A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
Primary Purpose
Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Generalized Anxiety Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Velibra
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder With Agoraphobia focused on measuring cognitive behavioral therapy, internet intervention, administrative-supported, anxiety, panic disorder, social anxiety disorder, generalized anxiety disorder, computerized CBT, anxiety disorders, velibra, psychotherapy
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)
Sites / Locations
- Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin BerlinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention (velibra)
Arm Description
Arm consisting of participants who receive velibra, an internet-based cognitive behavioral therapy program.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04793828
First Posted
February 22, 2021
Last Updated
February 10, 2023
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT04793828
Brief Title
A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
Official Title
The Effect of a Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Generalized Anxiety Disorder, Social Anxiety Disorder
Keywords
cognitive behavioral therapy, internet intervention, administrative-supported, anxiety, panic disorder, social anxiety disorder, generalized anxiety disorder, computerized CBT, anxiety disorders, velibra, psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention (velibra)
Arm Type
Experimental
Arm Description
Arm consisting of participants who receive velibra, an internet-based cognitive behavioral therapy program.
Intervention Type
Behavioral
Intervention Name(s)
Velibra
Intervention Description
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 Outcome Measure Information:
Title
Panic and Agoraphobia Scale (PAS)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Panic and Agoraphobia Scale (PAS)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Panic and Agoraphobia Scale (PAS)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Panic and Agoraphobia Scale (PAS)
Description
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.
Time Frame
1-month follow-up
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
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.
Time Frame
1-month follow-up
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
1-month follow-up
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
1-month follow-up
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
1-month follow-up
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
1-month follow-up
Title
ICD-10-Symptom-Rating (ISR)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
ICD-10-Symptom-Rating (ISR)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
ICD-10-Symptom-Rating (ISR)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
ICD-10-Symptom-Rating (ISR)
Description
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.
Time Frame
1-month follow-up
Title
Short-Form Health Survey (SF-12)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Short-Form Health Survey (SF-12)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Short-Form Health Survey (SF-12)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Short-Form Health Survey (SF-12)
Description
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.
Time Frame
1-month follow-up
Title
General Self--Efficacy Scale (GES)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
General Self--Efficacy Scale (GES)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
General Self--Efficacy Scale (GES)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
General Self--Efficacy Scale (GES)
Description
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.
Time Frame
1-month follow-up
Title
Internal, Powerful Others, and Chance Questionnaire (IPC)
Description
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.
Time Frame
Baseline (pre-treatment)
Title
Internal, Powerful Others, and Chance Questionnaire (IPC)
Description
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.
Time Frame
During the intervention (mid-treatment)
Title
Internal, Powerful Others, and Chance Questionnaire (IPC)
Description
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.
Time Frame
Immediately after / as soon as possible after the intervention (post-treatment)
Title
Internal, Powerful Others, and Chance Questionnaire (IPC)
Description
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.
Time Frame
1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Pyrkosch, Dipl.-Psych.
Phone
+49 30 450 517 214
Email
lena.pyrkosch@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Pyrkosch, Dipl.-Psych.
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Pyrkosch, Dipl.-Psych.
Phone
+49 30 450 517 214
Email
lena.pyrkosch@charite.de
12. IPD Sharing Statement
Learn more about this trial
A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
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