F40 F41
Conditions
Interventions
Group 1: Interventional = Online intervention "Novego" for the treatment of symptoms of an anxiety disorder for 6 weeks including measures to increase adherence after their inpatient/day clinic stay
G
Sponsors
Universitätsklinikum Hamburg-Eppendorf, AG für Angst- und Zwangsstörungen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Presence of a diagnosis of an anxiety disorder (ICD-10 criteria, assessment by the treating psychologists/doctors) • consent to participate in study (informed consent) • A previous inpatient- or outpatient-treatment of at least one week • Minimum Age: 18 Years • Maximum Age: 80 Years • willingness to participate in Novego anxiety and four online assessments • ability to provide informed consent • sufficient understanding of the German language
Exclusion criteria
Exclusion criteria: • Absence of a diagnosis of an anxiety disorder (ICD-10 criteria, assessment by the treating psychologists/doctors) • No consent to participate in study (informed consent) • No previous inpatient- or outpatient-treatment of at least one week • No willingness to participate in Novego anxiety and four online assessments • No ability to provide informed consent • No sufficient understanding of the German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter will be the Generalized Anxiety Disorder 7 Scale (GAD-7), a self-report questionnaire for the assessment of anxiety symptoms (T0, T1, T2, T3). Additionally, relapses will be analysed at T1, T2 and T3 and are defined as GAD-7 scores (1) > 8 (NHS, 2018) and (2) = 5 points more on the GAD-7 compared to the GAD-7 score at T0 (see Ali et al., 2017). (T0 = a baseline assessment during the week before discharge, T1 = an interim assessment after 3 weeks, T2 = a post assessment 6 weeks after the baseline assessment, T3 = a follow-up assessment 3 more months after T2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Adherence Perception Questionnaire (TAPQ): The TAPQ assesses patients‘ adherence to implement the strategies learned. The questionnaire was originally developed for the treatment with medication on physical diseases but was adapted for the present study and psychiatric context (T0, T1, T2, T3). Relapses: Relapses will be also assessed by the number of readmission to a psychiatric ward and emergency contacts to psychological-psychiatric facilities due to worsening of anxiety symptoms (T1, T2, T3). Pittsburgh Sleep Quality Index (PSQI): The PSQI is a self-report questionnaire that assesses subjective sleep quality over the past month and captures seven sleep-related clinically relevant domains: (1) sleep duration, (2) disturbances during sleep, (3) sleep latency, (4) dysfunction during the day due to sleepiness, (5) efficiency of sleep, (6) overall sleep quality and (7) need medication to sleep (T0,T1,T2,T3). Adherence: Adherence will be assessed by different parameters (i.e., number of modules processed, number of logins). Subjective appraisal of the measures for increasing adherence: Patients evaluate the adherence measures (T2). Public Speaking Anxiety Scale (PSAS): The PSAS is a self-report questionnaire that measures the extent of behavioral, cognitive, and physiological characteristics of speaking anxiety (T0,T1,T2,T3). Rosenberg Self-Esteem Scale (RSES): The RSES is a self-report questionnaire that assesses self-esteem (T0,T1,T2,T3). Liebowitz Social Anxiety Scale (LSAS-SR): The LSAS is a self-report questionnaire that measures the severity of social phobia (T0,T1,T2,T3). Patient Health Questionnaire (PHQ-9): The PHQ-9 is the depression module of the PHQ-D and assesses the presence and frequency of nine depressive symptoms (according to DSM-IV criteria for major depression) during the last two weeks (T0,T1,T2,T3). German adaptation of the Client Satisfaction Questionnaire (CSQ): The CSQ is a self-report questionnaire for the assessment of the | — |
Countries
Germany
Contacts
Public ContactFranziska Miegel
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed