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Completed

NCT Number: NCT02533310

Virtual Reality Immersive Method for Spider (Phobia) Exposure Therapy (VIMSE)

The aim of this study is to examine the efficacy of virtual reality exposure therapy as a treatment for specific phobia (spiders). A gamified virtual reality simulation of one-session therapy (VR-OST) will be compared to the gold-standard treatment in the form of traditional one-session phobia treatment (OST) using in-vivo stimuli. This study was powered to detect a non-inferiority margin of a 2-point difference between groups.

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Key information

Conditions

Phobia, Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology

Stockholm, 10691, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Score of 10 or less in Behavioral Approach Test
  • Individual meeting DSM-5 criteria according to interview for primary diagnosis of specific phobia, spider
  • Swedish residency
  • Fluent in Swedish

Exclusion criteria

  • Ongoing psychotherapy
  • Ongoing psychotropic medication (unless stabilized for three months)
  • Indication of suicidal ideation, as assessed by item 9 of the PHQ-9
  • Meets criteria for alcohol or substance use disorder
  • Meets criteria for serious mental disorder, such as bipolar disorder, schizophrenia or psychosis
  • Balance and/or eyesight problems (such as lack of stereoscopic vision) that could interfere with VR treatment

Treatment and study plan

OST treatment with in-vivo spiders

Other

Subjects are exposed to phobic stimuli with the aid of a trained psychotherapist during a session of maximum 3 hrs duration. The intensity of exposure is increased in four sequential steps, 1. learning to catch a spider with a glass and paper, 2. touching a spider, 3. letting a spider walk on your hand, 4. letting a spider walk on your body. These stages repeat with increasingly larger spiders. The goal of therapy is not absolute symptom reduction but sufficient reduction to allow the individual to expose themselves in everyday situations.

VR-OST treatment with virtual spiders

Other

The VR-OST treatment introduces a virtual gamified version of OST treatment using a modern virtual reality headset. Individuals advance themselves through increasing levels of exposure intensity with the assistance of an automated virtual therapist.

Primary outcomes

  1. Behavioral Approach Test (BAT)

    Time frame: Change from baseline on BAT (1 week)

    The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

  2. Behavioral Approach Test (BAT)

    Time frame: Change from baseline on BAT (12 week)

    The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

  3. Behavioral Approach Test (BAT)

    Time frame: Change from baseline on BAT (52 week)

    The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

Secondary outcomes

  1. Spider Phobia Questionnaire 31 (SPQ-31)

    Time frame: Change from baseline on SPQ-31 (1 week)

    SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia.

  2. Spider Phobia Questionnaire 31 (SPQ-31)

    Time frame: Change from baseline on SPQ-31 (12 week)

    SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia.

  3. Spider Phobia Questionnaire 31 (SPQ-31)

    Time frame: Change from baseline on SPQ-31 (52 week)

    SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia.

  4. Spider Phobia Questionnaire 31 (SPQ-31)

    Time frame: Change from baseline on SPQ-31 (3 year)

    SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia.

  5. Fear of Spiders Questionnaire 18 (FSQ-18)

    Time frame: Change from baseline in FSQ-18 (1 week)

    FSQ-18 features 18 questions about fear and avoidance of spiders.

  6. Fear of Spiders Questionnaire 18 (FSQ-18)

    Time frame: Change from baseline in FSQ-18 (12 week)

    FSQ-18 features 18 questions about fear and avoidance of spiders.

  7. Fear of Spiders Questionnaire 18 (FSQ-18)

    Time frame: Change from baseline in FSQ-18 (52 week)

    FSQ-18 features 18 questions about fear and avoidance of spiders.

  8. Fear of Spiders Questionnaire 18 (FSQ-18)

    Time frame: Change from baseline in FSQ-18 (3 year)

    FSQ-18 features 18 questions about fear and avoidance of spiders.

  9. Generalized Anxiety Disorder Assessment 7 (GAD-7)

    Time frame: Change from baseline in GAD-7 (1 week)

    GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

  10. Generalized Anxiety Disorder Assessment 7 (GAD-7)

    Time frame: Change from baseline in GAD-7 (12 week)

    GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

  11. Generalized Anxiety Disorder Assessment 7 (GAD-7)

    Time frame: Change from baseline in GAD-7 (52 week)

    GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

  12. Generalized Anxiety Disorder Assessment 7 (GAD-7)

    Time frame: Change from baseline in GAD-7 (3 year)

    GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

  13. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Change from baseline in PHQ-9 (1 week)

    PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

  14. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Change from baseline in PHQ-9 (12 week)

    PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

  15. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Change from baseline in PHQ-9 (52 week)

    PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

  16. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Change from baseline in PHQ-9 (3 year)

    PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

  17. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: Change from baseline in BBQ (1 week)

    BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

  18. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: Change from baseline in BBQ (12 week)

    BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

  19. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: Change from baseline in BBQ (52 week)

    BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

  20. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: Change from baseline in BBQ (3 year)

    BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

  21. Diagnostic criteria for specific phobia according to interview (DSM-5)

    Time frame: Change from baseline for specific phobia (DSM-5) (12 weeks)

  22. Diagnostic criteria for specific phobia according to interview (DSM-5)

    Time frame: Change from baseline for specific phobia (DSM-5) (52 weeks)

  23. Diagnostic criteria for specific phobia according to interview (DSM-5)

    Time frame: Change from baseline for specific phobia (DSM-5) (3 years)

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Registry information

Official study title

Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial

Acronym: VIMSE

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Aug 26, 2015
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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