Healthy SubjectsNCT03989518
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
A study testing Fear acquisition, Imaginal extinction and Reinstatement in people with Healthy Subjects, run by Uppsala University at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Fear acquisition, Imaginal extinction and Reinstatement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2019to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or over
- Fluent in Swedish
- Willing and able to provide informed consent and complete study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Healthy Subjects
- Being tested
- Fear acquisition, Imaginal extinction, Reinstatement
- Keywords
- Imaginal extinction, imaginal exposure, mental imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear acquisitionBehavioural
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 extinctionBehavioural
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.
ReinstatementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Simple stimuli | Experimental | Two perceptually simple stimuli are used during all experimental phases (geometrical figures). Receives: Behavioral: Fear acquisition; Behavioral: Imaginal extinction; Behavioral: 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. Receives: Behavioral: Fear acquisition; Behavioral: Imaginal extinction; Behavioral: Reinstatement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 3 (48 h after day 1)
Secondary outcomes (11)
Fear ratings
Ratings of subjective fear during the experimental procedure. Scale: 0 -100 (no fear at all - extreme fear)
Measured: Day 1
State-Trait Anxiety Inventory
This is a self-rated questionnaire measuring trait anxiety. Higher scores indicate higher level of trait-anxiety (range 20-80)
Measured: Day 1
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)
Measured: Day 1
Fear ratings
Ratings of subjective fear during the experimental procedure. Scale: 0 -100 (no fear at all - extreme fear)
Measured: Day 2 (24 h after day 1)
Vividness of mental imagery during imaginal extinction
Scale: 1-5; no image at all - image as clear and vivid as real life
Measured: Day 2 (24 h after day 1)
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)
Measured: Day 2 (24 h after day 1)
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)
Measured: Day 2 (24 h after day 1)
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)
Measured: Day 2 (24 h after day 1)
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 %
Measured: Day 2 (24 h after day 1)
Fear ratings
Ratings of subjective fear during the experimental procedure. Scale: 0 -100 (no fear at all - extreme fear)
Measured: Day 3 (48 h after day 1)
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 %
Measured: Day 3 (48 h after day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start25 Feb 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989518
- Sponsor's protocol ID
- 2019-00524
- Other IDs
- 2019
- Status last verified
- Oct 2019
- First submitted
- 13 Jun 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27840245
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
- ClinicalTrials.gov ID
- NCT03989518
- Acronym / sponsor ID
- 2019-00524
- Conditions
- Healthy Subjects
- Keywords
- Imaginal extinction, imaginal exposure, mental imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple stimuli | Experimental | Behavioral: Fear acquisition, Behavioral: Imaginal extinction, Behavioral: ReinstatementTwo perceptually simple stimuli are used during all experimental phases (geometrical figures). |
| Complex stimuli | Experimental | Behavioral: Fear acquisition, Behavioral: Imaginal extinction, Behavioral: ReinstatementTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over
- Fluent in Swedish
- Willing and able to provide informed consent and complete study procedures
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear acquisitionDay 1. Participants are exposed to two different visual stimuli. One of these stimuli is paired with a mild electric shock (i.e. conditioned stimuli). | Behavioural | Complex stimuli, Simple stimuli |
| Imaginal extinctionDay 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. | Behavioural | Complex stimuli, Simple stimuli |
| ReinstatementDay 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. | Behavioural | Complex stimuli, Simple stimuli |
Primary outcome
Skin conductance response (SCR)
Time frame: Day 1
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.
Skin conductance response (SCR)
Time frame: Day 2 (24 h after day1)
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.
Skin conductance response (SCR)
Time frame: Day 3 (48 h after day 1)
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.
11 secondary outcomes
Fear ratings
Time frame: Day 1
State-Trait Anxiety Inventory
Time frame: Day 1
Difficulties in emotion regulation scale
Time frame: Day 1
Fear ratings
Time frame: Day 2 (24 h after day 1)
Vividness of mental imagery during imaginal extinction
Time frame: Day 2 (24 h after day 1)
The Plymouth Sensory Imagery Questionnaire
Time frame: Day 2 (24 h after day 1)
The Vividness of Visual Imagery Questionnaire
Time frame: Day 2 (24 h after day 1)
Spontaneous use of imagery scale
Time frame: Day 2 (24 h after day 1)
Expectancy ratings
Time frame: Day 2 (24 h after day 1)
Fear ratings
Time frame: Day 3 (48 h after day 1)
Expectancy ratings
Time frame: Day 3 (48 h after day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Background: PubMed 27840245Agren 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fear acquisition, Imaginal extinction and Reinstatement in people with Healthy Subjects, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance response (SCR) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.