Clinical trial NCT01194765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Sensitivity
Lead sponsor: Dalhousie University
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from Pre-Treatment in Severity of Panic Symptoms at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Participants' Daily Functioning at 8 Weeks
timeFrame: 8 weeks
measure: Participant Satisfaction with Treatment at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in in General Anxiety Symptoms at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Social Anxiety Symptoms at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at 8 weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Drinking Motives at 8 weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Frequency of Binge Drinking at 8 weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Alcohol Expectancies at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Anxiety Sensitivity Level at 8 weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Anxiety Sensitivity Level at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Severity of Panic Symptoms at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Frequency and Intensity of Physical Exercise at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in in General Anxiety Symptoms at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in in General Anxiety Symptoms at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Frequency of Depressive Symptoms at 8 Weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Frequency of Depressive Symptoms at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Frequency of Depressive Symptoms at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Social Anxiety Symptoms at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Social Anxiety Symptoms at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Drinking Motives at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Drinking Motives at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Frequency of Binge Drinking at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Frequency of Binge Drinking at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Alcohol Expectancies at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Alcohol Expectancies at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Participants' Daily Functioning at Post-Treatment
timeFrame: 12 weeks
measure: Change from Pre-Treatment in Participants' Daily Functioning at Follow-up
timeFrame: 20 weeks
measure: Change from Pre-Treatment in Neuroticism at Post-Treatment
timeFrame: 12 weeks
measure: Changes from Pre-Treatment in Neuroticism at 8 weeks
timeFrame: 8 weeks
measure: Change from Pre-Treatment in Neuroticism at Follow-up
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Janine V Olthuis, BA (Honours)
role: PRINCIPAL_INVESTIGATOR
References: