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

NCT01194765 | Completed

• 1 other identifier: DAL10-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (39)

• Change from Pre-Treatment in Severity of Panic Symptoms at 8 Weeks

  8 weeks

• Change from Pre-Treatment in Participants' Daily Functioning at 8 Weeks

  8 weeks

• Participant Satisfaction with Treatment at Post-Treatment

  12 weeks

• Change from Pre-Treatment in in General Anxiety Symptoms at 8 Weeks

  8 weeks

• Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at 8 Weeks

  8 weeks

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

Other: Distance-based Cognitive Behavioural Therapy

Waiting List

NO INTERVENTION

Interventions

Distance-based Cognitive Behavioural Therapy OTHER

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

Also known as: Psychotherapy

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age
• high anxiety sensitivity

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 4J1, Canada

Location

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Janine V Olthuis, BA (Honours)

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychology PhD Candidate

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 3, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

CA (1)