UMIN-CTR Clinical Trial

Public title

Effectiveness and feasibility study of internet-based cognitive behavioral therapy for complicated grief in Japanese clinical setting

Acronym

An open label pilot study of internet-based cognitive behavioral therapy for complicated grief

Scientific Title

Effectiveness and feasibility study of internet-based cognitive behavioral therapy for complicated grief in Japanese clinical setting

Scientific Title:Acronym

An open label pilot study of internet-based cognitive behavioral therapy for complicated grief

Region

Japan

Condition

Complicated grief

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine effectiveness and feasibility of internet-based 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

Primary outcomes

Inventory of Complicated Grief(ICG)

Key secondary outcomes

1. Mini-International Neuropsychiatric Interview (M.I.N.I.)
2. Grief Related Avoidance Questionnaire (GRAQ)
3. Beck Depression Inventory-2 (BDI-2)
4. State-Trait Anxiety Inventory (STAI)
5. Impact of Event Scale Revised (IES-R)
6. Posttraumatic Cognition Inventory (PTCI)
7. Connor-Davidson Resilience Scale (CD-RISC)
8. MOS 36-Item Short-Form Health Survey (SF-36)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Internet-based Cognitive Behavioral Therapy for Complicated Grief (twice a week, 10 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

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 20 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 use PC and E-mail
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

25

Name of lead principal investigator

1st name
Middle name
Last name	Akemi Shirai

Organization

International University of Health and Welfare Graduate School

Division name

Research Institute of Health and Welfare Sciences, clinical psychology

Zip code

Address

Aoyama-1chomme tower 4F,1-3-3, Minami Aoyama, Minato-ku, Tokyo, Japan

TEL

03-6864-0302

Email

akeshira@iuhw.ac.jp

Name of contact person

1st name
Middle name
Last name	Akemi Shirai

Organization

International University of Health and Welfare Graduate School

Division name

Research Institute of Health and Welfare Sciences, clinical psychology

Zip code

Address

Aoyama-1chomme tower 4F,1-3-3, Minami Aoyama, Minato-ku, Tokyo, Japan

TEL

03-6406-8621

Homepage URL

http://www.j-itcg.jp/

Email

akeshira@iuhw.ac.jp

Institute

International University of Health and Welfare Graduate School Research Institute of Health and
Welfare Sciences, clinical psychology

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Musashino University
National Institute of Mental Health, National Center of Neurology and Psychiatry

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国際医療福祉大学大学院青山心理相談室（東京都）

Date of disclosure of the study information

2012

Year

02

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

12

Month

20

Day

Date of IRB

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

2016

Year

08

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

20

Day

Last modified on

2016

Year

08

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008641