Optimizing Psychotherapy for Anxiety Disorders

Anxiety Disorders Clinical Trial

— OPTIMAX  

Official title:

Optimizing Psychotherapy for Anxiety Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03945617
• Other study ID #: 10001C_169827
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2019
• Source: University of Zurich
• Contact: Birgit Kleim, Prof. Dr.
• Phone: +41 (0)44 384 23 51
• Email: b.kleim[@]psychologie.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Psychiatric University Hospital, Zurich, Swiss National Science Foundation, University of St.Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study website (German)