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IRCT20170411033378N11 IRCT 2023-05-18 Hamedan University of Medical Sciences The effect of group cognitive behavioral therapy on mood symptoms and temptation to substance use. GCBT The effect of group cognitive behavioral therapy on mood symptoms and temptation to substance use in male patients with bipolar disorder and substance dependence. 2023-06-05 anticipated 40 Complete https://irct.ir/trial/69974 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: The sampling method in this research is block randomization method. In this method, patients who meet the study entry criteria are divided equally and randomly into two intervention and control groups. For this purpose, blocks have been formed, within each block, half of the patients are placed in the intervention group and half of them are included in the control group. The main goal in this method is to balance the number of participants in each group. Considering that it is difficult to conduct group therapy for more than ten patients, and we have two intervention groups of ten, four blocks of ten are prepared. In each of these blocks, 5 patients are randomly placed in the intervention group (A) and 5 patients in the control group (B). The randomization sequence is provided through the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Due to the clarity of the intervention received by the members of the groups involved in the study, it is practically impossible to blind the study participants.Therefore, in order to blind and prevent bias in all stages, completing the questionnaires and analyzing the data are done by people who do not know whether the patients are in the intervention group or the control group (People other than cognitive behavioral therapists). N/A Condition 1: Bipolar disorder. Condition 2: Substance dependence. Intervention 1: Intervention group: the intervention group includes 2 closed groups of 10 people (due to the limitation in the number of people present in the therapy group). For these people, in addition to the usual care, group cognitive behavioral therapy sessions are held for 8 sessions, two sessions a week, in the evenings in the classrooms in the psychiatry departments by a trained psychiatric nursing student and with the presence of the psychiatric nursing faculty experienced in this field. Each session will last 1.5 hours and about 10 minutes between sessions will be considered for rest and a short reception. Sessions are systematic with specific content and specific assignments for patients. Intervention 2: Control group: does not receive intervention. Yes - There is a plan to make this available What will be shared: IPD briefly describe what specific participant data sets are to be shared When: Starting in Oct 2023 To whom: People working in academic institutions Conditions: People working in academic institutions Where to obtain: Via Email: sadeghianefat@gmail.com How to obtain: Via Email: sadeghianefat@gmail.com Comments:
public Efat Sadeghian
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.
Hamadan Iran (Islamic Republic of) 6861819453 6517838736 sadeghianefat@gmail.com Hamedan University of Medical Sciences scientific Efat Sadeghian
Hamedan University of Medical Sciences, In front of Mardom Park
Hamedan Iran (Islamic Republic of) 6517838698 +98 81 3838 0150 sadeghianefat@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) The diagnosis of bipolar disorder has been confirmed by a psychiatrist Have drug dependence Ability to communicate and answer questionnaires Being literate in reading and writing Consent to participate in the study Receive usual medical care and treatment Not having a physical or mental disability Not having another psychiatric disorder along with bipolar disorder Not participating in similar psychotherapy 18 years 65 years Male Entering the acute phase of the disease Absence in more than 2 sessions of group therapy sessions F31.9 F19.1 Bipolar affective disorder, unspecified Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances Rehabilitation N/A Intervention group: the intervention group includes 2 closed groups of 10 people (due to the limitation in the number of people present in the therapy group). For these people, in addition to the usual care, group cognitive behavioral therapy sessions are held for 8 sessions, two sessions a week, in the evenings in the classrooms in the psychiatry departments by a trained psychiatric nursing student and with the presence of the psychiatric nursing faculty experienced in this field. Each session will last 1.5 hours and about 10 minutes between sessions will be considered for rest and a short reception. Sessions are systematic with specific content and specific assignments for patients. Control group: does not receive intervention. Mania score in Hirschfeld Mood Disorder Questionnaire (2000). Timepoint: Measuring the mania score at the beginning of the study (before the start of the intervention), after the completion of the group cognitive behavioral therapy sessions, one month and three months after the completion of the sessions. Method of measurement: Hirschfeld Mood Disorder Questionnaire (2000). Depression score in Beck Depression Questionnaire (short form with 13 questions). Timepoint: Measuring the Depression score at the beginning of the study (before the start of the intervention), after the completion of the group cognitive behavioral therapy sessions, one month and three months after the completion of the sessions. Method of measurement: Depression Questionnaire (short form with 13 questions). Temptation score in Wright's Craving Beliefs Questionnaire (2003). Timepoint: Measuring the temptation score at the beginning of the study (before the start of the intervention), after the completion of the group cognitive behavioral therapy sessions, one month and three months after the completion of the sessions. Method of measurement: Wright's Craving Beliefs Questionnaire (2003). Hamadan University of Medical Sciences Approved 2023-04-29 Ethics committee of Hamadan University of Medical In front of Mardom Park, Hamedan University of Medical Sciences, Hamadan Hamadan Iran (Islamic Republic of)