Study to evaluate efficacy of an App-based CBT featuring virtual reality for anxiety disorders
Bartosz of Zurowski is recruiting patients for the clinical trial of Efficacy of an App-based CBT Featuring Virtual Reality for Anxiety Disorders (ALISA).
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.
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 researchers plan that March 3, 2020 will be the study start date. The indicative completion of the clinical trial will be expected in March 1, 2023.
The study will take place at the Zentrum für Integrative Psychiatrie, Univ. of Kiel, Kiel, Schleswig-Holstein, Germany; Zentrum für Integrative Psychiatrie, Univ. of Lübeck, Lübeck, Schleswig-Holstein, Germany.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05510804.
