Generalized Anxiety DisorderCBT+IMT-GADNCT01681329
Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder
A study testing Cognitive-behavioral therapy and Interpretation training in people with Generalized Anxiety Disorder, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD that has been tested in four previous clinical trials. 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 and Interpretation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jun 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
- Principal diagnosis of GAD
- Willingness to keep medication status stable while participating in the study
- Willingness to undergo randomization
Who cannot join
- Change in medication type or dose in 12 weeks before study entry
- Use of herbal products known to have CNS 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.
Canada1 site
Hôpital du Sacré-Coeur de Montréal, Clinique des troubles anxieux
Montreal, Quebec, H3M 3A9
About this study
Official title: Improving Outcomes for Adults With Generalized Anxiety Disorder: Combining Cognitive-Behavioral Treatment and Interpretation Modification Training
Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD that has been tested in four previous clinical trials. The findings show that 60 to 70% of affected individuals attain GAD remission and that 50 to 55% achieve high endstate functioning following the treatment. Although these numbers are encouraging, there remain a considerable proportion of individuals who do not fully benefit from treatment. In our most recent CIHR-funded treatment study, we assessed the impact of information processing on the efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret ambiguous information at pre-treatment was associated with greater GAD symptoms at post-treatment; and b) that patients who were less successful at changing their negative interpretation style were also less responsive to CBT. Given that computerized interpretation modification training has been shown to be effective for decreasing the negative interpretation style of anxious individuals, the goal of the current proposal is to determine whether such training can augment the efficacy of CBT for adults with GAD. A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training or b) CBT plus non-active training. CBT will consist of 14 weekly sessions, with interpretation modification training (or non-active training) administered prior to each session. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT.
Read the detailed description
Generalized Anxiety Disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. In Canada, the point prevalence of GAD is 3 to 4%, and the personal and social costs of GAD are well documented. Over the past decade, new cognitive-behavioural treatments have been developed for GAD. Our group has also developed a cognitive-behavioural treatment (CBT) protocol for GAD, which focuses on intolerance of uncertainty. There are now four published randomized clinical trials of the treatment, with results suggesting that it is more efficacious than wait-list control, supportive therapy, and applied relaxation. Although these results are encouraging, 30 to 40% of affected individuals do not attain diagnostic remission and 45 to 50% do not achieve high endstate functioning at post-treatment.
In an effort to augment the efficacy of the treatment protocol for GAD, we have recently examined a broad range of demographic and clinical variables that might predict a limited response to treatment. The results of our analyses suggest that a particular type of cognitive bias plays a key role in determining treatment response. Specifically, patients with a particularly negative interpretation style (i.e., the tendency to negatively interpret ambiguous information) have a greater probability of not attaining remission following CBT (they also show less improvement on other indicators of treatment outcome). In addition, change in interpretation style appears to mediate change in GAD symptoms over the course of CBT. Thus, the data suggest that treatment efficacy could be increased by adding training strategies that specifically address negatively biased interpretations of ambiguous information. Recently, a number of experimental investigations have shown that the tendency to negatively interpret ambiguous information can be decreased using computerized interpretation modification training. In fact, the data show that such changes can be maintained over time, can generalize to new situations, and can lead to corresponding changes in GAD symptoms and anxiety proneness. Thus, it appears that computerized interpretation modification training has the potential to increase the efficacy of current CBT protocols by directly targeting and decreasing the tendency to negatively interpret ambiguous information.
The proposed randomized clinical trial addresses the following question: Can computerized interpretation modification training augment the efficacy of CBT for GAD? A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training (CBT+IMT) or b) CBT plus non-active training (CBT+NA). CBT will consist of 14 weekly 50-minute sessions targeting intolerance of uncertainty via procedures such as problem-solving training and imaginal exposure. Participants randomized to the experimental condition will receive 10 minutes of computerized interpretation modification training prior to each CBT session. In interpretation modification training, respondents learn to endorse benign combinations and reject negative combinations of sentences and words, thus promoting new associative learning. Participants in the control condition will receive 10 minutes of non-active training, in which each sentence is paired with a word that is unrelated to the sentence or a word that is related to a non-threatening (and typically peripheral) aspect of the sentence. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT. Given previous findings on the key role of negative interpretation style in anxiety, the proposed study has the potential to increase our understanding and ability to treat individuals with GAD.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive-behavioral therapy, Interpretation training
- Keywords
- Cognitive-behavioral therapy, Interpretation modification training, Randomized clinical trial, Adults
- 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 therapyBehavioural
Also called Intolerance of uncertainty treatment
Cognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance
Interpretation trainingOther
Also called Cognitive bias modification for interpretations
Computerized interpretation training using Word-Sentence Association Paradigm
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy with interpretation training | Experimental | 14 sessions of cognitive-behavioral therapy combined with computerized interpretation modification training Receives: Behavioral: Cognitive-behavioral therapy; Other: Interpretation training |
| Cognitive-behavioral therapy with non-active training | Active comparator | 14 sessions of cognitive-behavioral therapy combined with computerized non-active training Receives: Behavioral: Cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in severity of GAD symptoms assessed by structured interview
Clinician's Severity Rating (CSR) scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Measured: Post-treatment (14 weeks)
Change from baseline in severity of GAD symptoms
Worry and Anxiety Questionnaire (WAQ)
Measured: Post-treatment (14 weeks)
Change from baseline in severity of worry
Penn State Worry Questionnaire (PSWQ)
Measured: Post-treatment (14 weeks)
Secondary outcomes (7)
Change from baseline in somatic anxiety
Beck Anxiety Inventory (BAI)
Measured: Post-treatment (14 weeks)
Change from baseline in depressive symptoms
Beck Depression Inventory, 2nd edition (BDI-II)
Measured: Post-treatment (14 weeks)
Change from baseline in hostile attitudes
Aggression Questionnaire, Hostility subscale (AQ-Host)
Measured: Post-treatment (14 weeks)
Change from baseline in intolerance of uncertainty
Intolerance of Uncertainty Scale (IUS)
Measured: Post-treatment (14 weeks)
Change from baseline in beliefs about worry
Why Worry, 2nd edition (WW-II)
Measured: Post-treatment (14 weeks)
Change from baseline in problem orientation
Negative Problem Orientation Questionnaire (NPOQ)
Measured: Post-treatment (14 weeks)
Change from baseline in cognitive avoidance
Cognitive Avoidance Questionnaire (CAQ)
Measured: Post-treatment (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2018
- Study completionJun 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 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, Université du Québec à Trois-Rivières, Université de Sherbrooke, Toronto Metropolitan University, Brown University
- 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
- NCT01681329
- Sponsor's protocol ID
- MOP-82771-12-04
- Acronym
- CBT+IMT-GAD
- Status last verified
- Jul 2018
- First submitted
- 5 Sep 2012
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Adults With Generalized Anxiety Disorder: Combining Cognitive-Behavioral Treatment and Interpretation Modification Training
- ClinicalTrials.gov ID
- NCT01681329
- Acronym / sponsor ID
- CBT+IMT-GAD / MOP-82771-12-04
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Cognitive-behavioral therapy, Interpretation modification training, Randomized clinical trial, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 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, Université du Québec à Trois-Rivières, Université de Sherbrooke, Toronto Metropolitan University, Brown University
- Study start
- Sep 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Sep 2012 (estimated)
- 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. Our group has developed a cognitive-behavioural treatment (CBT) for GAD that has been tested in four previous clinical trials. The findings show that 60 to 70% of affected individuals attain GAD remission and that 50 to 55% achieve high endstate functioning following the treatment. Although these numbers are encouraging, there remain a considerable proportion of individuals who do not fully benefit from treatment. In our most recent CIHR-funded treatment study, we assessed the impact of information processing on the efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret ambiguous information at pre-treatment was associated with greater GAD symptoms at post-treatment; and b) that patients who were less successful at changing their negative interpretation style were also less responsive to CBT. Given that computerized interpretation modification training has been shown to be effective for decreasing the negative interpretation style of anxious individuals, the goal of the current proposal is to determine whether such training can augment the efficacy of CBT for adults with GAD. A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training or b) CBT plus non-active training. CBT will consist of 14 weekly sessions, with interpretation modification training (or non-active training) administered prior to each session. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT.
Detailed description
Generalized Anxiety Disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. In Canada, the point prevalence of GAD is 3 to 4%, and the personal and social costs of GAD are well documented. Over the past decade, new cognitive-behavioural treatments have been developed for GAD. Our group has also developed a cognitive-behavioural treatment (CBT) protocol for GAD, which focuses on intolerance of uncertainty. There are now four published randomized clinical trials of the treatment, with results suggesting that it is more efficacious than wait-list control, supportive therapy, and applied relaxation. Although these results are encouraging, 30 to 40% of affected individuals do not attain diagnostic remission and 45 to 50% do not achieve high endstate functioning at post-treatment.
In an effort to augment the efficacy of the treatment protocol for GAD, we have recently examined a broad range of demographic and clinical variables that might predict a limited response to treatment. The results of our analyses suggest that a particular type of cognitive bias plays a key role in determining treatment response. Specifically, patients with a particularly negative interpretation style (i.e., the tendency to negatively interpret ambiguous information) have a greater probability of not attaining remission following CBT (they also show less improvement on other indicators of treatment outcome). In addition, change in interpretation style appears to mediate change in GAD symptoms over the course of CBT. Thus, the data suggest that treatment efficacy could be increased by adding training strategies that specifically address negatively biased interpretations of ambiguous information. Recently, a number of experimental investigations have shown that the tendency to negatively interpret ambiguous information can be decreased using computerized interpretation modification training. In fact, the data show that such changes can be maintained over time, can generalize to new situations, and can lead to corresponding changes in GAD symptoms and anxiety proneness. Thus, it appears that computerized interpretation modification training has the potential to increase the efficacy of current CBT protocols by directly targeting and decreasing the tendency to negatively interpret ambiguous information.
The proposed randomized clinical trial addresses the following question: Can computerized interpretation modification training augment the efficacy of CBT for GAD? A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training (CBT+IMT) or b) CBT plus non-active training (CBT+NA). CBT will consist of 14 weekly 50-minute sessions targeting intolerance of uncertainty via procedures such as problem-solving training and imaginal exposure. Participants randomized to the experimental condition will receive 10 minutes of computerized interpretation modification training prior to each CBT session. In interpretation modification training, respondents learn to endorse benign combinations and reject negative combinations of sentences and words, thus promoting new associative learning. Participants in the control condition will receive 10 minutes of non-active training, in which each sentence is paired with a word that is unrelated to the sentence or a word that is related to a non-threatening (and typically peripheral) aspect of the sentence. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT. Given previous findings on the key role of negative interpretation style in anxiety, the proposed study has the potential to increase our understanding and ability to treat individuals with GAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy with interpretation training | Experimental | Behavioral: Cognitive-behavioral therapy, Other: Interpretation training14 sessions of cognitive-behavioral therapy combined with computerized interpretation modification training |
| Cognitive-behavioral therapy with non-active training | Active comparator | Behavioral: Cognitive-behavioral therapy14 sessions of cognitive-behavioral therapy combined with computerized non-active training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Principal diagnosis of GAD
- Willingness to keep medication status stable while participating in the study
- Willingness to undergo randomization
Key exclusion criteria (8 listed)
- Change in medication type or dose in 12 weeks before study entry
- Use of herbal products known to have CNS 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-behavioral therapyAlso: Intolerance of uncertainty treatmentCognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance | Behavioural | Cognitive-behavioral therapy with interpretation training, Cognitive-behavioral therapy with non-active training |
| Interpretation trainingAlso: Cognitive bias modification for interpretationsComputerized interpretation training using Word-Sentence Association Paradigm | Other | Cognitive-behavioral therapy with interpretation training |
Primary outcome
Change from baseline in severity of GAD symptoms assessed by structured interview
Time frame: Post-treatment (14 weeks)
Clinician's Severity Rating (CSR) scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Change from baseline in severity of GAD symptoms
Time frame: Post-treatment (14 weeks)
Worry and Anxiety Questionnaire (WAQ)
Change from baseline in severity of worry
Time frame: Post-treatment (14 weeks)
Penn State Worry Questionnaire (PSWQ)
7 secondary outcomes
Change from baseline in somatic anxiety
Time frame: Post-treatment (14 weeks)
Change from baseline in depressive symptoms
Time frame: Post-treatment (14 weeks)
Change from baseline in hostile attitudes
Time frame: Post-treatment (14 weeks)
Change from baseline in intolerance of uncertainty
Time frame: Post-treatment (14 weeks)
Change from baseline in beliefs about worry
Time frame: Post-treatment (14 weeks)
Change from baseline in problem orientation
Time frame: Post-treatment (14 weeks)
Change from baseline in cognitive avoidance
Time frame: Post-treatment (14 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 20 Jul 2018.
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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
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 and Interpretation training 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 20 Jul 2018. 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?
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 severity of GAD symptoms assessed by structured interview (time frame: Post-treatment (14 weeks)). The study lists 3 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 20 Jul 2018.