All sessions lasted 1. The counterbalanced design can remove therapist effects from the comparison of treatments, insofar as therapist preferences or skills do not cause treatments to be delivered with different levels of enthusiasm or competence. Therapy supervision was provided by Shirley M. Exclusion criteria included current alcohol or drug dependence, unwilling- ness to refrain from substance abuse at treatment or work, current or lifetime DSM-IV psychotic disorder, current major depression with psychotic features, current or lifetime mania or bipolar disorder, significant cognitive impairment, or a cardiovascular disorder that was judged by a cardiologist to prevent participation in the exposure component of the TFGT. Psychotherapy research has been criticized for overly restricting the type of participants who can enter into clinical trials [13], thereby limiting the generaliz- ability of findings. Treatment was delivered weekly to groups of six participants for 30 weeks, followed by five monthly booster sessions. Efficacy of treatments for posttraumatic stress disorder:

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However, if experts in one of the study treatments are more skilled therapists than experts in the other, then such a design confounds skill with treatment. Med J Aust ; An Empirical and Clinical Synthesis. Statistical Analysis with Missing Data. If an experimental therapy is shown to be effective relative to a placebo therapy or care as usual, there is greater certainty that the effectiveness is due to specific aspects of the experimental therapy and not merely to nonspecific therapeutic factors.

They were not required to have formal training in exposure offidecenter or even in cognitive-behavioral therapy. On the one hand, it was important that the total number of sessions be realistic and comparable in both conditions.


Table 2 presents examples of sample sizes that were calculated by assuming that the cost per cluster is just the cluster sizes times the individual cost. Am J Officfcenter ; In this environment there is a perception of safety that aims to increase the capacity of each patient to tolerate exposure.

Data collection was completed in June Telephone supervision based on the tapes was provided weekly by a senior therapist chosen to monitor the therapy in each condition. In CSPwe attempted to optimize psychotherapy quality control through a number of features: In particular, personality disorders and current substance abuse were not excluded, because these conditions are frequently comorbid with PTSD in VA patients [7].

A correct analysis of the data must take the cluster effect into account. For sample size offficecenter, an effect size of d 5 0. Failing to include additional participants to compensate for this inflation could have substantial effects on type II error.

Clustering As described above, each site accrued 12 participants in each cohort before participants were stratified by CAPS severity and randomized to a treatment condition.

As indicated above, recruitment and screening created significant pressure for study staff. When the intraclass correlation is greater than 0. Of the potential participants who were contacted and mh to enter the second phase of screening, At the time, there had been relatively few randomized clinical trials of either pharmacotherapy or psycho- therapy for PTSD [4].

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Inflation of Variance Suppose ngroup 5 mk participants are assigned to k groups, m per group, then a direct calculation yields: Fuhriman A, Burlingame GM, eds. Case management in CSP was delivered according to a manualized protocol. A measure of life satisfaction for use in treatment planning and outcome assessment. In a psychotherapy study, there is no single control condition that serves the same purpose.


Assessment The decision of what to measure in a clinical trial can be one of the most dif- ficult to make, particularly for a study that is a substantial investment of resources. These staff were informed about the eligibility criteria and were encouraged in individual contacts and group set- tings to refer potentially eligible participants—a process that was repeated throughout the study.

Furthermore, we thought it likely that TFGT would be delivered by a broad range of therapists in clinical practice if it proved successful in CSP If m 5 6, an intraclass correlation of only 0.

Design of Department of Veterans Affairs Cooperative Study No. | Paula Schnurr –

Am J Psychia- officecneter ; It is our hope that sharing the details of CSP builds upon this remarkable contribution by providing information relevant to multisite trials of group interventions. Background and research plan. Because missing data methods rely on untestable hypotheses usually about the missing data mechanismin the conservative world of clinical trials they are appropriately used in the form of sensitivity analyses.

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