Comparison of the effectiveness of pharmacotherapy with sertraline versus Acceptance and Commitment Therapy (ACT) enriched with Compassion Focus Therapy (CFT) on depression, stress, and anxiety in addict patients undergoing Methadone Maintenance Therapy (MMT)
Evaluation of the effects of sertraline and Acceptance and Commitment Therapy (ACT) enriched with Compassion Focus Therapy (CFT) on depression, stress, and anxiety in addict patients undergoing Methadone Maintenance Therapy (MMT)
Design
This study is a quasi-experimental study with pre-test and post-test design. First, 60 addicts under methadone maintenance treatment will be selected by available sampling method and then randomly divided into three groups.
Settings and conduct
In addicts undergoing maintenance treatment with methadone referred to addiction treatment clinics in Yazd in 1400.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the following:
• Age range 20-45 years
• Methadone has been used for at least 6 months.
Exclusion criteria include the following:
• Severe mental disorder such as psychosis
• Existence of instant psychosis due to the use of psychotropic substances
• Having chronic physical illnesses that affect mood and emotions
• Simultaneous use of NA and similar classes
• Use of opiates and morphine
• Lack of regular participation in training classes
• Not doing homework
• Failure to complete the questionnaire in pre-test and post-test
Intervention groups
In the present study, patients will be divided into three groups.
The first group: treatment based on acceptance and commitment + treatment based on compassion
The second group: treatment based on acceptance and commitment + treatment based on compassion + treatment with sertraline
Group 3: Treatment with sertraline
Main outcome variables
Stress - Anxiety - Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N1
Registration date:2021-04-14, 1400/01/25
Registration timing:prospective
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of pharmacotherapy with sertraline versus Acceptance and Commitment Therapy (ACT) enriched with Compassion Focus Therapy (CFT) on depression, stress, and anxiety in addict patients undergoing Methadone Maintenance Therapy (MMT)
Public title
Evaluation of the effects of sertraline and Acceptance and Commitment Therapy (ACT) enriched with Compassion Focus Therapy (CFT) on depression, stress, and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
duration of methadon use for at least the 6 months
the age range of20_45 years
Exclusion criteria:
Existence of severe mental disorder such as psychosis
Existence of instant psychosis due to psychotropic consumption.
Simultaneous use of NA and similar classes.
Having chronic physical illnesses that affect mood and emotions.
Use of opiates and morphine
Not doing homework at home
Failure to complete the questionnaire in pre-test and post-test
Age
From 20 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the samples in each group, the subjects are divided into three groups A, B and C using the RAN() function of Excel software, and according to the type of intervention, drug use and participation in mental training classes. It is a treatment, there is no possibility of blindness, there is no intervener and the subjects, and only the statistical analyst does not know what kind of intervention was done by each group.
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
thics committee of ُ Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.171
Health conditions studied
1
Description of health condition studied
in addict patients undergoing Methadone Maintenance Therapy
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
depression score
Timepoint
28 days after intervention
Method of measurement
Examination of the patient and based on a standard questionnaire
Secondary outcomes
1
Description
depression, stress, and anxiety
Timepoint
Before and after treatment
Method of measurement
DASS-21
Intervention groups
1
Description
Intervention group: Acceptance and Commitment Therapy + Compassionate therapy, group-based acceptance and commitment sessions will be held in 8 1-hour sessions, once a week. The training course will last for two months. At the end of each session, a task is given. In this section, the titles and general structure of the sessions are briefly mentioned. The general framework of acceptance and commitment therapy sessions is based on Hayes et al.'s (1999) and Tohi (2007) Therapeutic Guidelines. The description of the sessions is as follows: Session 1: Familiarity with group members and establishing therapeutic relationship, determining the rules governing the therapy sessions, clarifying the therapeutic relationship, introducing and measuring emotion, starting creative helplessness and presenting homework, Session 2: reviewing homework and receiving feedback from Previous session (done in each session), Continuation of creative helplessness, metaphor of the hole and presentation of the task of the third session, introduction of control as a problem, discussion of the inner world and its difference with the outer world, metaphor of the polygraph and presentation of the task, fourth session : Introducing acceptance and desire as an alternative to control, guest metaphor and expression of pure and unclean feelings, Session 5: Familiarity with the hidden features of language that cause fusion, expression of fault, bus metaphor, Session 6: Introduction of its types, chess metaphor Introduction to the conceptualized past and future, Session 7: Moving towards a valuable life with a receptive and observant self, Identifying values and measuring the values of references, Session 8: Commitment to action and values despite obstacles, metaphor of seedlings, Evaluation of commitment to action, providing a permanent assignment, filling in a compassion-focused post-test: In this study, treatment-focused sessions Compassion will be held in 8 sessions of 120 minutes in a group and once a week. The treatment sessions were based on Gilbert's treatment plan (21). Description of compassion-focused therapy sessions: Session 1: Establishing a therapeutic relationship, familiarizing members with each other, explaining group rules, a brief explanation of CFT, a brief explanation of emotions, Training and implementation of mindfulness breathing exercises and homework Session 2: Review of the previous session's practice, introduction of three emotional regulation systems and how they interact with each other, familiarity with negative and threatening emotions from CFT perspective, the nature of compassion and homework Session Third: Reviewing the practice of the previous session, getting acquainted with the characteristics of people with compassion (kindness, empathy, tolerating distress, not judging), cultivating and understanding that others have flaws and problems, cultivating a sense of human commonality in the face of self-destructive feelings and shame, presentation Homework Session 4: Review of the previous session's practice, self-compassion training (wisdom, strength, kindness, not judging yourself and responsibility), how to illustrate about self-compassion, self-compassion growth training and homework, session 5: Review the previous session practice, practice compassion skills (compassionate behavior, compassionate mental image, compassionate feeling) and empathy training, session Sixth: Reviewing the practice of the previous session, cultivating compassion for others, teaching forgiveness, focusing oneself compassionately on others Session 7: Training to accept problems and face different challenges and changes ahead, homework Reviewing the practice of the previous session, Identify thoughts that hinder the cultivation of compassion and work on them, learn to write compassionate letters, session eight: for yourself and others, do compassion color exercises, compassion sound and image, homework, review and practice the skills presented in the sessions Prior and summary concepts reviewed
Category
Other
2
Description
Intervention group: Intervention group: Acceptance and commitment therapy + Compassion Focus Therapy + treatment with Sertraline
Category
Treatment - Drugs
3
Description
Intervention group: Sertraline
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Addiction treatment clinics
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mirzaie
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۹
Phone
+98 35 3820 3419
Email
mzabihi100@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