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IRCT20210804052079N1 IRCT 2022-06-02 Cognitive Sciences and Technologies Council The Effect of Episodic Future Thinking (EFT) on Craving CIREF The Effect of Cue-Exposure Combined with Episodic Future Thinking (CIREF) Intervention on Craving and Delay Discounting in Opioid Users Receiving Methadone Maintenance Treatment: A Pilot Study 2022-06-06 anticipated 28 Complete https://irct.ir/trial/63846 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In the present study, an intervention called " Intervention based on Episodic Future Thinking (EFT)" has been designed for the first time. It consists of 4 one-hour sessions. The protocol tries to be feasible and led participants to remain in the study. The set of opioid narrative cues, applied in the intervention have been completely personalized, Randomization description: After screening, participants meeting the required inclusion criteria will be randomly allocated to the intervention and the active control group through block randomization. The randomization list will be created using Python. In block randomization, there would be only six conditions in which two cells get “C” control and two cells get “T” trial for a block of four cells. As a result, the 6 outcomes will be as follows: 1: CCTT, 2: TTCC, 3: CTCT, 4: TCTC, 5: TCCT, 6: CTTC. Also, a number will be randomly assigned to each participant, Blinding description: In the present study, after screening and randomization, individuals will be officially included in the study. In the first session of the intervention, a brief description of the study process by the examiner will be provided to the participant. They will then be given an informed consent form. The information contained in the informed consent form and how to spend the study will be fully explained to the participants. In the process of conducting the study, participants will be blind to the intervention received. It should be noted that the staff present at the outpatient clinic will be blind to the whole intervention process. These people are: nurse, psychologist, assistant and also the technical manager of the clinic. All data recorded during the intervention sessions will be stored in the computer of the outpatient clinic (the venue of the intervention sessions) in an encrypted folder that only the researcher has access to, and will be deleted after the intervention and follow-up sessions. At the end of the intervention sessions, only the data obtained from the questionnaires will be provided to the data analyzer. N/A Opioid Substance Use. Intervention 1: Trial group: Episodic Future thinking group: In the first session, the subjects of the intervention group will be asked to generate the opioid-related cues for the the following for the next 6 time intervals, including: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year in future. Subjects will then scored them in terms of Valence, arousal, and vividness.Momentary craving, craving in the past period and the delay discounting will be measured. Next, the subject will be shown the cues of the relevant time intervals on the screen. In the first stage of the Episodic Future thinking, the subject will be asked to simulate a possible future event in his/her mind based on the related cue. In the second stage, he will be asked to predict all the details of the event in 2-3 minutes. The drug-related cues will trigger the drug-related memories which cause in negative retrieval. In the third stage, the subject's memory will be fragile and vulnerable due to stimulation. Now the person will be asked to think about the consequences of substance abuse and form a new interpretation and pursue this interpretation as a goal in his mind. This goal is actually a kind of new memory that is created in a person's mind called reappraisal. In the fourth step, the subject will be asked to plan small but strong steps to achieve the leading plan. These small steps will help him to have a predetermined plan to achieve his goal and also be able to manage his craving toward drug cues. After the intervention sessions, momentary craving, craving in the past period and delay discounting will be measured again. Intervention 2: Control group: Control group: Episodic Recent thinking group: In the first session, the subjects of the intervention group will be asked to generate the opioid-related cues for the the following for the next 6 time intervals, including: 1,3,5,7,9 days in the past. Subjects will then scored them in terms of Valence, arousal, and vividness.Momentary craving, craving in the past period and the delay discounting will be measured. Next, the subject will be shown the cues of the relevant time intervals on the screen. In the first stage of the Episodic Recent thinking, the subject will be asked to simulate a possible event in the recent past based on the related cue. In the second stage, he will be asked to predict all the details of the event in 2-3 minutes. Now the person will be asked to set a new goal toward the drug-related cue. In the fourth step, the subject will be asked to plan small steps to achieve the leading goal. After the intervention sessions, momentary craving, craving in the past period and delay discounting will be measured again. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Matin Toulami
No.7, Sheibani Alley, North Jamalzadeh St., West Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1418643514 +98 21 6642 6816 matin.toulami08@gmail.com Institute for Cognitive Science Studies scientific Tara Rezapour
Institute for Cognitive Science Studies, Cognitive Science Blvd.
Pardis Iran (Islamic Republic of) 1658344575 +98 21 7629 1130 tara_rezapour@yahoo.com Institute for Cognitive Science Studies Iran (Islamic Republic of) History of Opioid Use Methadone Maintenance Treatment Receivers Ability to Read and Write 18 years 45 years Both Chronic Mental Disorder History F11 Opioid related disorders Behavior Behavior Trial group: Episodic Future thinking group: In the first session, the subjects of the intervention group will be asked to generate the opioid-related cues for the the following for the next 6 time intervals, including: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year in future. Subjects will then scored them in terms of Valence, arousal, and vividness.Momentary craving, craving in the past period and the delay discounting will be measured. Next, the subject will be shown the cues of the relevant time intervals on the screen. In the first stage of the Episodic Future thinking, the subject will be asked to simulate a possible future event in his/her mind based on the related cue. In the second stage, he will be asked to predict all the details of the event in 2-3 minutes. The drug-related cues will trigger the drug-related memories which cause in negative retrieval. In the third stage, the subject's memory will be fragile and vulnerable due to stimulation. Now the person will be asked to think about the consequences of substance abuse and form a new interpretation and pursue this interpretation as a goal in his mind. This goal is actually a kind of new memory that is created in a person's mind called reappraisal. In the fourth step, the subject will be asked to plan small but strong steps to achieve the leading plan. These small steps will help him to have a predetermined plan to achieve his goal and also be able to manage his craving toward drug cues. After the intervention sessions, momentary craving, craving in the past period and delay discounting will be measured again. Control group: Control group: Episodic Recent thinking group: In the first session, the subjects of the intervention group will be asked to generate the opioid-related cues for the the following for the next 6 time intervals, including: 1,3,5,7,9 days in the past. Subjects will then scored them in terms of Valence, arousal, and vividness.Momentary craving, craving in the past period and the delay discounting will be measured. Next, the subject will be shown the cues of the relevant time intervals on the screen. In the first stage of the Episodic Recent thinking, the subject will be asked to simulate a possible event in the recent past based on the related cue. In the second stage, he will be asked to predict all the details of the event in 2-3 minutes. Now the person will be asked to set a new goal toward the drug-related cue. In the fourth step, the subject will be asked to plan small steps to achieve the leading goal. After the intervention sessions, momentary craving, craving in the past period and delay discounting will be measured again. The primary outcome measure of the present study will be momentary craving assessed by the score of 3 sub-scales of the Desire for Drug Questionnaire. The sub-scales including: questions 1, 2, 4, 6, 7, 10, 13, 14 investigate the patient’s “desire and intention to drug use”, questions 5, 9, 11, 12 investigate the “negative reinforcement for drug use" and questions 3 and 8 which are related to “drug abuse control”. There is no normal score for this questionnaire and the significance level of change is the evaluation criterion. Score received in each sub-scales will be assessed at baseline and after intervention. Timepoint: Baseline and after 4-week interventions. Method of measurement: 14-item Desire for Drug Questionnaire by Franken et al. will be used to assess the momentary craving. The primary outcome measure of the present study will be craving in the past period assessed by the score of 4 sub-scales of Obsessive Compulsive Drug Use Scale. The sub-scales including: questions 1, 2, 7, 8 investigate “desire and mental preoccupation with drugs”, questions 3 and 9 could be called as “the effect of desire for drug, and drug-related thoughts on the patient’s work and life”, questions 4, 6, 11 and 12 are related to “motivation, emotion, and lack of control” and questions 5 and 10 evaluate “resistance to drug use”. score for this questionnaire and the significance level of change is the evaluation criterion. Score received in each sub-scales will be assessed at baseline and after intervention. Timepoint: Baseline and after 4-week interventions. Method of measurement: 10-item Obsessive Compulsive Drug Use Scale by Franken et al. will be used to assess the craving in the past period. The secondary outcome of the present study is the score obtained in the dual monetary selection questionnaire. Timepoint: At baseline and after 4-weeks of intervention. Method of measurement: Delay Discounting will be assessed by Monetary Choice Questionnaire.Monetary Choice Questionnaires is a 27-item, brief dichotomous choice tasks that assess preference between small immediate and larger delayed monetary outcomes. Cognitive Sciences and Technologies Council Approved 2021-10-04 Research Ethics Committees of Institute for cognitive science studies Institute for Cognitive Science Studies, Cognitive Science Blvd, Pardis Pardis Tehran Iran (Islamic Republic of)