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Optimizing Psychotherapy for Anxiety Disorders (OPTIMAX)

Primary Purpose

Anxiety Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Unified Treatment Protocol
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring anxiety, cognitive behavior therapy, transdiagnostic treatment, prediction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Unified treatment protocol

Waitlist Control Group

Arm Description

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).

Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks

Outcomes

Primary Outcome Measures

Hamilton Anxiety Rating Scale
clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome
Overall Anxiety Severity and Impairment Scale
self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome

Secondary Outcome Measures

Hamilton Depression Scale
clinician rating of depressive symptoms; range: 0-66, with higher values representing worse outcome
Beck Depression Inventory
self report measure of depression; range: 0-63, with higher values indicating worse outcome
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
World Health Organization-5 Wellbeing Index
change in well-being; range: 0-25, with higher values indicating a better outcome
Beck Anxiety Inventory
self-report in anxiety symptoms, range 0-63, with higher values representing worse outcome

Full Information

First Posted
July 27, 2018
Last Updated
May 8, 2019
Sponsor
University of Zurich
Collaborators
Psychiatric University Hospital, Zurich, Swiss National Science Foundation, University of St.Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT03945617
Brief Title
Optimizing Psychotherapy for Anxiety Disorders
Acronym
OPTIMAX
Official Title
Optimizing Psychotherapy for Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Psychiatric University Hospital, Zurich, Swiss National Science Foundation, University of St.Gallen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
anxiety, cognitive behavior therapy, transdiagnostic treatment, prediction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is randomized controlled trial involving a before-after design with an intervention group that receives immediate access to treatment and a waitlist-control group.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded regarding treatment allocation
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unified treatment protocol
Arm Type
Experimental
Arm Description
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).
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Unified Treatment Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale
Description
clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome
Time Frame
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
Title
Overall Anxiety Severity and Impairment Scale
Description
self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome
Time Frame
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 Measure Information:
Title
Hamilton Depression Scale
Description
clinician rating of depressive symptoms; range: 0-66, with higher values representing worse outcome
Time Frame
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
Title
Beck Depression Inventory
Description
self report measure of depression; range: 0-63, with higher values indicating worse outcome
Time Frame
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
Title
Social Functioning Index (SFI)
Description
change in social functioning; Subscales: "work" (range: 1-15) and "leisure time" (range: 1-30), with higher numbers indicating worse outcome
Time Frame
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
Title
World Health Organization-5 Wellbeing Index
Description
change in well-being; range: 0-25, with higher values indicating a better outcome
Time Frame
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
Title
Beck Anxiety Inventory
Description
self-report in anxiety symptoms, range 0-63, with higher values representing worse outcome
Time Frame
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 Pre-specified Outcome Measures:
Title
Test of self-conscious affect
Description
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
Time Frame
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
Title
Thought Control questionnaire
Description
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Kleim, Prof. Dr.
Phone
+41 (0)44 384 23 51
Email
b.kleim@psychologie.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ava Schulz, Dr.
Phone
+41(0)443891582
Email
ava.schulz@uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Kleim, Prof. Dr.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ava Schulz, Dr.
Phone
044(0)3891582
Email
ava.schulz@uzh.ch
First Name & Middle Initial & Last Name & Degree
Christina Paersch, Dipl.-Psych.
Phone
+41443891582
Email
christina.paersch@uzh.ch
First Name & Middle Initial & Last Name & Degree
Birgit Kleim, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Ava Schulz, Dr.
First Name & Middle Initial & Last Name & Degree
Christina Paersch, Dipl.-Psych
First Name & Middle Initial & Last Name & Degree
Dominique Recher, M.Sc.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Optimizing Psychotherapy for Anxiety Disorders

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