Anxiety DisordersNCT02638363
An Investigation of General Predictors for CBT Outcome for Anxiety Disorders in a Naturalistic Setting
An observational study of Anxiety Disorders, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the predictive value of emotion regulation and attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety disorders in a naturalistic setting. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Dec 2017
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with anxiety disorders from outpatient clinics.
Who may be able to join
- meet the diagnostic criteria for an anxiety disorder (social anxiety, generalized anxiety, panic disorder and agoraphobia) as primary diagnosis whether first episode or recurrent
- are between 18 to 60 years of age
- provide written informed consent
- speak and understand Danish.
Who cannot join
- cognitive disabilities (assessed with sub scales from Wechsler Adult Intelligence Scale Fourth-Edition, < 70)
- alcohol or substance abuse (assessed during the preliminary consultations)
- receiving any other psychotherapy during the study. Patients receiving medical treatment (e.g., antidepressants, Benzodiazepines) will also be included in the study and the treatment will be monitored closely.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of General Predictors for Cognitive Behavioral Therapy Outcome for Anxiety Disorders in a Naturalistic Setting
The aim of this study is to investigate the predictive value of emotion regulation and attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety disorders in a naturalistic setting.
Read the detailed description
Anxiety disorders are a pervasive problem, with an estimated 12-month prevalence of 16.6 %, and they are associated with significant impairment and high social costs. Cognitive behavioral therapy (CBT) has shown to be effective and for treating of anxiety disorders. CBT is furthermore cost-effectiveness.This has made CBT the first choice of treatment for anxiety disorders in many mental health settings around the world. Despite this impressive evidence-base, a relatively large group of individuals do not benefit from CBT, relapse, or drop out of treatment. Thus, there is a clear and pressing need to improve the efficacy and effectiveness of CBT for anxiety disorders. One way in which to improve is to identify predictors of CBT outcome. In naturalistic clinical settings, identification of prognostic factors can help allocate resources to those presumed to benefit most from CBT, while also identifying those who may need additional CBT, adjunctive therapy, or entirely different treatment to maximize outcomes.
Current knowledge about who is most likely to benefit from CBT is sparse and stems primarily from well-controlled laboratory settings. These results may not generalize to patient outcomes in mental health settings, in which patients with more severe and comorbid disorders are often seen. Thus, naturalistic studies have the potential to significantly increase knowledge, inform clinical strategies, and thus improve the treatment offered in mental health settings. Furthermore, existing studies have mostly investigated socio-demographic factors as predictors of drop-out and non-response. However, these variables have shown to be either non-significant or inconsistent predictors of outcome. Results concerning comorbidity as a predictor are also mixed. In sum, knowledge on who is most likely to benefit from CBT is sparse, and to date no reliable predictors have been identified.
While prior work has primarily emphasized atheoretical predictors, it may prove more fruitful to focus on predictor variables stemming from psychological theories. Identifying such predictors can provide direct prognostic information for clinicians. Additionally, these predictors could also inform the development of adjunctive components of treatment that may optimize the treatment for those with poorer CBT outcome. Some exciting studies suggest that such a line of inquiry could yield relevant results.
Maintaining factors is one aspect highlighted by several therapeutic approaches/theories as crucial for the treatment of anxiety disorders, and accordingly these factors are often the target of cognitive and behavioral treatments. Emotion regulation and attentional control are examples of key maintaining factors in anxiety disorders. CBT, which aims to teach patients cognitive reappraisal of maladaptive cognitions and encourages approach (rather than avoidance) behavior via cognitive restructuring and exposure, may be more suitable for patients with certain characteristics. Specifically, recent research and theory suggest that it is crucial for effective treatment of anxiety disorders that clients learn to tolerate fear while being exposed to anxiety-provoking stimuli, rather than merely habituating to the stimuli. Learning to tolerate fear may require emotion regulation skills and the ability to control attention and this has been supported by recent studies. However, so far only certain areas of emotion regulation have been investigated and to date never in a naturalistic setting. Attentional control has never been examined as a predictor of CBT outcomes. Accordingly, this study is designed to investigate the predictive value of attentional control and of three facets of emotion regulation skills.
Attentional control There is strong evidence that individuals with anxiety disorders have biased attention towards threatening stimuli, but there is no consensus as to why these biases occur. Recent research suggests that it is not the threat bias per se that is problematic. Rather, individual differences in the ability to voluntarily control attention may affect the impact of threatening information hence increasing or decreasing the anxiety symptoms. A potential consequence may be that individuals with low ability to voluntarily control their attention have difficulties participating in exposure and/or do not progress in the exposure hierarchy, because the level of anxiety gets too high. This may subsequently lead to failure to learn that fear is not dangerous or even drop-out of CBT. Furthermore, a pronounced bias towards irrelevant negative information may take up so many resources that processing of important, relevant information is hampered, making it difficult to engage in goal-oriented behavior while experiencing anxiety.
Emotion regulation as predictor Novel theoretical frameworks emphasize that difficulties in emotion regulation are associated with the development and maintenance of anxiety disorders. Additionally, emotion regulation skills may be required to engage in and benefit from CBT. Furthermore, in an attempt to increase effectiveness, several newer treatments have included emotion regulation training in their treatments protocols.
The present study aims to examine attentional control and three facets of emotion regulation:
- awareness and understanding of emotions,
- acceptance of emotions, and
- the ability to engage in goal-directed behavior, and refrain from impulsive behavior, when experiencing negative emotions as general predictors of outcome in CBT for anxiety disorders in a naturalistic, community-based mental health setting.
Our secondary aim is to examine a theoretical variables (i.e., socio-demographic data and clinical characteristics, such as comorbidity) as predictors of CBT outcome, as these have yet to be examined as predictors in real-world clinical settings in a mixed anxious sample.
Investigators expect that low ability to control attention will be associated with poorer treatment outcome. Similarly, it is expected that high scores on emotion dysregulation will be related to poorer treatment outcome. Given the exploratory nature of this study we will also be interested in testing non-linear relationships.
Method In order to maximize external validity, investigators are conducting the study within two real-world treatment clinics and employing minimal exclusion criteria recruiting a sample with mixed principal anxiety disorders. Patients will be recruited from the two clinics.
- Conditions
- Anxiety Disorders
- Being tested
- Cognitive behavioral therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
The participants will receive 12-16 sessions of manualized group-based CBT with a maximum of 8 participants in each group. The therapists are trained psychiatrists, psychologists, or nurses under supervision. The treatment manuals are developed by mental health professionals in the Capital Region of Denmark. The treatment program includes traditional CBT components (e.g., psychoeducation, identification of thoughts and feelings, exposure, cognitive restructuring, and relapse prevention).
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
Self-report questionnaire to assess level of anxiety symptoms.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Sara Kerstine Kaya Nielsen, University of Copenhagen
- Investigators
- Sara KK Nielsen, MSc, Principal investigator, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638363
- Sponsor's protocol ID
- Precat
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2015
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen SK, Vangkilde S, Wolitzky-Taylor KB, Daniel SI, Hageman I. An investigation of general predictors for cognitive-behavioural therapy outcome for anxiety disorders in a routine clinical setting. BMJ Open. 2016 Mar 25;6(3):e010898. doi: 10.1136/bmjopen-2015-010898.
PubMed 27016248
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of General Predictors for Cognitive Behavioral Therapy Outcome for Anxiety Disorders in a Naturalistic Setting
- ClinicalTrials.gov ID
- NCT02638363
- Acronym / sponsor ID
- Precat
- Conditions
- Anxiety Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Dec 2015 (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.
The aim of this study is to investigate the predictive value of emotion regulation and attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety disorders in a naturalistic setting.
Detailed description
Anxiety disorders are a pervasive problem, with an estimated 12-month prevalence of 16.6 %, and they are associated with significant impairment and high social costs. Cognitive behavioral therapy (CBT) has shown to be effective and for treating of anxiety disorders. CBT is furthermore cost-effectiveness.This has made CBT the first choice of treatment for anxiety disorders in many mental health settings around the world. Despite this impressive evidence-base, a relatively large group of individuals do not benefit from CBT, relapse, or drop out of treatment. Thus, there is a clear and pressing need to improve the efficacy and effectiveness of CBT for anxiety disorders. One way in which to improve is to identify predictors of CBT outcome. In naturalistic clinical settings, identification of prognostic factors can help allocate resources to those presumed to benefit most from CBT, while also identifying those who may need additional CBT, adjunctive therapy, or entirely different treatment to maximize outcomes.
Current knowledge about who is most likely to benefit from CBT is sparse and stems primarily from well-controlled laboratory settings. These results may not generalize to patient outcomes in mental health settings, in which patients with more severe and comorbid disorders are often seen. Thus, naturalistic studies have the potential to significantly increase knowledge, inform clinical strategies, and thus improve the treatment offered in mental health settings. Furthermore, existing studies have mostly investigated socio-demographic factors as predictors of drop-out and non-response. However, these variables have shown to be either non-significant or inconsistent predictors of outcome. Results concerning comorbidity as a predictor are also mixed. In sum, knowledge on who is most likely to benefit from CBT is sparse, and to date no reliable predictors have been identified.
While prior work has primarily emphasized atheoretical predictors, it may prove more fruitful to focus on predictor variables stemming from psychological theories. Identifying such predictors can provide direct prognostic information for clinicians. Additionally, these predictors could also inform the development of adjunctive components of treatment that may optimize the treatment for those with poorer CBT outcome. Some exciting studies suggest that such a line of inquiry could yield relevant results.
Maintaining factors is one aspect highlighted by several therapeutic approaches/theories as crucial for the treatment of anxiety disorders, and accordingly these factors are often the target of cognitive and behavioral treatments. Emotion regulation and attentional control are examples of key maintaining factors in anxiety disorders. CBT, which aims to teach patients cognitive reappraisal of maladaptive cognitions and encourages approach (rather than avoidance) behavior via cognitive restructuring and exposure, may be more suitable for patients with certain characteristics. Specifically, recent research and theory suggest that it is crucial for effective treatment of anxiety disorders that clients learn to tolerate fear while being exposed to anxiety-provoking stimuli, rather than merely habituating to the stimuli. Learning to tolerate fear may require emotion regulation skills and the ability to control attention and this has been supported by recent studies. However, so far only certain areas of emotion regulation have been investigated and to date never in a naturalistic setting. Attentional control has never been examined as a predictor of CBT outcomes. Accordingly, this study is designed to investigate the predictive value of attentional control and of three facets of emotion regulation skills.
Attentional control There is strong evidence that individuals with anxiety disorders have biased attention towards threatening stimuli, but there is no consensus as to why these biases occur. Recent research suggests that it is not the threat bias per se that is problematic. Rather, individual differences in the ability to voluntarily control attention may affect the impact of threatening information hence increasing or decreasing the anxiety symptoms. A potential consequence may be that individuals with low ability to voluntarily control their attention have difficulties participating in exposure and/or do not progress in the exposure hierarchy, because the level of anxiety gets too high. This may subsequently lead to failure to learn that fear is not dangerous or even drop-out of CBT. Furthermore, a pronounced bias towards irrelevant negative information may take up so many resources that processing of important, relevant information is hampered, making it difficult to engage in goal-oriented behavior while experiencing anxiety.
Emotion regulation as predictor Novel theoretical frameworks emphasize that difficulties in emotion regulation are associated with the development and maintenance of anxiety disorders. Additionally, emotion regulation skills may be required to engage in and benefit from CBT. Furthermore, in an attempt to increase effectiveness, several newer treatments have included emotion regulation training in their treatments protocols.
The present study aims to examine attentional control and three facets of emotion regulation:
- awareness and understanding of emotions,
- acceptance of emotions, and
- the ability to engage in goal-directed behavior, and refrain from impulsive behavior, when experiencing negative emotions as general predictors of outcome in CBT for anxiety disorders in a naturalistic, community-based mental health setting.
Our secondary aim is to examine a theoretical variables (i.e., socio-demographic data and clinical characteristics, such as comorbidity) as predictors of CBT outcome, as these have yet to be examined as predictors in real-world clinical settings in a mixed anxious sample.
Investigators expect that low ability to control attention will be associated with poorer treatment outcome. Similarly, it is expected that high scores on emotion dysregulation will be related to poorer treatment outcome. Given the exploratory nature of this study we will also be interested in testing non-linear relationships.
Method In order to maximize external validity, investigators are conducting the study within two real-world treatment clinics and employing minimal exclusion criteria recruiting a sample with mixed principal anxiety disorders. Patients will be recruited from the two clinics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with anxiety disorders from outpatient clinics.
Key inclusion criteria (4 listed)
- meet the diagnostic criteria for an anxiety disorder (social anxiety, generalized anxiety, panic disorder and agoraphobia) as primary diagnosis whether first episode or recurrent
- are between 18 to 60 years of age
- provide written informed consent
- speak and understand Danish.
Key exclusion criteria (3 listed)
- cognitive disabilities (assessed with sub scales from Wechsler Adult Intelligence Scale Fourth-Edition, < 70)
- alcohol or substance abuse (assessed during the preliminary consultations)
- receiving any other psychotherapy during the study. Patients receiving medical treatment (e.g., antidepressants, Benzodiazepines) will also be included in the study and the treatment will be monitored closely.
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 therapyThe participants will receive 12-16 sessions of manualized group-based CBT with a maximum of 8 participants in each group. The therapists are trained psychiatrists, psychologists, or nurses under supervision. The treatment manuals are developed by mental health professionals in the Capital Region of Denmark. The treatment program includes traditional CBT components (e.g., psychoeducation, identification of thoughts and feelings, exposure, cognitive restructuring, and relapse prevention). | Behavioural | – |
Primary outcome
Beck Anxiety Inventory
Time frame: 9 months
Self-report questionnaire to assess level of anxiety symptoms.
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 1 May 2018.
- Derived from this study: PubMed 27016248Nielsen SK, Vangkilde S, Wolitzky-Taylor KB, Daniel SI, Hageman I. An investigation of general predictors for cognitive-behavioural therapy outcome for anxiety disorders in a routine clinical setting. BMJ Open. 2016 Mar 25;6(3):e010898. doi: 10.1136/bmjopen-2015-010898.
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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.
Sara KK Nielsen, MSc principal investigator
Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders, run by University of Copenhagen at 1 site in Denmark.
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 3 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 1 May 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 Denmark. 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?
Beck Anxiety Inventory (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02638363, which also lists 1 linked publication.
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 1 May 2018.