UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility and preliminary efficacy of group cognitive behavioral therapy for the bereaved with complicated grief (ENERGY)
Acronym	An open label study of the group cognitive behavioral therapy for complicated grief (ENERGY study)
Scientific Title	Feasibility and preliminary efficacy of group cognitive behavioral therapy for the bereaved with complicated grief (ENERGY)
Scientific Title:Acronym	An open label study of the group cognitive behavioral therapy for complicated grief (ENERGY study)
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 group cognitive behavioral therapy for complicated grief
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Inventory of Complicated Grief (ICG) score at post program, 3 months and 6 months after the program from the baseline will be compared.
Key secondary outcomes	Subjective depressive symptoms(BDI -II), subjective traumatic symptoms for bereavement(IES-R), Grief related avoidanceGRAQ), posttraumatic cognitions (PTCI), typical belief about grief(TBQ) and QOL(SF8) score at post program, 3 months and 6 months after the program from the baseline will be compared. Dropout rate and adverse events will be also evaluated. Subjective evaluation for the ENERGY program including the understandability of the program contents and instruction, sense of burden for completing of the program and feeling of satisfaction about the program will be conducted at the post program.

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	Behavior,custom Maneuver
Interventions/Control_1	Group cognitive behavioral therapy for complicated grief (once a fortnight, 6 sessions, and 3 hours /one session)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Experience of the death of important others and complicated grief as the most important clinical problem (the score of BGQ more than 5) 2. 12 months and over after the death of loved one 3. Those who can get permission to participate in this program from their doctor or counselor 4. Native Japanese speaker 5. Those who can give a written informed consent 6. Those who can give a written informed consent of legally authorized representative , if they are less than 20 years old 7. Those who can participate basically in all sessions
Key exclusion criteria	1.Those who meet a criterion for severe prolonged grief disorder by PG-13 2.Those who have difficulty to participate in or to continue the ENERGY program for the reason of presence of co-morbid psychiatric disorders (i.e. psychotic disorders, bipolar disorder, alcohol/drug dependence or abuse and group A personality disorder) and severe mental health problems (e.g. severe depressive symptoms, self- injury behaviors and suicide attempt) 3.Those who have severe cognitive dysfunctions that disturb completion of ENERGY program 4.Those who have severe or unstable physical disorders 5.Experience of individual cognitive behavioral therapy or concurrent structured psychotherapy without supportive counseling 6.Those who are impossible to participate in the ENERGY program more than half of all sessions 7.Those who are judged by the ENERGY study investigators as inadequate
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Satomi Middle name Last name Nakajima
Organization	Musashino University
Division name	Faculty of Human Sciences
Zip code	135-8181
Address	3-3-3 Ariake, Koto-Ku,Tokyo, Japan
TEL	03-5530-7618
Email	satonaka@musashino-u.ac.jp

Public contact
Name of contact person	1st name Satomi Middle name Last name Nakajima
Organization	Musashino University
Division name	Faculty of Human Sciences
Zip code	135-8181
Address	3-3-3 Ariake, Koto-Ku,Tokyo, Japan
TEL	03-5530-7618
Homepage URL
Email	satonaka@musashino-u.ac.jp

Sponsor
Institute	Faculty of Human Sciences, Musashino University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Iwate Prefectural Mental Health and Welfare Centre
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Musashino University
Address	3-3-3 Ariake, Koto-ku,Tokyo
Tel	03-5530-7730
Email	sankan@musashino-u.ac.jp

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	岩手県精神保健福祉センター(岩手県)（Iwate Prefectural Mental Health and Welfare Centre)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	34
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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 25 Day
Date of IRB	2015 Year 09 Month 25 Day
Anticipated trial start date	2015 Year 10 Month 24 Day
Last follow-up date	2019 Year 06 Month 15 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 06 Month 30 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 10 Month 22 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022483