Optimizing Psychotherapy for Anxiety Disorders (OPTIMAX)

Anxiety disorders are highly prevalent and are associated with a high burden of disease, costs and individual impairment worldwide. Psychotherapy, especially cognitive behavioral therapy (CBT), is the first line treatment for anxiety disorders. CBT is effective in modifying dysfunctional cognitions and reducing avoidance behavior, thus leading to a lasting reduction of symptoms.

Even though CBT is generally effective, around 50% of patients do not benefit sufficiently from this treatment. The current study aims at optimizing the treatment of anxiety disorders by identifying predictors of treatment response. Multiple (neuro-)psychological, biological, genetic and behavioral variables will be combined into a comprehensive prediction model of treatment outcome. Knowledge on predictors can then be used to improve therapy on an individual patient level.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Unified Treatment Protocol

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgit Kleim, Prof. Dr.; Phone Number: +41 (0)44 384 23 51; Email: b.kleim@psychologie.uzh.ch
• Study Contact Backup: Name: Ava Schulz, Dr.; Phone Number: +41(0)443891582; Email: ava.schulz@uzh.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Recruiting
    • University of Zurich
    • Contact: Ava Schulz, Dr.; Phone Number: 044(0)3891582; Email: ava.schulz@uzh.ch
    • Contact: Christina Paersch, Dipl.-Psych.; Phone Number: +41443891582; Email: christina.paersch@uzh.ch
    • Principal Investigator: Birgit Kleim, Prof. Dr.
    • Sub-Investigator: Ava Schulz, Dr.
    • Sub-Investigator: Christina Paersch, Dipl.-Psych
    • Sub-Investigator: Dominique Recher, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged between 18-65 years
• one of the following primary axis I disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM): Panic Disorder with or without Agoraphobia; Social Anxiety Disorder; Anxiety Disorder not otherwise specified, Adjustment Disorder with Anxiety, Adjustment Disorder with Mixed Anxiety and Depression; Specific Phobia; Generalized Anxiety Disorder
• if on medication If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase/therapy of the study
• not currently receiving other psychotherapeutic treatment for anxiety or another condition
• fluent German
• provision of written informed consent

Exclusion Criteria:

• concomitant psychotherapy
• medical relative contraindications involve conditions that impede thorough exposure, e.g. cardiovascular diseases, autoimmune diseases or pregnancy
• current or past schizophrenia, psychosis, or bipolar disorder
• current suicidal ideation.
• current substance/alcohol dependence or abuse
• cluster A or B personality disorder
• pregnancy (for women)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unified treatment protocol; This intervention group receives 16 sessions of CBT-based, individual psychotherapy using to the Unified Treatment Protocol for the treatment of emotional disorders by Barlow et al. (2011).	Behavioral: Unified Treatment Protocol; The Unified Treatment Protocol (UP) is a transdiagnostic psychotherapeutic treatment manual for emotional disorders, that is based on CBT principles and focuses on changing dysfunctional emotion regulation.
No Intervention: Waitlist Control Group; Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Rating Scale	clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome	change from T0 (entry to study) at mid-treatment (8 weeks after T0), change from T0 at post-treatment (after 16 weeks from T0), change from T0 at 6 months follow-up and change from T0 at one year from post-treatment
Overall Anxiety Severity and Impairment Scale	self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Scale	clinician rating of depressive symptoms; range: 0-66, with higher values representing worse outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Beck Depression Inventory	self report measure of depression; range: 0-63, with higher values indicating worse outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Social Functioning Index (SFI)	change in social functioning; Subscales: "work" (range: 1-15) and "leisure time" (range: 1-30), with higher numbers indicating worse outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
World Health Organization-5 Wellbeing Index	change in well-being; range: 0-25, with higher values indicating a better outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Beck Anxiety Inventory	self-report in anxiety symptoms, range 0-63, with higher values representing worse outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of self-conscious affect	self-report to index self-conscious affect; 3 subscales: shame self-talk, guilt self-talk, blaming others; each ranging from 0 to 55, with higher values indicating a worse outcome	change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Thought Control questionnaire	self-report measure to assess worry and reappraisal as cognitive strategies/information processing; subscales "worry" (range: 1-24, with higher values indicating worse outcome) and "reappraisal" (range:1-24, with higher values representing better outcome) are reported	change from T0 (entry to study) at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss National Science Foundation; Psychiatric University Hospital, Zurich; University of St.Gallen
• Investigators: Principal Investigator: Birgit Kleim, Prof. Dr., University of Zurich

Publications and helpful links

Helpful Links

• Study website (German)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: anxiety; cognitive behavior therapy; prediction; transdiagnostic treatment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 10001C_169827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No