AzTrials
AzTrials

Panic Disorder With AgoraphobiaNCT04793828

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

A study testing Velibra in people with Panic Disorder With Agoraphobia and Panic Disorder Without Agoraphobia, run by Charite University, Berlin, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Velibra
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
4 Jul 2020to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Germany1 site, 1 recruiting
  • Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

    Berlin, 10117

    Anna Wehrheim, M.Sc.-Psych., anna.wehrheim@charite.de

    Lena Pyrkosch, Dipl.-Psych., +49 30 450 517 214, lena.pyrkosch@charite.de

    Recruiting

Other trials in Germany

About this study

Official title: The Effect of a Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders

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.

Being tested
Velibra
Keywords
cognitive behavioral therapy, internet intervention, administrative-supported, anxiety, panic disorder, social anxiety disorder, generalized anxiety disorder, computerized CBT, anxiety disorders, velibra, psychotherapy
Medical subject headings
Generalized Anxiety Disorder, Phobia, Social, Anxiety Disorders, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VelibraBehavioural

    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.

Study groups in NCT04793828
Study groupRoleWhat they receive
Intervention (velibra)ExperimentalArm consisting of participants who receive velibra, an internet-based cognitive behavioral therapy program.
Receives: Behavioral: Velibra

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 1-month follow-up

Secondary outcomes (28)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start4 Jul 2020
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04793828
Sponsor's protocol ID
EA 1/322/19
Status last verified
May 2026
First submitted
22 Feb 2021
Last updated
7 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Velibra in people with Panic Disorder With Agoraphobia and Panic Disorder Without Agoraphobia, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Wehrheim, M.Sc.-Psych. (+49 30 450 517 017, anna.wehrheim@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Panic and Agoraphobia Scale (PAS) (time frame: Baseline (pre-treatment)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in