Trial design
This study has been developed based on a controlled randomized clinical trial, including the pretest, posttest, and two-month follow-up phase. The DBT has then been compared with a psycho-education treatment.
Sample size
As the sampling method comprises snowball sampling and strict eligibility criteria, based on similar pieces of research, at least 20 participants have been determined for each group [11]. However, it has been attempted to achieve a greater sample size.
Selection Criteria
To be included in the study, participants had to (1) attend MUD psychiatric diagnosis, (2) be at least 18 years old, (3) not have any current or past history of major psychiatric disorders, (4) not be using any other SUD treatment, and (5) be willing to attend intervention and complete surveys (questionnaires and urine kit). Exclusion criteria include (1) unwillingness to continue the study, (2) the absence of more than two sessions, (3) starting secondary psychotherapy, and (4) determine the use of other substances (except alcohol, nicotine, and caffeine) during any stages of research. Participants included inclusion criteria who referred to the clinic affiliated with Kermanshah University of Medical Sciences.
Participations, Procedure, and Randomization
Due to the non-existence of any Cannabis Use Disorder Treatment Center in Iran, there is no specific place to select patients. Any other way, patients who are in drug treatment centers referred for treating other drugs use disorders; and comorbidity of drug use is among the exclusion criteria in this study that may lead to misleading results. Therefore, the families and acquaintances of those who referred to the drug treatment center were interviewed. At this stage, from date November 01, 2019, to November 5, 2019, out of relatives and families of drug users referring to drug treatment centers, 15 were diagnosed with MUD. Then, using snowball sampling, after 15 days of investigation, 83 patients were diagnosed with MUD. Of the 83 MUD patients who were approached, 75 consented, eight declined to participate, and 14 were ineligible. The primary reasons for declining were anxiety of addiction stigma and time constraints. Most ineligible patients had multi illicit use disorders, so they did not meet the criteria for study entry. Therefore, 61 patients completed the baseline assessment and were included in the current analyses. These patients randomly assigned to each group with a random number table. From December 01, 2019, to march 20, 2020, interventions have been implemented. The follow-up phase started on march 21, 2020, and ended on May 20, 2020, (two-month follow-up). For control exclusion criteria before each session, a six-pack of six-drug kits for Methamphetamine, Amphetamine, Cannabis, Methadone, Benzodiazepines, and Morphine was administered to individuals through urine.
Blinding
Both groups were blind to the existence of another group of the research. However, patients were informed about participating in research and not about another group. One day after the end of treatment, the post-test was carried out by mental health technicians with a master's degree in psychology.
Outcomes measures
Abstinence: to identify abstainers, a Marijuana urine test kit prepared by Kian Teb Company (officially licensed by National Medical Device Directorate IR. IRAN) was used.
Marijuana smoking: For patients who have lapsed during the post-test of follow-up, a self-report scale was designed. On this scale, patient checkmarks consumed days 30-days ago. The first thirty days after the last session was considered as the post-test smoking pattern, and the second-month follow-up was considered as follow-up Marijuana use pattern.
Craving: The short-form of the Marijuana Craving Questionnaire (MCQ) is a 12 items self-report questionnaire with the ten-items for assessment of subjective cannabis craving. This scale consists of 4 factors, including compulsivity, emotionality, expectancy, and purposefulness. According to how patients were thinking or feeling ''right now,'' they placed checkmarks in the questionnaire, ranging from 1 or strongly disagree to 7 or strongly agree on this scale. Results showed that this questionnaire's internal consistency is suitable (α = 0.90). This measure was administered following a 12-hour deprivation period. The typical onset of Marijuana craving and withdrawal symptoms is approximately observed within one day after cessation; thus, the questionnaire scores in the current paper can be conceptualized as an index of the propensity to experience Marijuana craving following deprivation (20). In Iran’s MUD patients, MCQ internal consistency was α = 0.87. The details about MCQ psychometrics properties will be published as a separate study as soon as possible.
Acceptability: Acceptability of Intervention Measure (AIM) was employed to measure the acceptability of interventions. AIM measured on a 5-point Likert scale (from Completely Disagree with 1 point to Completely Agree with 5 points). The final score is calculated by mean points. This questionnaire developed by Weiner et al. (2017), and they reported Cronbach’s ɑ=85 for internal consistency (21).
Appropriateness: Intervention Appropriateness Measure (IAM) used for Appropriateness. The IAM consist of a four-item scale that measures perceived intervention appropriateness. Items are measured on a five-point Likert scale (Completely Disagree to Completely Agree), which calculates the mean score. Higher points mean participant feels this intervention is more appropriate for his/her. For this tool, Cronbach’s ɑ =0.91 and all Factor Loadings reported higher than 0.8 (21).
Intervention
Dialectical Behavior Therapy
DBT as a group intervention consisted of 16 sessions (meeting once a week for 90 minutes) with one psychotherapist and her co-therapist. The intervention protocol was an adaptation of DBT to SUD based on three basic manuals (11, 22, 23). The primary objective of the DBT is to reduce dysfunction in emotion regulation and craving via increasing cessation rates and improvement of skills. Table1 shows DBT contents per session. This treatment implanted by a Ph.D. of clinical psychology that blinded about another group and the main goals of the research.
Table 1.
DBT contents per session
Cessation
|
contents
|
Pre-session
|
Explanation of dialectical behavioral therapy, principles, and goals. brief introduction of the content of each session. familiarity with participants. Giving people an intervention booklet to read at home.
|
1st session
(mindfullness1)
|
introduce the concept of mindfulness and three mental states (wise, reasonable, emotional) and their relations with substance use.
|
2nd sessions
(mindfulness 2)
|
Teaching two clusters of mindful skills. first, include viewing, participation, and description. Second include non-judgmental stance and inclusive self-consciousness.
|
3rd session
|
summarizing the mindfulness sessions. Definition of addiction, common therapies of addiction, introduction, and teaching of dialectical avoidance technique, review of the positive and negative aspects of abstinence, explanation and Investigating the relapse and its cause, explaining the skill of the pure mind, the addicted mind, the types of behaviors related to the pure mentality and the addicted mentality, and the preparation of a list of supporters.
|
4rd -5th sessions
(Distress tolerance)
|
teaching distraction strategies with five skills include activities, comparisons, emotions, thoughts, contributing using away. through enjoyable activities, focusing on work or other topics, counting, leaving the situation, paying attention to daily tasks, distracting from thoughts and self-harm behaviors. teaching and training self-soothing with five senses.
|
6th -7th sessions
(Emotion regulation)
|
Definition of emotion, how emotions work, familiarity with emotion regulation skills. Emotion Identification Exercise, Emotion Registration Exercise. Identifying barriers to experiencing emotion in a healthy way and ways to overcome these barriers. Teaching creating short-term positive emotional experiences for experiencing positive emotional states.
|
8th -10th sessions
(Emotion regulation and distress tolerance in MUD context)
|
Explain the craving and its connection to the experience of emotions. Introducing methods for identifying values. importance committed action based on a list of important values in life. Develop new coping strategies in response to unpleasant emotions, sensations, and cognitions especially craving as multidimensional problem. teaching problem solving and behavior analysis.
|
11th session
|
Basic acceptance technique training. Living in the present moment theqniques.
|
12th -13th sessions
|
interpersonal effectiveness training. Participants learning assertiveness skills about substance users people. Other skills include Non-verbal communication, Verbal communication, Problem-solving, Decision-making and Listening skills.
|
14the – 16th sessions
|
Review sessions. Eliminate ambiguities. Exercise skills in the presence of other people.
|
Psychoeducation
Psychoeducation is an updated and straightforward information about Marijuana dangers and its management addiction as well as craving pamphlet. It is also more ethical than without offering any intervention. A psychiatrist with five years of experience in addiction psychotherapy implemented this intervention. This intervention includes problem-solving skills, assertiveness, and craving management in eight sessions and is designed for eliminated common practical factors among psychotherapies to specify pure DBT effects.
Therapists and Treatment Adherence
For checking adherence, audios of sessions were recorded with the consent of all the participants. Then a DBT researcher and psychotherapist who was not involved in the treatment groups checked contents secession. Sessions were divided into 15-minute modules that were chosen for adherence checks randomly. Treatment stance and the occurrence and depth of DBT processes were appraised. Based on the treatment manual, the modules rated the adherence level as either adequate or not adequate. The majority (83%) was judged as having been conducted adequately.
Statistical method
Demographic information was gathered and reported the frequency, mean, and standard deviation, and for outcomes, repeated measures ANOVA and chi-square tests were conducted by SPSS software version 26.