ClinicalTrials.gg
RecruitingNCT04793828Updated May 7, 2026

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

An interventional study of Velibra in Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia and Generalized Anxiety Disorder, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2020, registered Feb 2021).
  • Started Jul 2020; still recruiting 6 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • 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
03

In context

Generalized Anxiety Disorder

517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.

Browse Generalized Anxiety Disorder studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Internet access

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention (velibra)

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

    Behavioral: Velibra

Interventions

  • BehavioralVelibra

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (pre-treatment)

  2. 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.

    Time frame: During the intervention (mid-treatment)

  3. 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.

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

  4. 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.

    Time frame: 1-month follow-up

  5. 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.

    Time frame: Baseline (pre-treatment)

  6. 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.

    Time frame: During the intervention (mid-treatment)

  7. 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.

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

  8. 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.

    Time frame: 1-month follow-up

  9. 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.

    Time frame: Baseline (pre-treatment)

  10. 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.

    Time frame: During the intervention (mid-treatment)

  11. 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.

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

  12. 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.

    Time frame: 1-month follow-up

Secondary outcomes

  1. Beck Anxiety Inventory (BAI)

    The Beck Anxiety Inventory (BAI) is a self-report questionnaire used to measure the symptom severity of anxiety in general. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

    Time frame: Baseline (pre-treatment)

  2. Beck Anxiety Inventory (BAI)

    The Beck Anxiety Inventory (BAI) is a self-report questionnaire used to measure the symptom severity of anxiety in general. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

    Time frame: During the intervention (mid-treatment)

  3. Beck Anxiety Inventory (BAI)

    The Beck Anxiety Inventory (BAI) is a self-report questionnaire used to measure the symptom severity of anxiety in general. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

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

  4. Beck Anxiety Inventory (BAI)

    The Beck Anxiety Inventory (BAI) is a self-report questionnaire used to measure the symptom severity of anxiety in general. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

    Time frame: 1-month follow-up

  5. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire used to measure the symptom severity of depression. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

    Time frame: Baseline (pre-treatment)

  6. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire used to measure the symptom severity of depression. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

    Time frame: During the intervention (mid-treatment)

  7. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire used to measure the symptom severity of depression. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

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

  8. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire used to measure the symptom severity of depression. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 63, with higher scores indicating a worse outcome.

    Time frame: 1-month follow-up

  9. Anxiety Sensitivity Index (ASI)

    The Anxiety Sensitivity Index (ASI) is a self-report questionnaire used to measure anxiety sensitivity. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 64, with higher scores indicating a worse outcome.

    Time frame: Baseline (pre-treatment)

  10. Anxiety Sensitivity Index (ASI)

    The Anxiety Sensitivity Index (ASI) is a self-report questionnaire used to measure anxiety sensitivity. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 64, with higher scores indicating a worse outcome.

    Time frame: During the intervention (mid-treatment)

  11. Anxiety Sensitivity Index (ASI)

    The Anxiety Sensitivity Index (ASI) is a self-report questionnaire used to measure anxiety sensitivity. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 64, with higher scores indicating a worse outcome.

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

  12. Anxiety Sensitivity Index (ASI)

    The Anxiety Sensitivity Index (ASI) is a self-report questionnaire used to measure anxiety sensitivity. It is given to all study participants regardless of diagnosis. Total score values range from 0 to 64, with higher scores indicating a worse outcome.

    Time frame: 1-month follow-up

  13. ICD-10-Symptom-Rating (ISR)

    The ICD-10-Symptom-Rating (ISR) is a self-report questionnaire used to measure mental distress related to syndromes defined in the ICD-10. It is given to all study participants regardless of diagnosis. Total score values (based on subscale means) range from 0 to 4, with higher scores indicating a worse outcome.

    Time frame: Baseline (pre-treatment)

  14. ICD-10-Symptom-Rating (ISR)

    The ICD-10-Symptom-Rating (ISR) is a self-report questionnaire used to measure mental distress related to syndromes defined in the ICD-10. It is given to all study participants regardless of diagnosis. Total score values (based on subscale means) range from 0 to 4, with higher scores indicating a worse outcome.

    Time frame: During the intervention (mid-treatment)

  15. ICD-10-Symptom-Rating (ISR)

    The ICD-10-Symptom-Rating (ISR) is a self-report questionnaire used to measure mental distress related to syndromes defined in the ICD-10. It is given to all study participants regardless of diagnosis. Total score values (based on subscale means) range from 0 to 4, with higher scores indicating a worse outcome.

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

  16. ICD-10-Symptom-Rating (ISR)

    The ICD-10-Symptom-Rating (ISR) is a self-report questionnaire used to measure mental distress related to syndromes defined in the ICD-10. It is given to all study participants regardless of diagnosis. Total score values (based on subscale means) range from 0 to 4, with higher scores indicating a worse outcome.

    Time frame: 1-month follow-up

  17. Short-Form Health Survey (SF-12)

    The Short-Form Health Survey (SF-12) is a self-report questionnaire used to measure health-related quality of life. It is given to all study participants regardless of diagnosis. Values of the summary scores range from 0 to 100, with higher scores indicating a better outcome.

    Time frame: Baseline (pre-treatment)

  18. Short-Form Health Survey (SF-12)

    The Short-Form Health Survey (SF-12) is a self-report questionnaire used to measure health-related quality of life. It is given to all study participants regardless of diagnosis. Values of the summary scores range from 0 to 100, with higher scores indicating a better outcome.

    Time frame: During the intervention (mid-treatment)

  19. Short-Form Health Survey (SF-12)

    The Short-Form Health Survey (SF-12) is a self-report questionnaire used to measure health-related quality of life. It is given to all study participants regardless of diagnosis. Values of the summary scores range from 0 to 100, with higher scores indicating a better outcome.

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

  20. Short-Form Health Survey (SF-12)

    The Short-Form Health Survey (SF-12) is a self-report questionnaire used to measure health-related quality of life. It is given to all study participants regardless of diagnosis. Values of the summary scores range from 0 to 100, with higher scores indicating a better outcome.

    Time frame: 1-month follow-up

  21. General Self--Efficacy Scale (GES)

    The General Self--Efficacy Scale (GES) is a self-report questionnaire used to measure self-efficacy. It is given to all study participants regardless of diagnosis. Total score values range from 10 to 40, with higher scores indicating a better outcome.

    Time frame: Baseline (pre-treatment)

  22. General Self--Efficacy Scale (GES)

    The General Self--Efficacy Scale (GES) is a self-report questionnaire used to measure self-efficacy. It is given to all study participants regardless of diagnosis. Total score values range from 10 to 40, with higher scores indicating a better outcome.

    Time frame: During the intervention (mid-treatment)

  23. General Self--Efficacy Scale (GES)

    The General Self--Efficacy Scale (GES) is a self-report questionnaire used to measure self-efficacy. It is given to all study participants regardless of diagnosis. Total score values range from 10 to 40, with higher scores indicating a better outcome.

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

  24. General Self--Efficacy Scale (GES)

    The General Self--Efficacy Scale (GES) is a self-report questionnaire used to measure self-efficacy. It is given to all study participants regardless of diagnosis. Total score values range from 10 to 40, with higher scores indicating a better outcome.

    Time frame: 1-month follow-up

  25. Internal, Powerful Others, and Chance Questionnaire (IPC)

    The Internal, Powerful Others, and Chance Questionnaire (IPC) is a self-report questionnaire used to measure locus of control. It is given to all study participants regardless of diagnosis. Score values of each of the three subscales range from 8 to 48, with higher scores on the subscale of internal orientation indicating a better outcome and higher scores on the subscales of powerful others orientation and chance orientation indicating a worse outcome.

    Time frame: Baseline (pre-treatment)

  26. Internal, Powerful Others, and Chance Questionnaire (IPC)

    The Internal, Powerful Others, and Chance Questionnaire (IPC) is a self-report questionnaire used to measure locus of control. It is given to all study participants regardless of diagnosis. Score values of each of the three subscales range from 8 to 48, with higher scores on the subscale of internal orientation indicating a better outcome and higher scores on the subscales of powerful others orientation and chance orientation indicating a worse outcome.

    Time frame: During the intervention (mid-treatment)

  27. Internal, Powerful Others, and Chance Questionnaire (IPC)

    The Internal, Powerful Others, and Chance Questionnaire (IPC) is a self-report questionnaire used to measure locus of control. It is given to all study participants regardless of diagnosis. Score values of each of the three subscales range from 8 to 48, with higher scores on the subscale of internal orientation indicating a better outcome and higher scores on the subscales of powerful others orientation and chance orientation indicating a worse outcome.

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

  28. Internal, Powerful Others, and Chance Questionnaire (IPC)

    The Internal, Powerful Others, and Chance Questionnaire (IPC) is a self-report questionnaire used to measure locus of control. It is given to all study participants regardless of diagnosis. Score values of each of the three subscales range from 8 to 48, with higher scores on the subscale of internal orientation indicating a better outcome and higher scores on the subscales of powerful others orientation and chance orientation indicating a worse outcome.

    Time frame: 1-month follow-up

07

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
    Berlin, 10117, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04793828
Responsible party
Anna Wehrheim (Psychologist, Charite University, Berlin, Germany) — Principal investigator
First posted
Mar 11, 2021
Start date
Jul 4, 2020
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 7, 2026

Study contacts

Anna Wehrheim, M.Sc.-Psych.
Contact
anna.wehrheim@charite.de
+49 30 450 517 017
Lena Pyrkosch, Dipl.-Psych.
Contact
lena.pyrkosch@charite.de
+49 30 450 517 214
Lena Pyrkosch, Dipl.-Psych.
principal investigator · Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
Anna Wehrheim, M.Sc.-Psych.
principal investigator · Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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