Optimizing Psychotherapy for Anxiety Disorders

NCT ID: NCT03945617

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be blinded regarding treatment allocation

Study Groups

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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).

Group Type EXPERIMENTAL

Unified Treatment Protocol

Intervention Type BEHAVIORAL

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.

Waitlist Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychiatric University Hospital, Zurich

OTHER

Sponsor Role collaborator

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of St.Gallen

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Birgit Kleim, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University of Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Birgit Kleim, Prof. Dr.

Role: CONTACT

+41 (0)44 384 23 51

Ava Schulz, Dr.

Role: CONTACT

+41(0)443891582

Facility Contacts

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Ava Schulz, Dr.

Role: primary

044(0)3891582

Christina Paersch, Dipl.-Psych.

Role: backup

+41443891582

References

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Muller-Bardorff M, Schulz A, Paersch C, Recher D, Schlup B, Seifritz E, Kolassa IT, Kowatsch T, Fisher A, Galatzer-Levy I, Kleim B. Optimizing Outcomes in Psychotherapy for Anxiety Disorders Using Smartphone-Based and Passive Sensing Features: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 14;13:e42547. doi: 10.2196/42547.

Reference Type DERIVED
PMID: 38743473 (View on PubMed)

Other Identifiers

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10001C_169827

Identifier Type: -

Identifier Source: org_study_id

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