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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05168592
Other study ID # 2020-06930b
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 7, 2022
Est. completion date December 2022

Study information

Verified date April 2022
Source Uppsala University
Contact Thomas Ågren, PhD
Phone +46(0)184712124
Email thomas.agren@psyk.uu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In this study, participants undergo threat conditioning to two pictures (CS+, CS-) in order to acquire a conditioned threat response. After this, the conditioned threat response is diminished through imaginal extinction (i.e extinction to the mental imagery of CS+ and CS-). Functional magnetic resonance imaging (7T) is used to measure neural activations during threat conditioning and imaginal extinction. Skin conductance is used to measure arousal response. Subjective fear and mental imagery vividness ratings will also be collected. In this way, this study aims to characterize the neural underpinnings of imaginal extinction. Note that this study employs participants fearful of spiders. This is because data collection is shared with a related study (ClinicalTrials.gov ID 2020-06930a).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Willing and able to provide informed consent and complete study procedures - Fear of spiders (due to data collection together with ID 2020-06930a) Exclusion Criteria: - Current psychiatric disorder other than spider phobia. Current use of psychotropic medication. Current neurological conditions. MRI-contraindications (i.e metal implants in skull).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Threat conditioning
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.

Locations

Country Name City State
Sweden The Swedish 7T facility Lund

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood oxygen level dependent contrast (BOLD-signal) during threat conditioning and imaginal extinction. BOLD-signal is assessed using functional magnetic resonance imaging. Day 1
Primary 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 Task-specific mental imagery vividness during imaginal extinction Vividness of Imagery (scale:1-5; no image at all - image as clear and vivid as real life) Day 1
Secondary Ratings of subjective fear experienced during threat conditioning and imaginal extinction. Scale 0-100; no fear at all - extreme fear Day 1
Secondary Spielberger State-Trait Anxiety Inventory (STAI-T) STAI-T is a self-rated questionnaire included assess trait-anxiety in the participants. Scale: 20-80, where higher scores represent higher levels of trait anxiety. One week after Day 1
Secondary Vividness of visual imagery Questionnaire (VVIQ) VVIQ is used to measure individual differences in the Vividness of Visual mental Imagery; scale: 16-80 where higher scores represent a higher ability for visual imagery. One week after Day 1
See also
  Status Clinical Trial Phase
Completed NCT04162509 - Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders N/A
Completed NCT03907345 - Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure N/A
Recruiting NCT05193383 - Neural Mechanisms of Imaginal and in Vivo Exposure N/A