Generalized Anxiety DisorderNCT03099772
CBT for GAD: Impact of Cognitive Processing on Treatment Outcome
A study testing CBT-IU in people with Generalized Anxiety Disorder, run by Concordia University, Montreal.
Trial summary
Generalized anxiety disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Over the past 15 years, the investigators have developed a cognitive-behavioural treatment that leads to the remission of GAD in approximately 60% to 75% of affected individuals. 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?
- CBT-IU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Mar 2012
- 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
- At least 18 years of age
- Primary diagnosis of GAD
- Stability of medication in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for other medications)
- Willingness to keep medication status stable while participating in the study
Who cannot join
- Use of herbal products known to have CNS effects in the 2 weeks before study entry
- Evidence of suicidal intent (based on clinical judgement)
- Evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder
- Participation in other trials
- Evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycemia, anemia)
About this study
Official title: Cognitive-Behavioural Treatment for Generalized Anxiety Disorder: Impact of Cognitive Processing on Short- and Long-Term Outcomes
Generalized anxiety disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Over the past 15 years, the investigators have developed a cognitive-behavioural treatment that leads to the remission of GAD in approximately 60% to 75% of affected individuals. Although these numbers are encouraging, there remain a considerable proportion of patients who do not fully benefit from treatment. With the goal of improving treatment efficacy, the investigators have recently carried out a series of related studies on the way individuals with GAD and high worriers process uncertain or ambiguous information from their environment. The findings show that these individuals display biases in attention for, and appraisal of, uncertain or ambiguous information. Specifically, individuals with GAD and high worriers preferentially allocate their attention to uncertainty-related stimuli and appraise ambiguous information in a threatening manner. In this study, the investigators examine the impact of these information processing biases, measured at intake, on the efficacy of cognitive-behavioural treatment for GAD. The investigators also examine the impact of residual information processing biases, measured at posttreatment, on the maintenance of treatment gains over 18 months following treatment. The main hypotheses are (1) that high levels of pretreatment biases will predict poorer outcomes immediately following therapy, and (2) that high levels of posttreatment biases will predict relapse during the 18 months following therapy. If, as expected, information processing biases predict poor short- and long-term treatment outcomes for individuals with GAD, the investigators will expand the treatment to integrate strategies that directly target these biases in order to increase its efficacy.
Read the detailed description
Background: The investigators have developed a cognitive model of generalized anxiety disorder (GAD) that has intolerance of uncertainty as its central component. Based on this model, they have devised a cognitive-behavioural treatment (CBT) for GAD that helps affected individuals recognize, accept, and deal with the uncertainty of everyday life. Although the treatment leads to positive outcomes in most patients, a significant minority of treated individuals do not attain full remission. One potential avenue for improving the treatment of GAD is to identify disorder-specific modes of cognitive processing (or information processing) and to directly target these modes of processing in therapy. Accordingly, the investigators have carried out a series of related studies examining the relationship between cognitive processing and GAD. The findings from these studies show that individuals who have clinical or subclinical GAD (1) preferentially allocate their attention to uncertainty-related stimuli, and (2) make threatening appraisals of ambiguous information. Further, the data show that the tendency to make threatening appraisals of ambiguous information mediates the relationship between intolerance of uncertainty and the symptoms of GAD. This latter finding is consistent with cognitive theory, which asserts that information processing mediates the influence of cognitive vulnerability on the expression of symptoms of emotional disorders. This study aims to extend this line of research by investigating the impact of these cognitive processing biases on treatment outcome for patients with GAD.
Goals and hypotheses: The main goal of the study is to examine the impact of biases in cognitive processing on short- and long-term outcomes of cognitive-behavioural therapy for individuals with GAD. The study's main hypotheses are that: (1) preferential allocation of attention to uncertainty-related stimuli, assessed at pretreatment, will predict poorer response to treatment; (2) the tendency to appraise ambiguous information in a threatening manner, assessed at pretreatment, will predict poorer response to treatment; (3) preferential allocation of attention to uncertainty-related stimuli, assessed at posttreatment, will predict relapse during follow-up; and (4) the tendency to appraise ambiguous information in a threatening manner, assessed at posttreatment, will predict relapse during follow-up.
Method: The final sample consists of 80 adult patients with a principal diagnosis of GAD, recruited from the Anxiety Disorders Clinic of Sacré-Cœur Hospital of Montreal. Participants are assessed at 9 measurement times: pretreatment, midtreatment, posttreatment, and 3-, 6-, 9-, 12-, 15- and 18-month follow-up. Assessments include the Anxiety Disorders Interview Schedule for DSM-IV, a cognitive processing task (Ambiguous/Unambiguous Situations Diary), and a battery of standardized self-report measures. Treatment consists of an empirically supported CBT protocol for GAD, which is administered over 16 weekly sessions using a session-by-session treatment manual developed in earlier studies. Growth curve analysis with multilevel modeling will be the main analytic strategy used to determine the relationships between cognitive processing and change in a range of outcome variables while controlling for relevant clinical and sociodemographic variables.
Implications: The study has important theoretical and clinical implications. In terms of theory, it begins to bridge the gap between the considerable knowledge of the role of cognitive processing in anxiety and the lack of knowledge of the impact of cognitive processing on treatment outcomes. Surprisingly, although the role of cognitive processing in anxiety has been intensely studied, the impact of cognitive processing on GAD psychotherapy outcomes has never been examined. The proposed study also informs clinical practice as to the importance of (1) systematically assessing cognitive processing, and (2) integrating treatment interventions that specifically target biased cognitive processing into current GAD treatment protocols.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- CBT-IU
- Keywords
- Cognitive-Behavioral Therapy
- 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.
CBT-IUBehavioural
Cognitive-behavioral therapy for intolerance of uncertainty
| Study group | Role | What they receive |
|---|---|---|
| CBT-IU | Experimental | Cognitive-behavioral therapy for intolerance of uncertainty Receives: Behavioral: CBT-IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in symptoms of GAD and comorbid conditions at 4 months
Anxiety Disorders Interview Schedule for DSM-IV
Measured: Baseline and 4 months
Secondary outcomes (4)
Change from Baseline in symptoms of GAD at 4 months
Worry and Anxiety Questionnaire
Measured: Baseline and 4 months
Change from Baseline in worry at 4 months
Penn State Worry Questionnaire
Measured: Baseline and 4 months
Change from Baseline in symptoms of depression at 4 months
Beck Depression Inventory, 2nd Edition
Measured: Baseline and 4 months
Change from Baseline in symptoms of anxiety at 4 months
Beck Anxiety Inventory
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startApr 2007
- Primary completionMar 2012
- Study completionMar 2012
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
- Not applicable
- Intervention model
- Single group
- Model description
- Open trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Responsible party
- Principal investigator, Michel J Dugas, Ph.D., Concordia University, Montreal
- Investigators
- Michel J. Dugas, Ph.D., Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099772
- Sponsor's protocol ID
- UH2005-093
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioural Treatment for Generalized Anxiety Disorder: Impact of Cognitive Processing on Short- and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT03099772
- Acronym / sponsor ID
- UH2005-093
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Cognitive-Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Study start
- Apr 2007 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Apr 2017 (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.
Generalized anxiety disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Over the past 15 years, the investigators have developed a cognitive-behavioural treatment that leads to the remission of GAD in approximately 60% to 75% of affected individuals. Although these numbers are encouraging, there remain a considerable proportion of patients who do not fully benefit from treatment. With the goal of improving treatment efficacy, the investigators have recently carried out a series of related studies on the way individuals with GAD and high worriers process uncertain or ambiguous information from their environment. The findings show that these individuals display biases in attention for, and appraisal of, uncertain or ambiguous information. Specifically, individuals with GAD and high worriers preferentially allocate their attention to uncertainty-related stimuli and appraise ambiguous information in a threatening manner. In this study, the investigators examine the impact of these information processing biases, measured at intake, on the efficacy of cognitive-behavioural treatment for GAD. The investigators also examine the impact of residual information processing biases, measured at posttreatment, on the maintenance of treatment gains over 18 months following treatment. The main hypotheses are (1) that high levels of pretreatment biases will predict poorer outcomes immediately following therapy, and (2) that high levels of posttreatment biases will predict relapse during the 18 months following therapy. If, as expected, information processing biases predict poor short- and long-term treatment outcomes for individuals with GAD, the investigators will expand the treatment to integrate strategies that directly target these biases in order to increase its efficacy.
Detailed description
Background: The investigators have developed a cognitive model of generalized anxiety disorder (GAD) that has intolerance of uncertainty as its central component. Based on this model, they have devised a cognitive-behavioural treatment (CBT) for GAD that helps affected individuals recognize, accept, and deal with the uncertainty of everyday life. Although the treatment leads to positive outcomes in most patients, a significant minority of treated individuals do not attain full remission. One potential avenue for improving the treatment of GAD is to identify disorder-specific modes of cognitive processing (or information processing) and to directly target these modes of processing in therapy. Accordingly, the investigators have carried out a series of related studies examining the relationship between cognitive processing and GAD. The findings from these studies show that individuals who have clinical or subclinical GAD (1) preferentially allocate their attention to uncertainty-related stimuli, and (2) make threatening appraisals of ambiguous information. Further, the data show that the tendency to make threatening appraisals of ambiguous information mediates the relationship between intolerance of uncertainty and the symptoms of GAD. This latter finding is consistent with cognitive theory, which asserts that information processing mediates the influence of cognitive vulnerability on the expression of symptoms of emotional disorders. This study aims to extend this line of research by investigating the impact of these cognitive processing biases on treatment outcome for patients with GAD.
Goals and hypotheses: The main goal of the study is to examine the impact of biases in cognitive processing on short- and long-term outcomes of cognitive-behavioural therapy for individuals with GAD. The study's main hypotheses are that: (1) preferential allocation of attention to uncertainty-related stimuli, assessed at pretreatment, will predict poorer response to treatment; (2) the tendency to appraise ambiguous information in a threatening manner, assessed at pretreatment, will predict poorer response to treatment; (3) preferential allocation of attention to uncertainty-related stimuli, assessed at posttreatment, will predict relapse during follow-up; and (4) the tendency to appraise ambiguous information in a threatening manner, assessed at posttreatment, will predict relapse during follow-up.
Method: The final sample consists of 80 adult patients with a principal diagnosis of GAD, recruited from the Anxiety Disorders Clinic of Sacré-Cœur Hospital of Montreal. Participants are assessed at 9 measurement times: pretreatment, midtreatment, posttreatment, and 3-, 6-, 9-, 12-, 15- and 18-month follow-up. Assessments include the Anxiety Disorders Interview Schedule for DSM-IV, a cognitive processing task (Ambiguous/Unambiguous Situations Diary), and a battery of standardized self-report measures. Treatment consists of an empirically supported CBT protocol for GAD, which is administered over 16 weekly sessions using a session-by-session treatment manual developed in earlier studies. Growth curve analysis with multilevel modeling will be the main analytic strategy used to determine the relationships between cognitive processing and change in a range of outcome variables while controlling for relevant clinical and sociodemographic variables.
Implications: The study has important theoretical and clinical implications. In terms of theory, it begins to bridge the gap between the considerable knowledge of the role of cognitive processing in anxiety and the lack of knowledge of the impact of cognitive processing on treatment outcomes. Surprisingly, although the role of cognitive processing in anxiety has been intensely studied, the impact of cognitive processing on GAD psychotherapy outcomes has never been examined. The proposed study also informs clinical practice as to the importance of (1) systematically assessing cognitive processing, and (2) integrating treatment interventions that specifically target biased cognitive processing into current GAD treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open trial
| Arm | Type | Receives |
|---|---|---|
| CBT-IU | Experimental | Behavioral: CBT-IUCognitive-behavioral therapy for intolerance of uncertainty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Primary diagnosis of GAD
- Stability of medication in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for other medications)
- Willingness to keep medication status stable while participating in the study
Key exclusion criteria (5 listed)
- Use of herbal products known to have CNS effects in the 2 weeks before study entry
- Evidence of suicidal intent (based on clinical judgement)
- Evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder
- Participation in other trials
- Evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycemia, anemia)
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 |
|---|---|---|
| CBT-IUCognitive-behavioral therapy for intolerance of uncertainty | Behavioural | CBT-IU |
Primary outcome
Change from Baseline in symptoms of GAD and comorbid conditions at 4 months
Time frame: Baseline and 4 months
Anxiety Disorders Interview Schedule for DSM-IV
4 secondary outcomes
Change from Baseline in symptoms of GAD at 4 months
Time frame: Baseline and 4 months
Change from Baseline in worry at 4 months
Time frame: Baseline and 4 months
Change from Baseline in symptoms of depression at 4 months
Time frame: Baseline and 4 months
Change from Baseline in symptoms of anxiety at 4 months
Time frame: Baseline and 4 months
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Michel J. Dugas, Ph.D. principal investigator
Concordia University, Montreal
Questions about this trial
What is this clinical trial studying?
A study testing CBT-IU in people with Generalized Anxiety Disorder, run by Concordia University, Montreal.
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 4 inclusion and 5 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline in symptoms of GAD and comorbid conditions at 4 months (time frame: Baseline and 4 months). 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 4 Apr 2017.