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

NCT ID: NCT01194765

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Anxiety Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioural Therapy

Group Type: EXPERIMENTAL

Distance-based Cognitive Behavioural Therapy

Intervention Type: OTHER

Participants will engage in cognitive behavioural therapy to treat high anxiety sensitivity. Treatment will be delivered over the telephone.

Waiting List

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Distance-based Cognitive Behavioural Therapy

Participants will engage in cognitive behavioural therapy to treat high anxiety sensitivity. Treatment will be delivered over the telephone.

Intervention Type: OTHER

Other Intervention Names

Psychotherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalhousie University

OTHER

Sponsor Role: lead

Responsible Party

Janine Olthuis

Clinical Psychology PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janine V Olthuis, BA (Honours)

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

DAL10-01

Identifier Type: -

Identifier Source: org_study_id