UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039452 |
|---|---|
| Receipt number | R000044983 |
| Scientific Title | The effectiveness of acceptance and commitment therapy on stress and depression in adolescents 14 to 18 years of stuttering. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/13 22:48:23 |
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Basic information
Public title
The effectiveness of acceptance and commitment therapy on stress and depression in adolescents 14 to 18 years of stuttering.
Acronym
The effectiveness of ACT on stress and depression
Scientific Title
The effectiveness of acceptance and commitment therapy on stress and depression in adolescents 14 to 18 years of stuttering.
Scientific Title:Acronym
The Effectiveness of ACT Therapy on Stress and Depression in Adolescents with Stuttering
Region
| Asia(except Japan) |
Condition
Condition
in adolescents 14 to 18 years of stuttering
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of acceptance and commitment group therapy (ACT) on stress and depression in adolescents with stuttering.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
ACT treatment is effective in reducing stress and depression
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
5
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Pre-test adolescents with stuttering will first be taken.
Interventions/Control_2
The stuttering adolescents in the study were divided into control and experimental groups.
Interventions/Control_3
The intervention is performed on the experimental group and the control group does not receive any treatment.
Interventions/Control_4
The intervention protocol utilizes acceptance and commitment-based treatment based on the Strosahl, Hayse, and Wilson treatment guidelines
Interventions/Control_5
Running time will be eight hour and a half sessions in group, once a week.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 14 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stutter's diagnosis by speech therapist,Age 14 to 18 years, Parental consent of adolescents, and Adolescent consent to participate in the study, no co-treatment with intervention
Key exclusion criteria
Lack of regular attendance at treatment sessions, no homework, no pre-test and post-test questionnaires.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Zahra &amp;Mohsen |
| Middle name | |
| Last name | Babaei &amp; saeidmanesh |
Organization
University of Science and Art
Division name
phd
Zip code
8498139366 & 8916713335
Address
University of Science and Art, Daneshjoo Boulevard, Yazd
TEL
00983538264080
mitra.752001@yahoo.com
Public contact
Name of contact person
| 1st name | Zahra |
| Middle name | |
| Last name | Babaei |
Organization
University of Science and Art
Division name
Researcher
Zip code
8498139366
Address
No 3. Opposite mobilization of Imam Sajjad. Imam Boulevard.Talekhonche, Isfahan
TEL
00989139757808
Homepage URL
mitra.752001@yahoo.com
Sponsor or person
Institute
University of Science and Art Yazd
Institute
Department
Personal name
Funding Source
Organization
Personal
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
zahra babaei
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Science and Art
Address
University of Science and Art, Daneshjoo Boulevard, Yazd
Tel
0098 3538264080
natanael.752001@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://jrrs.mui.ac.ir/index.php/jrrs/issue/view/103
Publication of results
Partially published
Result
URL related to results and publications
http://jrrs.mui.ac.ir/index.php/jrrs/issue/view/103
Number of participants that the trial has enrolled
20
Results
The results showed that ACT significantly affected stress (P = 0.011) and depression (P = 0.014).
Results date posted
| 2020 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
The results of this study showed that ACT treatment is effective in reducing stress and depression
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 11 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044983
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/08/31 | 3433-21722-4-PB.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
