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Register:	ClinicalTrials.gov
Last refreshed on:	1 March 2021
Main ID:	NCT02533310
Date of registration:	24/08/2015
Prospective Registration:	No
Primary sponsor:	Stockholm University
Public title:	Virtual Reality Immersive Method for Spider (Phobia) Exposure Therapy (VIMSE) VIMSE
Scientific title:	Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial
Date of first enrolment:	August 1, 2015
Target sample size:	100
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02533310
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Sweden

Contacts

Name:	Per Carlbring, PhD
Address:
Telephone:
Email:
Affiliation:	Stockholm University

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Phobia, Specific

Intervention(s)

Other: OST treatment with in-vivo spiders

Other: VR-OST treatment with virtual spiders

Primary Outcome(s)

Behavioral Approach Test (BAT) [Time Frame: Change from baseline on BAT (12 week)]

Behavioral Approach Test (BAT) [Time Frame: Change from baseline on BAT (52 week)]

Behavioral Approach Test (BAT) [Time Frame: Change from baseline on BAT (1 week)]

Secondary Outcome(s)

Brunnsviken Brief Quality of Life Scale (BBQ) [Time Frame: Change from baseline in BBQ (3 year)]

Fear of Spiders Questionnaire 18 (FSQ-18) [Time Frame: Change from baseline in FSQ-18 (3 year)]

Spider Phobia Questionnaire 31 (SPQ-31) [Time Frame: Change from baseline on SPQ-31 (52 week)]

Brunnsviken Brief Quality of Life Scale (BBQ) [Time Frame: Change from baseline in BBQ (1 week)]

Brunnsviken Brief Quality of Life Scale (BBQ) [Time Frame: Change from baseline in BBQ (12 week)]

Diagnostic criteria for specific phobia according to interview (DSM-5) [Time Frame: Change from baseline for specific phobia (DSM-5) (12 weeks)]

Fear of Spiders Questionnaire 18 (FSQ-18) [Time Frame: Change from baseline in FSQ-18 (52 week)]

Generalized Anxiety Disorder Assessment 7 (GAD-7) [Time Frame: Change from baseline in GAD-7 (52 week)]

Patient Health Questionnaire 9 (PHQ-9) [Time Frame: Change from baseline in PHQ-9 (12 week)]

Spider Phobia Questionnaire 31 (SPQ-31) [Time Frame: Change from baseline on SPQ-31 (1 week)]

Brunnsviken Brief Quality of Life Scale (BBQ) [Time Frame: Change from baseline in BBQ (52 week)]

Diagnostic criteria for specific phobia according to interview (DSM-5) [Time Frame: Change from baseline for specific phobia (DSM-5) (52 weeks)]

Fear of Spiders Questionnaire 18 (FSQ-18) [Time Frame: Change from baseline in FSQ-18 (1 week)]

Patient Health Questionnaire 9 (PHQ-9) [Time Frame: Change from baseline in PHQ-9 (3 year)]

Diagnostic criteria for specific phobia according to interview (DSM-5) [Time Frame: Change from baseline for specific phobia (DSM-5) (3 years)]

Generalized Anxiety Disorder Assessment 7 (GAD-7) [Time Frame: Change from baseline in GAD-7 (12 week)]

Generalized Anxiety Disorder Assessment 7 (GAD-7) [Time Frame: Change from baseline in GAD-7 (3 year)]

Fear of Spiders Questionnaire 18 (FSQ-18) [Time Frame: Change from baseline in FSQ-18 (12 week)]

Generalized Anxiety Disorder Assessment 7 (GAD-7) [Time Frame: Change from baseline in GAD-7 (1 week)]

Spider Phobia Questionnaire 31 (SPQ-31) [Time Frame: Change from baseline on SPQ-31 (12 week)]

Patient Health Questionnaire 9 (PHQ-9) [Time Frame: Change from baseline in PHQ-9 (52 week)]

Spider Phobia Questionnaire 31 (SPQ-31) [Time Frame: Change from baseline on SPQ-31 (3 year)]

Patient Health Questionnaire 9 (PHQ-9) [Time Frame: Change from baseline in PHQ-9 (1 week)]

Secondary ID(s)

VIMSE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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