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Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial

Primary Purpose

Anxiety Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Distance-based Cognitive Behavioural Therapy
Sponsored by
Dalhousie University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years of age
  • high anxiety sensitivity

Exclusion Criteria:

  • 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

Sites / Locations

  • Dalhousie University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioural Therapy

Waiting List

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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

Full Information

First Posted
August 30, 2010
Last Updated
January 20, 2014
Sponsor
Dalhousie University
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1. Study Identification

Unique Protocol Identification Number
NCT01194765
Brief Title
Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial
Official Title
Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalhousie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Title
Waiting List
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Distance-based Cognitive Behavioural Therapy
Other Intervention Name(s)
Psychotherapy
Intervention Description
Participants will engage in cognitive behavioural therapy to treat high anxiety sensitivity. Treatment will be delivered over the telephone.
Primary Outcome Measure Information:
Title
Change from Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment
Description
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at post-treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from Pre-Treatment in Severity of Panic Symptoms at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Participants' Daily Functioning at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Participant Satisfaction with Treatment at Post-Treatment
Description
Participants' satisfaction with the treatment program and mode of treatment delivery will be assessed through a series of qualitative questions at post-treatment.
Time Frame
12 weeks
Title
Change from Pre-Treatment in in General Anxiety Symptoms at 8 Weeks
Description
Change from pre-treatment in participants' general anxiety symptoms, as measured by the Penn State Worry Questionnaire, will be assessed at 8 weeks.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Social Anxiety Symptoms at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Drinking Motives at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Frequency of Binge Drinking at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Alcohol Expectancies at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Anxiety Sensitivity Level at 8 weeks
Description
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at 8 weeks.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Anxiety Sensitivity Level at Follow-up
Description
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at follow-up.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Severity of Panic Symptoms at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Frequency and Intensity of Physical Exercise at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in in General Anxiety Symptoms at Post-Treatment
Description
Change from pre-treatment in participants' general anxiety symptoms, as measured by the Penn State Worry Questionnaire, will be assessed at post-treatment.
Time Frame
12 weeks
Title
Change from Pre-Treatment in in General Anxiety Symptoms at Follow-up
Description
Change from pre-treatment in participants' general anxiety symptoms, as measured by the Penn State Worry Questionnaire, will be assessed at follow-up.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Frequency of Depressive Symptoms at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change from Pre-Treatment in Frequency of Depressive Symptoms at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Frequency of Depressive Symptoms at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Social Anxiety Symptoms at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Social Anxiety Symptoms at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Drinking Motives at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Drinking Motives at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Frequency of Binge Drinking at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Frequency of Binge Drinking at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Alcohol Expectancies at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Alcohol Expectancies at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Participants' Daily Functioning at Post-Treatment
Description
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.
Time Frame
12 weeks
Title
Change from Pre-Treatment in Participants' Daily Functioning at Follow-up
Description
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.
Time Frame
20 weeks
Title
Change from Pre-Treatment in Neuroticism at Post-Treatment
Description
Changes from pre-treatment in participants' level of neuroticism as measured by the NEO Five Factor Inventory - Neuroticism subscale
Time Frame
12 weeks
Title
Changes from Pre-Treatment in Neuroticism at 8 weeks
Description
Changes from pre-treatment in participants' level of neuroticsm, as measured by the NEO Five Factor Inventory - Neuroticism subscale, at 8 weeks
Time Frame
8 weeks
Title
Change from Pre-Treatment in Neuroticism at Follow-up
Description
Change from pre-treatment in participants' level of neuroticism, as measured by the NEO Five Factor Inventory - Neuroticism subscale, at follow-up
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years of age high anxiety sensitivity Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janine V Olthuis, BA (Honours)
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4J1
Country
Canada

12. IPD Sharing Statement

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Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial

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