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NCT Number: NCT04793828

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.

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Key information

Conditions

Panic Disorder With Agoraphobia Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Panic Disorder Panic Disorder Without Agoraphobia Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 10117, Germany

Location status: Recruiting

Location contact

Anna Wehrheim, M.Sc.-Psych.

CONTACT

[email protected]

Lena Pyrkosch, Dipl.-Psych.

CONTACT

[email protected]

+49 30 450 517 214

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Panic and Agoraphobia Scale (PAS)

    Time frame: Baseline (pre-treatment)

    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.

  2. Panic and Agoraphobia Scale (PAS)

    Time frame: During the intervention (mid-treatment)

    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.

  3. Panic and Agoraphobia Scale (PAS)

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

    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.

  4. Panic and Agoraphobia Scale (PAS)

    Time frame: 1-month follow-up

    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.

  5. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: Baseline (pre-treatment)

    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.

  6. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: During the intervention (mid-treatment)

    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.

  7. Liebowitz Social Anxiety Scale (LSAS)

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

    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.

  8. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: 1-month follow-up

    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.

  9. Penn State Worry Questionnaire (PSWQ)

    Time frame: Baseline (pre-treatment)

    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.

  10. Penn State Worry Questionnaire (PSWQ)

    Time frame: During the intervention (mid-treatment)

    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.

  11. Penn State Worry Questionnaire (PSWQ)

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

    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.

  12. Penn State Worry Questionnaire (PSWQ)

    Time frame: 1-month follow-up

    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.

Secondary outcomes

  1. Beck Anxiety Inventory (BAI)

    Time frame: Baseline (pre-treatment)

    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.

  2. Beck Anxiety Inventory (BAI)

    Time frame: During the intervention (mid-treatment)

    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.

  3. Beck Anxiety Inventory (BAI)

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

    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.

  4. Beck Anxiety Inventory (BAI)

    Time frame: 1-month follow-up

    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.

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

    Time frame: Baseline (pre-treatment)

    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.

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

    Time frame: During the intervention (mid-treatment)

    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.

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

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

    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.

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

    Time frame: 1-month follow-up

    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.

  9. Anxiety Sensitivity Index (ASI)

    Time frame: Baseline (pre-treatment)

    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.

  10. Anxiety Sensitivity Index (ASI)

    Time frame: During the intervention (mid-treatment)

    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.

  11. Anxiety Sensitivity Index (ASI)

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

    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.

  12. Anxiety Sensitivity Index (ASI)

    Time frame: 1-month follow-up

    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.

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

    Time frame: Baseline (pre-treatment)

    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.

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

    Time frame: During the intervention (mid-treatment)

    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.

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

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

    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.

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

    Time frame: 1-month follow-up

    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.

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

    Time frame: Baseline (pre-treatment)

    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.

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

    Time frame: During the intervention (mid-treatment)

    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.

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

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

    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.

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

    Time frame: 1-month follow-up

    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.

  21. General Self--Efficacy Scale (GES)

    Time frame: Baseline (pre-treatment)

    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.

  22. General Self--Efficacy Scale (GES)

    Time frame: During the intervention (mid-treatment)

    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.

  23. General Self--Efficacy Scale (GES)

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

    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.

  24. General Self--Efficacy Scale (GES)

    Time frame: 1-month follow-up

    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.

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

    Time frame: Baseline (pre-treatment)

    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.

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

    Time frame: During the intervention (mid-treatment)

    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.

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

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

    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.

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

    Time frame: 1-month follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Wehrheim, M.Sc.-Psych.

CONTACT

[email protected]

+49 30 450 517 017

Lena Pyrkosch, Dipl.-Psych.

CONTACT

[email protected]

+49 30 450 517 214

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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