UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024095 |
|---|---|
| Receipt number | R000027738 |
| Scientific Title | A self-help form of Acceptance and Commitment Therapy administered via the internet: outcomes for adults in Japan who took sick leave due to depressive symptoms |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2017/06/26 16:55:01 |
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Basic information
Public title
A self-help form of Acceptance and Commitment Therapy administered via the internet: outcomes for adults in Japan who took sick leave due to depressive symptoms
Acronym
A self-help form of ACT intervention study
Scientific Title
A self-help form of Acceptance and Commitment Therapy administered via the internet: outcomes for adults in Japan who took sick leave due to depressive symptoms
Scientific Title:Acronym
A self-help form of ACT intervention study
Region
| Japan |
Condition
Condition
depressive symptoms
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a self-help form of Acceptance and Commitment Therapy using internet-delivery and to examine its effect on adults in Japan who took sick leave due to depressive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
As a primary outcome, psychological flexibility was assessed using the Japanese version of a revised version of the Acceptance and Action Questionnaire, and as secondary outcomes on three occasions: baseline (T1); 3 weeks (T2); and 6 weeks when the period of the program ended (T3).
Key secondary outcomes
As secondary outcomes, depressive symptoms were assessed using the Zung Self-Rating Depression Scale on three occasions: baseline (T1); 3 weeks (T2); and 6 weeks when the period of the program ended (T3).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Original stress management training of a self-help form of Acceptance and Commitment Therapy using internet-delivery
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
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults who had utilized sick leave from work due to depressive symptoms and who also had current access to a computer and an internet connection.
Key exclusion criteria
a. was in a hospital or had been discharged from a hospital within six months prior to the study.
b. had any history of suicide attempts. c. had a history of a psychological diagnosis other than depression.
d. did not have a doctor's permission if in outpatient treatment.
e. appeared severely depressed based on a score obtained on a screening test for depression.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maki Tominaga |
Organization
Kyoto Tachibana University
Division name
Faculty of Nursing
Zip code
Address
34 Yamada-cho, Ooyake Yamashina-ku
TEL
+81-75-574-4374
tominaga@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Tominaga |
Organization
Kyoto Tachibana University
Division name
Faculty of Nursing
Zip code
Address
34 Yamada-cho, Ooyake Yamashina-ku
TEL
+81-75-574-4374
Homepage URL
tominaga@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
a research grant from the Mitsubishi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都橘大学（京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Among the thirty-five participants, twenty-six participants completed the program and answered all questionnaire surveys. The majority of the participants who continued to participate in the program and answered all questionnaire surveys were female. The score of psychological flexibility at Time3 has significantly improved compared to baseline, while the effect size was relatively low. Additionally, one of the scores from the process measures showed a significant difference between Time2 and Time3. Although the numbers of participants who showed mildly and moderately depressed states had decreased, depressive symptom scores did not show significant changes across time. There were five positive comments about this program along with five negative ones.
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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
The article, "A self-help-based Acceptance and Commitment Therapy programme using Internet delivery: effect on adults intending to work who have utilized their sick leave due to depressive symptoms", was accepted by Journal of Person Centered Healthcare in 26 May 2017.
Management information
Registered date
| 2016 | Year | 09 | Month | 18 | Day |
Last modified on
| 2017 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027738
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