Roy‐Byrne 2005.
Methods | Study design: Randomised controlled trial | |
Participants | Setting: Primary care Diagnosis: Meeting Diagnostic and Statistical Manual (DSM‐IV) criteria for panic disorder with at least 1 panic attack in the prior week. The Composite International Diagnostic Interview (CIDI) used to determine eligibility. Inclusion criteria: Between 18 and 70 years of age, English speaking, access to a telephone, and willing to accept a combined treatment of anti‐anxiety medication and CBT. Exclusion criteria: Potentially life threatening co morbidities (i.e. suicidal ideation, terminal medical illness) or those expected to severely limit patient participation or adherence (e.g., psychosis, current substance abuse, dementia, pregnancy). Patients receiving psychiatric disability benefits or those already seeing a psychiatrist or cognitive‐behavioural therapist were excluded. Age: Mean 41.2 years Gender: 67% female Ethnicity: 66% white Country: United States Sample size (randomised): Total participants 232, intervention 119, control 113 |
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Interventions | Intervention: CBT Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), graduates (CM), psychiatrist (MH specialist) 2) a structured management plan: Patients received a video about panic disorder and a workbook including education on medication, its management and synergies with CBT. The medication algorithm involved dose titration of typically a Selective Serotonin Reuptake Inhibitor (SSRI) for at least 6 weeks or adjunctive medications (e.g., benzodiazepines). CMs coordinated care and delivered CBT, which targeted panic symptoms but also included modules to address depressive and social anxiety symptoms if required. Follow‐up calls monitored clinical status, reinforced medication use and CBT skills, and make further medication recommendations if necessary. 3) scheduled patient follow‐ups: CBT = 6 sessions in 3 months (3 face‐to‐face and then telephone if preferred) then 6 brief booster telephone calls at 6‐12 week intervals 4) enhanced inter‐professional communication: CMs relayed recommendations from MH specialist to PCP. CMs communicated with PCPs using rapid systems of 2‐way communication (i.e. telephone, fax, and e‐mail). CM received weekly supervision from MH specialist Control: Treatment as usual enhanced as PCPs were informed of diagnosis |
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Outcomes | Anxiety (Composite measure of high end state functioning): 3, 6, 9, 12 months Medication use: 3, 6, 9, 12 months Quality of Life (mental and physical health): 3, 6, 9, 12 months |
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Notes | CBT: cognitive behaviour therapy; CIDI: Composite International Diagnostic Interview; CM: case manager; MH: mental health; PCP: primary care provider | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Alternating assignment stratified by referred or screened |
Allocation concealment (selection bias) | Unclear risk | Insufficient information available to assess |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary outcome (composite measure of high end state functioning ‐current MDD, CESD, SF MCS) was: overall 56/232 (24%), 32/119 (27%) intervention and 24/113 (21%) control. Reasons for loss to follow‐up provided, with similar reasons for missing data across groups. Intention‐to‐treat analysis reported, no description of methods to manage missing data |
Selective reporting (reporting bias) | Low risk | Protocol available and all prespecified outcomes reported |
Other bias | Unclear risk | Insufficient information available to assess |
Implementation Integrity | Unclear risk | Insufficient information available to assess |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor was not aware of treatment allocation |