Clinical trial NCT04793828: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Panic and Agoraphobia Scale (PAS)
timeFrame: Baseline (pre-treatment)
measure: Panic and Agoraphobia Scale (PAS)
timeFrame: During the intervention (mid-treatment)
measure: Panic and Agoraphobia Scale (PAS)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Panic and Agoraphobia Scale (PAS)
timeFrame: 1-month follow-up
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Baseline (pre-treatment)
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: During the intervention (mid-treatment)
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 1-month follow-up
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline (pre-treatment)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: During the intervention (mid-treatment)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: 1-month follow-up
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline (pre-treatment)
measure: Beck Anxiety Inventory (BAI)
timeFrame: During the intervention (mid-treatment)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Beck Anxiety Inventory (BAI)
timeFrame: 1-month follow-up
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline (pre-treatment)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: During the intervention (mid-treatment)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 1-month follow-up
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Baseline (pre-treatment)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: During the intervention (mid-treatment)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: 1-month follow-up
measure: ICD-10-Symptom-Rating (ISR)
timeFrame: Baseline (pre-treatment)
measure: ICD-10-Symptom-Rating (ISR)
timeFrame: During the intervention (mid-treatment)
measure: ICD-10-Symptom-Rating (ISR)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: ICD-10-Symptom-Rating (ISR)
timeFrame: 1-month follow-up
measure: Short-Form Health Survey (SF-12)
timeFrame: Baseline (pre-treatment)
measure: Short-Form Health Survey (SF-12)
timeFrame: During the intervention (mid-treatment)
measure: Short-Form Health Survey (SF-12)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Short-Form Health Survey (SF-12)
timeFrame: 1-month follow-up
measure: General Self--Efficacy Scale (GES)
timeFrame: Baseline (pre-treatment)
measure: General Self--Efficacy Scale (GES)
timeFrame: During the intervention (mid-treatment)
measure: General Self--Efficacy Scale (GES)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: General Self--Efficacy Scale (GES)
timeFrame: 1-month follow-up
measure: Internal, Powerful Others, and Chance Questionnaire (IPC)
timeFrame: Baseline (pre-treatment)
measure: Internal, Powerful Others, and Chance Questionnaire (IPC)
timeFrame: During the intervention (mid-treatment)
measure: Internal, Powerful Others, and Chance Questionnaire (IPC)
timeFrame: Immediately after / as soon as possible after the intervention (post-treatment)
measure: Internal, Powerful Others, and Chance Questionnaire (IPC)
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
name: Lena Pyrkosch, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
name: Anna Wehrheim, M.Sc.-Psych.
role: PRINCIPAL_INVESTIGATOR
References: