Generalized AnxietyNCT03015285

CBT for Anxiety Sensitivity vs. Disorder-specific CBT: An RCT

A study testing Cognitive Behavioural Therapy in people with Generalized Anxiety and Stress Disorder, Posttraumatic, run by Nova Scotia Health Authority.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Generalized Anxiety, Stress Disorder, Posttraumatic, Social Anxiety
What is being tested?: Cognitive Behavioural Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: No sites listed yet
Study dates: 5 Dec 2016to 18 Feb 2022
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 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Literate
High Anxiety Sensitivity (high AS, participants must score ≥23 on the Anxiety Sensitivity Index - 3)
Live in the surrounding area of Halifax, Nova Scotia or Fredericton, New Brunswick
Must have a primary diagnosis of one of Agoraphobia, Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), Other Specified Anxiety Disorder, Major Depressive Disorder (MDD), Posttraumatic Stress Disorder (PTSD), or Illness Anxiety Disorder (IAD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5; APA, 2013) as determined by a Structured Clinical Interview for DSM-5 Disorders

Who cannot join

Must not have any contraindications to physical exercise
Must not be engaged in another current psychotherapy as it may interfere with the treatment under investigation
Need to be able to attend intervention sessions at Dalhousie University or the University of New Brunswick
Must not have current Bipolar Disorder and psychosis nor current suicidal intent

About this study

Official title: Comparing the Efficacy of CBT for Anxiety Sensitivity to Disorder-specific CBT in Reducing Mental Health Symptoms: A Randomized Controlled Trial

Adults with high anxiety sensitivity (AS) and a mental health diagnosis of anxiety, depression, or posttraumatic stress will be recruited and will be randomly assigned to either transdiagnostic cognitive behavioural therapy (CBT) for AS or disorder-specific CBT for their primary mental health problem. The study outcomes - AS, anxiety, mood, and substance use symptoms, and functional impairment - will be assessed at pre-and post-treatment and 6 and 12 months post-treatment via standardized self-report measures completed by participants and a standardized diagnostic interview.

Read the detailed description

While our previous work has provided some evidence that cognitive behavioural therapy (CBT) for anxiety sensitivity(AS) reduces mental health symptoms, the current study aims to determine whether this treatment works as well as traditional disorder-specific CBT (which aims to treat the specific disorder a person presents with, such as CBT for panic disorder for someone with panic disorder) in treating anxiety and depression. This will be the first study to have looked at this question.

Our objectives are to determine:

if there is a difference in the extent to which CBT for AS vs. disorder-specific CBT reduces, in the short- and long-term, a) AS, b) symptoms of a person's primary and secondary mental health problems, and c) functional disability (i.e., a person's ability to function in day-to-day life);
if the two treatments lead to differences in the number of participants who no longer meet the requirements for a diagnosis (of their primary or secondary mental health problems) in the short- and long-term; and
if the treatments are seen as similarly satisfactory by participants.

Eligible participants will be randomly assigned (via online random number generator) to either transdiagnostic CBT for AS or disorder-specific CBT for their primary mental health problem. Both CBT interventions are evidence-based, guided by treatment manuals/workbooks (provided to participants), and involve 12 weekly therapy sessions. The AS intervention will also involve a physical exercise component (i.e., running/brisk walking 3x/week starting on week 5) and participants will be provided with a wearable fitness device designed to provide physiological indices of arousal and track physical activity. The study outcomes - AS, anxiety, mood, and substance use symptoms, and functional impairment - will be assessed at pre-and post-treatment and 6 and 12 months post-treatment via standardized self-report measures completed by participants and a standardized diagnostic interview.

Conditions: Generalized Anxiety, Stress Disorder, Posttraumatic, Social Anxiety, Major Depression, Panic Disorder
Being tested: Cognitive Behavioural Therapy
Medical subject headings: Generalized Anxiety Disorder, Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioural TherapyBehavioural
A type of talk therapy called cognitive behaviour therapy (CBT) will be delivered to both groups.

Study groups in NCT03015285
Study group	Role	What they receive
Anxiety Sensitivity Cognitive Therapy	Experimental	Participants in the Cognitive Behavioural Therapy for AS condition will complete 8 weekly 50-minute therapy sessions and will be asked to continue with some parts of the intervention (i.e., interoceptive exposure) independently for the next 4 weeks, with short weekly check-ins by phone with their therapist. Receives: Behavioral: Cognitive Behavioural Therapy
Disorder specific Cognitive Therapy	Active comparator	Participants in the disorder-specific Cognitive Behavioural Therapy intervention will receive 12 weekly 50-minute therapy sessions following established, evidence-based protocols for each of the disorders included in the study. Receives: Behavioral: Cognitive Behavioural Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in anxiety sensitivity: the Anxiety Sensitivity Index - 3 (ASI-3)
The ASI-3 is an 18-item self-report measure that indexes the amount of fear an individual experiences with respect to anxiety-related body sensations. Participants indicate the extent to which they agree or disagree with each item (e.g., "It scares me when my heart beats rapidly") on a 5-point Likert-type scale.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
Change in primary diagnosis (e.g., anxiety disorder or depression) symptoms
Primary diagnosis (e.g., anxiety disorder or depression) symptoms, as measured by a standardized score on one of the Panic Attack Questionnaire - IV, the Fear Questionnaire, the Generalized Anxiety Disorder - 7-item, the Liebowitz Social Anxiety Scale, the PTSD Checklist for DSM-5, the Pain Anxiety Symptom Scale - 20-item, or the Patient Health Questionnaire - 9-item.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Change in comorbid diagnosis (e.g., anxiety disorders or depression) symptoms
Comorbid diagnosis (e.g., anxiety disorder or depression) symptoms, as measured by a standardized score on one of the Panic Attack Questionnaire - IV, the Fear Questionnaire, the Generalized Anxiety Disorder - 7-item, the Liebowitz Social Anxiety Scale, the PTSD Checklist for DSM-5, the Pain Anxiety Symptom Scale - 20-item, or the Patient Health Questionnaire - 9-item.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.

Secondary outcomes (9)

Diagnostic status as measured by the Structured Clinical Interview for DSM-5 (SCID-5)
Administered by a trained researcher blind to treatment condition. The SCID-5 has been widely used in numerous research studies and is well empirically validated. At each time point, we will assess participants' primary and secondary diagnoses as well as the overall number of diagnoses for which they qualify.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
General distress as measured by the Depression Anxiety Stress Scale (DASS-21)
The Depression Anxiety Stress Scales - 21. The DASS-21 is a shortened version of the 42-item DASS and is composed of three subscales: Depression, Anxiety, and Stress. Individuals indicate the extent to which a particular negative emotional state (e.g., "I found it difficult to relax") has applied to them over the past week on a 4-point Likert-type scale (0 = Did not apply to me at all to 3 = Applied to me very much or most of the time).
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
General distress as measured by the Clinical Outcomes in Routine Evaluation measure (CORE-10)
Clinical Outcomes in Routine Evaluation (CORE-10) is a brief, 10-item self-report measure designed to assess common presentations of symptoms of psychological distress. Participants are asked to indicate how often in the past week they have felt a series of symptoms (e.g., "I have felt tense, anxious, or nervous") on a 5-point Likert-type scale.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Functional disability as measured by the Sheehan Disability Scale (SDS)
The Sheehan Disability Scale will be used to measure functional impairment in three domains: work/school, family life, and social. Using a 10-point visual analogue scale, participants rate the extent to which their general mental health symptoms disrupt their work/school, family life/responsibilities, and social life. Participants also indicate the number of days their mental health symptoms caused them to miss school/work as well as the number of days their symptoms had caused their performance to be reduced during the past week. The SDS is well-validated and widely used with a range of populations.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Drinking Motives as measured by the Modified Drinking Motives Questionnaire - Revised (MDMQ-R)
The MDMQ-R measures drinking motives. Respondents estimate how often they drink for the reason specified in each item on a 5-point Likert-type scale.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Hazardous alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Despite being designed as a screening tool, the AUDIT is commonly used to assess alcohol use problems pre- and post-treatment. The AUDIT is a 10-item self-report measure that asks participants to report on their frequency of alcohol use, binge drinking, and alcohol-dependent behaviours. Responses are scored on 5-point Likert-type scales. Finally, participants report if they have experienced problems caused by alcohol use on a 3-point Likert-type scale.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Alcohol-related problems as measured by the Short Inventory of Problems (SIP-2R)
The SIP-2R consists of the three items from each of five subscales. Participants are asked to indicate the frequency with which they have experienced each of 15 drinking-related problems on a 4-point Likert-type scale.
Measured: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Treatment alliance as measured by the Working Alliance Inventory - Short-form (WAI-SR)
The WAI-SR is a 12-item self-report questionnaire comprised of three subscales: Goals, or agreement on the goals of therapy, Tasks, or agreement on the tasks of therapy, and Bonds, or the bond between the therapist and the client. Participants indicate the extent to which each of these statements reflects their experience on a 5-point Likert-type scale.
Measured: Only at 12 weeks
Treatment satisfaction as measured by several short researcher-generated questions
In order to assess satisfaction with the different components of treatment, participants will answer a series of open-ended questions about their experience (e.g., "Was the treatment convenient for you to engage in?"; "Did you find the telephone therapy sessions helpful?") after all parts of treatment are completed (i.e., at 12 weeks).
Measured: Only at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201618 Feb 2022

First posted10 Jan 2017 (estimated)
Study start5 Dec 2016
Primary completion18 Feb 2022
Study completion18 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Generalized AnxietyStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03015285
Sponsor's protocol ID: 1021903
Status last verified: Aug 2024
First submitted: 19 Dec 2016
Last updated: 21 Aug 2024
Results posted: No
Data monitoring committee: No
Individual data sharing: No: Data will only be shared between investigators at the two study sites once it has been de-identified and entered into a data analytic program in order to protect participants' privacy and confidentiality.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Efficacy of CBT for Anxiety Sensitivity to Disorder-specific CBT in Reducing Mental Health Symptoms: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03015285
Acronym / sponsor ID: 1021903
Conditions: Generalized Anxiety, Stress Disorder, Posttraumatic, Social Anxiety, Major Depression, Panic Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Nova Scotia Health AuthorityUniversity, hospital or other
Collaborators: University of New Brunswick, Canadian Institutes of Health Research (CIHR), Dalhousie University
Study start: 5 Dec 2016 (actual)
Primary completion: 18 Feb 2022 (actual)
Study completion: 18 Feb 2022 (actual)
First posted: 10 Jan 2017 (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.

Detailed description

Our objectives are to determine:

if there is a difference in the extent to which CBT for AS vs. disorder-specific CBT reduces, in the short- and long-term, a) AS, b) symptoms of a person's primary and secondary mental health problems, and c) functional disability (i.e., a person's ability to function in day-to-day life);
if the two treatments lead to differences in the number of participants who no longer meet the requirements for a diagnosis (of their primary or secondary mental health problems) in the short- and long-term; and
if the treatments are seen as similarly satisfactory by participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Anxiety Sensitivity Cognitive Therapy	Experimental	Behavioral: Cognitive Behavioural TherapyParticipants in the Cognitive Behavioural Therapy for AS condition will complete 8 weekly 50-minute therapy sessions and will be asked to continue with some parts of the intervention (i.e., interoceptive exposure) independently for the next 4 weeks, with short weekly check-ins by phone with their therapist.
Disorder specific Cognitive Therapy	Active comparator	Behavioral: Cognitive Behavioural TherapyParticipants in the disorder-specific Cognitive Behavioural Therapy intervention will receive 12 weekly 50-minute therapy sessions following established, evidence-based protocols for each of the disorders included in the study.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Literate
High Anxiety Sensitivity (high AS, participants must score ≥23 on the Anxiety Sensitivity Index - 3)
Live in the surrounding area of Halifax, Nova Scotia or Fredericton, New Brunswick
Must have a primary diagnosis of one of Agoraphobia, Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), Other Specified Anxiety Disorder, Major Depressive Disorder (MDD), Posttraumatic Stress Disorder (PTSD), or Illness Anxiety Disorder (IAD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5; APA, 2013) as determined by a Structured Clinical Interview for DSM-5 Disorders

Key exclusion criteria (4 listed)

Must not have any contraindications to physical exercise
Must not be engaged in another current psychotherapy as it may interfere with the treatment under investigation
Need to be able to attend intervention sessions at Dalhousie University or the University of New Brunswick
Must not have current Bipolar Disorder and psychosis nor current suicidal intent

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 TherapyA type of talk therapy called cognitive behaviour therapy (CBT) will be delivered to both groups.	Behavioural	Anxiety Sensitivity Cognitive Therapy, Disorder specific Cognitive Therapy

Primary outcome

Change in anxiety sensitivity: the Anxiety Sensitivity Index - 3 (ASI-3)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
The ASI-3 is an 18-item self-report measure that indexes the amount of fear an individual experiences with respect to anxiety-related body sensations. Participants indicate the extent to which they agree or disagree with each item (e.g., "It scares me when my heart beats rapidly") on a 5-point Likert-type scale.
Change in primary diagnosis (e.g., anxiety disorder or depression) symptoms
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Primary diagnosis (e.g., anxiety disorder or depression) symptoms, as measured by a standardized score on one of the Panic Attack Questionnaire - IV, the Fear Questionnaire, the Generalized Anxiety Disorder - 7-item, the Liebowitz Social Anxiety Scale, the PTSD Checklist for DSM-5, the Pain Anxiety Symptom Scale - 20-item, or the Patient Health Questionnaire - 9-item.
Change in comorbid diagnosis (e.g., anxiety disorders or depression) symptoms
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
Comorbid diagnosis (e.g., anxiety disorder or depression) symptoms, as measured by a standardized score on one of the Panic Attack Questionnaire - IV, the Fear Questionnaire, the Generalized Anxiety Disorder - 7-item, the Liebowitz Social Anxiety Scale, the PTSD Checklist for DSM-5, the Pain Anxiety Symptom Scale - 20-item, or the Patient Health Questionnaire - 9-item.

9 secondary outcomes

Diagnostic status as measured by the Structured Clinical Interview for DSM-5 (SCID-5)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
General distress as measured by the Depression Anxiety Stress Scale (DASS-21)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
General distress as measured by the Clinical Outcomes in Routine Evaluation measure (CORE-10)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Functional disability as measured by the Sheehan Disability Scale (SDS)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Drinking Motives as measured by the Modified Drinking Motives Questionnaire - Revised (MDMQ-R)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Hazardous alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Alcohol-related problems as measured by the Short Inventory of Problems (SIP-2R)
Time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
Treatment alliance as measured by the Working Alliance Inventory - Short-form (WAI-SR)
Time frame: Only at 12 weeks
Treatment satisfaction as measured by several short researcher-generated questions
Time frame: Only at 12 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 21 Aug 2024.
Individual participant dataSharing planned: No. Data will only be shared between investigators at the two study sites once it has been de-identified and entered into a data analytic program in order to protect participants' privacy and confidentiality.

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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.

Margo Watt, PhD principal investigator

St. Francis Xavier University

Janine Olthuis, PhD principal investigator

University of New Brunswick

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioural Therapy in people with Generalized Anxiety and Stress Disorder, Posttraumatic, run by Nova Scotia Health Authority.

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 4 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 21 Aug 2024. 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 in anxiety sensitivity: the Anxiety Sensitivity Index - 3 (ASI-3) (time frame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.). 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?

On the ClinicalTrials.gov record for NCT03015285.

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 21 Aug 2024.