CR Before:Engaging in Cognitive Intervention Before ExposureNCT03628105
The Effect of Cognitive Restructuring Before Exposure for Claustrophobia on Expectancy and Outcome
A study testing CR Before Exposure and CR After Exposure in people with CR Before:Engaging in Cognitive Intervention Before Exposure and CR After:Engaging in Cognitive Intervention After Exposure, run by Kirstyn L. Krause at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- CR Before:Engaging in Cognitive Intervention Before Exposure, CR After:Engaging in Cognitive Intervention After Exposure
- What is being tested?
- CR Before Exposure and CR After Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2018to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Self-reported proficiency in English language.
- High claustrophobic fear as demonstrated by:
- 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.
- Endorsement of claustrophobia according to the DSM-5 criteria for Specific Phobia, with or without Criterion F.
- 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.
Who cannot join
- Current or past cognitive behavioral therapy (i.e., cognitive therapy, exposure) for claustrophobia or anxiety and related disorders in the past year
- Change in dose of psychotropic medication in the past 3 months.
- Use of benzodiazepine more frequently than once per week in the past 3 months.
- Diagnosis of current (past month) panic disorder or agoraphobia.
- Claustrophobia due to or worsened by current (past month) posttraumatic stress disorder (PTSD).
- Participants with current (past month) diagnosis of severe depression, bipolar disorder, alcohol/substance use, or psychosis.
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- Presence of imminent suicidality or homicidality.
- 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).
- 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).
- Weight or height exceeding maximum capacity of claustrophobic chamber (e.g., weight over 250 lbs, height over 6 feet 5 inches).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- CR Before:Engaging in Cognitive Intervention Before Exposure, CR After:Engaging in Cognitive Intervention After Exposure
- Being tested
- CR Before Exposure, CR After Exposure
- Keywords
- Anxiety, Specific Phobia, Claustrophobia, Exposure, Cognitive therapy, Cognitive restructuring, Consolidation, Inhibitory learning, Expectancy violation, Expectancy, Exposure therapy, Anxiety disorder
- Medical subject headings
- Anxiety Disorders, Phobia, Specific, Claustrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR Before ExposureBehavioural
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 ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CR Before Exposure | Experimental | 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. Receives: Behavioral: CR Before Exposure |
| CR After Exposure | Experimental | 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. Receives: Behavioral: CR After Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Behavioral Approach at posttreatment and 1-month follow-up
The BAT includes eight 30-second cumulative steps designed to elicit increasing fear of suffocation and restriction (e.g., sleeping bag, mask, hand-cuffs, blankets), and is adapted from Deacon et al. (2010). An index of behavioral approach will be calculated by summing the number of points accrued in each step.
Measured: 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.
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Peak Fear at posttreatment and 1-month follow-up
Self-report measure assessing the highest level of fear experienced during the final completed step of the BAT at pretreatment from 0% (No Fear) to 100% (Extreme fear).
Measured: 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.
Change from pretreatment (i.e., baseline) self-reported claustrophobic anxiety as measured by Claustrophobia Questionnaire: Total score at posttreatment and 1-month follow-up
Self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of suffocation and restriction. 26 items are summed to create a total score. Total scores range from 0 to 104 with higher scores indicating greater claustrophobic anxiety.
Measured: 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 (16)
Behavioral Approach Test (BAT): Urge to Escape
Self-report measure assessing the strongest urge to escape experienced during the final completed step of the BAT at pretreatment from 0% (No Urge to Escape) to 100% (Extreme Urge to Escape).
Measured: 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.
Self-reported Suffocation Anxiety as measured by the Claustrophobia Questionnaire: Suffocation subscale
Subscale self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of suffocation. Fourteen items are summed to create a subscale score. Scores range from 0 to 56 with greater scores indicating greater suffocation anxiety.
Measured: 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.
Self-reported Restriction Anxiety as measured by the Claustrophobia Questionnaire: Restriction subscale
Subscale self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of restriction. Twelve items are summed to create a subscale score. Scores range from 0 to 48 with greater scores indicating greater restriction anxiety.
Measured: 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.
Self-reported Fear of Suffocation as measured by the Claustrophobia General Cognitions Questionnaire: Suffocation subscale
Subscale self-report measure of the likelihood of claustrophobic cognitions about suffocation while in enclosed spaces. Eight items are summed to create a subscale score. Scores range from 0 to 40 with greater scores indicating greater fear of suffocation.
Measured: 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.
Self-reported Fear of Inability to Escape as measured by the Claustrophobia General Cognitions Questionnaire: Inability to Escape subscale
Subscale self-report measure of the likelihood of claustrophobic cognitions about inability to escape while in enclosed spaces. Eight items are summed to create a subscale score. Scores range from 0 to 40 with greater scores indicating greater fear of inability to escape.
Measured: 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.
Self-reported Fear of Loss of Control as measured by the Claustrophobia General Cognitions Questionnaire: Loss of control subscale
Subscale self-report measure of the likelihood of claustrophobic cognitions about loss of control while in enclosed spaces. Nine items are summed to create a subscale scores. Scores range from 0 to 45 with greater scores indicating greater fear of loss of control.
Measured: 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.
Expected Feared Outcome: Personal
Verbal self-report measure evaluating the extent to which the participant believes his or her personal expected feared (selected from the CGCQ) would occur in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (Not at all) to 100% (Completely).
Measured: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Suffocation
Verbal self-report measure used to evaluate the extent to which the participant believes he or she will suffocate when in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (Not at all) to 100% (Completely).
Measured: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Restriction
Verbal self-report measure used to evaluate the extent to which the participant believes he or she will become trapped when in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (Not at all) to 100% (Completely).
Measured: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Peak Fear
Verbal self-report measure used to evaluate the highest amount of fear participants believe they will experience in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (No Fear) to 100% (Extreme Fear).
Measured: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Urge to Escape
Verbal self-report measure used to evaluate the strongest urge to escape participants believe they will experience in a frightening claustrophobic exposure exercise for a specified duration on a scale from 0% (No Urge to Escape) to 100% (Extreme Urge to Escape).
Measured: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Peak Fear
The highest level of fear the participant experienced during the previous claustrophobic exposure trial on a scale from 0% (No Fear) to 100% (Extreme fear).
Measured: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Urge to Escape
The strongest urge to escape the participant experienced during the previous claustrophobic exposure trial on a scale from 0% (No urge to escape) to 100% (Extreme urge to escape).
Measured: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Mean Expectancy Violation: Personal
The mean of the 6 change scores calculated for Expectancy Violation: Personal (i.e., the difference between the Perceived Actual Outcome: Personal rating after each exposure trial from the Expected Feared Outcome: Personal rating before each exposure trial - see Other pre-specified outcomes). Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Personal.
Measured: Mean of 6 Expectancy Violation: Personal change scores calculated on day 1 during the intervention.
Mean Expectancy Violation: Suffocation
The mean of the 6 change scores calculated for Expectancy Violation: Suffocation (i.e., the difference between the Perceived Actual Outcome: Suffocation rating after each exposure trial from the Expected Feared Outcome: Suffocation rating before each exposure trial - see Other pre-specified outcomes). Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Suffocation.
Measured: Mean of 6 Expectancy Violation: Suffocation change scores calculated on day 1 during the intervention.
Mean Expectancy Violation: Restriction
The mean of the 6 change scores calculated for Expectancy Violation: Restriction (i.e., the difference between the Perceived Actual Outcome: Restriction rating after each exposure trial from the Expected Feared Outcome: Restriction rating before each exposure trial - see Other pre-specified outcomes). Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Restriction.
Measured: Mean of 6 Expectancy Violation: Restriction change scores calculated on day 1 during the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start23 Aug 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CR Before:Engaging in Cognitive Intervention Before ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirstyn L. Krause
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirstyn L. Krause, Toronto Metropolitan University
- Investigators
- Kirstyn L Krause, MA, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628105
- Sponsor's protocol ID
- REB 2018-161
- Status last verified
- Dec 2019
- First submitted
- 10 Jul 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study will be disseminated via conference presentations, journal publications, and through the investigator's lab website. Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.
Publications
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.
PubMed 18005936Craske 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.
PubMed 24864005Deacon 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.
PubMed 19892318Krause 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.
PubMed 35156404
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Restructuring Before Exposure for Claustrophobia on Expectancy and Outcome
- ClinicalTrials.gov ID
- NCT03628105
- Acronym / sponsor ID
- REB 2018-161
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Kirstyn L. KrauseUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CR Before Exposure | Experimental | Behavioral: CR Before ExposureParticipants 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. |
| CR After Exposure | Experimental | Behavioral: CR After ExposureParticipants in this arm will complete the 15-minute questionnaire filler task before exposure and receive 15 minutes of CR (consolidation) after engaging in exposure. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported proficiency in English language.
- High claustrophobic fear as demonstrated by:
Key exclusion criteria (10 listed)
- Current or past cognitive behavioral therapy (i.e., cognitive therapy, exposure) for claustrophobia or anxiety and related disorders in the past year
- Change in dose of psychotropic medication in the past 3 months.
- Use of benzodiazepine more frequently than once per week in the past 3 months.
- Diagnosis of current (past month) panic disorder or agoraphobia.
- Claustrophobia due to or worsened by current (past month) posttraumatic stress disorder (PTSD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CR Before ExposureParticipants 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. | Behavioural | CR Before Exposure |
| CR After ExposureParticipants 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. | Behavioural | CR After Exposure |
Primary outcome
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Behavioral Approach at posttreatment and 1-month follow-up
Time frame: 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.
The BAT includes eight 30-second cumulative steps designed to elicit increasing fear of suffocation and restriction (e.g., sleeping bag, mask, hand-cuffs, blankets), and is adapted from Deacon et al. (2010). An index of behavioral approach will be calculated by summing the number of points accrued in each step.
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Peak Fear at posttreatment and 1-month follow-up
Time frame: 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.
Self-report measure assessing the highest level of fear experienced during the final completed step of the BAT at pretreatment from 0% (No Fear) to 100% (Extreme fear).
Change from pretreatment (i.e., baseline) self-reported claustrophobic anxiety as measured by Claustrophobia Questionnaire: Total score at posttreatment and 1-month follow-up
Time frame: 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.
Self-report measure assessing the severity of claustrophobic anxiety in situations eliciting fear of suffocation and restriction. 26 items are summed to create a total score. Total scores range from 0 to 104 with higher scores indicating greater claustrophobic anxiety.
16 secondary outcomes
Behavioral Approach Test (BAT): Urge to Escape
Time frame: 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.
Self-reported Suffocation Anxiety as measured by the Claustrophobia Questionnaire: Suffocation subscale
Time frame: 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.
Self-reported Restriction Anxiety as measured by the Claustrophobia Questionnaire: Restriction subscale
Time frame: 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.
Self-reported Fear of Suffocation as measured by the Claustrophobia General Cognitions Questionnaire: Suffocation subscale
Time frame: 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.
Self-reported Fear of Inability to Escape as measured by the Claustrophobia General Cognitions Questionnaire: Inability to Escape subscale
Time frame: 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.
Self-reported Fear of Loss of Control as measured by the Claustrophobia General Cognitions Questionnaire: Loss of control subscale
Time frame: 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.
Expected Feared Outcome: Personal
Time frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Suffocation
Time frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Restriction
Time frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Peak Fear
Time frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Expected Feared Outcome: Urge to Escape
Time frame: Administered eight times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Peak Fear
Time frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Urge to Escape
Time frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Mean Expectancy Violation: Personal
Time frame: Mean of 6 Expectancy Violation: Personal change scores calculated on day 1 during the intervention.
Mean Expectancy Violation: Suffocation
Time frame: Mean of 6 Expectancy Violation: Suffocation change scores calculated on day 1 during the intervention.
Mean Expectancy Violation: Restriction
Time frame: Mean of 6 Expectancy Violation: Restriction change scores calculated on day 1 during the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 18005936Craske 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.
- Background: PubMed 24864005Craske 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.
- Background: PubMed 19892318Deacon 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.
- Derived from this study: PubMed 35156404Krause 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.
- Individual participant dataSharing planned: No. Results of the study will be disseminated via conference presentations, journal publications, and through the investigator's lab website. Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirstyn L Krause, MA principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CR Before Exposure and CR After Exposure in people with CR Before:Engaging in Cognitive Intervention Before Exposure and CR After:Engaging in Cognitive Intervention After Exposure, run by Kirstyn L. Krause at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pretreatment (i.e., baseline) Behavioral Approach Test (BAT): Behavioral Approach at posttreatment and 1-month follow-up (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628105, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.