Clinical trial NCT02533310: Virtual Reality Immersive Method for Spider (Phobia) Exposure Therapy (VIMSE)
Official title: Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia, Specific
Keywords: Specific phobia
Exposure therapy
Virtual reality
Randomized controlled trial
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Behavioral Approach Test (BAT)
timeFrame: Change from baseline on BAT (1 week)
measure: Behavioral Approach Test (BAT)
timeFrame: Change from baseline on BAT (12 week)
measure: Behavioral Approach Test (BAT)
timeFrame: Change from baseline on BAT (52 week)
Secondary outcomes:
measure: Spider Phobia Questionnaire 31 (SPQ-31)
timeFrame: Change from baseline on SPQ-31 (1 week)
measure: Spider Phobia Questionnaire 31 (SPQ-31)
timeFrame: Change from baseline on SPQ-31 (12 week)
measure: Spider Phobia Questionnaire 31 (SPQ-31)
timeFrame: Change from baseline on SPQ-31 (52 week)
measure: Spider Phobia Questionnaire 31 (SPQ-31)
timeFrame: Change from baseline on SPQ-31 (3 year)
measure: Fear of Spiders Questionnaire 18 (FSQ-18)
timeFrame: Change from baseline in FSQ-18 (1 week)
measure: Fear of Spiders Questionnaire 18 (FSQ-18)
timeFrame: Change from baseline in FSQ-18 (12 week)
measure: Fear of Spiders Questionnaire 18 (FSQ-18)
timeFrame: Change from baseline in FSQ-18 (52 week)
measure: Fear of Spiders Questionnaire 18 (FSQ-18)
timeFrame: Change from baseline in FSQ-18 (3 year)
measure: Generalized Anxiety Disorder Assessment 7 (GAD-7)
timeFrame: Change from baseline in GAD-7 (1 week)
measure: Generalized Anxiety Disorder Assessment 7 (GAD-7)
timeFrame: Change from baseline in GAD-7 (12 week)
measure: Generalized Anxiety Disorder Assessment 7 (GAD-7)
timeFrame: Change from baseline in GAD-7 (52 week)
measure: Generalized Anxiety Disorder Assessment 7 (GAD-7)
timeFrame: Change from baseline in GAD-7 (3 year)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from baseline in PHQ-9 (1 week)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from baseline in PHQ-9 (12 week)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from baseline in PHQ-9 (52 week)
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from baseline in PHQ-9 (3 year)
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline in BBQ (1 week)
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline in BBQ (12 week)
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline in BBQ (52 week)
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline in BBQ (3 year)
measure: Diagnostic criteria for specific phobia according to interview (DSM-5)
timeFrame: Change from baseline for specific phobia (DSM-5) (12 weeks)
measure: Diagnostic criteria for specific phobia according to interview (DSM-5)
timeFrame: Change from baseline for specific phobia (DSM-5) (52 weeks)
measure: Diagnostic criteria for specific phobia according to interview (DSM-5)
timeFrame: Change from baseline for specific phobia (DSM-5) (3 years)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Psychology
Study officials:
affiliation: Stockholm University
name: Per Carlbring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miloff A, Lindner P, Dafgard P, Deak S, Garke M, Hamilton W, Heinsoo J, Kristoffersson G, Rafi J, Sindemark K, Sjolund J, Zenger M, Reuterskiold L, Andersson G, Carlbring P. Automated virtual reality exposure therapy for spider phobia vs. in-vivo one-session treatment: A randomized non-inferiority trial. Behav Res Ther. 2019 Jul;118:130-140. doi: 10.1016/j.brat.2019.04.004. Epub 2019 Apr 16.
citation: Miloff A, Lindner P, Hamilton W, Reuterskiold L, Andersson G, Carlbring P. Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. Trials. 2016 Feb 2;17:60. doi: 10.1186/s13063-016-1171-1.