UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041131 |
|---|---|
| Receipt number | R000046968 |
| Scientific Title | Impacts of cognitive behavioral financial therapy on anxiety among employees on loan |
| Date of disclosure of the study information | 2020/07/19 |
| Last modified on | 2020/07/16 22:10:41 |
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Basic information
Public title
Impacts of cognitive behavioral financial therapy on anxiety among employees on loan
Acronym
Reduction of financial anxiety using CBFT
Scientific Title
Impacts of cognitive behavioral financial therapy on anxiety among employees on loan
Scientific Title:Acronym
Reduction of financial anxiety using CBFT
Region
| Africa |
Condition
Condition
Financial Anxiety
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study investigated the impacts of cognitive behavioral financial therapy on anxiety among employees on loan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Financial Anxiety Scale, Time 1, Time 2, 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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
CBFT-program by cognitive behavioral financial therapists and counselling psychologists whose focuses were on helping the participants identify and change their dysfunctional beliefs about loan and other money-related issues to bring about adaptive emotional and behavioral changes. The intervention was implemented using English language. The therapists have basic training in cognitive-behavioral approaches and counselling psychology practiced for more than 10 years. Approximately, CBFT-Program lasted for 3 months (April- June). Each therapy session lasted for 90 minutes per 2 weeks.
Interventions/Control_2
The participants in the waitlisted control group did not receive CBFT-program until after Time 1, Time 2 and Time 3.
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
| 30 | years-old | <= |
Age-upper limit
| 51 | years-old | > |
Gender
Male and Female
Key inclusion criteria
i) must have been indebted for 12 months and beyond, ii) the loan must be domiciled in micro finance bank, iii) must be a civil servant, iv) appointment must be confirmed by the employer, v) must be an attempted or married employee, vi) must show wiliness to participate till the end of the program.
Key exclusion criteria
Participant who did not meet up with inclusion criteria were excluded based on the following exclusion criteria: a) any indebted employee receiving treatment from helping professionals, b) any indebted employee who do not complete and return the written inform consent, c) indebted employee whose loan is domiciled in commercial banks, d) indebted employees whose loan duration is below 1 year.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria
Division name
Educational Foundations
Zip code
410001
Address
Room 203, Department of Educational Foundations, University of Nigeria
TEL
+2347066725165
moses.ede@unn.edu.ng
Public contact
Name of contact person
| 1st name | Uchechukwu |
| Middle name | Hope |
| Last name | Ekwueme |
Organization
University of Nigeria
Division name
Department of Educational Foundations
Zip code
410001
Address
Room 203, Department of Educational Foundations, University of Nigeria
TEL
+2347067863885
Homepage URL
hope.onah@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
Nigeria
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Education, University of Nigeria
Address
Room 203, Department of Educational Foundations, University of Nigeria
Tel
+2348137258914
chiedu.eseadi@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
| 2020 | Year | 07 | Month | 19 | 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
106
Results
The result of two-ways Analysis of covariance (ANCOVA) revealed continuous decline in the mean financial anxiety scores of employees on loan in the treatment group over time as measured by FAS-A and FAS-P).
Results date posted
| 2020 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were identified to have financial anxiety disorders associated with indebtedness using two measures: (FAS-A and FAS-P)
Participant flow
Adverse events
We did not record any adverse events during the study
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 11 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 16 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046968
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