Comparison of the effectiveness of mindfulness based group therapy with usual in the individual reduction of risk factors for relapse in opioid addicted
The aim of this quasi-experimental study is Comparison of the effectiveness of mindfulness based group therapy with usual in the individual reduction of risk factors for relapse in opiod addicted. The patients who have the opium abuse according to the psychiatric interventions are accepted based on the entry measures. Under study population are the patients who are dependent on the opium substances, provided in the Iranian National Center for Addiction Study to treatment with methadone with the accessible sampling method of 30 people who are the volunteer of the medical services and the entry measurements in a random way and 15 people in each group are studied as the treatment and control group. Each individual intervention is in 8 sessions one a week. The primary evaluation before the treatment is the pre-test and the entry measurements in two groups. The intervention group is based on mindfulness based group therapy in 8 treatment sessions. After interventions, the final evaluation and post-test and the treatment process are fully considered. The control group similar to the intervention group participates in the primary or pre-test evaluations and the final or post-test evaluations. This group would not receive the any other psychotherapy intervention or pharmaceutical treatment than the normal treatment in INCAS center. The evaluation occurs via alcohol and craving, alcohol and drug use consequences, mindfulness, acceptance, meditation practice, difficulties in emotion regulation scale, addiction severity index, depression, anxiety and stress scale questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031612826N1
Registration date:2013-06-28, 1392/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Saeed Imani
Name of organization / entity
Tehran University of Medical Sciences-Tehran Psychiatric Institute
Country
Iran (Islamic Republic of)
Phone
+98 21
Email address
psychology2008@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mindfulness based group therapy with usual in the individual reduction of risk factors for relapse in opioid addicted
Public title
Effectiveness of mindfulness based group therapy reduction of risk factors for relapse in opioid addicted
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having age between 15 to 40 years old; at least one study tips; having a history of opioid abuse and patients agreed to participate in research on informed consent.
Exclusion criteria: psychotic symptoms; organic brain disorder; have serious thoughts about suicide, which may be impossible to participate in research.
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
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
Tehran University of Medical Sciences and Health Services
Street address
Keshavarz Blvd, Qods St, University of Central- Floor - Sixth
City
tehran
Postal code
Approval date
2012-12-30, 1391/10/10
Ethics committee reference number
130/2083/ص/91
Health conditions studied
1
Description of health condition studied
Opioid Dependence
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Improvement in a situation of opiates,retention in treatment and ratio negative drug test for methamphetamine, morphine and benzodiazepines
Timepoint
Before treatment and after treatment
Method of measurement
The evaluation occurs via eligibility screening, alcohol and craving, alcohol and drug use consequences, mindfulness, acceptance, meditation practice, difficulties in emotion regulation scale, addiction severity index, depression, anxiety and stress scale questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Mindfulness based group therapy; receive 8 sessions (in addition to the primary and final evaluations). Mindfulness based group therapy sessions were held once per week, each session lasting 2 hours. Mindfulness based group therapy were performed based on Bowen, Chawala and Marlatt treatment Manual. Mindfulness based group therapy is provided by a doctoral student in clinical psychology.
Category
Prevention
2
Description
Control group did not receive treatment for eight weeks except treatment as usual INCAS and were evaluated only 2 times.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies
Full name of responsible person
Dr. Ali Reza Nowrozi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Rahim Nia
Street address
St Ghods, Keshavarz blv.
City
Tehran
Grant name
123700
Grant code / Reference number
30121
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences - Tehran Psychiatric Institute
Full name of responsible person
Saeed Iamni
Position
PhD candidate in Clinical Psychology
Other areas of specialty/work
Street address
Tehran Psychiatric Institute, Shahid Mansoori Alley, neyayesh- St. St satarkhan