Objective: There is little evidence-based knowledge of how psychotherapists should handle both sudden gains and more gradual session-by-session changes, either in general or in individuals suffering from generalized anxiety disorder. Methods: Using an ABAB crossed-therapist randomized clinical implementation trial design (N = 80 patients and 20 therapists), we contrasted a Prolonged Focus on Change (PFC, N = 40) implementation with a State-Of-The-Art (SOTA, N = 40) implementation. Both implementations were based on a widely used cognitive behavioral therapy approach (Mastery of your Anxiety and Worry package) with the only difference that in the PFC implementation, the therapists were instructed to systematically explore eventual changes at the beginning of the therapy sessions. Results: Based on a 3-level hierarchical linear model, PFC implementation showed faster symptom reduction in worry over therapy (i.e., linear change) and a decelerated (quadratic) change until 12-month follow-up in comparison to the SOTA implementation. Conclusion: These findings provide clinically useful information about potential short-term and long-term effects of exploring occurring change in GAD populations. Randomized clinical implementation trial designs are a step forward allowing to experimentally investigate basic psychotherapeutic strategies in process-based psychotherapy.What is the public health significance of this article? This randomized clinical implementation trial provides empirical evidence for good clinical wisdom that exploring occurring change is helpful to facilitate further change during therapy. These results underscore the relevance of understanding patient's proactive engagement in change behaviors, competences, skills, and behavioral preferences in individuals that suffer from generalized anxiety disorder to positively impact worry outcomes.
Objective:The investigation of session-to-session effects of working alliance on symptoms and coping experiences in patients diagnosed with generalized anxiety disorder. In addition, investigating these effects dependent on whether therapists are primed to work with patients strength (resource priming) or to adhere to the treatment manual (adherence priming). Method: Data was drawn from a randomized controlled trial in which 57 patients were randomly assigned to either the resource priming condition or the adherence priming condition. Within-and between patient associations were disentangled using dynamic structural equation modeling. Results: The total score of the working alliance, as well as all its overlapping components (i.e., goal agreement, task consensus, bond) showed significant within-patient effects on next session coping experiences. More specifically, better alliance scores in one session were followed by more coping experiences in the subsequent session. With regard to anxiety symptoms, an association was found only with the working alliance total score as well as for the bonds component, but not for the goals and task components of the working alliance. The priming condition (resource priming vs. adherence priming) had no influence on the within-patient alliance-outcome association. Betweenpatient alliance associations were only present with coping experiences, but not with anxiety symptoms. Conclusion:The findings provide further empirical evidence for the hypothesis that the working alliance may be a robust facilitative factor for change in CBT treatments for generalized anxiety disorder, which evolves irrespective of the strictness with which therapists adhere to the treatment manual. What is the public health significance of this article?The present study shows that for a homogeneous sample of patients suffering from generalized anxiety disorder, fluctuations in patients' ratings of the working alliance predict anxiety symptoms and coping experiences in the subsequent session. This alliance-outcome association was more pronounced for patients with higher average alliance scores over the course of the treatment but was not influenced by the strictness with which therapists adhered to the treatment manual.
BackgroundBona fide psychotherapy approaches are effective treatments for generalized anxiety disorder (GAD) compared to no-treatment conditions. Treatment manuals and protocols allow a relatively high degree of freedom for the way therapists implement these overall treatment packages and there is a systematic lack of knowledge on how therapists should customize these treatments. The present study experimentally examines two implementation strategies of customizing a bona fide psychotherapy approach based on a 16 session time-limited cognitive-behavioral therapy (CBT) protocol and their relation to the post-session and ultimate treatment outcomes.MethodsThis trial contrasts two different implementation strategies of how to customize the in-session structure of a manual-based CBT-protocol for GAD. The patients will be randomly assigned to two implementation conditions: (1) a systematic focus on subtle changes lasting from 7 to 20 min at the check-in phase of every psychotherapy session and (2) a state-of-the-art (SOTA) check-in phase lasting several minutes mainly focused on the session goals. Potential therapist effects will be examined based on an ABAB crossed-therapist design. Treatment outcomes will be assessed at the following times: post-session outcomes, treatment outcome at post assessment and 6- as well as 12-month follow-up.DiscussionThe proposed randomized clinical implementation trial addresses the clinically relevant question of how to customize a bona fide psychotherapy protocol experimentally contrasting two implementation strategies. Through the development and testing of the proposed implementation design, this trial has the potential to inform therapists about efficacious implementation strategies of how to customize a manual-based treatment protocol in respect to the timing of the in-session structure.Trial registrationThis trial was registered at ClinicalTrials.gov (NCT03079336) at March 14, 2017.
Despite meta-analytic evidence showing that alliance is associated with posttreatment outcomes, several open questions still remain regarding this relation. First, we investigate whether (or not) the progressive aggregation of early alliance assessments increases the alliance-outcome relation across 2 distress and 4 subjective change measures. Second, we investigate whether the alliance-outcome relations using subjective change measures are independent from intake distress and early response. Third, we explore whether the progressive aggregation of the alliance on outcomes becomes particularly apparent between or within therapists again investigating these six outcome measures. Data were drawn from N ϭ 430 patients treated by N ϭ 151 therapists. Patient ratings of early alliance were assessed after Session 1 to 6. For outcome, 2 commonly used distress measures at intake and at posttreatment and 4 measures of retrospectively evaluated subjective change at posttreatment are integrated into a series of multilevel models. The proportion of variance in outcome predicted by alliance scores varied considerably depending on the number of alliance assessments which were aggregated, as well as on the type of outcome assessment (distress vs. subjective change measures) explaining up to 15% of outcome variance. Improvements in the strength of prediction with aggregated alliance assessments were most pronounced for subjective change measures for between-therapist components of the alliance. Examining associations with subjective change measures provides an additional, patient-centered perspective of the relation between early alliance and treatment outcomes. Public Significance StatementDespite ongoing encouragement to systematically consider patient-centered outcomes in clinical research, subjective change measures (i.e., how patients evaluate the change during psychotherapy) are still neglected in guidelines of how to conduct trial research. The present study shows that the alliance-outcome relation is dependent on the number of aggregated alliance assessments, the type of outcome assessment (i.e., distress vs. subjective change measures) and whether intake and early response are adjusted for or not. Aggregated early alliance assessments were shown to relate most strongly to retrospectively evaluated subjective change at posttreatment. Examining associations with subjective change measures provide additional clinical perspectives on process and outcomes when conducting clinical trials and routine outcome monitoring.
Background Individuals suffering from an anxiety disorder are characterized by chronically low heart rate variability (HRV) compared to healthy individuals during resting state conditions. However, when examining HRV and HR in response to a stressor, mixed results have been obtained when comparing anxious and non-anxious groups. Methods The primary aim of the present study was to investigate HRV and HR responding in 26 clinically anxious and 14 control individuals before, during and after a stressful working memory task. Results Results indicate no between-group differences in HRV and HR at baseline. When starting the working memory task, the control group decreased significantly in HRV and the anxious group did not differ substantially in their change pattern from baseline to the start of the stressor. Finally, during the recovery phase of the working memory task, the clinically anxious and control individuals did not differ in their HFV or HR response compared to baseline. Conclusions From a clinical perspective, the results suggest that screening for the presence of anxiety disorders may help to identify patients with impaired HRV and HR functioning and to intervene on these important patient characteristics early in the treatment process.
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