Long-term psychiatric morbidity after a natural disaster: In the first phase, the referral source was consulted to establish provisional psychiatric diagnoses, and patient records were searched to confirm that the veteran had served in the Vietnam War theater. It is possible that dropouts from treatment received care outside the study that resembled the treatment to which they were not assigned, e. Participants completed question- naires monthly during the 7 months of active treatment. In CSP , we attempted to optimize psychotherapy quality control through a number of features: 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. In a clinical trial that requires participants to give up treatments other than those delivered in the trial, case management can serve as a point of individual contact for each participant so that adequate monitoring of clinical status is ensured and assistance with additional services e.

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Inflation of Variance Suppose ngroup 5 mk participants are assigned to k groups, m per group, then a mn calculation yields: A cause for cautious optimism. The Long Journey Home: In addition to these methodological implications, the substantive findings of CSP will provide information relevant to the treatment of chronic PTSD, as well as a unique, group-based model of exposure therapy [10]. Log In Sign Up. Conceptual framework and item selection. Under the intent-to-treat principle, these noncompliant participants will be counted in their original treatment groups.


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One challenge was recruitment, which required that participants accepted into the study wait until we had identified enough participants to fill two therapy groups.

Two therapists led each m. Control Clin Trials ; All assessments were audiotaped. Enter the email address you signed up with and we’ll email you a reset link.

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However, the most significant challenges came from the effects of group clustering on sample size estimation and data analysis. Remember me on this computer. When the intraclass correlation is greater than 0.

Psychotherapy research, posttraumatic stress disorder PTSDgroup therapy, mili- tary veterans Address reprint requests to: Arch Gen Psychiatry ; Therapy supervision was provided by Shirley M. J Trauma Stress ;8: Formal screening of referral sources in the first phase of our screening process provided a quick and efficient way to rule out ineligible participants so that more time could be allotted to in-person assessments of potential participants.

As can be seen from Table 2, even small intraclass correlations can have substantial effects on the needed sample size.

Click here to sign up. In the first phase, the mbb source was consulted to establish provisional psychiatric diagnoses, and patient records were searched to confirm that the veteran had served in the Vietnam War theater.


Case management in CSP was delivered according to a manualized protocol. Am J Psychiatry ; Prior to enrollment for a given cohort, study staff worked with referral sources to develop a list of potential eligible participants.

Statistical Analysis with Missing Data. Whereas industrial pharmaceutical quality control ensures that all dispensed pharmacological agents are comparable in a medication trial, no such assurance can be built into a psychotherapy trial.

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 officeecnter therapeutic factors.

Trauma focus group therapy for combat-related PTSD.

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The results will be reported elsewhere. Table 1 lists the assessment schedule.

We initiated case management at this time to respond to their clinical needs, with the hope of preventing dropout before participants entered active treatment. American Psychiatric Association; Effectiveness and cost of the inpatient treatment of post- traumatic stress disorder: All sessions were videotaped. Failing to include additional participants to compensate for this inflation could have substantial effects on type II error.