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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03989518
Other study ID # 2019-00524
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2019
Est. completion date October 30, 2019

Study information

Verified date October 2019
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study takes part over three consecutive days, with fear conditioning to visual stimuli on day 1, imaginal extinction on day 2, and a fear reinstatement procedure, again to visual stimuli, on day 3. Skin conductance is used to measure fear responses.

Participants' are randomized to receive conditioning, extinction and reinstatement with either complex or simple stimuli. During imaginal extinction, imagery of each experimental stimulus is prompted through different verbal instructions.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Age 18 or over

Fluent in Swedish

Willing and able to provide informed consent and complete study procedures

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fear acquisition
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).
Imaginal extinction
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.
Reinstatement
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.

Locations

Country Name City State
Sweden Uppsala University, Departement of Psychology Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Agren T, Björkstrand 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Task compliance Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %. Day 1
Other Task compliance Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %. Day 2 (24 h after day 1)
Other Task compliance Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %. Day 3 (48 h after day 1)
Primary 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
Primary 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)
Primary 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 Fear ratings Ratings of subjective fear during the experimental procedure. Scale: 0 -100 (no fear at all - extreme fear) Day 1
Secondary State-Trait Anxiety Inventory This is a self-rated questionnaire measuring trait anxiety. Higher scores indicate higher level of trait-anxiety (range 20-80) Day 1
Secondary Difficulties in emotion regulation scale This is a self-rated questionnaire measuring difficulties in emotion regulation. Higher scores indicate higher level of difficulties in emotion regulation (range 36-180) Day 1
Secondary Fear ratings Ratings of subjective fear during the experimental procedure. Scale: 0 -100 (no fear at all - extreme fear) Day 2 (24 h after day 1)
Secondary Vividness of mental imagery during imaginal extinction Scale: 1-5; no image at all - image as clear and vivid as real life Day 2 (24 h after day 1)
Secondary The Plymouth Sensory Imagery Questionnaire This is a self-rated questionnaire measuring vividness of mental imagery across different sensory modalities. Higher scores indicate higher level of vividness. (range 0-70) Day 2 (24 h after day 1)
Secondary The Vividness of Visual Imagery Questionnaire This is a self-rated questionnaire measuring vividness of visual mental imagery. Only eyes open section is administered. Higher scores indicate higher level of vividness (range 0-80) Day 2 (24 h after day 1)
Secondary Spontaneous use of imagery scale This is a self-rated questionnaire measuring spontaneous use of imagery. Higher scores higher levels use of spontaneous use of imagery (range 12- 60) Day 2 (24 h after day 1)
Secondary Expectancy ratings After the imaginal extinction procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 % Day 2 (24 h after day 1)
Secondary Fear ratings Ratings of subjective fear during the experimental procedure. Scale: 0 -100 (no fear at all - extreme fear) Day 3 (48 h after day 1)
Secondary Expectancy ratings After the reinstatement procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 % Day 3 (48 h after day 1)
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