Efficacy of an App-based CBT Featuring Virtual Reality for Anxiety Disorders

NCT ID: NCT05510804

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-03
• Study Completion Date: 2023-03-01

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)

Conditions

Anxiety; Social Phobia; Panic Disorder; Agoraphobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ALISA (therapist-assisted digital self-help intervention)

structured app-based self-help programme with scheduled therapist assistance

Group Type: EXPERIMENTAL

ALISA

Intervention Type: COMBINATION_PRODUCT

assisted self-help smartphone application featuring virtual reality within a structured CBT programme / low-frequency scheduled therapist assistance

TAU (supportive therapist contacts)

low-frequency supportive therapist contacts

Group Type: ACTIVE_COMPARATOR

ALISA

Intervention Type: COMBINATION_PRODUCT

assisted self-help smartphone application featuring virtual reality within a structured CBT programme / low-frequency scheduled therapist assistance

Interventions

ALISA

assisted self-help smartphone application featuring virtual reality within a structured CBT programme / low-frequency scheduled therapist assistance

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Invirto

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zentrum für Integrative Psychiatrie

OTHER

Sponsor Role: collaborator

Bartosz of Zurowski

OTHER

Sponsor Role: lead

Responsible Party

Bartosz of Zurowski

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bartosz Zurowski

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Integrative Psychiatrie, Univ. of Luebeck

Locations

Zentrum für Integrative Psychiatrie, Univ. of Kiel

Kiel, Schleswig-Holstein, Germany

Site Status: RECRUITING

Zentrum für Integrative Psychiatrie, Univ. of Lübeck

Lübeck, Schleswig-Holstein, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Bartosz Zurowski, MD

Role: CONTACT

bartosz.zurowski@uksh.de

+4945150098831

Lars John, MD

Role: CONTACT

lars.john@uksh.de

+4943150098008

Facility Contacts

Lars John, MD

Role: primary

lars.john@uksh.de

+4943150098008

Bartosz Zurowski, MD

Role: primary

bartosz.zurowski@uksh.de

+4945150098831

Other Identifiers

AZ 19-187

Identifier Type: -

Identifier Source: org_study_id