Generalized Anxiety DisorderCBTforGADNCT03650465
Comparing Different CBT Approaches in GAD
A study testing Cognitive-behavioral therapy (CBT) in people with Generalized Anxiety Disorder, run by Babes-Bolyai University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive-behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteRomania
- Study dates
- 16 May 2009to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of generalized anxiety disorder (GAD)
Who cannot join
- severe major depression
- bipolar disorder
- panic disorder
- substance use/abuse/dependence
- psychotic disorders
- suicidal or homicidal ideation
Show all 11Show fewer
- organic brain syndrome
- disabling medical conditions
- mental retardation
- concurrent treatment with psychotropic drug
- psychotherapy outside study
Trial locations and contacts
1 site in 1 country.
Romania1 site
Babes-Bolyai University, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca, Non-US/Non-Canadian, 400015
About this study
Official title: Cognitive-behavioral Therapy (CBT) for Generalized Anxiety Disorder: Preliminary Data of Various Contrasting CBT Approaches in a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive-behavioral therapy (CBT)
- Keywords
- generalized anxiety, GAD, worry, CBT, REBT, ACT
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy (CBT)Behavioural
Cognitive-behavioral therapy (CBT)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive-behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized anxiety symptoms
Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Measured: 20 sessions, approximately 16 weeks
Worry
Penn State Worry Questionnaire (PSWQ)
Measured: 20 sessions, approximately 16 weeks
Secondary outcomes (2)
Automatic thoughts frequency
Automatic Thoughts Questionnaire (ATQ)
Measured: 20 sessions, approximately 16 weeks
Automatic thoughts believability
Automatic Thoughts Questionnaire (ATQ)
Measured: 20 sessions, approximately 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start16 May 2009
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Ellis Institute, New York
- Responsible party
- Principal investigator, Daniel David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650465
- Sponsor's protocol ID
- BabesBolyaiU
- Acronym
- CBTforGAD
- Status last verified
- Jan 2019
- First submitted
- 22 Dec 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Therapy (CBT) for Generalized Anxiety Disorder: Preliminary Data of Various Contrasting CBT Approaches in a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03650465
- Acronym / sponsor ID
- CBTforGAD / BabesBolyaiU
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety, GAD, worry, CBT, REBT, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- Albert Ellis Institute, New York
- Study start
- 16 May 2009 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT/BTP | Experimental | Behavioral: Cognitive-behavioral therapy (CBT)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. |
| REBT | Experimental | Behavioral: Cognitive-behavioral therapy (CBT)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. |
| ACT/ABBT | Experimental | Behavioral: Cognitive-behavioral therapy (CBT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary diagnosis of generalized anxiety disorder (GAD)
Key exclusion criteria (11 listed)
- severe major depression
- bipolar disorder
- panic disorder
- substance use/abuse/dependence
- psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapy (CBT)Cognitive-behavioral therapy (CBT) | Behavioural | ACT/ABBT, CT/BTP, REBT |
Primary outcome
Generalized anxiety symptoms
Time frame: 20 sessions, approximately 16 weeks
Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Worry
Time frame: 20 sessions, approximately 16 weeks
Penn State Worry Questionnaire (PSWQ)
2 secondary outcomes
Automatic thoughts frequency
Time frame: 20 sessions, approximately 16 weeks
Automatic thoughts believability
Time frame: 20 sessions, approximately 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy (CBT) in people with Generalized Anxiety Disorder, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized anxiety symptoms (time frame: 20 sessions, approximately 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.