Study of the effectiveness of a combination of methadone treatment with group treatment based on Acceptance & Commitment therapy (ACT) versus methadone treatment in the prevention rate of relapse in people with abuse opioids.
Objectives: Study of the effectiveness of a combination of Methadone treatment with group treatment based on Acceptance & Commitment therapy (ACT) versus Methadone treatment in the prevention rate of relapse in people with abuse opioids. Study design: Intervention, randomly allocated to intervention & control groups, not blind, non-placebo. The method of the study: The study population: Patients treated with Methadone in drug rehabilitation center is the Zanjan city. Inclusion criteria: Having informed consent to participate in research; Taking at least two weeks Methadone; Being male; Having a minimum of 18 & maximum of 45 years old. Exclusion criteria: Patient will be deleted after the two meeting absence; More severe problems, such as suicidal thoughts or have psychotic disorders. After screening and study of variables, the available sample size of 30 patients will be selected randomly assigned to experimental and control groups. Randomization was simple and to draw from the list of patients was performed. The study interventions in the study for combination therapy with Methadone treatment protocol based on Acceptance & Commitment Therapy Acceptance & Commitment Hayes (2002) is used. Time Intervention will take two months. 8 is a 90-minute session. The primary outcome or consequences of the study: The effectiveness of Methadone & Acceptance & Commitment group combination therapy & Methadone therapy in the prevention rate of relapse in people with opium abuse. Inclusion criteria: Having informed consent to participate in research; Taking at least two weeks Methadone; Being male; Having a minimum of 18 & maximum of 45 years old. Exclusion criteria: Patient will be deleted after the two meeting absence; More severe problems, such as suicidal thoughts or have psychotic disorders
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062328603N1
Registration date:2017-03-02, 1395/12/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-02, 1395/12/12
Registrant information
Name
Abbas Hemmat
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 4766
Email address
samhemmat@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of a combination of methadone treatment with group treatment based on Acceptance & Commitment therapy (ACT) versus methadone treatment in the prevention rate of relapse in people with abuse opioids.
Public title
Comparison between the effectiveness of methadone & Acceptance & Commitment group combination therapy & methadone therapy in the prevention rate of relapse in people with opium abuse.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having informed consent to participate in research; Taking at least two weeks Methadone; Being male; Having a minimum of 18 & maximum of 45 years old. Exclusion criteria: Patient will be deleted after the two meeting absence; More severe problems, such as suicidal thoughts or have psychotic disorders
Age
From 18 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences; Azadi Bolvar; Zanjan
City
Zanjan
Postal code
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
ZUMS.REC.1395.34
Health conditions studied
1
Description of health condition studied
Mental & behavioural disorders due to use of opioids
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Relapse prevention
Timepoint
Before the intervention, The intervention, Three months after the intervention.
Method of measurement
Cravings questionnaire (DDQ), urine test kits
Secondary outcomes
1
Description
Anxiety
Timepoint
Before the intervention; The intervention time; Three months after the intervention.
Method of measurement
Beck Anxiety Inventory
2
Description
Depression
Timepoint
Before the intervention; The intervention time; Three months after the intervention.
Method of measurement
Beck Depression Inventory
3
Description
Craving
Timepoint
Before the intervention; The intervention time; Three months after the intervention.
Method of measurement
Craving Questionnaire (DDQ)
4
Description
Quality of life
Timepoint
Before the intervention; The intervention time; Three months after the intervention.
Method of measurement
Quality of Life Questionnaire (WHO)
Intervention groups
1
Description
Intervention groups: Combination therapy with Methadone therapy uses a protocol based on Acceptance & Commitment Therapy Acceptance & Commitment Hayes (2002). Sessions: 8 sessions of 90 minutes.
Category
Prevention
2
Description
Control group: Methadone; Drug name: Methadone; Dose: 20 cc; Duration: 5 Months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohsen Dadashi
Street address
Shahid Beheshti Hospital; Street Arg; Zanjan
City
Zanjan
2
Recruitment center
Name of recruitment center
Harm Reduction Center
Full name of responsible person
Ali Navidi
Street address
Harm reduction; crossroads Saadi; Zanjan
City
Zanjan
3
Recruitment center
Name of recruitment center
Specialized Addiction Raja Clinic
Full name of responsible person
Reza Mousavi
Street address
Beheshti Hospital; Gate the Arg; Sadi Crossroad; Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Zanjan University of Medical Sciences
Full name of responsible person
Soghrat Faghihzade
Street address
Zanjan University of Medical Sciences; Azadi Bolvar; Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
PHD of Clinical Psychology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital; Street Arg; Zanjan
City
Zanjan
Postal code
Phone
+98 24 3370 3156
Fax
Email
Psy.mohsen@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Abbas Hemmat
Position
M.Sc. condidate in clinical psychology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital; Street Arg; Zanjan
City
Zanjan
Postal code
Phone
+98 24 3342 4766
Fax
Email
Hemmat5a@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Abbas Hemmat
Position
M.Sc. Condidate in clinical psychology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital; Street Arg; Zanjan
City
Zanjan
Postal code
Phone
Fax
Email
Hemmat5a@yahoo. com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)