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. 2023 May 9;2023(5):CD013350. doi: 10.1002/14651858.CD013350.pub2

Ganavadiya 2018.

Study characteristics
Methods Study design: randomized controlled trial
Country: India
Setting: inpatient substance use treatment center
Eligibility criteria: included were patients admitted to the addiction treatment center with addiction to tobacco and alcohol, having a high level of tobacco dependence (Fagerstrom scale>5), and agreed to stay as inpatients in the treatment center for 25‐30 days. Excluded were participants with addiction only to alcohol and/or other substances and not tobacco, who were undergoing pharmacological interventions during the study period, who had known drug hypersensitivities, patients with epilepsy, pregnant, lactation, serious physical comorbidities, or low levels of dependence.
Duration of follow‐up: 2 months
Informed consent: not reported
Ethical approvals: not reported
Participants Sample size: 83 (27 reading‐writing therapy, 28 games‐narrative therapy, 28 motivational intervention only)
Description of the target population: patients in inpatient treatment with alcohol and tobacco dependence
Age: 32.2 years (SD=9.12)
Sex: 100% male
Race/Ethnicity: not reported
Marital status: not reported
Harmful alcohol use (baseline): practice: 2.89 (SD = 1.56)
Co‐occurring disorders: 100% tobacco dependence
Interventions Type: non‐pharmacologic
Description: A) Reading‐writing therapy + motivational intervention: use of self‐help materials to motivate and guide behavior change. In each group session participants were given autobiographies of previous patients who had successful substance use treatment outcomes to read. In writing therapy, participants were given a diary and pen. They were asked to express their experience with substance use, adverse consequences, and potential benefits of reducing their substance use in these diaries; B) Games‐narrative therapy + motivational intervention: Cognitive, behavioral and motivational approaches to promote interaction between patients and divert participant's attention to rigorous activity to mask craving and withdrawal symptoms. The games included short mind games and puzzles. The narrative/story therapy consisted of sharing stories related to their personal life and addiction, including the relationship between their substance use and personal life circumstances.
Delivery and frequency: A) not reported, group‐based; B) 2 hours per day for 25‐30 days of inpatient treatment, group or individual sessions
Duration and provider: A) trained counselors
Comparison group: motivational interviewing consisting of group counseling, individual counseling, and Anonymous meetings over the course of 25‐30 days of inpatient treatment; Provider was a trained counselor
Outcomes Primary outcome(s): alcohol practice
Primary outcome measurement tool(s): Knowledge, Attitudes, and Practices related to alcohol
Secondary outcome(s): none
Secondary outcome measurement tool(s): N/A
Time points: 1, 2 months
Notes Study funding and conflicts of interest: not reported
Linked study records: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "The randomization and group allocation were done on a quota basis in the de‐addiction center by the center in charge. The first five eligible participants admitted to the de‐addiction center were allotted to Group A, and then, the next five eligible participants to Group B and Group C, respectively. This group allocation strategy was followed as it was convenient to administer the intervention. The group code was entered on the assessment form of the participant following randomization and the information on the actual intervention offered to different groups was concealed from the investigator to ensure blinding in the study." Pg. 3
Allocation concealment (selection bias) High risk Quote: "The randomization and group allocation were done on a quota basis in the de‐addiction center by the center in charge. The first five eligible participants admitted to the de‐addiction center were allotted to Group A, and then, the next five eligible participants to Group B and Group C, respectively. This group allocation strategy was followed as it was convenient to administer the intervention. The group code was entered on the assessment form of the participant following randomization and the information on the actual intervention offered to different groups was concealed from the investigator to ensure blinding in the study." Pg. 3
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel cannot be blinded for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcomes reported by participant not blind to intervention
Quote: "The randomization and group allocation were done on a quota basis in the de‐addiction center by the center in charge. The first five eligible participants admitted to the de‐addiction center were allotted to Group A, and then, the next five eligible participants to Group B and Group C, respectively. This group allocation strategy was followed as it was convenient to administer the intervention. The group code was entered on the assessment form of the participant following randomization and the information on the actual intervention offered to different groups was concealed from the investigator to ensure blinding in the study." Pg. 3.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not described
Selective reporting (reporting bias) Unclear risk Protocol not available