Investigating the effect of cognitive hypnotherapy (COGNITIVE HYPNOTHERAPY) in preventing the relapse of opium use in men treated with methadone compared to the control group in the addiction treatment center.
Determining the effect of cognitive hypnotherapy in preventing the relapse of opium use in men treated with methadone in the addiction treatment center affiliated to 5 Azar Hospital in 2023
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 38 patients. The rand function of Excel software was used for randomization.
Settings and conduct
place: Addiction center affiliated with 5 Azar Hospital, Gorgan
The samples are easily selected from the referring patients and are divided into two intervention groups (methadone and cognitive hypnotherapy) and control group (only methadone). After obtaining ethical permits and obtaining informed consent from the patients, first a checklist of their demographic variables will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
• All opium consuming men who have completed a one-month detoxification course and are undergoing maintenance treatment with methadone.
• Age 18-55 years,
• Not using other drugs and narcotic drugs for a month before
• At least primary education
• No history of using stimulants
Exit criteria:
Absence of more than 2 sessions of cognitive hypnotherapy.
• The patient's non-cooperation to monitor the urine test before intervention, after cognitive hypnotherapy and 3 months and 6 months after treatment sessions.
• Serious medical illness or major psychiatric disorder (depression, psychosis, etc.) based on a clinical interview by a psychiatric assistant.
Intervention groups
For the cognitive hypnotherapy intervention group, including 8 sessions of 60 minutes (the number of people in each session is maximum 8 people), it will be held once a week by a psychiatric specialist and relaxation by a psychiatric assistant.
For the control group, only methadone is administered.
Main outcome variables
1- Impulsivity
2- Desire to consume shortened items.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170108031818N4
Registration date:2023-05-20, 1402/02/30
Registration timing:prospective
Last update:2023-05-20, 1402/02/30
Update count:0
Registration date
2023-05-20, 1402/02/30
Registrant information
Name
fatemeh mehravar
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 893 7199
Email address
mehravar10261@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cognitive hypnotherapy (COGNITIVE HYPNOTHERAPY) in preventing the relapse of opium use in men treated with methadone compared to the control group in the addiction treatment center.
Public title
The effect of cognitive hypnotherapy in preventing the relapse of opium use in men treated with methadone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All opium consuming men who have completed a one-month detoxification course and are undergoing maintenance treatment with methadone and have a file in the addiction treatment center affiliated to 5 Azar Hospital in Gorgan.
Age 18–55 years
Not using other drugs and narcotic drugs for a month before
At least elementary education
No history of stimulant drug use
Exclusion criteria:
Absence of more than 2 sessions of cognitive hypnotherapy
Non-cooperation of the patient to monitor the urine test before intervention, after cognitive hypnotherapy and 3 months and 6 months after treatment sessions.
Serious medical illness or major psychiatric disorder (depression, psychosis, etc.) based on a clinical interview by a psychiatric assistant
Age
From 18 years old to 55 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are placed in one of the treatment groups including only methadone treatment or in the treatment group with methadone and cognitive hypnotherapy as a simple randomization and by lottery.
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 Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, shast kola St.,
City
Gorgan
Province
Golestan
Postal code
49157468
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.GOUMS.REC.1401.602
Health conditions studied
1
Description of health condition studied
Men treated with methadone
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Opium relapse
Timepoint
3 months later and 6 months later.
Method of measurement
The morphine urine test is a multi-drug test, and if morphine is positive in this test, it is considered as a relapse of drug abuse.
Secondary outcomes
1
Description
impulsiveness
Timepoint
3 months later and 6 months later.
Method of measurement
Ernst Barratt Impulsivity Questionnaire
2
Description
Reduced drug cravings
Timepoint
3 months later and 6 months later
Method of measurement
with the Abbreviated Substance Craving Scale
Intervention groups
1
Description
Intervention group: For the cognitive hypnotherapy intervention group, including 8 sessions of 60 minutes (the number of people in each session is maximum 8 people), it will be held once a week by a psychiatric specialist, and relaxation will be conducted by a psychiatric assistant. Cognitive hypnotherapy will consist of 8 sessions of 60 minutes that will be held once a week.In the first session, along with getting to know the patient and the current life situation of the patient and his family, as well as explaining the hypnosis treatment program and examining the patients' views on hypnosis, the progressive muscle relaxation method will be taught to the patients. At the end of the session, they are asked to do this exercise for 20 minutes every day until the next week, when it is time for the second session.In the second session, the patient will be explained about the unconscious and the effect of insinuations on it, hypnotherapy, insinuations related to relaxation and reducing mental pressure, and teaching exercises will be done.The purpose of the third session is to increase self-confidence and calmness in the patient. They will be familiar with the reminders of drug addiction such as time, place, friends, music, etc.The fourth session: While deepening the trance, they will learn about the harms of drug use and its negative effects.5th and 6th session: While taking the patients to the deepest depth of trance, insinuations of aversion to substances will be done.Seventh session: In deep ecstasy, the positive effects of staying in the desert, such as taking care of personal and family matters, deepening family relationships, work progress and prevention of damages, increasing self-confidence and morale of oneself and family members, educational progress of children, etc. will be suggested.The eighth session: The exercises that are done in the previous sessions will be reviewed and conditional suggestions will be made to make it easier to induce trance in the patient at home, and the patient will be told about self-hypnosis to eliminate the problems that arise as a result. Quitting occurs for him to use (such as insomnia, restlessness, pain, depression and temptation).The follow-up of patients after the completion of cognitive hypnotherapy sessions will be 3 months later and 6 months later. In this way, during a phone call with the participants, they are requested to come for a morphine urine test. The positive result indicates the existence of drug use during the last three days and is considered as a relapse of drug abuse.
Category
Prevention
2
Description
Control group: Methadone only
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
De-addiction center affiliated with Panj Azar Hospital, Gorgan
Full name of responsible person
Mohammad Zaman Kamkar
Street address
Golestan University of Medical Sciences, Shast kola St.
City
Gorgan
Province
Golestan
Postal code
461574698
Phone
+98 911 371 5318
Email
kamkar۷۲@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges Beigom Mirbehbahani
Street address
Golestan University of Medical Sciences, Shast kola St.
City
Gorgan
Province
Golestan
Postal code
4258425696
Phone
+98 17 3216 7105
Email
merbehbahani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Zaman Kamkar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan University of Medical Sciences, Shast kola St.
City
Gorgan
Province
Golestan
Postal code
455435552
Phone
0173215846
Email
kamkar۷۲@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Zaman Kamkar
Position
Associate Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan University of Medical Sciences, Shast kola St.
City
Gorgan
Province
Golestan
Postal code
4652865253
Phone
+98 17 3566 5254
Email
kamkar۷۲@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Zaman Kamkar
Position
Associate Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan University of Medical Sciences, Shast kola St
City
Gorgan
Province
Golestan
Postal code
425595255821
Phone
017325816565
Email
kamkar۷۲@yahoo.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