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Comparing Different CBT Approaches in GAD (CBTforGAD)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Cognitive-behavioral therapy (CBT)
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring generalized anxiety, GAD, worry, CBT, REBT, ACT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary diagnosis of generalized anxiety disorder (GAD)

Exclusion Criteria:

  • 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

Sites / Locations

  • Babes-Bolyai University, Department of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CT/BTP

REBT

ACT/ABBT

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Generalized anxiety symptoms
Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Worry
Penn State Worry Questionnaire (PSWQ)

Secondary Outcome Measures

Automatic thoughts frequency
Automatic Thoughts Questionnaire (ATQ)
Automatic thoughts believability
Automatic Thoughts Questionnaire (ATQ)

Full Information

First Posted
December 22, 2017
Last Updated
January 14, 2019
Sponsor
Babes-Bolyai University
Collaborators
Albert Ellis Institute, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03650465
Brief Title
Comparing Different CBT Approaches in GAD
Acronym
CBTforGAD
Official Title
Cognitive-behavioral Therapy (CBT) for Generalized Anxiety Disorder: Preliminary Data of Various Contrasting CBT Approaches in a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 16, 2009 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University
Collaborators
Albert Ellis Institute, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The goal of our present study is to compare the most established and studied CBT protocol for GAD, namely Borkovec's treatment package (BTP) with two other forms of CBT: Rational Emotive Behavior Therapy (REBT; Ellis, 1977) and Acceptance and Commitment Therapy (ACT; Hayes et al., 2012). These two forms of therapy were chosen for both conceptual and practical reasons. At a conceptual level, we wanted to compare forms of CBT with distinct approaches to dysfunctional thoughts. A fundamental postulate of the cognitive model of psychopathology is that the modification of dysfunctional thoughts (i.e., cognitive change) is central to treating psychological disorders, as "all therapies work by altering dysfunctional cognitions, either directly or indirectly". Both classical Beck's cognitive therapy (CT; Beck, 1976), which is an integrated part in Borkovec's GAD treatment package (CT/BTP), and REBT focus on changing dysfunctional thoughts, but they differ fundamentally in their approach to achieving this change. More specifically, Beck's CT focuses primarily on modifying mental representations of relevant circumstances in the forms of dysfunctional descriptions and inferences (i.e., "cold" cognitions: "I will fail."). REBT on the other hand focuses mainly on "hot" cognitions in the form of evaluations/appraisals (i.e., rational and irrational beliefs), which refer to the ways in which "cold" cognitions/ representations are processed in terms of their relevance for personal well-being (i.e., "I must not fail and it is awful if I fail."). In contrast to both CT and REBT, ACT does not directly attempt to modify the content of the thoughts at all, but aims to change the individual's relationship to dysfunctional beliefs (i.e., the significance of having these beliefs), a process through which cognitions are thought to become "neutralized" (i.e., defused) and the anxiety/distress related to them is reduced or accepted. At a practical level, we wanted to investigate how different forms of CBT (i.e., REBT and ACT/ABBT) would measure up to the established package based on Borkovec's treatment protocol (CT/BTP). According to REBT, core irrational beliefs (e.g., "I must not fail and it is awful if I fail."), in interaction to various activating events (e.g., a test situation), generate automatic thoughts in the form of descriptions/inferences (e.g., "I will fail here.") that are then further processed by automatic thoughts in the form of specific irrational beliefs derived from the core irrational beliefs (e.g., "I must not fail here and it is awful if I fail here.") that than further generate anxiety symptoms. In its general form, REBT is focused on changing both core beliefs and automatic thoughts, but in its specific form, used here, REBT is focused on changing the core irrational beliefs seen as the fundamental etiopathogenetic mechanisms of GAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
generalized anxiety, GAD, worry, CBT, REBT, ACT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT/BTP
Arm Type
Experimental
Arm Description
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.
Arm Title
REBT
Arm Type
Experimental
Arm Description
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.
Arm Title
ACT/ABBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy (CBT)
Intervention Description
Cognitive-behavioral therapy (CBT)
Primary Outcome Measure Information:
Title
Generalized anxiety symptoms
Description
Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Time Frame
20 sessions, approximately 16 weeks
Title
Worry
Description
Penn State Worry Questionnaire (PSWQ)
Time Frame
20 sessions, approximately 16 weeks
Secondary Outcome Measure Information:
Title
Automatic thoughts frequency
Description
Automatic Thoughts Questionnaire (ATQ)
Time Frame
20 sessions, approximately 16 weeks
Title
Automatic thoughts believability
Description
Automatic Thoughts Questionnaire (ATQ)
Time Frame
20 sessions, approximately 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary diagnosis of generalized anxiety disorder (GAD) Exclusion Criteria: 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
Facility Information:
Facility Name
Babes-Bolyai University, Department of Clinical Psychology and Psychotherapy
City
Cluj Napoca
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
400015
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparing Different CBT Approaches in GAD

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