Clinical trial NCT03079336: Implementation of Psychological Treatment in Generalized Anxiety
Official title: Design Development in Randomized Clinical Trials - Psychological Treatment in Generalized Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Randomized controlled design development
Translational Research
Psychological Interventions
Contextual Model of Psychotherapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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").

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to 6 months treatment completion of a latent 5-facet, self-report outcome-factor
timeFrame: Baseline, treatment completion after 6 months (16 sessions)
Secondary outcomes:
Other outcomes:
measure: Penn State Worry Questionnaire [PSWQ]
timeFrame: Baseline, treatment completion after 6 months (16 sessions)
measure: Beck Anxiety Inventory [BAI]
timeFrame: Baseline, treatment completion after 6 months (16 sessions)
measure: Beck Depression Inventory II [BDI-II]
timeFrame: Baseline, treatment completion after 6 months (16 sessions)
measure: Short version of the Symptom Check List [SCL-9]
timeFrame: Baseline, treatment completion after 6 months (16 sessions)
measure: Short version of the Resource Self-Report Questionnaire [RES]
timeFrame: Baseline, treatment completion after 6 months (16 sessions)
Locations:
city: Zurich
country: Switzerland
facility: Department of Psychology, University of Zürich
Study officials:
affiliation: Department of Psychology, University of Zürich
name: Christoph Flueckiger, Prof Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.