UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019453 |
|---|---|
| Receipt number | R000022483 |
| Scientific Title | Feasibility and preliminary efficacy of group cognitive behavioral therapy for the bereaved with complicated grief (ENERGY) |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2020/05/08 23:06:28 |
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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
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
satonaka@musashino-u.ac.jp
Sponsor or person
Institute
Faculty of Human Sciences, Musashino University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022483
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