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. 2015 May 11;2015(5):CD009652. doi: 10.1002/14651858.CD009652.pub2

Elliott 2005.

Methods RCT.
Participants 53 Illicit drug users attending a drug clinic for methadone maintenance in Scotland. Mean age 30.6 years (SD = 6.5), 53% male.
N = 24 patients in intervention group 1. N = 29 patients in intervention group 2.
Interventions The psychological interventions that are tested in the present study were developed from CBT designed for those suffering from panic disorder or co‐morbid anxiety who are withdrawing from BZDs. The following elements were used in the interventions: a) providing information and education about the effects of withdrawal, anxiety and sleep problems; b) visualising withdrawal symptoms; c) diaphragmatic breathing, progressive muscle relaxation exercises and guided imagery to address anxiety; d) sleep planning and encouraging good sleeping habits. Patients were requested to undertake fortnightly visits during which their diazepam medication was reviewed and the additional psychological support offered. Both the enhanced and limited intervention groups were given an initial orientation session, which focused on a general overview of the diazepam reduction plan and the psychological support. It outlined the frequency and details of reductions and familiarised the patient with the contents of the reduction handbook, which they were allowed to keep. The reduction handbook contained the information and descriptions of exercises designed to address three areas of difficulty that might be experienced when withdrawing from diazepam; withdrawal effects, anxiety and stress, and sleep difficulties. Both intervention groups undertook a further six visits during which they developed their skills and practised the basic exercises.
Intervention group 1: Enhanced intervention ‐ skills training and skills reinforcement. The enhanced group undertook further skills training whilst those in the limited intervention group were given verbal advice on request and referred back to the reduction handbook. The skills training involved further practice and development of the basic techniques designed to help with drug withdrawal, anxiety and sleep problems such as visualising withdrawal symptoms, breathing and relaxation exercises, and sleep planning.
Intervention group 2: Limited intervention ‐ skills training and verbal advice on request.
Outcomes Outcome measures at baseline and at 6 months follow‐up consisted of daily prescribed diazepam dose. Self‐reported illicit drug use. Severity of dependence. Depression and sleep quality were also measured.
Notes Funding source: Chief Scientist Office, Scottish Executive UK.
Declaration of interest: Not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "After this block randomisation patients were randomly allocated to either arm by a statistician offsite and allocation was telephoned back to clinic.  Patients were interviewed and then block randomised depending on whether dose of BDZ above or below equivalent of 30mgs diazepam then randomised".
Allocation concealment (selection bias) Low risk "Patients were randomly allocated to either arm by a statistician offsite and allocation was telephoned back to clinic".
Blinding (performance bias and detection bias) 
 All outcomes Low risk Prescription data for BZD dose.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Prescription data for BZD dose.
Blinding of outcome assessor (detection bias) subjective outcomes Low risk "The interviewers were blind as to the allocation of the respondent's intervention group".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT analyses performed.
Selective reporting (reporting bias) Low risk The study protocol is not available but the published reports include all expected outcomes, including those that were pre‐specified in the method section.