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Anxiety DisordersNCT03934385

Optimizing Exposure Therapy With Mental Rehearsal

A study testing Mental Rehearsal and Exposure in people with Anxiety Disorders and Arachnophobia, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety Disorders, Arachnophobia
What is being tested?
Mental Rehearsal and Exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
23 Oct 2018to 26 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Severe allergies to bees/spiders/insects

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

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.

Read the 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.

Being tested
Mental Rehearsal, Exposure
Keywords
anxiety, consolidation, extinction, mental rehearsal
Medical subject headings
Anxiety Disorders, Arachnophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental RehearsalBehavioural

    Also called mental retrieval

    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).

  • ExposureBehavioural

    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.

Study groups in NCT03934385
Study groupRoleWhat they receive
Mental RehearsalExperimentalBetween-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).
Receives: Behavioral: Mental Rehearsal; Behavioral: Exposure
Control RehearsalActive comparatorBetween-session rehearsal/retrieval exercises focused upon an unrelated, recent academic experience.
Receives: Behavioral: Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from baseline to post-treatment (i.e., 8-10 days)

  2. Behavioral Approach Test (BAT) steps

    Number of test steps fully completed

    Measured: Change from baseline to post-treatment (i.e., 8-10 days)

  3. SCR anticipation

    Change in SCR from baseline to BAT anticipation

    Measured: Change from baseline to post-treatment (i.e., 8-10 days)

  4. SCR across BAT steps

    SCR during each 30-second test step fully completed

    Measured: Change from baseline to post-treatment (i.e., 8-10 days)

  5. Confidence ratings

    Repeated confidence ratings on a scale from 0 (no confidence) to 100 (complete confidence) recorded throughout BAT

    Measured: Change from baseline to post-treatment (i.e., 8-10 days)

  6. Distress ratings

    Repeated anticipatory and maximum distress ratings on a scale from 0 (no distress) to 100 (severe distress) recorded throughout BAT

    Measured: Change from baseline to post-treatment (i.e., 8-10 days)

Secondary outcomes (6)
  1. 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).

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. Aerobic exercise

    Brief 4-item self-report measure that assesses time spent doing scheduled and unscheduled aerobic activity during a typical week.

    Measured: Baseline

  4. 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.

    Measured: Session 1 and Session 2 (i.e., 3 days)

  5. 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.

    Measured: Session 1 and Session 2 (i.e., 3 days)

  6. 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.

    Measured: Session 1 and Session 2 (i.e., 3 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start23 Oct 2018
  3. Primary completion26 Nov 2019
  4. Study completion26 Nov 2019

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03934385
Sponsor's protocol ID
AM74RL539
Status last verified
Dec 2019
First submitted
25 Apr 2019
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Anderson MC, Bjork RA, Bjork EL. Remembering can cause forgetting: retrieval dynamics in long-term memory. J Exp Psychol Learn Mem Cogn. 1994 Sep;20(5):1063-87. doi: 10.1037//0278-7393.20.5.1063.

    PubMed 7931095
  • Aubry AV, Serrano PA, Burghardt NS. Molecular Mechanisms of Stress-Induced Increases in Fear Memory Consolidation within the Amygdala. Front Behav Neurosci. 2016 Oct 21;10:191. doi: 10.3389/fnbeh.2016.00191. eCollection 2016.

    PubMed 27818625
  • 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

  • Bouton ME, Westbrook RF, Corcoran KA, Maren S. Contextual and temporal modulation of extinction: behavioral and biological mechanisms. Biol Psychiatry. 2006 Aug 15;60(4):352-60. doi: 10.1016/j.biopsych.2005.12.015. Epub 2006 Apr 17.

    PubMed 16616731
  • Bramham CR, Messaoudi E. BDNF function in adult synaptic plasticity: the synaptic consolidation hypothesis. Prog Neurobiol. 2005 Jun;76(2):99-125. doi: 10.1016/j.pneurobio.2005.06.003.

    PubMed 16099088
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771
  • Cahill L, Gorski L, Le K. Enhanced human memory consolidation with post-learning stress: interaction with the degree of arousal at encoding. Learn Mem. 2003 Jul-Aug;10(4):270-4. doi: 10.1101/lm.62403.

    PubMed 12888545
  • Cahill L, McGaugh JL. A novel demonstration of enhanced memory associated with emotional arousal. Conscious Cogn. 1995 Dec;4(4):410-21. doi: 10.1006/ccog.1995.1048.

    PubMed 8750416
  • Cain CK, Blouin AM, Barad M. Adrenergic transmission facilitates extinction of conditional fear in mice. Learn Mem. 2004 Mar-Apr;11(2):179-87. doi: 10.1101/lm.71504.

    PubMed 15054133
  • Choy Y, Fyer AJ, Lipsitz JD. Treatment of specific phobia in adults. Clin Psychol Rev. 2007 Apr;27(3):266-86. doi: 10.1016/j.cpr.2006.10.002. Epub 2006 Nov 15.

    PubMed 17112646

Questions about this trial

What is this clinical trial studying?

A study testing Mental Rehearsal and Exposure in people with Anxiety Disorders and Arachnophobia, run by University of California, Los Angeles at 1 site in United States.

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 2 inclusion and 1 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 18 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 United States. 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?

Spider Phobia Questionnaire (SPQ; Klorman et al, 1974) (time frame: Change from baseline to post-treatment (i.e., 8-10 days)). The study lists 6 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 NCT03934385, which also lists 52 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 18 Dec 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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