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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793828
• Other study ID #: EA 1/322/19
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Lena Pyrkosch, Dipl.-Psych.
• Phone: +49 30 450 517 214
• Email: lena.pyrkosch[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Panic Disorder With Agoraphobia
• Panic Disorder Without Agoraphobia
• Phobia, Social
• Social Anxiety Disorder

Intervention

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 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.

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (pre-treatment)
Primary	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.	During the intervention (mid-treatment)
Primary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Primary	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.	1-month follow-up
Primary	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.	Baseline (pre-treatment)
Primary	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.	During the intervention (mid-treatment)
Primary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Primary	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.	1-month follow-up
Primary	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.	Baseline (pre-treatment)
Primary	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.	During the intervention (mid-treatment)
Primary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Primary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up
Secondary	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.	Baseline (pre-treatment)
Secondary	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.	During the intervention (mid-treatment)
Secondary	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.	Immediately after / as soon as possible after the intervention (post-treatment)
Secondary	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.	1-month follow-up