A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders

NCT ID: NCT04793828

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-04

Study Completion Date

2025-12-31

Brief Summary

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The project's aim is to investigate the effect of a transdiagnostic, self-guided, internet-based cognitive behavioral therapy program in waitlist patients with anxiety disorders.

Detailed Description

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Patients who fulfill the inclusion criteria and are interested in psychotherapy are offered participation in the study to bridge the waiting time for face-to-face psychotherapy. After obtaining informed consent, a pre-treatment assessment is conducted. Then, participants are provided access to velibra, an internet-based cognitive behavioral therapy program which they can work through at their own pace. While velibra is a self-guided program, participants are supported by study personnel during four assessments at four time points: pre-treatment, mid-treatment (after the first three velibra modules), post-treatment and at the one-month follow-up. The investigators expect improvements on the primary as well as the secondary outcomes. Furthermore, the investigators are interested in studying the acceptability of velibra and whether positive changes already become observable after the first three modules, i.e., at the mid-treatment assessment.

Conditions

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Panic Disorder With Agoraphobia Panic Disorder Without Agoraphobia Generalized Anxiety Disorder Social Anxiety Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention (velibra)

Arm consisting of participants who receive velibra, an internet-based cognitive behavioral therapy program.

Group Type EXPERIMENTAL

Velibra

Intervention Type BEHAVIORAL

Velibra is an internet-based cognitive behavioral therapy program developed by GAIA AG. It consists of six modules which are meant to be completed over a span of 6 weeks. The first module educates participants about anxiety and the treatment program. The second module focuses on cognitive techniques for dealing with anxiety. In the third module, relaxation techniques are practiced. The fourth module encourages the participant to practice non-anxious behaviors. In the fifth module, the central topic is the experience of social situations in non-anxious ways. The sixth and final module consists of a summary and recapitulation of the most important content.

Interventions

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Velibra

Velibra is an internet-based cognitive behavioral therapy program developed by GAIA AG. It consists of six modules which are meant to be completed over a span of 6 weeks. The first module educates participants about anxiety and the treatment program. The second module focuses on cognitive techniques for dealing with anxiety. In the third module, relaxation techniques are practiced. The fourth module encourages the participant to practice non-anxious behaviors. In the fifth module, the central topic is the experience of social situations in non-anxious ways. The sixth and final module consists of a summary and recapitulation of the most important content.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of panic disorder with or without agoraphobia, social anxiety disorder, or generalized anxiety disorder
* Knowledge of German that is sufficient for engaging with the treatment and responding to the questionnaires
* Written informed consent
* Internet access

Exclusion Criteria

* Diagnoses of severe mental comorbidities (e.g., schizophrenia, severe major depression, borderline personality disorder)
* Acute suicidality
* Started or changed anxiolytic pharmacotherapy recently (currently or in the past four weeks)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Lena Pyrkosch

Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lena Pyrkosch, Dipl.-Psych.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

Anna Wehrheim, M.Sc.-Psych.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

Locations

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Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anna Wehrheim, M.Sc.-Psych.

Role: CONTACT

+49 30 450 517 017

Lena Pyrkosch, Dipl.-Psych.

Role: CONTACT

+49 30 450 517 214

Facility Contacts

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Anna Wehrheim, M.Sc.-Psych.

Role: primary

Lena Pyrkosch, Dipl.-Psych.

Role: backup

+49 30 450 517 214

Other Identifiers

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EA 1/322/19

Identifier Type: -

Identifier Source: org_study_id

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