A Single-blinded, Randomized Clinical Trial of How to Implement an Evidence-based Treatment for Generalized Anxiety Disorder [IMPLEMENT] — Effects of Three Different Strategies of Implementation

Abstract

BackgroundDespite long-standing calls to disseminate evidence-based treatments for generalized anxiety (GAD), modest progress has been made in the study of how such treatments should be implemented. The primary objective of this study was to test three competing strategies on how to implement a cognitive behavioral treatment (CBT) for out-patients with GAD (i.e., comparison of one compensation vs. two capitalization models).MethodsFor our three-arm, single-blinded, randomized controlled trial (implementation of CBT for GAD [IMPLEMENT]), we recruited adults with GAD using advertisements in high-circulation newspapers to participate in a 14-session cognitive behavioral treatment (Mastery of your Anxiety and Worry, MAW-packet). We randomly assigned eligible patients using a full randomization procedure (1:1:1) to three different conditions of implementation: adherence priming (compensation model), which had a systematized focus on patients' individual GAD symptoms and how to compensate for these symptoms within the MAW-packet, and resource priming and supportive resource priming (capitalization model), which had systematized focuses on patients' strengths and abilities and how these strengths can be capitalized within the same packet. In the intention-to-treat population an outcome composite of primary and secondary symptoms-related self-report questionnaires was analyzed based on a hierarchical linear growth model from intake to 6-month follow-up assessment. This trial is registered at ClinicalTrials.gov (identifier: NCT02039193) and is closed to new participants.FindingsFrom June 2012 to Nov. 2014, from 411 participants that were screened, 57 eligible participants were recruited and randomly assigned to three conditions. Forty-nine patients (86%) provided outcome data at post-assessment (14% dropout rate). All three conditions showed a highly significant reduction of symptoms over time. However, compared with the adherence priming condition, both resource priming conditions indicated faster symptom reduction. The observer ratings of a sub-sample of recorded videos (n = 100) showed that the therapists in the resource priming conditions conducted more strength-oriented interventions in comparison with the adherence priming condition. No patients died or attempted suicide.InterpretationTo our knowledge, this is the first trial that focuses on capitalization and compensation models during the implementation of one prescriptive treatment packet for GAD. We have shown that GAD related symptoms were significantly faster reduced by the resource priming conditions, although the limitations of our study included a well-educated population. If replicated, our results suggest that therapists who implement a mental health treatment for GAD might profit from a systematized focus on capitalization models.Funding (SNSF-Nr. PZ00P1_136937/1) awarded to CF.

Theorie-Praxis-Netzwerke in verhaltenstherapeutischer Ausbildung: Schulung, Selbsterfahrung und Einsatz in der Therapie am Beispiel von Achtsamkeit

“…Während aktuell Tausende von randomisierten kontrollierten Psychotherapiestudien (RCTs) vorliegen, die in Hunderten von Meta-Analysen zusammengefasst wurden [Hofmann et al, 2012], sind die spezifischen Mechanismen für therapeutische Verände-rungen kaum bekannt [Flückiger et al, 2015;Mander et al, 2015b;McMain et al, 2015]. Dies mag unter anderem daran liegen, dass die RCTs typischerweise komplexe Therapiemanuale evaluieren, die aus einer Vielzahl einzelner therapeutischer Bausteine zusammengesetzt sind.…”

Mindfulness and progressive muscle relaxation as standardized session‐introduction in individual therapy: A randomized controlled trial

“…Recently, it has been highlighted that randomized controlled trials (RCTs) should be conducted in routine individual therapy to address issues of external validity (Flückiger et al, 2016;Lutz et al, 2015;McHugh & Barlow, 2010). As outlined above, it is of clinical relevance to investigate mindfulness exercises in individual therapy (Dimidjian & Segal, 2015;Michalak et al, 2015).…”

How to customize a bona fide psychotherapy for generalized anxiety disorder? A two-arms, patient blinded, ABAB crossed-therapist randomized clinical implementation trial design [IMPLEMENT 2.0]

“…With respect to the differences between the two comparative conditions, based on prior studies with transdiagnostic disorders [ 94 ], social phobia [ 95 ], depression [ 96 ], and GAD [ 64 ], we planned to demonstrate a medium effect size of Cohen’s d = 0.40 between the implementation conditions on the outcome composite. Assuming an α error level of 0.05, a statistical power (1-Beta) of 0.80, and a correlation of 0.40 between the pre- and post-measurements, the proposed study of 40 participants in each condition treated by 20 therapists is able to detect such an effect size [ 97 ].…”

“…In a prior three-arm, single-blinded, randomized controlled implementation trial (IMPLEMENT 1.0; [ 64 ]) we recruited 57 adults with GAD to participate in a cognitive behavioral treatment approach very similar to the approach used in our current trial. We randomly assigned eligible patients to three different priming conditions: (1) adherence priming, in which the peer-priming with the therapist had a systematized focus on patients’ individual GAD symptoms and how to compensate for these symptoms within the manual, (2) resource priming, in which the peer-priming with the therapist had systematized foci on patients’ strengths and abilities and how these strengths can be capitalized within the same package and (3) supportive resource priming (that additionally allowed the invitation of a supportive person into therapy sessions).…”

“…[ 66 ])? Treatment outcomes: What are the differences in the treatment efficacy of the two randomized implementation conditions, (1) in dropout rates, (2) in self-reported primary and secondary outcomes [ 64 ]? Therapist effects: Are the implementation effects robust across therapists?…”