NCT05168592

Brief Summary

Imaginal exposure is a widely used and effective psychological treatment technique in which patients are exposed to fearful stimuli and situations using mental imagery. This study examines imaginal extinction, an experimental analogue of imaginal exposure that allows the study of this treatment technique under controlled circumstances. During imaginal extinction, conditioned fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. The neural underpinnings of imaginal extinction is not known, and hence, this study examines neural activations during imaginal extinction using psychophysiology and brain imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

December 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

December 9, 2021

Last Update Submit

August 23, 2024

Conditions

Keywords

Threat conditioningExtinctionImaginal ExtinctionMental Imagery

Outcome Measures

Primary Outcomes (2)

  • Blood oxygen level dependent contrast (BOLD-signal) during threat conditioning and imaginal extinction.

    BOLD-signal is assessed using functional magnetic resonance imaging.

    Day 1

  • Physiological arousal response during threat conditioning and imaginal extinction.

    Skin conductance responses are used as a measure of physiological arousal response (i.e. event-related rise in electrodermal activity to stimuli).

    Day 1

Secondary Outcomes (4)

  • Task-specific mental imagery vividness during imaginal extinction

    Day 1

  • Ratings of subjective fear experienced during threat conditioning and imaginal extinction.

    Day 1

  • Spielberger State-Trait Anxiety Inventory (STAI-T)

    One week after Day 1

  • Vividness of visual imagery Questionnaire (VVIQ)

    One week after Day 1

Study Arms (1)

Imaginal extinction

EXPERIMENTAL

Conditioned fear will be diminished using imaginal extinction.

Behavioral: Threat conditioningBehavioral: Imaginal extinction

Interventions

Day 1: The participant is repeatedly shown two stimulus (CS+,CS-), one at a time. CS+ is paired with an electric shock. CS- acts as a control stimulus. The stimuli consist of photos of two different objects. Stimuli will be counterbalanced between participants.

Imaginal extinction

Day 1: Participants are repeatedly instructed to produce mental imagery of the two stimuli used during threat conditioning. Imagery is prompted through different written instructions presented in pseudo-randomized order on a screen. No shocks will be delivered.

Imaginal extinction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing and able to provide informed consent and complete study procedures
  • Fear of spiders (due to data collection together with ID 2020-06930a)

You may not qualify if:

  • Current psychiatric disorder other than spider phobia. Current use of psychotropic medication. Current neurological conditions. MRI-contraindications (i.e metal implants in skull).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Swedish 7T facility

Lund, 22242, Sweden

Location

MeSH Terms

Conditions

Arachnophobia

Study Officials

  • Thoma Ågren, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 23, 2021

Study Start

April 7, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

We plan to share anonymous behavioural and brain imaging data, training material, Statistical Analysis plan, and informed consent form on the project site on Open Science Framework (https://osf.io/s54dz/).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available from completion of analysis and publication, and onwards.
Access Criteria
Anonymous behavioural and brain imaging data, training material, and Statistical Analysis plan will be made public on the project site on Open Science Framework (https://osf.io/s54dz/)

Locations