Effect of Acceptance and Commitment Therapy (Acceptance and Commitment Therapy) on admission, perceived stress and obsessive-compulsive use of narcotic drugs in methadone-treated male patients referred to Shahid Beheshti Hospital in Kerman
The aim of this study was to evaluate the efficacy of Acceptance and Commitment Therapy (ACT) on admission, perceived stress and craving in methadone-treated male patients referred to Shahid Beheshti Hospital in Kerman.
Design
Clinical practice with a control group without randomized blindness This study will be performed on 66 addicted men methadone treated. These individuals will be randomly divided into two groups of 33
Settings and conduct
This study will be carried out at Shahid Beheshti Hospital in Kerman. The subjects of both experimental and control groups in the two stages of pre-test and post-test were questionnaires before the OCDUS, Acceptance Questionnaire-Second Edition (AAQ-II), the perceived stress questionnaire of 14 items (PSS-14), completed before and after the intervention. Participants were re-evaluated three months after the completion of ACT sessions.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include aged 20 to 45 years, at least 6 months of methadone intake, primary education to a diploma, the absence of severe psychiatric disorders, including psychosis, and the absence of acute and chronic physical and psychological disorders affecting the person's mood and mood Was
Intervention groups
The control group performed routine care, but the intervention group received ten sessions of ninety-minute therapies based on admission and awareness
Main outcome variables
Changes in perceived stress, changes in acceptance and practice, changes in obsessive compulsive drug use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190510043544N1
Registration date:2019-05-23, 1398/03/02
Registration timing:registered_while_recruiting
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
sahar salajeghe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 1396
Email address
saharsalajeghe1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Acceptance and Commitment Therapy (Acceptance and Commitment Therapy) on admission, perceived stress and obsessive-compulsive use of narcotic drugs in methadone-treated male patients referred to Shahid Beheshti Hospital in Kerman
Public title
Effect of Acceptance and Commitment Therapy (Acceptance and Commitment Therapy) on admission, perceived stress and obsessive-compulsive use of narcotic drugs in methadone-treated male patients referred to Shahid Beheshti Hospital in Kerman
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a 20 to 45 year old
Passed at least 6 months of taking methadone
Elementary education up to diploma
Being a man
Exclusion criteria:
Severe psychiatric disorders, including psychosis
Acute and chronic physical illnesses had an effect on the person's mood and emotional state
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 66 addicted men methadone treatment clients were selected from randomly selected random sampling from a random sampling period in Shahid Beheshti Hospital. After obtaining conscientious consent with simple randomization using Lottery method was divided into two groups of 33 participants (intervention and control)
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 Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences Vice-President of Research and Technology, Avicenna Street
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.KMU.REC.1397.291
Health conditions studied
1
Description of health condition studied
Drug addiction
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
Alert drug use
Timepoint
The first and ninety days after the end of treatment sessions
Method of measurement
Questionnaire
2
Description
Perceived Stress
Timepoint
The first and ninety days after the end of treatment sessions
Method of measurement
Questionnaire
3
Description
Acceptance and practice
Timepoint
The first and ninety days after the end of treatment sessions
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 33 methadone addicted men who were scheduled to receive ten classes of acceptance and awareness therapy in a nine-
Category
Behavior
2
Description
Control group: 33 addicted men were treated with methadone for which no additional action was taken during this period
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Sahar Salajeghe
Street address
Boulevard Republic
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3211 0408
Email
saharsalajeghe1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
DR Abbas Pardakhty
Street address
Vice-Chancellor for Research and Technology of Kerman University of Science Sciences and Technology, Avicenna Street
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3815
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Salajeghe
Position
Resident Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Republican Boulevard, Shahid Beheshti Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3221 0408
Email
saharsalajeghe1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Salajeghe
Position
Resident Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Republican Avenue of the Shahid Beheshti Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3211 0408
Email
saharsalajeghe1373@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Salajeghe
Position
Resident Psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Republican Avenue of the Shahid Beheshti Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3211 0408
Email
saharsalajeghe1373@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available