NCT05193383

Brief Summary

Imaginal exposure is a widely used and effective psychological treatment technique. Recent research suggests that neural activations and emotional responses during imaginal exposure are similar to those elicited during in vivo exposure. However, to the investigators knowledge, no direct comparison between in vivo and imaginal exposure has been performed during neuroimaging. This study compares neural activations and emotional responses during imaginal and in vivo exposure. This study also explores the generalizability of fear reduction achieved through imaginal exposure to fear responses elicited by in vivo stimuli, and vice versa, in a follow-up session approximately one week later. A better understanding of the mechanisms behind both types of exposure could have significant clinical utility, as well as elucidate the differences between fear created from outward stimuli and fear created from inward stimuli, such as mental imagery.

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
3 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

Imaginal exposureExposureMental Imagery

Outcome Measures

Primary Outcomes (5)

  • Blood oxygen level dependent contrast (BOLD-signal) during exposure to fearful stimuli (in vivo or imaginal).

    BOLD-signal is assessed using functional magnetic resonance imaging.

    Day 1

  • Physiological arousal response during exposure (in vivo or imaginal).

    Skin-conductance responses are used as a measure of physiological arousal response, i.e. event-related rise in electrodermal activity as a response to stimulus. Unit of measure is microSiemens.

    Day 1

  • Physiological arousal response during follow-up exposure

    Skin-conductance responses are used as a measure of physiological arousal response, i.e. event-related rise in electrodermal activity as a response to stimulus. Unit of measure is microSiemens.

    One week after Day 1

  • Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli

    Scale 0-100; no fear at all - extreme fear

    Day1

  • Ratings of subjective fear experienced during exposure to fearful stimuli and neutral stimuli

    Scale 0-100; no fear at all - extreme fear

    One week after Day 1

Secondary Outcomes (6)

  • Ratings of subjective fear participants expect to experience during exposure to fearful stimuli

    Day 1 & one week after Day 1

  • Number of approach-avoidance decisions during an approach-avoidance behaviour task using fearful stimuli (spiders)

    One week after Day 1

  • Task-specific mental imagery vividness ratings to fearful and neutral stimuli during imaginal exposure, and follow-up exposure (not applicable during in vivo exposure).

    Day 1 & one week after 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

  • +1 more secondary outcomes

Study Arms (2)

Imaginal exposure

EXPERIMENTAL

Exposure to mental imagery including a fearful stimulus (spider) and corresponding scenes including a neutral stimulus (leaf)

Behavioral: Imaginal exposureBehavioral: ExposureBehavioral: Approach-avoidance conflict

In vivo exposure

EXPERIMENTAL

Exposure to video clips including a fearful stimulus (spider) and corresponding clips including a neutral stimulus (leaf)

Behavioral: ExposureBehavioral: Approach-avoidance conflictBehavioral: In vivo exposure

Interventions

Session 1 (Day 1): Participants receive repeated exposure to mental imagery of fear-provoking stimuli (spiders) and neutral stimuli (leaves) while undergoing brain imaging med fMRI.

Imaginal exposure
ExposureBEHAVIORAL

Session 2 (Ca one week): Participants receive both imaginal and in vivo exposure to fear-provoking stimuli and neutral stimuli (both arms are exposed to both video clips (in vivo exposure) and mental imagery (imaginal exposure). Session 2 is conducted in the laboratory, i.e., no brain imaging.

Imaginal exposureIn vivo exposure

Session 2 (Ca one week): Spider fear is probed by an approach-avoidance conflict task. Participants can receive varying small rewards for watching pictures of spiders, or avoid the spider pictures at the cost of not receiving a reward (neutral pictures are shown instead).

Imaginal exposureIn vivo exposure

Session 1 (Day 1): in vivo exposure. Participants receive repeated exposure to film clips of fear-provoking stimuli (spiders) and neutral stimuli (leaves) while undergoing brain imaging med fMRI.

In vivo exposure

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

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

Related Publications (1)

  • Hoppe JM, Holmes EA, Agren T. Exploring the neural basis of fear produced by mental imagery: imaginal exposure in individuals fearful of spiders. Philos Trans R Soc Lond B Biol Sci. 2021 Feb;376(1817):20190690. doi: 10.1098/rstb.2019.0690. Epub 2020 Dec 14.

MeSH Terms

Conditions

Arachnophobia

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thomas Ă…gren, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 14, 2022

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/vmrpw/).

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

Locations