NCT03969160

Brief Summary

This study explores the brain basis of imaginal exposure, a widely used psychological treatment technique. Specifically, this study uses functional magnetic resonance imaging to examine brain areas activated during imaginal exposure, in individuals fearful of spiders. Physiological responses and subjective fear experienced during imaginal exposure are also assessed. The primary aim of this study is to explore differences in neural activity during exposure to phobic, compared to neutral, mental imagery. The study will focus primarily on exploratory whole brain analyses, but will also include regions of interest analyses on brain areas previously associated with imaginal exposure. The experimental procedure consists of repeated exposure to mental imagery, i.e. imagery of short durations, including either highly emotion-provoking or neutral content, prompted by verbal instructions. A secondary aim is to explore the effects of repeated exposure to mental imagery, used during the experimental procedure, on subjective fear and physiological responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

November 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 24, 2019

Last Update Submit

May 29, 2019

Conditions

Keywords

Imaginal exposurebrain imagingmental imagery

Outcome Measures

Primary Outcomes (2)

  • Blood oxygen level dependent contrast (BOLD-signal)

    BOLD-signal is assessed using functional magnetic resonance imaging.

    Day 1

  • Physiological response during exposure to mental imagery

    Skin-conductance responses are used as a measure of physiological response.

    Day 1

Secondary Outcomes (10)

  • Physiological response during exposure to mental imagery

    Follow-up (one week after day 1)

  • Differences in physiological response during exposure to mental imagery, during day 1 compared to the follow-up session.

    Difference between day 1 and the follow-up session (one week after day 1)

  • Ratings of subjective fear participants' expect to experience during exposure to mental imagery

    Day 1

  • Ratings of subjective fear experienced during exposure to mental imagery

    Day 1

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

    Day 1

  • +5 more secondary outcomes

Other Outcomes (5)

  • Spider Phobia Questionnaire (SPQ)

    Recruitment

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

    Day 1

  • Number of intrusive mental imagery of phobic stimuli

    7 days, starting on day 1.

  • +2 more other outcomes

Study Arms (1)

Imaginal exposure

EXPERIMENTAL

The experimental procedure consists of imaginal exposure to mental imagery of phobic and neutral stimuli, prompted through recorded verbal instructions. Participants' repeat the experimental procedure one week later in a follow-up session. Brain imaging data is only collected during day 1

Behavioral: Imaginal exposure

Interventions

Imaginal exposure to mental imagery of phobic and neutral stimuli

Imaginal exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Significant fear of spiders

You may not qualify if:

  • Current psychiatric disorder other than spider phobia
  • Substance abuse
  • Neurological disease
  • Psychological treatment or psychotropic medication within six months
  • Magnetic resonance imaging contradiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uppsala University Hospital - Akademiska sjukhuset

Uppsala, Sweden

Location

Uppsala University, Departement of Psychology

Uppsala, Sweden

Location

MeSH Terms

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

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

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 31, 2019

Study Start

November 11, 2017

Primary Completion

February 14, 2018

Study Completion

February 22, 2018

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations