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

Not Applicable

Recruiting

• Conditions: Panic Disorder With Agoraphobia; Panic Disorder Without Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder
• Interventions: Behavioral: Velibra

• Registration Number: NCT04793828
• Lead Sponsor: Charite University, Berlin, Germany

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.

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.

Study Timeline

• Study Start: 2020-07-04
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention (velibra)	Velibra	Arm consisting of participants who receive velibra, an internet-based cognitive behavioral therapy program.

Primary Outcome Measures

Name	Time	Method
Penn State Worry Questionnaire (PSWQ)	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.
Liebowitz Social Anxiety Scale (LSAS)	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.
Panic and Agoraphobia Scale (PAS)	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.

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (BAI)	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.
Internal, Powerful Others, and Chance Questionnaire (IPC)	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.
Beck Depression Inventory-II (BDI-II)	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.
ICD-10-Symptom-Rating (ISR)	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.
Short-Form Health Survey (SF-12)	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.
Anxiety Sensitivity Index (ASI)	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.
General Self--Efficacy Scale (GES)	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.

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany