NCT05510804

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

December 7, 2021

Last Update Submit

August 19, 2022

Conditions

AnxietySocial PhobiaPanic DisorderAgoraphobia

Keywords

Digital Health ApplicationExposureVirtual RealityCognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Beck Anxiety Inventory (BAI)

    standard self-report instrument (21 items) for anxiety applicable in all three disorders investigated

    6 months after inclusion

Secondary Outcomes (5)

  • Change in Clinical Global Impression CGI

    through intervention completion, on average month 3

  • Change in Global Assessment of Functioning (GAF)

    through intervention completion, on average month 3

  • Change in WHO QoL L-1

    6 months after inclusion

  • Change in WHO QoL L-1

    12 months after inclusion

  • Change in Beck Anxiety Inventory (BAI)

    12 months after inclusion

Other Outcomes (2)

  • Change in Beck Depression Inventory (BDI II)

    6 months after inclusion

  • Change in Beck Depression Inventory (BDI II)

    12 months after inclusion

Study Arms (2)

ALISA (therapist-assisted digital self-help intervention)

EXPERIMENTAL

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

Combination Product: ALISA

TAU (supportive therapist contacts)

ACTIVE COMPARATOR

low-frequency supportive therapist contacts

Combination Product: ALISA

Interventions

ALISACOMBINATION_PRODUCT

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

Also known as: Invirto
ALISA (therapist-assisted digital self-help intervention)TAU (supportive therapist contacts)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zentrum für Integrative Psychiatrie, Univ. of Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Zentrum für Integrative Psychiatrie, Univ. of Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPhobia, SocialPanic DisorderAgoraphobia

Condition Hierarchy (Ancestors)

Mental DisordersPhobic Disorders

Study Officials

  • Bartosz Zurowski

    Zentrum für Integrative Psychiatrie, Univ. of Luebeck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartosz Zurowski, MD

CONTACT

+4945150098831bartosz.zurowski@uksh.de

Lars John, MD

CONTACT

+4943150098008lars.john@uksh.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT with 2:1 allocation either to Intervention or TAU (low-frequency unstructured contacts with therapist)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2021

First Posted

August 22, 2022

Study Start

March 3, 2020

Primary Completion

October 1, 2022

Study Completion

March 1, 2023

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)