F40.0 F41.0 F40.1
Conditions
Interventions
Group 1: Intervention group with immediate access to "Invirto aftercare"
Group 2: Control group: care as usual with delayed access (after end of study period) to "Invirto aftercare"
Sponsors
Sympatient GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
Exclusion criteria: ? Acute suicidality ? Current ongoing psychotherapeutic treatment at baseline assessment ? Diagnosis of schizophrenic or bipolar disorder ? Contraindication to the Invirto aftercare medical device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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). 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001): The PHQ-9 is the depression module of the PHQ-D and measures the presence and frequency of nine depressive symptoms (according to DSM-IV criteria for major depression) during the past two weeks (T0, T1, T2). Perceived Health Competence Scale (PHCS; Smith et al., 1995): The PHCS measures subjective health competence in self-report. The questionnaire was originally designed for the somatic domain and was adapted for mental health for the planned study (T0, T1, T2). Work and Social Adjustment Scale (WSAS; Mundt et al., 2002): The WSAS uses five items in self-report to assess functional impairment due to a specific problem in daily life (T0, T1, T2). Short scale for measuring general self-efficacy beliefs (ASKU; Beierlein et al., 2013): The ASKU is used to assess self-assessment of one's self-efficacy competence with three items (T0, T1, T2). Treatment Adherence Perception Questionnaire (TAPQ; Sanford & Rivers, 2020): The TAPQ measures patients' adherence to learned strategies. Originally developed for the somatic domain, the questionnaire was adapted specifically for the planned study for the psychiatric domain (T1, T2). Timeline Followback (TLFB; Carey et al., 2001): The TLFB is a method for retrospectively recording daily alcohol or drug use. For the present study, the online version of the TLFB was adapted for anxiety disorders and surveys the occurrence of panic attacks, anxiety symptoms, and depression symptoms in the past 6 weeks (T1, T2). Relapses: Patient's relapses are assessed using the Reliable Change Index (RCI). The RCI is a measure calculated to survey significant changes (worsening) in an individual's measures. The RCI is calculated using measures of the primary endpoints (PAS and LSAS). In addition, contacts to the health care system are assessed (e.g., of (partial) inpatient admissions, somatic evaluations) to survey relapse (T1, T2). Client Satisfaction Questionnaire (CSQ-8; Sc | — |
Countries
Germany
Contacts
Public ContactLena Jelinek
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed