Clinical trial NCT03628105: The Effect of Cognitive Restructuring Before Exposure for Claustrophobia on Expectancy and Outcome
Official title: The Effect of Cognitive Restructuring Before Exposure for Claustrophobia on Expectancy and Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CR Before:Engaging in Cognitive Intervention Before Exposure
CR After:Engaging in Cognitive Intervention After Exposure
Keywords: Anxiety
Specific Phobia
Claustrophobia
Exposure
Cognitive therapy
Cognitive restructuring
Consolidation
Inhibitory learning
Expectancy violation
Expectancy
Exposure therapy
Anxiety disorder
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 97
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will complete baseline pretreatment outcome measures at the first visit to the lab. All participants will watch the same psychoeducation video explaining the nature of anxiety and rationale for exposure therapy. Participants will then be randomly assigned to either the CR Before condition or the CR After condition. CR Before will complete 15 minutes of CR (Preparation) before engaging in six 5-minute exposure trials in a claustrophobic chamber, and complete the 15-minute filler task after exposure. CR After will complete the 15-minute filler task before exposure, engage in six 5-minute exposure trials in a claustrophobic chamber, and engage in 15 minutes of CR (Consolidation) after exposure. Participants will complete posttreatment outcome measures immediately following the intervention. Participants will return one month later to complete followup outcome measures.
Primary purpose: TREATMENT

Brief summary: Whether used alone or in combination with other approaches, strategies such as cognitive restructuring (CR) and exposure are well-established treatments for anxiety. CR involves identifying and challenging thoughts, beliefs, or assumptions that maintain anxiety, and exposure involves confronting feared situations, typically in a gradual manner. Many theories have been proposed to explain why exposure is effective. One theory posits that corrective learning occurs only when expectations about the outcome of a situation are violated. Therefore, exposure is thought to be effective when the discrepancy between the expected and actual outcome is maximized. One group of researches has suggested that engaging in CR prior to exposure will prematurely reduce the discrepancy between expectancy and outcome, resulting in less inhibitory learning. As such, they recommend that CR only be conducted after exposure in order to consolidate learning about expectancy violation. This recommendation has not been experimentally studied and is in contrast to what is typically practiced clinically. CR is often introduced in therapy prior to exposure. The present study will determine whether conducting CR before exposure results in (1) greater initial reductions in expectation following CR before exposure, (2) less expectancy violation, and (3) poorer treatment gains at posttreatment and 1-month followup. Eighty-two participants with claustrophobia will be randomly assigned to receive either CR before exposure or CR after exposure. The intervention will be conducted in a single session.

Detailed description: Inhibitory learning is the extinction of a behavioral response through repeated presentations of a conditioned stimulus (CS) in the absence of an unconditioned stimulus (US, CS-noUS). The CS first elicits a behavioral response through excitatory learning - repeated pairing with the US that naturally elicits the same behavioral response (CS-US). One way that inhibitory learning can be maximized in exposure is by violating one's expectancy about CS-US relationship, such that the individual is surprised by the outcome (e.g., CS-noUS). The purpose of the present study is to evaluate the recommendation to avoid cognitive interventions before exposure. Specifically, the aim is to discover whether cognitive interventions before exposure prematurely reduce expected feared outcome ratings, leading to smaller expectancy violation and poorer inhibitory learning (i.e., exposure session or intervention gains) compared to conducting exposures with a consolidation period following exposure.

Eligibility criteria: Inclusion Criteria:

1. Self-reported proficiency in English language.
2. High claustrophobic fear as demonstrated by:

   1. Self-report of moderate anxiety (score of at least 2 out of 4) if participant had to lie down in small dark chamber without windows for several minutes.
   2. Endorsement of claustrophobia according to the DSM-5 criteria for Specific Phobia, with or without Criterion F.
   3. Exiting of wooden claustrophobic chamber before 2 minutes have passed, or self-reported fear rating at or exceeding 50/100 fear while in the chamber.

Exclusion Criteria:

1. Current or past cognitive behavioral therapy (i.e., cognitive therapy, exposure) for claustrophobia or anxiety and related disorders in the past year
2. Change in dose of psychotropic medication in the past 3 months.
3. Use of benzodiazepine more frequently than once per week in the past 3 months.
4. Diagnosis of current (past month) panic disorder or agoraphobia.
5. Claustrophobia due to or worsened by current (past month) posttraumatic stress disorder (PTSD).
6. Participants with current (past month) diagnosis of severe depression, bipolar disorder, alcohol/substance use, or psychosis.
7. Presence of imminent suicidality or homicidality.
8. Self-reported medical condition that may make it dangerous for participant to experience heightened emotions or arousal (e.g., heart condition/disease, respiratory problem, asthma triggered by intense emotion/arousal).
9. Participation in professional treatment for claustrophobia between the end of the first lab meeting and the 1-month follow-up (Note: This does not include self-help exposure practice).
10. Weight or height exceeding maximum capacity of claustrophobic chamber (e.g., weight over 250 lbs, height over 6 feet 5 inches).

Primary outcomes:
measure: Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Behavioral Approach at posttreatment and 1-month follow-up
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Peak Fear at posttreatment and 1-month follow-up
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Change from pretreatment (i.e., baseline) self-reported claustrophobic anxiety as measured by Claustrophobia Questionnaire: Total score at posttreatment and 1-month follow-up
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
Secondary outcomes:
measure: Behavioral Approach Test (BAT): Urge to Escape
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Self-reported Suffocation Anxiety as measured by the Claustrophobia Questionnaire: Suffocation subscale
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Self-reported Restriction Anxiety as measured by the Claustrophobia Questionnaire: Restriction subscale
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Self-reported Fear of Suffocation as measured by the Claustrophobia General Cognitions Questionnaire: Suffocation subscale
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Self-reported Fear of Inability to Escape as measured by the Claustrophobia General Cognitions Questionnaire: Inability to Escape subscale
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Self-reported Fear of Loss of Control as measured by the Claustrophobia General Cognitions Questionnaire: Loss of control subscale
timeFrame: Administered before the intervention on day 1 (pretreatment), immediately after the intervention on day 1 (posttreatment, same day as pretreatment) and at 1-month follow-up.
measure: Expected Feared Outcome: Personal
timeFrame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Expected Feared Outcome: Suffocation
timeFrame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Expected Feared Outcome: Restriction
timeFrame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Expected Feared Outcome: Peak Fear
timeFrame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Expected Feared Outcome: Urge to Escape
timeFrame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Perceived Actual Outcome: Peak Fear
timeFrame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Perceived Actual Outcome: Urge to Escape
timeFrame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Mean Expectancy Violation: Personal
timeFrame: Mean of 6 Expectancy Violation: Personal change scores calculated on day 1 during the intervention.
measure: Mean Expectancy Violation: Suffocation
timeFrame: Mean of 6 Expectancy Violation: Suffocation change scores calculated on day 1 during the intervention.
measure: Mean Expectancy Violation: Restriction
timeFrame: Mean of 6 Expectancy Violation: Restriction change scores calculated on day 1 during the intervention.
Other outcomes:
measure: Self-reported depression, anxiety, and stress as measured by the Depression Anxiety Stress Scales (21-item version)
timeFrame: Administered once on day 1 at pretreatment.
measure: Treatment expectancy and credibility as measured by the Credibility/Expectancy Questionnaire
timeFrame: Administered once on day 1 during the intervention.
measure: Perceived Actual Outcome: Personal
timeFrame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Perceived Actual Outcome: Suffocation
timeFrame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Perceived Actual Outcome: Restriction
timeFrame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
measure: Expectancy Violation: Personal
timeFrame: Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
measure: Expectancy Violation: Suffocation
timeFrame: Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
measure: Expectancy Violation: Restriction
timeFrame: Change score calculated using expected feared outcome and perceived actual outcome ratings completed 6 times (for each of the 6 exposure trials) on day 1 during the intervention.
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Kirstyn L Krause, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craske MG, Kircanski K, Zelikowsky M, Mystkowski J, Chowdhury N, Baker A. Optimizing inhibitory learning during exposure therapy. Behav Res Ther. 2008 Jan;46(1):5-27. doi: 10.1016/j.brat.2007.10.003. Epub 2007 Oct 7.
citation: Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014 Jul;58:10-23. doi: 10.1016/j.brat.2014.04.006. Epub 2014 May 9.
citation: Deacon BJ, Sy JT, Lickel JJ, Nelson EA. Does the judicious use of safety behaviors improve the efficacy and acceptability of exposure therapy for claustrophobic fear? J Behav Ther Exp Psychiatry. 2010 Mar;41(1):71-80. doi: 10.1016/j.jbtep.2009.10.004. Epub 2009 Oct 24.
citation: Krause KL, Koerner N, Antony MM. Cognitive Restructuring Before Versus After Exposure: Effect on Expectancy and Outcome in Individuals With Claustrophobia. Behav Modif. 2022 Nov;46(6):1432-1459. doi: 10.1177/01454455221075754. Epub 2022 Feb 12.