Determining the effectiveness of group compassion focused therapy in opiate addicts under methadone maintenance treatment
Design
The statistical population consisted of all opium addicts who referred to Iran Psychiatric Hospital in Tehran in 1398. From the selection of subjects according to the entry criteria, the subjects are assigned to experimental and control groups. Each group consists of 15 samples. Of course, considering the issue of dropping the subjects, the number of subjects is initially more than 15 people. All participants completed demographic questionnaires and the quality of life questionnaire and Beck Depression Inventory and the four-system anxiety scale at the beginning of the sessions and again at the end of the treatment session and again two months after the end of the sessions.
Settings and conduct
Iran Psychiatric Hospital
Participants/Inclusion and exclusion criteria
Entry Criteria:
primary diagnosis of opiate dependence according to DSM5 criteria, being male, having 20 to 50 years of age, having a minimum level of education, a history of consuming medication, a minimum methadone treatment time of one day and a maximum of 6 months. Severe psychiatric and personality disorders
Intervention groups
group compassion focused therapy
Main outcome variables
Quality of Life - Anxiety - Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019855N8
Registration date:2019-04-25, 1398/02/05
Registration timing:retrospective
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
Samira Masumian
Name of organization / entity
Tehran Psychiatry Institue
Country
Iran (Islamic Republic of)
Phone
+98 21 3349 6990
Email address
samira.masumian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group compassion focused therapy in opiate addicts under methadone maintenance treatment with a two-month follow-up
Public title
group compassion focused therapy in opiate addicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary and primary diagnosis of opioid dependence according to DSM5 criteria when entering methadone treatment
Age 20 to 50
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Male
Phase
1-2
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Through the lottery, Through the lottery so that the names of the patients are written in a sheet and selected by draw.
Blinding (investigator's opinion)
Single blinded
Blinding description
The main therapist and the assessing person from the groups are not known
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Next to Milad Tower- Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.IUMS.REC.1397.1075
Health conditions studied
1
Description of health condition studied
opioids use disorder
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after and 2 months after treatment
Method of measurement
Anxiety Quad System Scale
2
Description
Quality of Life
Timepoint
Before and after and 2 months after treatment
Method of measurement
World Health Organization Quality of Life Questionnaire
3
Description
Depression
Timepoint
Before and after and 2 months after treatment
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group compassion focused therapy: The program is based on Gilbert's Guide in eight 90-minute sessions on a weekly basis:1) First session; explanation of the rules and familiarity with the work of the group; explaining and introducing the group to the logic of compassion-based therapy and the goals of treatment;2) second session; explaining the concept of self-compassion and its two bipolar components3) Session 3: Learning to distance and watch wisely, break the identity of the thoughts, change self-criticism to self-correction4) Fourth session; teaching attention, thinking, behavior and feeling comfortable5) Fifth Session; Wandering Minds, Transparent Images, Locations and Incarnate Color Enhancements, Creating a Safe Place6) Sixth session; the mind of consciousness, attention and sensibility, consciousness and action mind, mindfulness and consciousness7) Seventh session; focusing on self-compassion toward others, expanding compassion towards oneself using memory, creating an amiable ideal8) Session eighth; overview of previous sessions, lessons and exercises, treatment termination
Category
Treatment - Other
2
Description
Control group: The control group receives their usual drug therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Hospital
Full name of responsible person
Samira Masumian
Street address
Mansouri alley- Avenue praying- Street Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazam Malakoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
30
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
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
Clinical Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mansouri alley- Avenue praying- Street Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
Clinical Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mansouri alley- Avenue praying- Street Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
Clinical Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mansouri alley- Avenue praying- Street Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Results should be published in the article
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The effectiveness of group compassion focused therapy in opiate addicts under methadone maintenance treatment with a two-month follow-up
When the data will become available and for how long
Year 1387
To whom data/document is available
Specialists and therapists
Under which criteria data/document could be used
For psychotherapy
From where data/document is obtainable
Researcher of the project
What processes are involved for a request to access data/document