An interventional study of CR Before Exposure and CR After Exposure in CR Before:Engaging in Cognitive Intervention Before Exposure and CR After:Engaging in Cognitive Intervention After Exposure, sponsored by Kirstyn L. Krause. Completed at 1 site in Canada. Open to participants aged 17 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by Kirstyn L. Krause · Not applicable, Interventional, and Treatment
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.
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.
5,113 studies on the registry are indexed under Anxiety Disorders; 1,418 are open to participants now.
This study's enrollment of 97 is above the median of 80 across 4,380 interventional studies indexed under Anxiety Disorders.
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High claustrophobic fear as demonstrated by:
Exclusion Criteria:
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.
Behavioral: CR Before 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.
Behavioral: CR After 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.
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.
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.
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.
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).
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.
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.
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.
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).
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
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.
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
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.
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
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.
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
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.
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
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.
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
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).
Time frame: 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).
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Mean of 6 Expectancy Violation: Restriction change scores calculated on day 1 during the intervention.
Self-reported depression, anxiety, and stress as measured by the Depression Anxiety Stress Scales (21-item version)
Self-report questionnaire measuring emotional states of depression, anxiety, and stress in the past week. Each subscale contains 7 items, which are first summed, then doubled. Scores on each subscale can range from 0 to 42, with greater scores indicating greater levels of distress
Time frame: Administered once on day 1 at pretreatment.
Treatment expectancy and credibility as measured by the Credibility/Expectancy Questionnaire
Self-report measure assessing the perceived credibility and expectancy of exposure therapy. Answers to each of the 6 items are transformed into standard scores and summed to create either a total score, or a subscale credibility score or treatment expectancy score. The range of scores is not exact given that standard scores indicate deviations from the mean. According to the normal distribution, approximately 99.7% of participants should fall within a score -3 and +3 for each item, yielding a likely total range between -15 and +15 for the total score and -9 and +9 for each subscale score (credibility, treatment expectancy). Greater scores indicating greater treatment expectancy and credibility ratings.
Time frame: Administered once on day 1 during the intervention.
Perceived Actual Outcome: Personal
Verbal self-report measure used to evaluate how strongly the participant believes their Expected Feared Outcome: Personal actually occurred during the previous claustrophobic exposure trial on a scale from 0% (Not at all) to 100% (Completely).
Time frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Suffocation
Verbal self-report measure used to evaluate how strongly the participant believes their Expected Feared Outcome: Suffocation actually occurred during the previous claustrophobic exposure trial on a scale from 0% (Not at all) to 100% (Completely).
Time frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Perceived Actual Outcome: Restriction
Verbal self-report measure used to evaluate how strongly the participant believes their Expected Feared Outcome: Restriction actually occurred during the previous claustrophobic exposure trial on a scale from 0% (Not at all) to 100% (Completely).
Time frame: Administered six times on day 1 (during the intervention) and one time at 1-month follow-up.
Expectancy Violation: Personal
Change score calculated by subtracting the Perceived Actual Outcome: Personal rating (see "Other Pre-specified Outcome Measures" for definition) after each exposure trial from the Expected Feared Outcome: Personal rating before each exposure trial. Scores can range between 0% and 100% with greater scores indicating greater Expectancy Violation: Personal.
Time frame: 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.
Expectancy Violation: Suffocation
Change score calculated by subtracting the Perceived Actual Outcome: Suffocation rating (see "Other Pre-specified Outcome Measures" for definition) after each exposure trial from the Expected Feared Outcome: Suffocation rating before each exposure trial. Scores can range between 0% and 100% with greater scores indicating greater Expectancy Violation: Suffocation.
Time frame: 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.
Expectancy Violation: Restriction
Change score calculated by subtracting the Perceived Actual Outcome: Restriction rating (see "Other Pre-specified Outcome Measures" for definition) after each exposure trial from the Expected Feared Outcome: Restriction rating before each exposure trial. Scores can range between 0% and 100% with greater scores indicating greater Mean Expectancy Violation: Suffocation.
Time frame: 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.
Plan to share: 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.
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