Feedback was given to maintain consistency within and across interviewers over the course of the study. Between-group therapy outcome research: The results will be reported elsewhere. Statistical Analysis with Missing Data. Those who were taking psychoactive medications had to be on a stable treatment regimen i. Procedure At each of the ten study sites, participants were referred to a masters- or doctoral-level interviewer by clinical staff. This research was supported by a grant to M.

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The problem of therapist effects often comes up in psychotherapy research. The waiting period also was potentially difficult for participants because they were required to termi- nate most forms of ongoing therapy. Follow-up assessments were conducted at the end of treatment 7 months and the end of boosters 12 months for all participants. Sample size formulae for intervention studies with the cluster as unit of randomization.

In this environment there is a perception of safety that aims to increase the capacity officecneter each patient to tolerate exposure. The independent raters also made global ratings of adherence and competence and rated specific elements to provide a manipulation check, e. However, the likelihood of complications due to exposure is elevated in chronic, combat-related PTSD relative to other conditions [8].

The primary outcome is PTSD severity; other symptoms, functional status, quality of life, physical health, and service utilization also were assessed. The pivotal comparison was at the end of treatment.

The study provides an example of how to address the unique challenges posed by multisite trials of officecented psychotherapy through attention to meth- odological and statistical issues. With computerized recording, we could have reduced the officecenterr associated with duplicating, mailing, and storing such a large number of tapes.


Therefore, we adjusted the sample size to account for treat- ment group clustering and propose to handle the site effects in the analysis. The results will be reported elsewhere. Despite this substantial amount of treatment, improvements in symptoms and functioning were modest and had questionable clinical significance [7].

Analyses of subsequent outcomes will concentrate on the question of the durability of effects. Instead, to ensure that therapist effects were balanced across treatments, we officscenter therapists to the single treat- ment each was to deliver.

Diagnostic and Statistical Manual of Mental Disor- ders. Case man- agement was begun as soon as a participant was enrolled to minimize dropout during this holding period and to provide interim clinical care because partici- pants were required to give up most jb of therapy.

Feedback was given to maintain consistency within and across interviewers over the course of the study.

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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. Prior to being accepted into the last phase of screening, potential participants who reported any indication of cardiovascular problems were referred to a cardiologist to determine whether the problems would make it dangerous for the participant to tolerate the physiological arousal that can occur during the exposure component of TFGT.

Analysis by intention-to-treat implies complete follow-up of outcomes in participants, and this in turn requires their cooperation with measurement. Reliability, validity, and diagnostic utility. At the time, there had been relatively few randomized clinical trials of either pharmacotherapy or psycho- therapy for PTSD [4]. Of the potential participants who were contacted and invited to enter the second phase of screening, Many VA patients exhibit a high level of symptoms and functional difficulties even after treatment [7].


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The provision of additional treatment was recorded for use in data analysis. Clin Psychol Psychother ;5: The Long Journey Home: Also, by demonstrating the efficacy of exposure therapy when delivered in a group officecrnter, CSP will expand the available tools for addressing the long- term sequelae of traumatic exposure. Background and research plan.

However, participants were mbb asked to sign the consent form until they returned for diagnostic interviewing in the third phase of screening. When the intraclass correlation is greater than 0. The second phase consisted of an interview that contained demographic questions intended to facilitate otficecenter of potential participants who were ruled in versus ruled out of the study, questions about cardiovascular health, a brief assessment of cognitive function [25], and questions about willingness to adhere to study conditions.

In offieccenter cases, the change was documented for use in data analysis. The specific treatment, trauma focus group therapy TFGT [10], embeds exposure in a group context that includes psychoeducation, cognitive restructuring, a developmental perspective, relapse prevention, and coping skills training.

Global ratings of protocol adherence and therapist competence were made for all tapes in each condition by the senior therapist for that condition.