Optimizing Psychotherapy for Anxiety Disorders

NCT03945617 | Unknown DMC

• 1 other identifier: 10001C_169827
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

anxiety; cognitive behavior therapy; transdiagnostic treatment; prediction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Hamilton Depression Scale

  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

• Beck Depression Inventory

  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

• Social Functioning Index (SFI)

  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

• World Health Organization-5 Wellbeing Index

  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

• Beck Anxiety Inventory

  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 (2)

• Test of self-conscious affect

  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

• Thought Control questionnaire

  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

Study Arms (2)

Unified treatment protocol

EXPERIMENTAL

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).

Behavioral: Unified Treatment Protocol

Waitlist Control Group

NO INTERVENTION

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

Interventions

Unified Treatment Protocol 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.

Unified treatment protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• Psychiatric University Hospital, Zurich: collaborator
• Swiss National Science Foundation: collaborator
• University of St.Gallen: collaborator

Study Sites (1)

University of Zurich

Zurich, 8032, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 38743473 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Birgit Kleim, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Kleim, Prof. Dr.

CONTACT

+41 (0)44 384 23 51; b.kleim@psychologie.uzh.ch

Ava Schulz, Dr.

CONTACT

+41(0)443891582; ava.schulz@uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded regarding treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: May 10, 2019
• Study Start: January 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: December 31, 2023
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

CH (1)