Implementation of Psychological Treatment in Generalized Anxiety (IMPLEMENT2_0)

Design Development in Randomized Clinical Trials - Psychological Treatment in Generalized Anxiety

Pragmatic randomized controlled trial (expected N = 80) of cognitive-behavioral therapy (CBT) to contrast two psychotherapeutic implementation strategies (State-of-the-Art welcome phase vs. prolonged focus on sudden changes). Blinded allocation of implementation strategy for patients; open label for therapists (no blinding possible), randomized allocation for patients, therapist allocation via ABAB-design (crossed-therapist design). Post treatment self-reported outcome will be measured based on a latent outcome factor (i. e. "outcome composite").

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Implementation - SOTA; Behavioral: Mastery your Anxiety and Worry (MAW); Behavioral: Implementation - Prolonged focus on changes

Detailed Description

State of research. The proposed trial has a common theme, i.e., the understanding of the enduring efficacy of psychological treatments in individuals who suffer from general anxiety disorder (GAD). There is meta-analytic evidence that bona fide psychotherapy is an effective treatment for GAD, but also for individuals that suffers from anxiety and depression. Nonetheless, in spite of the empirical evidence of the overall efficacy, there is a lack of randomized controlled studies that systematically investigate the therapists' variability (i. e. therapist effects) within the very same treatment protocol. The development of study designs to investigate potential health professional effects along treatment effects is a general claim for human interventions. This protocol includes one of the very first process-outcome trials in GAD that systematically examine theory-based patients' and therapists' characteristics simultaneously using longitudinal multilevel methodology.

Along with investigating therapist and patient characteristics, two methods for timing the check-in phase at the beginning of each session will be compared by keeping constant the standardized treatment manual for patients with GAD: (a) prolonged focus on subtle changes check-in condition lasting from 7 to 20 minutes and (b) a state of the art (SOA) check-in phase lasting from 5 to 10 minutes. To address the nested data structure, therapists will be allocated by a single-subject ABAB-design. A total of 80 patients (40 participants in each of the two conditions) with a primary GAD diagnosis will be treated by 20 advanced cognitive-behavioral therapy trainees at the psychotherapy outpatient clinic in the department of psychology at the university of Zürich.

Relevance. (a) Study population. GAD is a neglected disorder in the Swiss mental health system. GAD is associated with personal suffering, a reduced quality of life, and high economic costs. (b) Design development. Systematic integration of potential therapist effects is a neglected aspect in many areas of evidence-based human interventions (inside but also outside of psychological interventions). (c) Treatment development. Evidence-based treatments are usually far from being fully efficacious. There is a debate about innovative research agendas and how to foster the efficacy of such treatments. (d) Experimental process-outcome research. There is a need for future research to investigate theory-based therapist effects and in-session timing within rigorous experimental process-outcome research designs to better understand the factors involved in therapeutic change (e.g. http://www.nature.com/news/therapy-deficit-1.11477).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8050
    • Department of Psychology, University of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. fulfill the diagnostic criteria for GAD based on the structured interview for DSM,
2. are 18 years of age or older,
3. Mastery of German language
4. are seeking out a cognitive-behavioral therapy (CBT) for GAD at the outpatient clinic (Attenhoferstrasse 9) of the Institute for Psychology of the University of Zürich
5. Informed consent as documented by signature

Exclusion Criteria:

1. Acute Suicidal Ideation (BDI Suicide item > 1 or suicidal ideation in the telephone interview)
2. Currently taking a psychotic or bipolar disorder medication, or
3. Currently receiving treatment from a professional psychotherapist/psychiatrist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: State of the art (SOTA) check-in phase; The therapists will apply the usual SOTA check-in phase lasting between 5 and 10 minutes, as recommended in the preexisting guideline including reviewing progress in self-help and agenda setting (Zinbarg et al., 2006).	Behavioral: Implementation - SOTA; The implementation of an evidence-based treatment is largely principle-based - allowing considerable therapeutic flexibility in determining and timing of different treatment aspects. In this condition progress, subtle changes and sudden gains may be an explicit topic and there is no restraint to avoid such topics. However, the therapists are not obligated to take a systematized focus on potential subtle changes and they may use the timing of the sessions to involve the patients into the other tasks of therapy.; Behavioral: Mastery your Anxiety and Worry (MAW); In the present study, the MAW-packet will be applied within a usual 16-session individual therapy format and up to 3 further booster sessions. The session format of 50-60 minute usually consists of (a) a check-in phase of 5 to 15 minutes that includes a patients welcoming, reviewing self-help and agenda setting, (b) a working phase around 35-45 minutes that focuses on the previously agreed session goals, (c) a feedback phase of 5 to 10 minutes that summarizes the session and previews the upcoming self-help assignment.; Other Names: Cognitive Behavioral Therapy
EXPERIMENTAL: Prolonged focus on subtle changes; Based on the robust findings that over 90% of the patients will experience subtle changes, the therapists will extend the above mentioned check-in phase by systematized focus for 7 to 20 minutes capitalizing on small and subtle changes and exceptions.	Behavioral: Mastery your Anxiety and Worry (MAW); In the present study, the MAW-packet will be applied within a usual 16-session individual therapy format and up to 3 further booster sessions. The session format of 50-60 minute usually consists of (a) a check-in phase of 5 to 15 minutes that includes a patients welcoming, reviewing self-help and agenda setting, (b) a working phase around 35-45 minutes that focuses on the previously agreed session goals, (c) a feedback phase of 5 to 10 minutes that summarizes the session and previews the upcoming self-help assignment.; Other Names: Cognitive Behavioral Therapy; Behavioral: Implementation - Prolonged focus on changes; Systematized sequence of exploration of subtle changes at a prolonged check-in phase: (1) the precise change situation, (2) related emotional states, (3) related helpful thoughts and self-verbalizations, (4) reinforcement of generalized self-efficacy and treatment motivation, (5) benefit for the upcoming session goals (Flückiger, Grosse Holtforth, et al. 2013, 2014).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to 6 months treatment completion of a latent 5-facet, self-report outcome-factor	Latent factor of the below-mentioned 5 self-report questionnaires (outcome composite)	Baseline, treatment completion after 6 months (16 sessions)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penn State Worry Questionnaire [PSWQ]	Self-report worry inventory (Meyer et al., 1990)	Baseline, treatment completion after 6 months (16 sessions)
Beck Anxiety Inventory [BAI]	Self-report anxiety inventory (Beck et al., 1988)	Baseline, treatment completion after 6 months (16 sessions)
Beck Depression Inventory II [BDI-II]	Self-report depression inventory (Beck et al., 1996)	Baseline, treatment completion after 6 months (16 sessions)
Short version of the Symptom Check List [SCL-9]	Self-report symptom severity index (Klaghofer & Brähler, 2001)	Baseline, treatment completion after 6 months (16 sessions)
Short version of the Resource Self-Report Questionnaire [RES]	Self-report resource inventory (Troesken & Grawe, 2004)	Baseline, treatment completion after 6 months (16 sessions)

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Christoph Flueckiger, Prof Dr., Department of Psychology, University of Zürich

Publications and helpful links

General Publications

• Fluckiger C, Visla A, Wolfer C, Hilpert P, Zinbarg RE, Lutz W, Grosse Holtforth M, Allemand M. Exploring change in cognitive-behavioral therapy for generalized anxiety disorder-A two-arms ABAB crossed-therapist randomized clinical implementation trial. J Consult Clin Psychol. 2021 May;89(5):454-468. doi: 10.1037/ccp0000639. Epub 2021 Apr 8.
• Visla A, Allemand M, Fluckiger C. Within- and between-patients associations between self-efficacy, outcome expectation, and symptom change in cognitive behavioral therapy for generalized anxiety disorder. J Clin Psychol. 2023 Jan;79(1):86-104. doi: 10.1002/jclp.23407. Epub 2022 Jul 4.
• Visla A, Constantino MJ, Fluckiger C. Predictors of change in patient treatment outcome expectation during cognitive-behavioral psychotherapy for generalized anxiety disorder. Psychotherapy (Chic). 2021 Jun;58(2):219-229. doi: 10.1037/pst0000371.
• Fluckiger C, Horvath AO, Brandt H. The evolution of patients' concept of the alliance and its relation to outcome: A dynamic latent-class structural equation modeling approach. J Couns Psychol. 2022 Jan;69(1):51-62. doi: 10.1037/cou0000555. Epub 2021 Jul 1.
• Fluckiger C, Wolfer C, Held J, Hilpert P, Rubel J, Allemand M, Zinbarg RE, Visla A. 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]. BMC Psychiatry. 2018 Apr 3;18(1):86. doi: 10.1186/s12888-018-1666-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (ACTUAL): March 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Translational Research; Randomized controlled design development; Psychological Interventions; Contextual Model of Psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PP00P1_163702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO