NCT03989518

Brief Summary

Imaginal exposure is a widely used psychological treatment technique. Imaginal extinction is an experimental analogue of imaginal exposure, that allows the study of this treatment technique under controlled circumstances (Agren, Björkstrand, \& Fredrikson, 2017). During imaginal extinction, experimentally induced fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. However, it is not known to what extent fear reduction depends on the mental imagery produced during this procedure. A better understanding of the mechanisms driving the effects of imaginal exposure and the factors moderating fear reduction could have significant clinical utility, by suggesting mechanistically informed ways to improve this treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

June 13, 2019

Last Update Submit

October 31, 2019

Conditions

Keywords

Imaginal extinction, imaginal exposure, mental imagery

Outcome Measures

Primary Outcomes (3)

  • Skin conductance response (SCR)

    SCR is used as a measure of physiological fear responses. Differences in fear responses are used to assess fear learning during fear acquisition and to explore main effects and interactions between fear learning, stimulus complexity and capacity for mental imagery.

    Day 1

  • Skin conductance response (SCR)

    SCR is used as a measure of physiological fear responses.Differences in fear responses are used to assess fear reduction during imaginal extinction, and to explore main effects and interactions between fear reduction, stimulus complexity and capacity for mental imagery.

    Day 2 (24 h after day1)

  • Skin conductance response (SCR)

    SCR is used as a measure of physiological fear responses.Differences in fear response are used to assess return of fear during reinstatement, and to explore main effects and interactions between return of fear, stimulus complexity and capacity for mental imagery.

    Day 3 (48 h after day 1)

Secondary Outcomes (11)

  • Fear ratings

    Day 1

  • State-Trait Anxiety Inventory

    Day 1

  • Difficulties in emotion regulation scale

    Day 1

  • Fear ratings

    Day 2 (24 h after day 1)

  • Vividness of mental imagery during imaginal extinction

    Day 2 (24 h after day 1)

  • +6 more secondary outcomes

Other Outcomes (3)

  • Task compliance

    Day 1

  • Task compliance

    Day 2 (24 h after day 1)

  • Task compliance

    Day 3 (48 h after day 1)

Study Arms (2)

Simple stimuli

EXPERIMENTAL

Two perceptually simple stimuli are used during all experimental phases (geometrical figures).

Behavioral: Fear acquisitionBehavioral: Imaginal extinctionBehavioral: Reinstatement

Complex stimuli

EXPERIMENTAL

Two complex stimuli are used in all experimental phases. Stimuli consist of photographs of real objects of the same size and shape as the simple stimuli, but include perceptually more complex patterns, details and colors.

Behavioral: Fear acquisitionBehavioral: Imaginal extinctionBehavioral: Reinstatement

Interventions

Day 1. Participants are exposed to two different visual stimuli. One of these stimuli is paired with a mild electric shock (i.e. conditioned stimuli).

Complex stimuliSimple stimuli

Day 2 (24 hours after Day 1). Participants are exposed to mental imagery of the stimuli used during fear conditioning. Imagery is prompted through different verbal instructions presented in a pseudo-randomized order. No shocks are delivered. Prior to imaginal extinction, participants receive task specific training.

Complex stimuliSimple stimuli
ReinstatementBEHAVIORAL

Day 3 (48 h after day1). Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2). Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus. No further shocks are delivered. This procedure allows the study of long term effects of imaginal extinction.

Complex stimuliSimple stimuli

Eligibility Criteria

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

You may qualify if:

  • Age 18 or over
  • Fluent in Swedish
  • Willing and able to provide informed consent and complete study procedures

You may not qualify if:

  • Current psychiatric disorder
  • Use of psychotropic medication within 6 months prior to study start
  • Receiving psychological treatment within 6 months prior to study start
  • Current neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University, Departement of Psychology

Uppsala, Sweden

Location

Related Publications (1)

  • Agren T, Bjorkstrand J, Fredrikson M. Disruption of human fear reconsolidation using imaginal and in vivo extinction. Behav Brain Res. 2017 Feb 15;319:9-15. doi: 10.1016/j.bbr.2016.11.014. Epub 2016 Nov 10.

    PMID: 27840245BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 18, 2019

Study Start

February 25, 2019

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

November 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available upon publication.

Locations