuse and group A personality disorder 2. History of psychotic disorders and bipolar disorder 3. History of alcohol/drug dependence or abuse in past 3 months 4. History of suicidal attempt or severe self-injury in past 6 months 5. Those who have difficulty for intervention such as cognitive impairment and mental retardation 6. Other mental/ physical conditions that may interfere this intervention 7. Ongoing or scheduled court litigation related to bereavement 8. Concurrent psychotherapy without supportive counseling 9. Pregnant or lactating woman 10. Concurrent other clinical trails 11. Those who are judged by screening doctors as inadequate
Target sample size	15

Research contact person
Name of lead principal investigator	Satomi Nakajima
Organization	Fukushima Medical University
Division name	Radiation Medical Science Center for the Fukushima Health Management Survey
Address	1 Hikariga-oka, Fukushima City,Fukushima,Japan
TEL	024-547-1887
Email	snakajim@fmu.ac.jp

Public contact
Name of contact person	Satomi Nakajima
Organization	Fukushima Medical University
Division name	Radiation Medical Science Center for the Fukushima Health Management Survey
Address	1 Hikariga-oka, Fukushima City,Fukushima,Japan
TEL	024-547-1887
Homepage URL	http://www.j-cgt.jp/
Email	snakajim@fmu.ac.jp

Sponsor
Institute	National Center for Cognitive Behavioral Therapy and research, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Musashino University International University of Health and Welfare Graduate School
Name of secondary funｄer(s)

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	国立精神・神経医療研究センター病院（東京都） 武蔵野大学心理臨床センター（東京都） 国際医療福祉大学大学院青山心理相談室（東京都）

Other administrative information
Date of disclosure of the study information	2009 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 11 Day
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 09 Month 30 Day
Last modified on	2017 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003133