A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Velibra.
- Who it may be relevant to
- Registry conditions: Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Generalized Anxiety Disorder, Social Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
Overview
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
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.
Interventions
- Behavioral 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 to
Primary outcome measures
- Panic and Agoraphobia Scale (PAS) [Time frame: Baseline (pre-treatment)]
- Panic and Agoraphobia Scale (PAS) [Time frame: During the intervention (mid-treatment)]
- Panic and Agoraphobia Scale (PAS) [Time frame: Immediately after / as soon as possible after the intervention (post-treatment)]
- Panic and Agoraphobia Scale (PAS) [Time frame: 1-month follow-up]
- Liebowitz Social Anxiety Scale (LSAS) [Time frame: Baseline (pre-treatment)]
- Liebowitz Social Anxiety Scale (LSAS) [Time frame: During the intervention (mid-treatment)]
- Liebowitz Social Anxiety Scale (LSAS) [Time frame: Immediately after / as soon as possible after the intervention (post-treatment)]
- Liebowitz Social Anxiety Scale (LSAS) [Time frame: 1-month follow-up]
- Penn State Worry Questionnaire (PSWQ) [Time frame: Baseline (pre-treatment)]
- Penn State Worry Questionnaire (PSWQ) [Time frame: During the intervention (mid-treatment)]
Secondary outcome measures (12)
- Beck Anxiety Inventory (BAI) [Time frame: Baseline (pre-treatment)]
- Beck Anxiety Inventory (BAI) [Time frame: During the intervention (mid-treatment)]
- Beck Anxiety Inventory (BAI) [Time frame: Immediately after / as soon as possible after the intervention (post-treatment)]
- Beck Anxiety Inventory (BAI) [Time frame: 1-month follow-up]
- Beck Depression Inventory-II (BDI-II) [Time frame: Baseline (pre-treatment)]
- Beck Depression Inventory-II (BDI-II) [Time frame: During the intervention (mid-treatment)]
- Beck Depression Inventory-II (BDI-II) [Time frame: Immediately after / as soon as possible after the intervention (post-treatment)]
- Beck Depression Inventory-II (BDI-II) [Time frame: 1-month follow-up]
- Anxiety Sensitivity Index (ASI) [Time frame: Baseline (pre-treatment)]
- Anxiety Sensitivity Index (ASI) [Time frame: During the intervention (mid-treatment)]
- Anxiety Sensitivity Index (ASI) [Time frame: Immediately after / as soon as possible after the intervention (post-treatment)]
- Anxiety Sensitivity Index (ASI) [Time frame: 1-month follow-up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Ber — Berlin
Identifiers
NCT: NCT04793828 · EA 1/322/19