Optimizing Psychotherapy for Anxiety Disorders (OPTIMAX)

University of Zurich (UZH)

Status: Unknown

Conditions: Anxiety Disorders

Treatments: Behavioral: Unified Treatment Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03945617

10001C_169827

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Unified treatment protocol

Experimental group

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).

Treatment:

Behavioral: Unified Treatment Protocol

Waitlist Control Group

No Intervention group

Description:

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