Efficacy of an App-based CBT Featuring Virtual Reality for Anxiety Disorders (ALISA)
Primary Purpose
Anxiety, Social Phobia, Panic Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ALISA
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Digital Health Application, Exposure, Virtual Reality, Cognitive Behavior Therapy
Eligibility Criteria
Inclusion Criteria:
- Primary diagnosis: Agoraphobia w/without PD (F 40.0, F40.01) OR Panic disorder (F41.0) OR Social anxiety disorder (phobia) (F40.1)
- Smartphone availability
Exclusion Criteria:
- history of stroke or heart attack
- angina pectoris
- cardiac arrhythmia
- untreated high blood pressure
- severe asthma or chronic obstructive pulmonary disease (COPD)
- (supposed) pregnancy
- severe visual impairment
- severe nausea and/or vestibular impairment
- epilepsy
- neuropsychiatric condition (i.e. dementia)
- psychiatric disorder associated with substance abuse
- psychotic disorder
- severe episode of major depression or manic episode
- suicidal ideation or behavior
Sites / Locations
- Zentrum für Integrative Psychiatrie, Univ. of KielRecruiting
- Zentrum für Integrative Psychiatrie, Univ. of LübeckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ALISA (therapist-assisted digital self-help intervention)
TAU (supportive therapist contacts)
Arm Description
structured app-based self-help programme with scheduled therapist assistance
low-frequency supportive therapist contacts
Outcomes
Primary Outcome Measures
Change in Beck Anxiety Inventory (BAI)
standard self-report instrument (21 items) for anxiety applicable in all three disorders investigated
Secondary Outcome Measures
Change in Clinical Global Impression CGI
broadly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders It is a brief 3-item observer-rated scale for clinical practice and research.
Change in Global Assessment of Functioning (GAF)
broadly used and WHO-recommended scale to evaluate an individual's' psychological, social, and occupational functioning (0-100)
Change in WHO QoL L-1
one-item assessment of quality of life
Change in WHO QoL L-1
one-item assessment of quality of life
Change in Beck Anxiety Inventory (BAI)
standard self-report instrument (21 items) for anxiety applicable in all three disorders
Full Information
NCT ID
NCT05510804
First Posted
December 7, 2021
Last Updated
August 19, 2022
Sponsor
Bartosz of Zurowski
Collaborators
Zentrum für Integrative Psychiatrie
1. Study Identification
Unique Protocol Identification Number
NCT05510804
Brief Title
Efficacy of an App-based CBT Featuring Virtual Reality for Anxiety Disorders
Acronym
ALISA
Official Title
Ambulante Leitlinienkonforme Intervention im Selbstmanagement für Angststörungen (ALISA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bartosz of Zurowski
Collaborators
Zentrum für Integrative Psychiatrie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary aim is to evaluate the efficacy of a (minimally) therapist-guided app-based psychotherapy with virtual reality exposure therapy (ALISA) in participants with agoraphobia with or without panic disorder, social anxiety disorder or panic disorder. Participants are diagnosed applying a structured clinical interview by qualified psychologists and then they are randomly allocated to either the intervention group (ALISA) or a control group, receiving supportive psychotherapy while on a waiting list for a structured therapy programme. The investigators hypothesize that participants receiving ALISA compared to controls will present lower levels of anxiety and a higher quality of life at six-month follow-up after start of the intervention, according to Beck Anxiety Inventory (BAI, primary outcome measure) and WHO-QoL, respectively.
Detailed Description
Primary aim is to evaluate the efficacy of a (minimally) therapist-guided app-based psychotherapy with virtual reality exposure therapy (ALISA) in participants with agoraphobia (with or without panic disorder), social anxiety disorder or panic disorder. The intervention has been developed by Sympatient GmbH in cooperation with the University of Luebeck, Dept. of Psychiatry. It consists of scheduled therapist assistance, a smartphone-based application consisting of eight CBT-based courses including instructive therapist videos, questionnaires and VR exposure scenarios presented via VR goggles as well as interoceptive exposures.
Participants are diagnosed according to a structured clinical interview (SCID) by experienced and trained clinical psychologists. Then they are randomly allocated to either the intervention group (ALISA) or a control group offered supportive psychotherapy while being on a waiting list for a structured therapy programme of an outpatient unit for patients with anxiety disorders. The investigators hypothesize that participants receiving ALISA - as compared to controls - will present lower levels of anxiety and a higher quality of life at 6-month follow-up after start of the intervention, according to Beck Anxiety Inventory (BAI, primary outcome measure) and WHO-QoL (L-1), respectively. Furthermore, the investigators hypothesize that the reduction of anxiety (ANOVA; group x time) can be shown at 1-year follow up. The investigators expect ALISA to be effective in each of the three disorder-specific therapy schedules (social phobia, panic disorder, agoraphobia w/without panic disorder). Therefore, disorder-specific symptom scales have been additionally adopted: Panic and Agoraphobia Scale (PAS) and Liebowitz Social Phobia Scale. Co-morbid depression and global functioning will be assessed using CGI and GAF as secondary outcome measures, respectively.
The allocation to the groups was conducted on the basis of random numbers generated by Microsoft Excel 2013 and with the restriction that the ratio of intervention to control group participants was 2:1. This unequal randomization was chosen for ethical reasons including a more reliable assessment of adverse events in the intervention group with a higher power. A planned sample size of n = 41 for each of the three diagnoses in the intervention group and n = 21 for each of the three diagnoses in the control group was calculated to detect a significant difference with an effect size of Cohens´s d = 0.9 with a probability of 90% and α = 2.5. Adding an estimated dropout-rate of 20%, each diagnosis group should include n = 49 participants in the intervention group and n = 25 in the control group, resulting in a total of N = 222 participants. (Multiple) imputation will be applied to deal with missing data. Results of Intention to treat analyses and following per protocol analyses will be reported.
Using records of cooperating health insurances, a health economic analysis of the intervention will be performed. Given that patients with untreated anxiety disorders show a markedly increased use of health system, a successful reduction of anxiety, once proven, should have an impact on patient's use of the health system in general (exploratory analysis)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Social Phobia, Panic Disorder, Agoraphobia
Keywords
Digital Health Application, Exposure, Virtual Reality, Cognitive Behavior Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT with 2:1 allocation either to Intervention or TAU (low-frequency unstructured contacts with therapist)
Masking
Investigator
Allocation
Randomized
Enrollment
222 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALISA (therapist-assisted digital self-help intervention)
Arm Type
Experimental
Arm Description
structured app-based self-help programme with scheduled therapist assistance
Arm Title
TAU (supportive therapist contacts)
Arm Type
Active Comparator
Arm Description
low-frequency supportive therapist contacts
Intervention Type
Combination Product
Intervention Name(s)
ALISA
Other Intervention Name(s)
Invirto
Intervention Description
assisted self-help smartphone application featuring virtual reality within a structured CBT programme / low-frequency scheduled therapist assistance
Primary Outcome Measure Information:
Title
Change in Beck Anxiety Inventory (BAI)
Description
standard self-report instrument (21 items) for anxiety applicable in all three disorders investigated
Time Frame
6 months after inclusion
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression CGI
Description
broadly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders It is a brief 3-item observer-rated scale for clinical practice and research.
Time Frame
through intervention completion, on average month 3
Title
Change in Global Assessment of Functioning (GAF)
Description
broadly used and WHO-recommended scale to evaluate an individual's' psychological, social, and occupational functioning (0-100)
Time Frame
through intervention completion, on average month 3
Title
Change in WHO QoL L-1
Description
one-item assessment of quality of life
Time Frame
6 months after inclusion
Title
Change in WHO QoL L-1
Description
one-item assessment of quality of life
Time Frame
12 months after inclusion
Title
Change in Beck Anxiety Inventory (BAI)
Description
standard self-report instrument (21 items) for anxiety applicable in all three disorders
Time Frame
12 months after inclusion
Other Pre-specified Outcome Measures:
Title
Change in Beck Depression Inventory (BDI II)
Description
standard self-report instrument (21 items) measuring depressive symptoms
Time Frame
6 months after inclusion
Title
Change in Beck Depression Inventory (BDI II)
Description
standard self-report instrument (21 items) measuring depressive symptoms
Time Frame
12 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary diagnosis: Agoraphobia w/without PD (F 40.0, F40.01) OR Panic disorder (F41.0) OR Social anxiety disorder (phobia) (F40.1)
Smartphone availability
Exclusion Criteria:
history of stroke or heart attack
angina pectoris
cardiac arrhythmia
untreated high blood pressure
severe asthma or chronic obstructive pulmonary disease (COPD)
(supposed) pregnancy
severe visual impairment
severe nausea and/or vestibular impairment
epilepsy
neuropsychiatric condition (i.e. dementia)
psychiatric disorder associated with substance abuse
psychotic disorder
severe episode of major depression or manic episode
suicidal ideation or behavior
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bartosz Zurowski, MD
Phone
+4945150098831
Email
bartosz.zurowski@uksh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Lars John, MD
Phone
+4943150098008
Email
lars.john@uksh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartosz Zurowski
Organizational Affiliation
Zentrum für Integrative Psychiatrie, Univ. of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Integrative Psychiatrie, Univ. of Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars John, MD
Phone
+4943150098008
Email
lars.john@uksh.de
Facility Name
Zentrum für Integrative Psychiatrie, Univ. of Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartosz Zurowski, MD
Phone
+4945150098831
Email
bartosz.zurowski@uksh.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of an App-based CBT Featuring Virtual Reality for Anxiety Disorders
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