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. 2015 May 10;2015(5):CD007803. doi: 10.1002/14651858.CD007803.pub2

Nave 2012.

Methods Design: double‐blind, randomised pilot study
Study duration: 1 week (1 session, plus assessment 1 week before)
Follow‐up: 1 week
Country: USA
Participants Sample size: 20 adult participants were randomised
Recruitment: Not reported
Inclusion criteria ‐ diagnostic classification criteria: DSM‐IV Specific Phobia
Inclusion criteria ‐ rating scales: Mini‐International Neuropsychiatric Interview (MINI), Snake Questionnaire
Included disorders: specific phobia: snake phobia
Co‐morbidities: 1 participant in DCS group had co‐morbid depressive disorder
Gender: 40% male (both groups)
Mean age: placebo group mean age 39.00 years (SD 13.91); DCS group mean age 34.60 years (SD 12.69)
Ethnicity: 80% of placebo group was White; 60% of DCS group was White
Pharmacotherapy during the study: Naturalistic prescribing allowed. 3 participants in placebo group were taking medication; 2 participants in DCS group were taking medication (types of medication not reported)
Interventions
  1. Intervention: Participants received 50 mg of DCS 1 hour prior to 1 session of graded exposure therapy (N = 10)

  2. Comparison: Participants received placebo pill 1 hour prior to 1 session of graded exposure therapy (N = 10)


Therapists: Not reported
Outcomes Response; withdrawals; anxiety: Snake Questionnaire
Notes Funding from industry: No, study was funded by departmental funds at Hartford Hospital
Medication supplied by industry: Not reported
Any author work for industry: No
Study ID: NCT01450306
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, but does not report method of sequence generation
Allocation concealment (selection bias) Unclear risk Details of allocation concealment were not provided
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Subjects received DCS or "an identically packaged placebo capsule". Other details to assure blinding not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Details regarding blinding of assessors not provided
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised subjects participated in study and clinical follow‐up assessment
Selective reporting (reporting bias) Low risk All outcomes stated in protocol were reported
Other bias Low risk The study appears to be free of other sources of bias