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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036362
Receipt No. 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

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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
Email 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
Email moses.ede@unn.edu.ng

Sponsor
Institute University of Nigeria
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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