Clinical trial NCT03945617: Optimizing Psychotherapy for Anxiety Disorders
Official title: Optimizing Psychotherapy for Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: anxiety
cognitive behavior therapy
transdiagnostic treatment
prediction
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Psychiatric University Hospital, Zurich
name: Swiss National Science Foundation
name: University of St.Gallen
First posted: 2019-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: 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
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: 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 outcomes:
measure: Hamilton Depression Scale
timeFrame: 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
measure: Beck Depression Inventory
timeFrame: 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
measure: Social Functioning Index (SFI)
timeFrame: 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
measure: World Health Organization-5 Wellbeing Index
timeFrame: 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
measure: Beck Anxiety Inventory
timeFrame: 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 outcomes:
measure: Test of self-conscious affect
timeFrame: 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
measure: Thought Control questionnaire
timeFrame: 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
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Birgit Kleim, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: