NCT03650465

Brief Summary

Cognitive-behavior therapy (CBT) is considered the "golden standard" psychotherapy for generalized anxiety disorder (GAD). However, it entails different approaches and blanket statements remain hard to formulate. We conducted a randomized controlled trial to compare the most studied CBT protocol for GAD - Borkovec's treatment package - with two other forms : Rational Emotive Behavior Therapy and Acceptance and Commitment Therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2009

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

9.4 years

First QC Date

December 22, 2017

Last Update Submit

January 14, 2019

Conditions

Keywords

generalized anxietyGADworryCBTREBTACT

Outcome Measures

Primary Outcomes (2)

  • Generalized anxiety symptoms

    Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)

    20 sessions, approximately 16 weeks

  • Worry

    Penn State Worry Questionnaire (PSWQ)

    20 sessions, approximately 16 weeks

Secondary Outcomes (2)

  • Automatic thoughts frequency

    20 sessions, approximately 16 weeks

  • Automatic thoughts believability

    20 sessions, approximately 16 weeks

Study Arms (3)

CT/BTP

EXPERIMENTAL

Cognitive-behavioral therapy (CBT) in the form of Borkovec's treatment package (CT/BTP for GAD) was derived from Borkovec and Costello's (1993) therapeutic approach, relying on principles of CT for anxiety (A. T. Beck \& Emery, 1985) and including applied relaxation. The CT/BTP protocol included several directions as primary goals in therapy: providing a cognitive conceptualization of the problem, identifying and restructuring automatic thoughts, intermediate and core beliefs through cognitive and behavioral techniques (i.e., behavioral experiments), enhancing adaptive behavior (i.e., activity scheduling, dealing with avoidance behavior, social skills training), and using applied relaxation as a coping strategy.

Behavioral: Cognitive-behavioral therapy (CBT)

REBT

EXPERIMENTAL

Cognitive-behavioral therapy (CBT) in the form of REBT was based on the approach of Dryden \& DiGiuseppe (1990), having as a central tenet changing dysfunctional emotions (e.g., anxiety) into functional ones (e.g., healthy anxiety/concern) by changing irrational beliefs into rational beliefs using cognitive, emotive, and behavioral techniques. The structure of an REBT session parallels the CT/BTP session structure including the same elements, but often with a different content. In its elegant/specific form, used here, REBT is focused on changing the core irrational beliefs (i.e., evaluative beliefs/appraisals) seen as the fundamental etiopathogenetic mechanism of GAD.

Behavioral: Cognitive-behavioral therapy (CBT)

ACT/ABBT

EXPERIMENTAL

Cognitive-behavioral therapy (CBT) in the form of the ACT/ABBT protocol was derived from the principles and techniques proposed by Eifert and Forsyth (2005) and Roemer and Orsillo (2005). From this perspective, GAD is maintained by dysfunctional reactions to internal experiences (i.e., emotions, thoughts, bodily sensations), experiential avoidance, and behavioral restriction, so the treatment aims to address all of these problems. In this sense, ACT/ABBT includes three major treatment goals: (1) education about the nature of anxiety, worry and the role of experiential avoidance; (2) practicing mindfulness and acceptance skills when dealing with disturbing internal experiences; and (3) identifying values and following valued action paths when facing obstacles.

Behavioral: Cognitive-behavioral therapy (CBT)

Interventions

Cognitive-behavioral therapy (CBT)

ACT/ABBTCT/BTPREBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary diagnosis of generalized anxiety disorder (GAD)

You may not qualify if:

  • severe major depression
  • bipolar disorder
  • panic disorder
  • substance use/abuse/dependence
  • psychotic disorders
  • suicidal or homicidal ideation
  • organic brain syndrome
  • disabling medical conditions
  • mental retardation
  • concurrent treatment with psychotropic drug
  • psychotherapy outside study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University, Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, Non-US/Non-Canadian, 400015, Romania

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2017

First Posted

August 28, 2018

Study Start

May 16, 2009

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations