NCT03934385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

April 25, 2019

Last Update Submit

December 16, 2019

Conditions

Keywords

anxietyconsolidationextinctionmental rehearsal

Outcome Measures

Primary Outcomes (6)

  • 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)

  • Behavioral Approach Test (BAT) steps

    Number of test steps fully completed

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

  • SCR anticipation

    Change in SCR from baseline to BAT anticipation

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

  • SCR across BAT steps

    SCR during each 30-second test step fully completed

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

  • 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)

  • 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 Outcomes (6)

  • Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995)

    Baseline

  • Pittsburgh Sleep Quality Index (PSQI; Buysse et al, 1989)

    Baseline

  • Aerobic exercise

    Baseline

  • Surprise

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

  • US expectancy

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

  • +1 more secondary outcomes

Study Arms (2)

Mental Rehearsal

EXPERIMENTAL

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 RehearsalBehavioral: Exposure

Control Rehearsal

ACTIVE COMPARATOR

Between-session rehearsal/retrieval exercises focused upon an unrelated, recent academic experience.

Behavioral: Exposure

Interventions

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).

Also known as: mental retrieval
Mental Rehearsal
ExposureBEHAVIORAL

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.

Control RehearsalMental Rehearsal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe allergies to bees/spiders/insects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (52)

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MeSH Terms

Conditions

Anxiety DisordersArachnophobia

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Anastasia L McGlade, MA

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Michelle G Craske, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 1, 2019

Study Start

October 23, 2018

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations