Anxiety Disorders Clinical Trial
Official title:
Optimizing Exposure Therapy With Mental Rehearsal
Verified date | December 2019 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment response rates for cognitive behavioral therapy (CBT) across anxiety disorders
average approximately 50% post-treatment (Loerinc et al, 2015), evidencing significant
'return of fear', the re-emergence of a partially or fully extinguished fear (Rachman, 1989).
Thus, recent research has amplified efforts toward improving treatment methodology in an
attempt to optimize clinical outcomes. Many efforts have targeted exposure therapy, an
evidence-based behavioral technique during which a patient is strategically and repeatedly
exposed to his or her feared stimulus in an effort to generate new non-fear associations with
that stimulus. One such effort involves mental rehearsal, where information is reinstated
using either a cue from extinction training or imaginal recounting of previous successful
exposures (Craske et al, 2014). Prior research has assessed the effects of mental rehearsal
via reinstatement of the extinction context (i.e., treatment context) or of cues/items from
the treatment context that may indicate safety (e.g., Mystkowski et al, 2006; Culver,
Stoyanova, & Craske, 2011). However, this research has produced inconsistent results and
contains an inherent limitation, as retrieval cues may become a safety signal and inhibit new
learning (Dibbets, Havermans, & Arntz, 2008).
In an effort to address these limitations, the current study recruits spider-fearful
participants for a treatment trial consisting of exposures in conjunction with either a
mental rehearsal intervention, or a control rehearsal intervention. The overarching goal of
this project is to evaluate the extent to which a between-session, technology-guided mental
rehearsal intervention may optimize exposure therapy outcomes. We also seek to evaluate
potential mechanisms of mental rehearsal.
Participants complete three laboratory visits, including two sessions of exposures with live
spiders. Participants are randomized to either a mental rehearsal or control rehearsal
condition to measure potential mechanisms and moderators of mental rehearsal.
Laboratory-based assessments include measures of subjective, behavioral, and
psychophysiological responses to spiders.
Status | Completed |
Enrollment | 72 |
Est. completion date | November 26, 2019 |
Est. primary completion date | November 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - English-speaking - Elevated score on Spider Phobia Questionnaire (SPQ) Exclusion Criteria: - Severe allergies to bees/spiders/insects |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
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* Note: There are 52 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spider Phobia Questionnaire (SPQ; Klorman et al, 1974) | 31-item true/false questionnaire assessing symptoms of arachnophobia. Scores range from 0 to 31, with greater scores representing greater fear of spiders. Spider phobic individuals have obtained mean scores of 23.20 (SD = 2.90) and 23.76 (SD = 3.80) on the SPQ (Klorman et al, 1974; Murris & Merckelbach, 1996). | Change from baseline to post-treatment (i.e., 8-10 days) | |
Primary | Behavioral Approach Test (BAT) steps | Number of test steps fully completed | Change from baseline to post-treatment (i.e., 8-10 days) | |
Primary | SCR anticipation | Change in SCR from baseline to BAT anticipation | Change from baseline to post-treatment (i.e., 8-10 days) | |
Primary | SCR across BAT steps | SCR during each 30-second test step fully completed | Change from baseline to post-treatment (i.e., 8-10 days) | |
Primary | Confidence ratings | Repeated confidence ratings on a scale from 0 (no confidence) to 100 (complete confidence) recorded throughout BAT | Change from baseline to post-treatment (i.e., 8-10 days) | |
Primary | Distress ratings | Repeated anticipatory and maximum distress ratings on a scale from 0 (no distress) to 100 (severe distress) recorded throughout BAT | Change from baseline to post-treatment (i.e., 8-10 days) | |
Secondary | Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995) | 21-item self-report measure that assesses severity of symptoms of depression, anxiety, and stress. We use scores on the Stress subscale, which consists of 7 items measuring chronic non-specific arousal (e.g., difficulty relaxing, nervous energy, agitation, irritability). The minimum score on this subscale is 0 and the maximum score is 42 (0-14 = normal, 15-18 = mild, 19-25 = moderate, 26-33 = severe, 34+ = extremely severe). | Baseline | |
Secondary | Pittsburgh Sleep Quality Index (PSQI; Buysse et al, 1989) | 18-item self-report measure that assesses sleep quality and disturbances over the past month. We use the global score, which sums seven component scores. Scores range from 0 to 21, with a score of 5 or greater indicating poor sleep quality. | Baseline | |
Secondary | Aerobic exercise | Brief 4-item self-report measure that assesses time spent doing scheduled and unscheduled aerobic activity during a typical week. | Baseline | |
Secondary | Surprise | Ratings of surprise on a 5-pt Likert scale (1 = not at all surprised, 5 = extremely surprised) concerning the outcome of exposures. Scores are averaged across two exposure sessions. Scores range from 1 to 5, with greater values indicating greater surprise with the outcome of exposures. | Session 1 and Session 2 (i.e., 3 days) | |
Secondary | US expectancy | Ratings of US expectancy on a 5-pt Likert scale (0 = not at all likely, 5 = extremely likely) concerning a participant's estimated likelihood of the feared outcome occurring with the same context and stimulus as in vivo exposures. Scores are averaged across two exposure sessions. Scores range from 1 to 5, with greater values indicating greater US expectancy post-exposures. | Session 1 and Session 2 (i.e., 3 days) | |
Secondary | Non-fear generalization | Ratings of US expectancy on a 5-pt Likert scale (0 = not at all likely, 5 = extremely likely) concerning a participant's estimated likelihood of the feared outcome occurring with a different spider outside the lab. Scores are averaged across two exposure sessions. Scores range from 1 to 5, with lower values indicating greater ability to generalize safety learning. | Session 1 and Session 2 (i.e., 3 days) |
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