[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Individuals were eligible for the study if they were (1) assigned a principal (most interfering and severe) diagnosis of panic disorder with or without agoraphobia (PD/A), generalized anxiety disorder, obsessive-compulsive disorder (OCD), or social anxiety disorder; (2) 18 years or older; and (3) fluent in English. Following long-standing procedures in our clinical trials, individuals taking psychotropic medications at the time of enrollment were required to be stable on the same dose for at least 6 weeks prior to enrolling in the study and were requested to maintain these medications and dosages during treatment.
Excluded criteria: Exclusion criteria consisted primarily of conditions that required prioritization for immediate or simultaneous treatment: specifically, a current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder; current high risk of suicide; or recent (within 3 months) history of substance use disorder, with the exception of nicotine (1 patient), marijuana (0 patients), and caffeine (0 patients). Individuals were also excluded if they received at least 8 sessions of cognitive behavioral therapy within the past 5 years. Anyone receiving non–cognitive behavioral therapy focused on an emotional disorder agreed to discontinue that treatment
Pretreatment: No baseline differences in demografic and diagnostic baseline charateristics
Intervention Characteristics
Intervention
Control
Grad af angst, HAM-A, mean final, SD, alle angstlidelser
Grad af angst, GAD ADIS CSR, mean change, 95% CI, kun GAD patienter
Grad af angst, Generalized Anxiety Disorder Severioty Scale (GADSS), mean change, 95% CI, Kun GAD patienter
Funktion, The overall anxiety severity and impairment scale, mean (SD), alle angstlidelser
Funktion, The Work and Social adjustment Scale, mean, SD, alle angstlidelser
Bedring, number of patients no longer meeting diagnostic criteria at ADIS
Fraflad, alle årsager
Sponsorship source: This study was funded by grant R01 MH090053 from the National Institute of Mental Health.
Country: USA
Setting: Outpatient clinic
Authors name: David H. Barlow
Institution: Center for Anxiety and Related Disorders, Boston University
Email: dhbarlow@bu.edu
Address: David H. Barlow, PhD, Center for Anxiety and Related Disorders, Boston University, 648 Beacon St, Sixth Floor, Boston, MA 02215
Wrong comparator
Wrong comparator
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "a research assistant who was not involved in those evaluations randomized patients by principal diagnosis (PD/A, generalized anxiety disorder, OCD, and social anxiety disorder) using a computerized block randomization with a 2:2:1 allocation ratio to the UP, SDP, and WLC study conditions, respectively."
Judgement Comment: The allocation sequence was computer generated
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Quote: "The project coordinator (T.J.F.) who was re-sponsible for final determination of study eligibility was blinded to the randomization sequence."
Judgement Comment: The allocation sequence was concealed for the project coordinator enrolling the participants
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "Participants were unaware of the study hyopothesis and were instructed not to reveal their randomization status to raters prior to each assessment. To further protect blinding, raters were located separately from therapists and a new rater was assigned in the event of an unintentional unblinding."
Judgement Comment: The participants were unaware of the study hyopothesis, thus the researchers tried to blind the participants receiving the two active interventions. Personels not blinded. Project coordinator likely blinded and participants unaware of study hypotheses and instructed not to reveal allocation to blinded assessors.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "Participants were unaware of the study hyopothesis and were instructed not to reveal their randomization status to raters prior to each assessment. To further protect blinding, raters were located separately from therapists and a new rater was assigned in the event of an unintentional unblinding."
Judgement Comment: Participants unaware of study hypotheses and instructed not to reveal allocation to blinded assessors. The Work and Social adjustment Scale and The overall anxiety severity and impairment scale were self-reported. HAM-A, ADIS were clinician rated. CGI was clinician rated. Diagnosis specific outcomes GADSS og LSAS were clinician rated.
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "analyses were conducted with Mplus 7.2 47 on the intent- to-treat sample that included all randomized patients (ie, 88 patients for the UP, 91 for the SDP, and 44 for the WLC condition). Missing data were accommodated using multiple imputation (10 000 imputed data sets) and robust maximum likelihood methods under a missing at random assumption."
Judgement Comment: 12,5% (UP) vs 30% (SDP) did not complete treatment as randomized. Balanced incomplete posttreatment assessment between groups. Appropriate ITT analysis but with possible moderate risk of attrition bias.
Reporting bias due to selective outcome reporting
Quote: "clinicaltrials.gov Identifier: NCT01243606"
Judgement Comment: Protocol available, the study reports on all the pre-specified outcomes
Bias due to problems not covered elsewhere in the table
Judgement Comment: The study appears to be free of other sources of bias