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]

Christoph Flückiger*, Christine Wolfer, Judith Held, Peter Hilpert, Julian Rubel, Mathias Allemand, Richard E. Zinbarg, Andreea Vîslă

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Background: Bona 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. Methods: This 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. Discussion: The 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 registration: This trial was registered at ClinicalTrials.gov( NCT03079336 ) at March 14, 2017.

Original languageEnglish (US)
Article number86
JournalBMC Psychiatry
Volume18
Issue number1
DOIs
StatePublished - Apr 3 2018

Keywords

  • Cognitive behavior therapy
  • Early change
  • Evidence-based practice
  • Generalized anxiety disorder
  • Personalized medicine
  • Randomized clinical trial
  • Responsiveness
  • Sudden gains
  • Therapist effects
  • Translational science

ASJC Scopus subject areas

  • Psychiatry and Mental health

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