UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036362 |
|---|---|
| Receipt number | R000041421 |
| Scientific Title | Group cognitive-behavioural therapy and psychological distress |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/03/31 21:49:48 |
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Basic information
Public title
Effects of group cognitive-behavioural therapy on psychological distress of awaiting-trial prison inmates
Acronym
GroupCBT-Psychologica-Distress
Scientific Title
Group cognitive-behavioural therapy and psychological distress
Scientific Title:Acronym
GroupCBT-Psychologica-Distress
Region
| Africa |
Condition
Condition
Psychological Distress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effect of cognitive behavioural therapy on psychological distress among awaiting-trial prison inmates in Nigeria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived Emotional Distress Inventory (PEDI)= Time 1, Time 2 and Time 3
General Health Questionnaire GHQ-12 = Time 1, Time 2 and Time 3
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Cognitive behavioural intervention Group: The intervention lasted for 12 weekly sessions (3 months) with 2 hours in each meeting (session).
Interventions/Control_2
No intervention Group: This group was waitlisted
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
The selected participants satisfied some inclusion criteria as follows: any prison inmate who had spent 7 months and above in prison yard without trial, with moderate to severe psychological distress, absence of major clinical disease in their medical history, volition to participate in the study, completion of written informed consent and General Health Questionnaire and Perceived Emotional Distress Inventory.
Key exclusion criteria
For the exclusion criteria, having a protracted illness, demonstrating psychotic problems being convicted after trial, and non-completion of our written informed consent, unable to fill the general health questionnaire and Perceived Emotional Distress Inventory.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Bonaventure |
| Middle name | Ngozi |
| Last name | Nwokeoma |
Organization
University Of Nigeria
Division name
Department of Sociology and Anthropology
Zip code
410001
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
TEL
+2348037089645
bonaventure.nwokeoma@unn.edu.ng
Public contact
Name of contact person
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria, Nsukka
Division name
Department of Educational Foundations
Zip code
410001
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
TEL
+2347066725165
Homepage URL
moses.ede@unn.edu.ng
Sponsor or person
Institute
University of Nigeria
Institute
Department
Personal name
Funding Source
Organization
University of Nigeria
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Nigeria
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
Tel
+2347066725165
moses.ede@unn.edu.ng
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
| 2019 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
38
Results
The result showed that there was no significant difference in psychological distress between the treatment and no intervention groups. The results showed that CBT had a significant effect on psychological distress of awaiting-trial prison inmates when compared to their counterparts in the no intervention group at Time2. Additionally, the efficacy of CBT on psychological distress of awaiting-trial prison inmates was significantly sustained at the follow-up measurements (Time 3).
Results date posted
| 2019 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
At time 1, no significant difference in psychological distress between the treatment and control groups was obtained with regards to anxiety, depression, hopelessness and anger as measured by Perceived Emotional Distress Inventory (PEDI) and General Health Questionnaire
Participant flow
We assessed 51 potential participants for eligibility. Out of the 51, a total of 38 participants were randomized and 13 was excluded based on some reasons. The 38 participants were allocated into Cognitive behavioural Intervention group and no intervention group. The intervention group recieved treatment whereas the later recieved nothing. None of the participants in the treatment group droped/discontinued at Time 1, Time 2 and Time 3.
Adverse events
There was no adverse events during the study
Outcome measures
Perceived Emotional Distress Inventory (PEDI)
General Health Questionnaire GHQ-12
Plan to share IPD
https://www.umin.ac.jp/icdr/index.html
IPD sharing Plan description
https://www.umin.ac.jp/icdr/index.html
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 13 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 27 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 05 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041421
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