Implementation of Psychological Treatment in Generalized Anxiety

Generalized Anxiety Disorder Clinical Trial

— IMPLEMENT2_0  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079336
• Other study ID #: PP00P1_163702
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2022

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Psychology, University of Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Flückiger C, Vîsla 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Penn State Worry Questionnaire [PSWQ]	Self-report worry inventory (Meyer et al., 1990)	Baseline, treatment completion after 6 months (16 sessions)
Other	Beck Anxiety Inventory [BAI]	Self-report anxiety inventory (Beck et al., 1988)	Baseline, treatment completion after 6 months (16 sessions)
Other	Beck Depression Inventory II [BDI-II]	Self-report depression inventory (Beck et al., 1996)	Baseline, treatment completion after 6 months (16 sessions)
Other	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)
Other	Short version of the Resource Self-Report Questionnaire [RES]	Self-report resource inventory (Troesken & Grawe, 2004)	Baseline, treatment completion after 6 months (16 sessions)
Primary	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)

External Links

•   webpage of the study office