Evaluation of the effects of motivational interviewing on beliefs related to substances, craving anddesire for treatment in methamphetamine-dependent psychotic patients
Evaluation of the effects of motivational interviewing on beliefs related to substances, craving and desire for treatment in methamphetamine-dependent sychotic patients
Design
Clinical trial with control group, randomized, phase 2 on 32 patients. Block randomization in blocks of 4 is used for randomization
Settings and conduct
An intervention group and a control group are both included in this investigation. In this study, patients admitted to Amirkabir Hospital's psychiatric ward with a clinical diagnosis of psychosis brought on by methamphetamine use according to DSM 5 criteria will be purposely chosen and randomly divided into two groups. This study will not use blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
DSM-5-based clinical diagnosis of methamphetamine-induced psychosis
Occurrence of psychotic symptoms is up to one month after consumption
Exclusion criteria:
Restless and aggressive patients or with other symptoms interfering with treatment
Intervention groups
In both groups, patients filled out three questionnaires before starting the study, including: the questionnaire of beliefs related to drug and stages of readiness for change and enthusiasm for addiction treatment and also a measuring the temptation to use drugs after quitting and patients in the intervention group will participate in a 50-minute motivational interviewing session, and then, one week later, these three questionnaires will be provided to them to complete again. The information collected from these three questionnaires, which were filled out by both groups in both before and after the therapeutic intervention, would then be compared
Main outcome variables
beliefs related to substances
Craving
desire for treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221018056234N1
Registration date:2022-12-17, 1401/09/26
Registration timing:registered_while_recruiting
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Fatemeh Solhmirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 4510
Email address
fatemeh.solhmirzaei76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of motivational interviewing on beliefs related to substances, craving anddesire for treatment in methamphetamine-dependent psychotic patients
Public title
the effects of motivational interviewing on beliefs related to substances, craving anddesire for treatment in methamphetamine-dependent psychotic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
DSM-5-based clinical diagnosis of methamphetamine-induced psychosis .
Occurrence of psychotic symptoms is up to one month after consumption.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of the block randomization type. The number of samples assigned to each of the studied groups is equal. The size of all the blocks is equal and we will have 4 blocks in this two-group trial (including 2 participants in the intervention group and 2 participants in the control group). The randomization tool is also from the Random Allocation software. software is used that these random sequence generation softwares are capable of generating random sequence by block method in addition to simple randomization.
In this method, each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of the registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences