Clinical trial NCT04259190: A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure
Official title: Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety Sensitivity
Keywords: anxiety sensitivity
panic
interoceptive exposure
exposure therapy
values
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
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: The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.

Detailed description: Cognitive behavioral models of panic disorder maintain that recurrent, unexpected panic attacks result from anxiety sensitivity, or the fear of anxiety-related physiological sensations (e.g., fear of increased heart rate) and catastrophic misinterpretations regarding the danger of those sensations (e.g., misinterpreting increased heart rate as an oncoming heart attack). From these models and subsequent clinical research, interoceptive exposure has emerged as the most efficacious component of cognitive behavioral therapy for panic disorder treatment and, as expected, an efficacious intervention for decreasing anxiety sensitivity. Nevertheless, small-to-moderate effect sizes, wide variability in response rates and dropout rates indicated that panic disorder treatments may benefit from modifications to improve upon retention, response rates, and symptom reduction.

Patient motivation and lack of engagement have been identified as factors to intervene upon. Numerous therapeutic techniques have been used to facilitate patient motivation in treatment; however, one specific direction that has gained increasing empirical interest is the inclusion of values identification. Values have been incorporated as a motivational component in empirically supported behavioral techniques and treatments, including Motivational Interviewing, Behavioral Activation Treatment for Depression packages, and Acceptance and Commitment Therapy. Evidence from randomized controlled trials have generally supported the inclusion of packages containing values components in facilitating exposure therapy, and preliminary evidence has specifically favored the inclusion of packages containing values components in exposure therapy in cognitive behavioral therapy for panic disorder. However, there is no research known by the author that examines the influence of values on motivation in interoceptive exposure. Therefore, research examining the effect of a values component in isolation motivation in and acceptability of interoceptive exposure exercises has the potential to further improve treatment efficacy reducing costs associated with panic disorder and the many other conditions treated by interoceptive exposure. Therefore, the purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention among a clinical analogue sample with elevated anxiety sensitivity.

Eligibility criteria: Inclusion Criteria:

* Score ≥ 23 on the Anxiety Sensitivity Index - 3 (ASI-3)

Exclusion Criteria:

* Seizures
* Hypertension
* Heart problems
* Current pregnancy
* Asthma
* Other health conditions exacerbated by intense exercise

Primary outcomes:
measure: Willingness to tolerate distress
timeFrame: change from pre-intervention to immediately post-intervention
Secondary outcomes:
measure: Straw breathing BAT peak fear ratings
timeFrame: pre-intervention
measure: Overbreathing BAT peak fear ratings
timeFrame: immediately post-intervention
measure: Between trial fear ratings
timeFrame: change from pre-intervention to immediately post-intervention
measure: Anxiety Sensitivity Index - 3 (ASI-3)
timeFrame: change from pre-intervention to immediately post-intervention
measure: Albany Panic and Phobia Questionnaire (APPQ)
timeFrame: change from pre-intervention to immediately post-intervention
measure: Between trial tolerability ratings
timeFrame: change from pre-intervention to immediately post-intervention
measure: Treatment Acceptability Questionnaire
timeFrame: immediately post-intervention
Other outcomes:
Locations:
city: University
country: United States
facility: University of Mississippi
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gina Boullion, M.S.
role: PRINCIPAL_INVESTIGATOR
References: