Research project to test the efficacy of an online follow-up program for patients with anxiety disorder using randomized controlled designs

Not Applicable

Recruiting

• Conditions: F40.0; F41.0; F40.1; Agoraphobia; Panic disorder [episodic paroxysmal anxiety]; Social phobias

• Registration Number: DRKS00030936
• Lead Sponsor: Sympatient GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

? Presence of a primary diagnosed anxiety disorder (for RCT-A: agoraphobia with/without panic disorder F40.0-/6B32; for RCT-P: panic disorder F41.0/6B34; for RCT-S: social phobia F40.1/6B34).
? Current, at least mild, anxiety symptomatology as measured by a summed score of at least 30 on the LSAS for the RCT-S, or at least 8 on the PAS for the RCT-A and RCT-P at the time of baseline interview (T0)
? One prior psychotherapeutic treatment for the anxiety disorder completed within the past 12 months
? No current medication for the anxiety disorder or medication stable for at least 4 weeks before inclusion
? Presence of internet access and a device to use Invirto Aftercare.
? Sufficient understanding of the German language
? Willingness to use Invirto Nachsorge on their own responsibility.

Exclusion Criteria

?Acute suicidality
?Current ongoing psychotherapeutic treatment at baseline assessment
?Diagnosis of schizophrenic or bipolar disorder
?Contraindication to the Invirto aftercare medical device

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome refers to disorder-specific anxiety symptomatology (RCT-S: Liebowitz Social Anxiety Scale (LSAS); RCT-P and RCT-A: Panic and Agoraphobia Scale (PAS)) after 12 weeks. <br><br>Liebowitz Social Anxiety Scale (LSAS-SR; Baker et al., 2002): The LSAS is a self-report instrument designed to measure the severity of social phobia (T0, T1, T2).<br><br>Panic and Agoraphobia Scale (PAS; Bandelow, 1995): The PAS measures symptoms of panic disorder and agoraphobia within the past week. Thirteen items are used to assess five domains that limit quality of life in patients with panic disorder: panic attacks, agoraphobic avoidance, anticipatory anxiety, restriction, and health fears (T0, T1, T2).