Anxiety SensitivityNCT01194765
Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial
A study testing Distance-based Cognitive Behavioural Therapy in people with Anxiety Sensitivity, run by Dalhousie University at 1 site in Canada.
Trial summary
Anxiety disorders are common pervasive conditions with serious psychosocial implications. Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the onset and maintenance of anxiety disorders (Schmidt et al., 1999). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Sensitivity
- What is being tested?
- Distance-based Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- high anxiety sensitivity
Who cannot join
- cannot speak English
- illiteracy
- poor physical health (i.e., inadvisable to participate in physical exercise)
- engaged in another form of psychotherapy
- using pharmacotherapy for less than 3 months
- anyone who changes dose or type of pharmacotherapy during study
- psychosis
- suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Anxiety disorders are common pervasive conditions with serious psychosocial implications. Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of anxiety-related arousal sensations (i.e., increased heart rate) that arises from the tendency to interpret these sensations catastrophically, believing that they will have serious physical, psychological, or social consequences (Reiss, 1991).
Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et al., 2006). Unfortunately, access to effective psychological treatments is limited by a number of barriers such as a lack of treatment availability or qualified clinicians in an area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of a distance-based CBT program on decreasing AS among those with high AS. A distance delivery approach (e.g., via telephone) is one way to minimize treatment barriers and increase access to care while still delivering empirically supported treatment. Recent research suggests distance delivery is promising (Lovell et al., 2006).
The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's (2008) brief CBT for AS. The program will include weekly modules on psychoeducation, cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with high AS will be recruited and randomly assigned to the treatment condition or wait-list control (after twelve weeks the wait-list group will receive treatment). In the treatment condition, participants will be assigned weekly reading and homework from the treatment manual. In addition, a therapist will guide them through the treatment by providing individualized support and feedback through weekly half-hour telephone sessions. Treatment outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be assessed. We hypothesize that this treatment program will be effective in reducing high AS and anxiety symptom frequency and severity. We also expect this project to yield information about the utility of distance treatment delivery for mental health care.
- Conditions
- Anxiety Sensitivity
- Being tested
- Distance-based Cognitive Behavioural Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance-based Cognitive Behavioural TherapyOther
Also called Psychotherapy
Participants will engage in cognitive behavioural therapy to treat high anxiety sensitivity. Treatment will be delivered over the telephone.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Not described Receives: Other: Distance-based Cognitive Behavioural Therapy |
| Waiting List | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at post-treatment.
Measured: 12 weeks
Secondary outcomes (39)
Change from Pre-Treatment in Severity of Panic Symptoms at 8 Weeks
Change from pre-treatment in participants' severity of panic symptoms, as measured by sections of the Panic Attack Questionnaire - IV, will be measured at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Participants' Daily Functioning at 8 Weeks
Change from pre-treatment in the amount that participants' symptoms interfere with their daily functioning, as measured by the Sheehan Disability Scale, will be assessed at 8 weeks.
Measured: 8 weeks
Participant Satisfaction with Treatment at Post-Treatment
Participants' satisfaction with the treatment program and mode of treatment delivery will be assessed through a series of qualitative questions at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in in General Anxiety Symptoms at 8 Weeks
Change from pre-treatment in participants' general anxiety symptoms, as measured by the Penn State Worry Questionnaire, will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at 8 Weeks
Change from pre-treatment in participants' frequency of pain-related anxiety symptoms, as measured by the Pain Anxiety Symptom Scale - 20, will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Social Anxiety Symptoms at 8 Weeks
Change from pre-treatment in participants' level of social anxiety symptoms and amount of avoidance of social situations, as measured by the Liebowitz Social Anxiety Scale, will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at 8 weeks
For those participants who identify posttraumatic stress symptoms pre-treatment, any change in the frequency or severity of these symptoms from pre-treatment to 8 weeks will be assessed using the Modified PTSD Symptom Scale.
Measured: 8 weeks
Change from Pre-Treatment in Drinking Motives at 8 weeks
Change from pre-treatment in participants' drinking motives (reasons for engaging in alcohol use, e.g., social, conformity, coping, or enhancement motives) at 8 weeks, as measured by the Modified Drinking Motives Questionnaire Revised, will be assessed.
Measured: 8 weeks
Change from Pre-Treatment in Frequency of Binge Drinking at 8 weeks
Change from pre-treatment in participants' frequency of binge drinking (i.e., the number of times they imbibe 4 or more drinks within 2 hours for women or 5 or more drinks within 2 hours for men) will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at 8 Weeks
Change from pre-treatment in the quantity and frequency of negative alcohol-related consequences experienced by participants' at 8 weeks, as measured by the Short Inventory of Problems, will be assessed.
Measured: 8 weeks
Change from Pre-Treatment in Alcohol Expectancies at 8 Weeks
Change from pre-treatment in participants' endorsement of relief and reward alcohol expectancies, as measured by the Alcohol Craving Questionnaire, will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Anxiety Sensitivity Level at 8 weeks
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Anxiety Sensitivity Level at Follow-up
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Severity of Panic Symptoms at Post-Treatment
Change from pre-treatment in participants' severity of panic symptoms, as measured by sections of the Panic Attack Questionnaire - IV, will be measured at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Frequency and Intensity of Physical Exercise at Follow-up
Change from pre-treatment in participants' frequency of low-, moderate- and vigorous intensity physical exercise, as measured by the Physical Activity Measure - Modified version, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in in General Anxiety Symptoms at Post-Treatment
Change from pre-treatment in participants' general anxiety symptoms, as measured by the Penn State Worry Questionnaire, will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in in General Anxiety Symptoms at Follow-up
Change from pre-treatment in participants' general anxiety symptoms, as measured by the Penn State Worry Questionnaire, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Post-Treatment
Change from pre-treatment in participants' frequency of pain-related anxiety symptoms, as measured by the Pain Anxiety Symptom Scale - 20, will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Follow-up
Change from pre-treatment in participants' frequency of pain-related anxiety symptoms, as measured by the Pain Anxiety Symptom Scale - 20, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Frequency of Depressive Symptoms at 8 Weeks
Change from pre-treatment in participants' frequency of depressive symptoms, as measured by the Depression Anxiety Stress Scales - 20, will be assessed at 8 weeks.
Measured: 8 weeks
Change from Pre-Treatment in Frequency of Depressive Symptoms at Post-Treatment
Change from pre-treatment in participants' frequency of depressive symptoms, as measured by the Depression Anxiety Stress Scales - 20, will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Frequency of Depressive Symptoms at Follow-up
Change from pre-treatment in participants' frequency of depressive symptoms, as measured by the Depression Anxiety Stress Scales - 20, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Social Anxiety Symptoms at Post-Treatment
Change from pre-treatment in participants' level of social anxiety symptoms and amount of avoidance of social situations, as measured by the Liebowitz Social Anxiety Scale, will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Social Anxiety Symptoms at Follow-up
Change from pre-treatment in participants' level of social anxiety symptoms and amount of avoidance of social situations, as measured by the Liebowitz Social Anxiety Scale, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Post-Treatment
For those participants who identify posttraumatic stress symptoms pre-treatment, any change in the frequency or severity of these symptoms from pre-treatment to post-treatment will be assessed using the Modified PTSD Symptom Scale.
Measured: 12 weeks
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Follow-up
For those participants who identify posttraumatic stress symptoms pre-treatment, any change in the frequency or severity of these symptoms from pre-treatment to follow-up will be assessed using the Modified PTSD Symptom Scale.
Measured: 20 weeks
Change from Pre-Treatment in Drinking Motives at Post-Treatment
Change from pre-treatment in participants' drinking motives (reasons for engaging in alcohol use, e.g., social, conformity, coping, or enhancement motives) at post-treatment, as measured by the Modified Drinking Motives Questionnaire Revised, will be assessed.
Measured: 12 weeks
Change from Pre-Treatment in Drinking Motives at Follow-up
Change from pre-treatment in participants' drinking motives (reasons for engaging in alcohol use, e.g., social, conformity, coping, or enhancement motives) at follow-up, as measured by the Modified Drinking Motives Questionnaire Revised, will be assessed.
Measured: 20 weeks
Change from Pre-Treatment in Frequency of Binge Drinking at Post-Treatment
Change from pre-treatment in participants' frequency of binge drinking (i.e., the number of times they imbibe 4 or more drinks within 2 hours for women or 5 or more drinks within 2 hours for men) will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Frequency of Binge Drinking at Follow-up
Change from pre-treatment in participants' frequency of binge drinking (i.e., the number of times they imbibe 4 or more drinks within 2 hours for women or 5 or more drinks within 2 hours for men) will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Post-Treatment
Change from pre-treatment in the quantity and frequency of negative alcohol-related consequences experienced by participants' at post-treatment, as measured by the Short Inventory of Problems, will be assessed.
Measured: 12 weeks
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Follow-up
Change from pre-treatment in the quantity and frequency of negative alcohol-related consequences experienced by participants' at follow-up, as measured by the Short Inventory of Problems, will be assessed.
Measured: 20 weeks
Change from Pre-Treatment in Alcohol Expectancies at Post-Treatment
Change from pre-treatment in participants' endorsement of relief and reward alcohol expectancies, as measured by the Alcohol Craving Questionnaire, will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Alcohol Expectancies at Follow-up
Change from pre-treatment in participants' endorsement of relief and reward alcohol expectancies, as measured by the Alcohol Craving Questionnaire, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Participants' Daily Functioning at Post-Treatment
Change from pre-treatment in the amount that participants' symptoms interfere with their daily functioning, as measured by the Sheehan Disability Scale, will be assessed at post-treatment.
Measured: 12 weeks
Change from Pre-Treatment in Participants' Daily Functioning at Follow-up
Change from pre-treatment in the amount that participants' symptoms interfere with their daily functioning, as measured by the Sheehan Disability Scale, will be assessed at follow-up.
Measured: 20 weeks
Change from Pre-Treatment in Neuroticism at Post-Treatment
Changes from pre-treatment in participants' level of neuroticism as measured by the NEO Five Factor Inventory - Neuroticism subscale
Measured: 12 weeks
Changes from Pre-Treatment in Neuroticism at 8 weeks
Changes from pre-treatment in participants' level of neuroticsm, as measured by the NEO Five Factor Inventory - Neuroticism subscale, at 8 weeks
Measured: 8 weeks
Change from Pre-Treatment in Neuroticism at Follow-up
Change from pre-treatment in participants' level of neuroticism, as measured by the NEO Five Factor Inventory - Neuroticism subscale, at follow-up
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SensitivityStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janine Olthuis, Dalhousie University
- Investigators
- Janine V Olthuis, BA (Honours), Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194765
- Sponsor's protocol ID
- DAL10-01
- Status last verified
- Jan 2014
- First submitted
- 30 Aug 2010
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01194765
- Acronym / sponsor ID
- DAL10-01
- Conditions
- Anxiety Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Sep 2010 (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.
Anxiety disorders are common pervasive conditions with serious psychosocial implications. Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of anxiety-related arousal sensations (i.e., increased heart rate) that arises from the tendency to interpret these sensations catastrophically, believing that they will have serious physical, psychological, or social consequences (Reiss, 1991).
Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et al., 2006). Unfortunately, access to effective psychological treatments is limited by a number of barriers such as a lack of treatment availability or qualified clinicians in an area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of a distance-based CBT program on decreasing AS among those with high AS. A distance delivery approach (e.g., via telephone) is one way to minimize treatment barriers and increase access to care while still delivering empirically supported treatment. Recent research suggests distance delivery is promising (Lovell et al., 2006).
The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's (2008) brief CBT for AS. The program will include weekly modules on psychoeducation, cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with high AS will be recruited and randomly assigned to the treatment condition or wait-list control (after twelve weeks the wait-list group will receive treatment). In the treatment condition, participants will be assigned weekly reading and homework from the treatment manual. In addition, a therapist will guide them through the treatment by providing individualized support and feedback through weekly half-hour telephone sessions. Treatment outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be assessed. We hypothesize that this treatment program will be effective in reducing high AS and anxiety symptom frequency and severity. We also expect this project to yield information about the utility of distance treatment delivery for mental health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Other: Distance-based Cognitive Behavioural Therapy |
| Waiting List | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- high anxiety sensitivity
Key exclusion criteria (8 listed)
- cannot speak English
- illiteracy
- poor physical health (i.e., inadvisable to participate in physical exercise)
- engaged in another form of psychotherapy
- using pharmacotherapy for less than 3 months
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 |
|---|---|---|
| Distance-based Cognitive Behavioural TherapyAlso: PsychotherapyParticipants will engage in cognitive behavioural therapy to treat high anxiety sensitivity. Treatment will be delivered over the telephone. | Other | Cognitive Behavioural Therapy |
Primary outcome
Change from Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment
Time frame: 12 weeks
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at post-treatment.
39 secondary outcomes
Change from Pre-Treatment in Severity of Panic Symptoms at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Participants' Daily Functioning at 8 Weeks
Time frame: 8 weeks
Participant Satisfaction with Treatment at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in in General Anxiety Symptoms at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Social Anxiety Symptoms at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at 8 weeks
Time frame: 8 weeks
Change from Pre-Treatment in Drinking Motives at 8 weeks
Time frame: 8 weeks
Change from Pre-Treatment in Frequency of Binge Drinking at 8 weeks
Time frame: 8 weeks
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Alcohol Expectancies at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Anxiety Sensitivity Level at 8 weeks
Time frame: 8 weeks
Change from Pre-Treatment in Anxiety Sensitivity Level at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Severity of Panic Symptoms at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Frequency and Intensity of Physical Exercise at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in in General Anxiety Symptoms at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in in General Anxiety Symptoms at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Frequency of Depressive Symptoms at 8 Weeks
Time frame: 8 weeks
Change from Pre-Treatment in Frequency of Depressive Symptoms at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Frequency of Depressive Symptoms at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Social Anxiety Symptoms at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Social Anxiety Symptoms at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Drinking Motives at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Drinking Motives at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Frequency of Binge Drinking at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Frequency of Binge Drinking at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Alcohol Expectancies at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Alcohol Expectancies at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Participants' Daily Functioning at Post-Treatment
Time frame: 12 weeks
Change from Pre-Treatment in Participants' Daily Functioning at Follow-up
Time frame: 20 weeks
Change from Pre-Treatment in Neuroticism at Post-Treatment
Time frame: 12 weeks
Changes from Pre-Treatment in Neuroticism at 8 weeks
Time frame: 8 weeks
Change from Pre-Treatment in Neuroticism at Follow-up
Time frame: 20 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 22 Jan 2014.
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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.
Janine V Olthuis, BA (Honours) principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distance-based Cognitive Behavioural Therapy in people with Anxiety Sensitivity, run by Dalhousie University 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 2 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 22 Jan 2014. 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 Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment (time frame: 12 weeks). 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 22 Jan 2014.