The Effect of Cognitive Restructuring Before Exposure for Claustrophobia on Expectancy and Outcome

NCT ID: NCT03628105

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2019-11-15

Brief Summary

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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

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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.

Conditions

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CR Before:Engaging in Cognitive Intervention Before Exposure CR After:Engaging in Cognitive Intervention After Exposure

Keywords

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Anxiety Specific Phobia Claustrophobia Exposure Cognitive therapy Cognitive restructuring Consolidation Inhibitory learning Expectancy violation Expectancy Exposure therapy Anxiety disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CR Before Exposure

Participants in this arm will receive 15 minutes of CR (preparation) before engaging in exposure and will complete the 15-minute questionnaire filler task after exposure.

Group Type EXPERIMENTAL

CR Before Exposure

Intervention Type BEHAVIORAL

Participants complete 15 minutes of CR (Preparation) using the "evidence technique" outlined in the cognitive-behavioral manual Mind Over Mood (Greenberger \& Padesky, 2016). This technique involves evaluating the validity of expected feared outcomes. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Finally, participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted after exposure in the other arm of the study.

CR After Exposure

Participants in this arm will complete the 15-minute questionnaire filler task before exposure and receive 15 minutes of CR (consolidation) after engaging in exposure.

Group Type EXPERIMENTAL

CR After Exposure

Intervention Type BEHAVIORAL

Participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted before exposure in the other arm of the study. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Then, participants complete 15 minutes of CR (Consolidation, Craske et al.'s, 2014) by calculating the difference between predicted and actual expected feared outcomes, and identifying identify (1) whether they believe their feared outcomes occurred (Yes/No), (2) describe how they know this to be true, and (3) reflect on what they learned about their feared outcome or expectancy through exposure.

Interventions

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CR Before Exposure

Participants complete 15 minutes of CR (Preparation) using the "evidence technique" outlined in the cognitive-behavioral manual Mind Over Mood (Greenberger \& Padesky, 2016). This technique involves evaluating the validity of expected feared outcomes. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Finally, participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted after exposure in the other arm of the study.

Intervention Type BEHAVIORAL

CR After Exposure

Participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted before exposure in the other arm of the study. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Then, participants complete 15 minutes of CR (Consolidation, Craske et al.'s, 2014) by calculating the difference between predicted and actual expected feared outcomes, and identifying identify (1) whether they believe their feared outcomes occurred (Yes/No), (2) describe how they know this to be true, and (3) reflect on what they learned about their feared outcome or expectancy through exposure.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirstyn L. Krause

OTHER

Sponsor Role lead

Responsible Party

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Kirstyn L. Krause

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kirstyn L Krause, MA

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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Ryerson University

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 18005936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24864005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19892318 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35156404 (View on PubMed)

Other Identifiers

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REB 2018-161

Identifier Type: -

Identifier Source: org_study_id