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

NCT04793828 | Recruiting

• 1 other identifier: EA 1/322/19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

cognitive behavioral therapy; internet intervention; administrative-supported; anxiety; panic disorder; social anxiety disorder; generalized anxiety disorder; computerized CBT; anxiety disorders; velibra; psychotherapy

Outcome Measures

Primary Outcomes (12)

• Panic and Agoraphobia Scale (PAS)

  The Panic and Agoraphobia Scale (PAS) is a self-report questionnaire used to measure the symptom severity of panic disorder with or without agoraphobia. It is given to study participants diagnosed with panic disorder with or without agoraphobia. Total score values range from 0 to 52, with higher scores indicating a worse outcome.

  Baseline (pre-treatment)

• Panic and Agoraphobia Scale (PAS)

  The Panic and Agoraphobia Scale (PAS) is a self-report questionnaire used to measure the symptom severity of panic disorder with or without agoraphobia. It is given to study participants diagnosed with panic disorder with or without agoraphobia. Total score values range from 0 to 52, with higher scores indicating a worse outcome.

  During the intervention (mid-treatment)

• Panic and Agoraphobia Scale (PAS)

  The Panic and Agoraphobia Scale (PAS) is a self-report questionnaire used to measure the symptom severity of panic disorder with or without agoraphobia. It is given to study participants diagnosed with panic disorder with or without agoraphobia. Total score values range from 0 to 52, with higher scores indicating a worse outcome.

  Immediately after / as soon as possible after the intervention (post-treatment)

• Panic and Agoraphobia Scale (PAS)

  The Panic and Agoraphobia Scale (PAS) is a self-report questionnaire used to measure the symptom severity of panic disorder with or without agoraphobia. It is given to study participants diagnosed with panic disorder with or without agoraphobia. Total score values range from 0 to 52, with higher scores indicating a worse outcome.

  1-month follow-up

• Liebowitz Social Anxiety Scale (LSAS)

  The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire used to measure the symptom severity of social anxiety disorder. It is given to study participants diagnosed with social anxiety disorder. Total score values range from 0 to 72, with higher scores indicating a worse outcome.

  Baseline (pre-treatment)

• Liebowitz Social Anxiety Scale (LSAS)

  The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire used to measure the symptom severity of social anxiety disorder. It is given to study participants diagnosed with social anxiety disorder. Total score values range from 0 to 72, with higher scores indicating a worse outcome.

  During the intervention (mid-treatment)

• Liebowitz Social Anxiety Scale (LSAS)

  The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire used to measure the symptom severity of social anxiety disorder. It is given to study participants diagnosed with social anxiety disorder. Total score values range from 0 to 72, with higher scores indicating a worse outcome.

  Immediately after / as soon as possible after the intervention (post-treatment)

• Liebowitz Social Anxiety Scale (LSAS)

  The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire used to measure the symptom severity of social anxiety disorder. It is given to study participants diagnosed with social anxiety disorder. Total score values range from 0 to 72, with higher scores indicating a worse outcome.

  1-month follow-up

• Penn State Worry Questionnaire (PSWQ)

  The Penn State Worry Questionnaire (PSWQ) is a self-report questionnaire used to measure the symptom severity of generalized anxiety disorder It is given to study participants diagnosed with generalized anxiety disorder. Total score values range from 16 to 80, with higher scores indicating a worse outcome.

  Baseline (pre-treatment)

• Penn State Worry Questionnaire (PSWQ)

  The Penn State Worry Questionnaire (PSWQ) is a self-report questionnaire used to measure the symptom severity of generalized anxiety disorder It is given to study participants diagnosed with generalized anxiety disorder. Total score values range from 16 to 80, with higher scores indicating a worse outcome.

  During the intervention (mid-treatment)

• Penn State Worry Questionnaire (PSWQ)

  The Penn State Worry Questionnaire (PSWQ) is a self-report questionnaire used to measure the symptom severity of generalized anxiety disorder It is given to study participants diagnosed with generalized anxiety disorder. Total score values range from 16 to 80, with higher scores indicating a worse outcome.

  Immediately after / as soon as possible after the intervention (post-treatment)

• Penn State Worry Questionnaire (PSWQ)

  The Penn State Worry Questionnaire (PSWQ) is a self-report questionnaire used to measure the symptom severity of generalized anxiety disorder It is given to study participants diagnosed with generalized anxiety disorder. Total score values range from 16 to 80, with higher scores indicating a worse outcome.

  1-month follow-up

Secondary Outcomes (28)

• Beck Anxiety Inventory (BAI)

  Baseline (pre-treatment)

• Beck Anxiety Inventory (BAI)

  During the intervention (mid-treatment)

• Beck Anxiety Inventory (BAI)

  Immediately after / as soon as possible after the intervention (post-treatment)

• Beck Anxiety Inventory (BAI)

  1-month follow-up

• Beck Depression Inventory-II (BDI-II)

  Baseline (pre-treatment)

Study Arms (1)

Intervention (velibra)

EXPERIMENTAL

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

Behavioral: Velibra

Interventions

Velibra 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.

Intervention (velibra)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Anxiety Disorders; Panic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Lena Pyrkosch, Dipl.-Psych.

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

  PRINCIPAL INVESTIGATOR

• Anna Wehrheim, M.Sc.-Psych.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Wehrheim, M.Sc.-Psych.

CONTACT

+49 30 450 517 017; anna.wehrheim@charite.de

Lena Pyrkosch, Dipl.-Psych.

CONTACT

+49 30 450 517 214; lena.pyrkosch@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 11, 2021
• Study Start: July 4, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

DE (1)