Implementation of Psychological Treatment in Generalized Anxiety

NCT03079336 | Completed DMC

• 1 other identifier: PP00P1_163702
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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").

Conditions

Generalized Anxiety Disorder

Keywords

Randomized controlled design development; Translational Research; Psychological Interventions; Contextual Model of Psychotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Penn State Worry Questionnaire [PSWQ]

  Baseline, treatment completion after 6 months (16 sessions)

• Beck Anxiety Inventory [BAI]

  Baseline, treatment completion after 6 months (16 sessions)

• Beck Depression Inventory II [BDI-II]

  Baseline, treatment completion after 6 months (16 sessions)

Study Arms (2)

State of the art (SOTA) check-in phase

EXPERIMENTAL

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; Behavioral: Mastery your Anxiety and Worry (MAW)

Prolonged focus on subtle changes

EXPERIMENTAL

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: Implementation - Prolonged focus on changes; Behavioral: Mastery your Anxiety and Worry (MAW)

Interventions

Implementation - SOTA BEHAVIORAL

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.

State of the art (SOTA) check-in phase

Implementation - Prolonged focus on changes BEHAVIORAL

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).

Prolonged focus on subtle changes

Mastery your Anxiety and Worry (MAW) BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy

Prolonged focus on subtle changes; State of the art (SOTA) check-in phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfill the diagnostic criteria for GAD based on the structured interview for DSM,
• are 18 years of age or older,
• Mastery of German language
• 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
• Informed consent as documented by signature

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Psychology, University of Zürich

Zurich, 8050, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 33829819 RESULT

• 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.

  PMID: 35781807 DERIVED

• 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.

  PMID: 34410791 DERIVED

• 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.

  PMID: 34197151 DERIVED

• 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.

  PMID: 29614982 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christoph Flueckiger, Prof Dr.

  Department of Psychology, University of Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: March 14, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)