Generalized Anxiety DisorderNCT01958788
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
A study testing Cognitive-Behavioural Treatment in people with Generalized Anxiety Disorder, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and uncontrollable worry. Our research group has developed a cognitive-behavioural treatment (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about… 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-Behavioural Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 GAD (as assessed by semi-structured clinical interviews)
- Score of 58 or greater on the (Intolerance of Uncertainty Scale)
- Willingness to keep medication status stable while participating in the study
Who cannot join
- Change in medication type or dose in 12 weeks before study entry
- Use of herbal products known to have central nervous system effects in the 2 weeks before study entry
- Evidence of suicidal intent
- Evidence of current substance abuse
- Evidence of current or past schizophrenia, bipolar disorder or organic mental disorder
- Current participation in other trials
- Concurrent psychotherapy during treatment phase of trial
- Evidence of anxiety symptoms due to a general medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Challenging Uncertainty: Behavioural Experiments in the Treatment of Generalized Anxiety Disorder
Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and uncontrollable worry. Our research group has developed a cognitive-behavioural treatment (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about uncertainty and its consequences (Dugas \& Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous clinical trials: approximately 70% of participants fully remit from GAD following treatment and maintain these gains over extended follow-up periods. These results, while positive, do suggest that a substantial minority of individuals do not fully benefit from the existing treatment protocol. Across our randomized clinical trials, individuals who do not achieve diagnostic remission of GAD continue to endorse elevated levels of intolerance of uncertainty. This suggests that the current CBT protocol does not effectively reduce intolerance of uncertainty in some treated individuals. To address this, we have developed a modified version of the original CBT protocol that targets intolerance of uncertainty more directly. The goal of the current proposal is to determine whether this newly developed CBT protocol with fewer components can deliver comparable or superior GAD symptom reduction. A total of 7 participants with a primary diagnosis of GAD received the newly developed CBT protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and 6-month follow-ups. The proposed study will provide information about the efficacy of this new CBT protocol in reducing GAD symptoms.
Read the detailed description
Generalized anxiety disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. This common and debilitating anxiety disorder is associated with significant distress as well as substantial impairment in occupational, social, and daily functioning. As a result, effective treatment for GAD is essential. Several cognitive-behavioural treatment (CBT) protocols have been developed for GAD, including an efficacious treatment developed by our research group. This CBT protocol for GAD centres upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about uncertainty and its consequences (Dugas \& Robichaud, 2007). Previous research has shown that individuals with GAD demonstrate high intolerance of uncertainty, and that there are a number of potential pathways by which intolerance of uncertainty may lead to symptoms of GAD (see Dugas \& Robichaud, 2007 for a review). Our CBT protocol targeting intolerance of uncertainty has demonstrated good efficacy across four published randomized clinical trials: approximately 70% of participants have fully remitted from GAD following treatment and have maintained these gains over extended follow-up periods. These results, while positive, do suggest that a substantial minority of individuals do not fully benefit from the existing treatment protocol. Across our randomized clinical trials, individuals who do not achieve diagnostic remission of GAD continue to endorse elevated levels of intolerance of uncertainty. This suggests that the current CBT protocol does not effectively reduce intolerance of uncertainty in some treated individuals. Additionally, the existing treatment protocol has 6 major components, utilizes a number of cognitive and behavioural techniques (including symptom monitoring, motivational interviewing, situational exposure, problem-solving training, and imaginal exposure), and requires at least 14 sessions to implement. Recent literature (e.g., Cougle et al., 2011) has suggested that there is increased need for parsimony and efficiency in CBT protocols. As a result, our research group is investigating new methods of targeting intolerance of uncertainty that demonstrate greater parsimony and efficiency.
Our previous CBT protocol for GAD targeted intolerance of uncertainty directly through situational exposure, and indirectly through motivational interviewing, problem-solving training, and imaginal exposure. In an effort to streamline and strengthen GAD treatment, the newly developed CBT protocol only targets intolerance of uncertainty directly. In this new CBT protocol, intolerance of uncertainty was targeted using behavioural experiments in which participants identified and tested out their beliefs about uncertainty. The extant literature suggests that behavioural experiments are an efficacious way to target the emotional, cognitive, and behavioural components of anxiety disorders and may be superior to habituation-based exposure paradigms (McMillan \& Lee, 2010; Salkovskis et al., 2007).
The current study examined if a newly developed CBT protocol with fewer components could deliver comparable GAD symptom reduction. Seven (7) individuals with a primary diagnosis of GAD completed 12 sessions of CBT using a newly developed treatment protocol focusing exclusively on intolerance of uncertainty. The treatment consisted of 50-minute, weekly sessions targeting intolerance of uncertainty primarily via behavioural experiments. The three treatment components included: (1) psychoeducation and uncertainty awareness training; (2) testing beliefs about uncertainty (via behavioural experiments); and (3) relapse prevention. Measures of GAD symptoms, general psychopathology, and intolerance of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and 6-month follow-ups. Our main outcomes of interest were effect sizes (i.e., relative magnitude of change from pre-posttreatment, pretreatment to 6-month follow-up, and posttreatment to 6-month follow-up).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive-Behavioural Treatment
- Keywords
- Cognitive-behavioral treatment, Generalized anxiety disorder, Worry, Behavioral experiments, Safety behaviors, Anxiety
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioural TreatmentBehavioural
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioural Treatment | Experimental | 12 sessions of cognitive-behavioral treatment targeting negative beliefs about uncertainty Receives: Behavioral: Cognitive-Behavioural Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Secondary outcomes (6)
Worry and Anxiety Questionnaire (WAQ)
The WAQ is a questionnaire assessing self-reported symptoms of GAD. Scores range from 0 to 56, with higher scores indicating greater severity of self-rated GAD symptoms. The measure was used to assess change from baseline in self-reported GAD symptoms (WAQ).
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Intolerance of Uncertainty Scale (IUS)
The IUS is a self-report questionnaire assessing intolerance of uncertainty, or the tendency to view uncertainty and its consequences as negative. Scores range from 27 to 135, with higher scores representing greater intolerance of uncertainty. The IUS was used to assess change from baseline in self-reported intolerance of uncertainty.
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a self-report questionnaire assessing excessive and uncontrollable worry. Scores range from 16 to 80, with greater scores indicating greater worry. The PSWQ was used to evaluate change from baseline in self-reported worry.
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
GAD Safety Behaviours Questionnaire (GAD-SBQ)
The GAD-SBQ is a self-report questionnaire assessing the tendency to use safety behaviours to cope with anxiety, such as reassurance-seeking and overpreparation. Scores range from 18 to 90, with greater scores indicating greater use of safety behaviours. The GA-SBQ was used to evaluate change from baseline in self-reported safety behaviours.
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Beck Anxiety Inventory (BAI)
The BAI is a self-report questionnaire assessing affective, cognitive, and somatic anxiety over the preceding week. Scores range from 0 to 63, with greater scores representing greater self-reported anxiety. The BAI was used to evaluate change from baseline in self-reported anxiety.
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Beck Depression Inventory, 2nd Edition (BDI-II)
The BDI-II is a self-report questionnaire assessing a variety of depressive symptoms, including low mood, anhedonia, and worthlessness. Scores range from 0 to 63, with greater scores indicating greater depressive symptoms. The BDI-II was used to evaluate change from baseline in self-reported depressive symptoms.
Measured: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Responsible party
- Principal investigator, Elizabeth A. Hebert, Concordia University, Montreal
- Investigators
- Elizabeth A Hebert, M.A., Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958788
- Sponsor's protocol ID
- MOP-69066-620
- Status last verified
- Jan 2016
- First submitted
- 7 Oct 2013
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenging Uncertainty: Behavioural Experiments in the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01958788
- Acronym / sponsor ID
- MOP-69066-620
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Cognitive-behavioral treatment, Generalized anxiety disorder, Worry, Behavioral experiments, Safety behaviors, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 23 Feb 2016
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 an anxiety disorder characterized by excessive and uncontrollable worry. Our research group has developed a cognitive-behavioural treatment (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about uncertainty and its consequences (Dugas \& Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous clinical trials: approximately 70% of participants fully remit from GAD following treatment and maintain these gains over extended follow-up periods. These results, while positive, do suggest that a substantial minority of individuals do not fully benefit from the existing treatment protocol. Across our randomized clinical trials, individuals who do not achieve diagnostic remission of GAD continue to endorse elevated levels of intolerance of uncertainty. This suggests that the current CBT protocol does not effectively reduce intolerance of uncertainty in some treated individuals. To address this, we have developed a modified version of the original CBT protocol that targets intolerance of uncertainty more directly. The goal of the current proposal is to determine whether this newly developed CBT protocol with fewer components can deliver comparable or superior GAD symptom reduction. A total of 7 participants with a primary diagnosis of GAD received the newly developed CBT protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and 6-month follow-ups. The proposed study will provide information about the efficacy of this new CBT protocol in reducing GAD symptoms.
Detailed description
Generalized anxiety disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. This common and debilitating anxiety disorder is associated with significant distress as well as substantial impairment in occupational, social, and daily functioning. As a result, effective treatment for GAD is essential. Several cognitive-behavioural treatment (CBT) protocols have been developed for GAD, including an efficacious treatment developed by our research group. This CBT protocol for GAD centres upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about uncertainty and its consequences (Dugas \& Robichaud, 2007). Previous research has shown that individuals with GAD demonstrate high intolerance of uncertainty, and that there are a number of potential pathways by which intolerance of uncertainty may lead to symptoms of GAD (see Dugas \& Robichaud, 2007 for a review). Our CBT protocol targeting intolerance of uncertainty has demonstrated good efficacy across four published randomized clinical trials: approximately 70% of participants have fully remitted from GAD following treatment and have maintained these gains over extended follow-up periods. These results, while positive, do suggest that a substantial minority of individuals do not fully benefit from the existing treatment protocol. Across our randomized clinical trials, individuals who do not achieve diagnostic remission of GAD continue to endorse elevated levels of intolerance of uncertainty. This suggests that the current CBT protocol does not effectively reduce intolerance of uncertainty in some treated individuals. Additionally, the existing treatment protocol has 6 major components, utilizes a number of cognitive and behavioural techniques (including symptom monitoring, motivational interviewing, situational exposure, problem-solving training, and imaginal exposure), and requires at least 14 sessions to implement. Recent literature (e.g., Cougle et al., 2011) has suggested that there is increased need for parsimony and efficiency in CBT protocols. As a result, our research group is investigating new methods of targeting intolerance of uncertainty that demonstrate greater parsimony and efficiency.
Our previous CBT protocol for GAD targeted intolerance of uncertainty directly through situational exposure, and indirectly through motivational interviewing, problem-solving training, and imaginal exposure. In an effort to streamline and strengthen GAD treatment, the newly developed CBT protocol only targets intolerance of uncertainty directly. In this new CBT protocol, intolerance of uncertainty was targeted using behavioural experiments in which participants identified and tested out their beliefs about uncertainty. The extant literature suggests that behavioural experiments are an efficacious way to target the emotional, cognitive, and behavioural components of anxiety disorders and may be superior to habituation-based exposure paradigms (McMillan \& Lee, 2010; Salkovskis et al., 2007).
The current study examined if a newly developed CBT protocol with fewer components could deliver comparable GAD symptom reduction. Seven (7) individuals with a primary diagnosis of GAD completed 12 sessions of CBT using a newly developed treatment protocol focusing exclusively on intolerance of uncertainty. The treatment consisted of 50-minute, weekly sessions targeting intolerance of uncertainty primarily via behavioural experiments. The three treatment components included: (1) psychoeducation and uncertainty awareness training; (2) testing beliefs about uncertainty (via behavioural experiments); and (3) relapse prevention. Measures of GAD symptoms, general psychopathology, and intolerance of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and 6-month follow-ups. Our main outcomes of interest were effect sizes (i.e., relative magnitude of change from pre-posttreatment, pretreatment to 6-month follow-up, and posttreatment to 6-month follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioural Treatment | Experimental | Behavioral: Cognitive-Behavioural Treatment12 sessions of cognitive-behavioral treatment targeting negative beliefs about uncertainty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of GAD (as assessed by semi-structured clinical interviews)
- Score of 58 or greater on the (Intolerance of Uncertainty Scale)
- Willingness to keep medication status stable while participating in the study
Key exclusion criteria (8 listed)
- Change in medication type or dose in 12 weeks before study entry
- Use of herbal products known to have central nervous system effects in the 2 weeks before study entry
- Evidence of suicidal intent
- Evidence of current substance abuse
- Evidence of current or past schizophrenia, bipolar disorder or organic mental disorder
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-Behavioural Treatment12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty. | Behavioural | Cognitive-Behavioural Treatment |
Primary outcome
Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.
6 secondary outcomes
Worry and Anxiety Questionnaire (WAQ)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Intolerance of Uncertainty Scale (IUS)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Penn State Worry Questionnaire (PSWQ)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
GAD Safety Behaviours Questionnaire (GAD-SBQ)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Beck Anxiety Inventory (BAI)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Beck Depression Inventory, 2nd Edition (BDI-II)
Time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
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.
Elizabeth A Hebert, M.A. principal investigator
Concordia University, Montreal
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-Behavioural Treatment in people with Generalized Anxiety Disorder, run by Concordia University, Montreal at 1 site in Canada.
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 3 inclusion and 8 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 23 Feb 2016. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) (time frame: Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up). 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 23 Feb 2016.