UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040530 |
|---|---|
| Receipt number | R000046236 |
| Scientific Title | Modification of Attention Bias in Alcohol Use Disorders Suppresses relapse: An Intervention Study |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2024/06/02 14:41:59 |
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Basic information
Public title
Effects of interventions combining attentional bias modification and cognitive behavior therapy on the risk of re-drinking or relapse in patients with alcohol use disorders
Acronym
An interventional study of attentional bias modification in patients with alcohol use disorders
Scientific Title
Modification of Attention Bias in Alcohol Use Disorders Suppresses relapse: An Intervention Study
Scientific Title:Acronym
An interventional study of attentional bias modification in patients with alcohol use disorders
Region
| Japan |
Condition
Condition
Alcohol use disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of intervention combined with correction training of attention bias and cognitive behavioral therapy on reduction of re-drinking risk for people with alcohol use disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alcohol Relapse Risk Scale
Key secondary outcomes
Behavioral inhibition system/behavioral approach system scales
Attention bias measurement
Low Frequency/High Frequency
Amount of saliva
Profile of Mood States 2nd Edition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
For the experimental group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 6 programs
Interventions/Control_2
For the control group, we will perform a placebo carefulness correction exercise in 6 sessions (about 20 minutes) out of all 6 programs.
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Persons admitted to Tokyo Alcohol Medical Center, Narimasu Welfare Hospital and diagnosed with alcoholism.
(2) Those who have cognitive function and can obtain the consent of the research.
(3) Those who have passed the withdrawal period and are judged to be able to intervene by the attending physician.
Key exclusion criteria
(1) Those with mental disorders other than alcoholic disorders
(2) Those who are scheduled to be discharged within 2 months
(3) Those who have been transferred from another hospital
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Amano |
| Middle name | |
| Last name | Yoshifumi |
Organization
Graduate School of Saitama Prefectural University
Division name
Doctoral Course
Zip code
3438540
Address
820 Sannomiya, Koshigaya City, Saitama Prefecture
TEL
0489710500
2091002e@spu.ac.jp
Public contact
Name of contact person
| 1st name | Amano |
| Middle name | |
| Last name | Yoshifumi |
Organization
Narimasu welfare hospital
Division name
Occupational therapy division
Zip code
1750091
Address
1-19-1, Misono, Itabashi-ku, Tokyo
TEL
03-3939-1191
Homepage URL
2091002e@spu.ac.jp
Sponsor or person
Institute
Graduate School of Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University Graduate School Ethics Committee
Address
820 Sannomiya, Koshigaya City, Saitama Prefecture
Tel
0489710500
rinri@spu.ac.jp
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 | 01 | Day |
Related information
URL releasing protocol
No.
Publication of results
Unpublished
Result
URL related to results and publications
No.
Number of participants that the trial has enrolled
32
Results
Data from a total of 32 people, 16 in the intervention group and 16 in the control group, were analyzed. There was no interaction between group and time for ARRS Total and AB Reaction time, and a main effect of time was observed (z = -2.58, p = 0.01). For AB Reaction time, there was no interaction between group and time, and a main effect of time was observed (z = -2.8, p = 0.01). Neither interaction nor main effect was observed for Craving.
Results date posted
| 2023 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 32 participants. 16 in the intervention group and 16 in the control group. All participants were male. The age of the intervention group was 46 years (IQR = 14), and the age of the control group was 46 years (IQR = 14). He was 47 years old (IQR=11).
Participant flow
Eligibility criteria for participants were: (1) AUD patients admitted to the open ward specializing in alcohol dependence at Narimasu Kosei Hospital; (2) Two weeks have passed since the date of admission, and after the withdrawal management period, the attending physician Those who received permission to leave the hospital and received instructions for rehabilitation intervention, and (3) those who desired to participate in a CBT program. Exclusion criteria were: (1) those with a mental illness other than alcohol-induced mental illness, and (2) AUD. (3) female patients, and (4) those who were discharged from the hospital for some reason during the intervention were excluded from the analysis. Due to metabolic differences, women were excluded from this study.
Adverse events
There were no reportable adverse events.
Outcome measures
Regarding ARRS Total, we analyzed using GLM with the intervention group, control group (group), and intervention period (time) as explanatory variables, and age and the initial value of ARRS Total as covariates and found that there was no interaction between group and time. There was no main effect of group (z = 0.15, p = 0.89), but a main effect of time (z = -2.58, p = 0.01). Bonferroni's post hoc test was performed on ARRS before and after the intervention, and there was a significant difference before and after the intervention period (z = 2.57, pBonferroni = 0.04).
When examining the intervention effect of 6 weeks of ABM treatment on male AUD patients who underwent CBT using GLM with Craving set as the objective variable, the goodness of fit of the model was　AIC = 771.3, R2 = Craving was the objective variable, intervention group, non-intervention group (group), and intervention period (time) were used as explanatory variables, and age and Craving initial value were input as covariates. As a result of analysis using GLM, it was found that Craving There was no interaction between group and time (z = 0.78, p = 0.44). There was no main effect of group for the combined ABM and CBT intervention compared to the CBT only intervention (z = 1.82, p = 0.07), there was no main effect of time for Craving (z = -0.7, p = 0.48).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046236
