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Optimizing Exposure Therapy With Mental Rehearsal

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ClinicalTrials.gov Identifier: NCT03934385
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Anastasia McGlade, MA, University of California, Los Angeles

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anxiety Disorders Arachnophobia Behavioral: Mental Rehearsal Behavioral: Exposure Not Applicable

Detailed Description:

Return of fear is the re-emergence of a partially or fully extinguished fear (Rachman, 1989). Due to relatively low treatment response rates for CBT at post-treatment (Loerinc et al, 2015), this study seeks to assess the efficacy of mental rehearsal (MR) in a different, less context-dependent manner than prior efforts (e.g., Mystkowski et al, 2006; Culver, Stoyanova, & Craske, 2011). Participants in the MR condition rehearse the new learning contingency, that is, that their feared outcome did not occur when they approached a live spider. Violation of expectancies engenders new, secondary learning that competes with the older fear memory (Craske et al, 2008; Bjork, 2003). As secondary, non-fear learning is repeatedly retrieved, the original fear memory is gradually suppressed, rendering it less recallable in the future (Bjork, 2011). Thus, repeatedly retrieving non-fear learning acquired from exposures is purported to strengthen the non-fear memory and reduce symptoms of arachnophobia. MR is conducted between sessions in an effort to reduce short-term return of fear by enhancing consolidation of non-fear learning via rehearsal efforts in multiple environments/contexts.

The overall aim of the current study is to evaluate a method for enhancing the effectiveness of exposure therapy, and more specifically, to test the extent to which a novel between-session mental rehearsal intervention may optimize treatment outcomes in individuals with excessive fear of spiders. An important secondary aim is to better understand cognitive and affective mechanisms underlying benefits of mental rehearsal.

The experiment consists of three sessions, spanning 8-10 days. Session 1 begins with a pre-treatment assessment consisting of self-report questionnaires and a behavioral approach test (BAT) with a live spider. During the BAT, confidence and distress ratings are obtained and psychophysiological responses (i.e., SCR) are recorded. Participants then complete a series of exposures with a live spider. At Session 2 (two to three days later), participants return to complete a second series of exposures with a live spider. At Session 3 (five to seven days later), participants complete a post-treatment assessment with self-report questionnaires and BAT, again with concurrent confidence and distress ratings and psychophysiological recordings.

Between sessions, participants are randomized to mentally rehearse information from exposures (i.e., MR) or from an unrelated recent academic experience (i.e., Control). MR exercises guide participants in retrieving and consolidating learning from exposures, emphasizing the inhibitory relationship between the conditioned stimulus (CS) and the unconditioned stimulus (US) (i.e., that approaching the spider did not result in their anticipated/feared outcome).

Measures span self-report, behavioral, and psychophysiological data. Fear of spiders is assessed with self-reported symptoms and measures taken during pre- and post-treatment BATs. During each BAT, skin conductance response (SCR) serves as a physiological index of fearful arousal. Baseline SCR is collected during a two-minute period at the start of pre- and post-treatment assessments. At both BATs, anticipatory SCR is collected during a one-minute period immediately prior to starting the BAT, and SCR is then continuously recorded throughout completion of the BAT. In addition to SCR, number of steps completed (0 to 9) and repeated ratings of confidence, anticipatory distress, and maximum distress during the BAT serve as important indices of fear.

Self-reported stress, sleep quality, aerobic exercise, and knowledge of spiders are assessed as potential moderators of mental rehearsal and symptom change. Post-exposure ratings of surprise, US expectancy, and generalization of non-fear learning will additionally be evaluated as treatment mechanisms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Exposure Therapy With Mental Rehearsal
Actual Study Start Date : October 23, 2018
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : November 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mental Rehearsal
Between-session rehearsal/retrieval exercises focused upon consolidating non-fear learning gained from exposures by prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditioned stimulus (i.e., spider) and unconditioned stimulus (e.g., bite/attack).
Behavioral: Mental Rehearsal
After each exposure session, participants complete three rehearsal/retrieval exercises that involve viewing images of spiders and completing multiple-choice and free-response questions. Exercises involve retrieving information specific to the spider exposures, reflecting on the experience, and highlighting expectancy violation (i.e., that the participant's feared outcome did not occur).
Other Name: mental retrieval

Behavioral: Exposure
All participants complete two exposure sessions. The first set of exposures consists of ten 30-second trials hovering one's hand 3 inches over a live tarantula. The second set of exposures consists of ten 30-second trials placing one's hand inside the spider's terrarium with all five fingertips touching the bottom.

Active Comparator: Control Rehearsal
Between-session rehearsal/retrieval exercises focused upon an unrelated, recent academic experience.
Behavioral: Exposure
All participants complete two exposure sessions. The first set of exposures consists of ten 30-second trials hovering one's hand 3 inches over a live tarantula. The second set of exposures consists of ten 30-second trials placing one's hand inside the spider's terrarium with all five fingertips touching the bottom.




Primary Outcome Measures :
  1. Spider Phobia Questionnaire (SPQ; Klorman et al, 1974) [ Time Frame: Change from baseline to post-treatment (i.e., 8-10 days) ]
    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).

  2. Behavioral Approach Test (BAT) steps [ Time Frame: Change from baseline to post-treatment (i.e., 8-10 days) ]
    Number of test steps fully completed

  3. SCR anticipation [ Time Frame: Change from baseline to post-treatment (i.e., 8-10 days) ]
    Change in SCR from baseline to BAT anticipation

  4. SCR across BAT steps [ Time Frame: Change from baseline to post-treatment (i.e., 8-10 days) ]
    SCR during each 30-second test step fully completed

  5. Confidence ratings [ Time Frame: Change from baseline to post-treatment (i.e., 8-10 days) ]
    Repeated confidence ratings on a scale from 0 (no confidence) to 100 (complete confidence) recorded throughout BAT

  6. Distress ratings [ Time Frame: Change from baseline to post-treatment (i.e., 8-10 days) ]
    Repeated anticipatory and maximum distress ratings on a scale from 0 (no distress) to 100 (severe distress) recorded throughout BAT


Secondary Outcome Measures :
  1. Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995) [ Time Frame: Baseline ]
    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).

  2. Pittsburgh Sleep Quality Index (PSQI; Buysse et al, 1989) [ Time Frame: Baseline ]
    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.

  3. Aerobic exercise [ Time Frame: Baseline ]
    Brief 4-item self-report measure that assesses time spent doing scheduled and unscheduled aerobic activity during a typical week.

  4. Surprise [ Time Frame: Session 1 and Session 2 (i.e., 3 days) ]
    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.

  5. US expectancy [ Time Frame: Session 1 and Session 2 (i.e., 3 days) ]
    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.

  6. Non-fear generalization [ Time Frame: Session 1 and Session 2 (i.e., 3 days) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • Elevated score on Spider Phobia Questionnaire (SPQ)

Exclusion Criteria:

  • Severe allergies to bees/spiders/insects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934385


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Anastasia L McGlade, MA University of California, Los Angeles
Principal Investigator: Michelle G Craske, PhD University of California, Los Angeles
Publications:
Bjork, E. L., & Bjork, R. A. (2011). Making things hard on yourself, but in a good way: Creating desirable difficulties to enhance learning. In M. A. Gernsbacher, R. W. Pew, L. M. Hough, J. R. Pomerantz (Eds.) & FABBS Foundation, Psychology and the real world: Essays illustrating fundamental contributions to society (pp. 56-64). New York, NY, US: Worth Publishers.
Bjork, R. A. (2003). Interference and forgetting. In J. H. Byrne (Ed.), Encyclopedia of learning and memory, 2nd ed., (pp. 268-273). New York: Macmillan Reference USA.
Bjork, R.A. (2011). On the symbiosis of learning, remembering, and forgetting. In A. S. Benjamin (Ed.), Successful remembering and successful forgetting: a Festschrift in honor of Robert A. Bjork (pp. 1-22). London, UK: Psychology Press.
Bjork, R. A., & Bjork, E. L. (1992). A new theory of disuse and an old theory of stimulus fluctuation. In A. Healy, S. Kosslyn, & R. Shiffrin (Eds.), From learning processes to cognitive processes: Essays in honor of William K. Estes (pp. 35-67). Hillsdale, NJ: Erlbaum.
Bloom, K. C., & Shuell, T. J. (1981). Effects of massed and distributed practice on the learning and retention of second-language vocabulary. The Journal of Educational Research, 74(4), 245-248. doi:10.1080/00220671.1981.10885317
Bouton, M. E., & Swartzentruber, D. (1991). Sources of relapse after extinction in Pavlovian and instrumental learning. Clinical Psychology Review, 11, 123-140. doi:10.1016/0272-7358(91)90091-8
Christopoulos, G. I., Uy, M. A., & Yap, W. J. (2016). The body and the brain: measuring skin conductance response to understand the emotional experience. Organizational Research Methods, 1-27. doi:10.1177/1094428116681073
Donovan, J. J., & Radosevich, D. J. (1999). A meta-analytic review of the distribution of practice effect: Now you see it, now you don't. Journal of Applied Psychology, 84(5), 795-805. doi:10.1037/0021-9010.84.5.795
Driskell, J. E., Willis, R. P., & Copper, C. (1992). Effect of overlearning on retention. Journal of Applied Psychology, 77, 615-622. doi:10.1037/0021-9010.77.5.615
Klorman, R., Weerts, T.C., Hastings, J.E., Melamed, B.G., Lang, P.J. (1974). Psychometric descriptions of some specific fear questionnaires. Behavior Therapy, 5, 401-409. doi:10.1016/S0005-7894(74)80008-0
Lang, A. J., Craske, M. G., & Bjork, R. A. (1999). Implications of a new theory of disuse for the treatment of emotional disorders. Clinical Psychology: Science and Practice, 6, 80-94. doi:10.1093/clipsy/6.1.80
Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety Stress Scales. (2nd Ed.) Sydney: Psychology Foundation.
Rachman, S. (1989). The return of fear: Review and prospect. Clinical Psychology Review, 9, 147-168. doi:10.1016/0272-7358(89)90025-1

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Responsible Party: Anastasia McGlade, MA, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03934385    
Other Study ID Numbers: AM74RL539
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anastasia McGlade, MA, University of California, Los Angeles:
anxiety
consolidation
extinction
mental rehearsal
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders