E84
Conditions
Interventions
Group 1: Interventionel = Self-help manual „MukoHelp“ adressing anxiety and depressive symptoms in patients with CF
Group 2: Waitlist control group = The waitlist control group does not receive the s
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of cystic fibrosis (CF) • Self-reported depressive or anxiety symptoms • Consent to use MukoHelp and to participate in three online surveys • Ability to consent • Sufficient understanding of the German language
Exclusion criteria
Exclusion criteria: acute suicidality
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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (corresponding to the DSM-IV criteria for major depression) during the last two weeks (T0,T1,T2). Short Form Health 36 (SF-36): The questionnaire assesses the overall health state by 36 items (T0,T1,T2). Self-reported medical parameters: The present weight, the present Fev1 value (Forced Expiratory Pressure in one second) and the present hemoglobin value are assessed by self-report (T0,T1,T2). Cystic Fibrosis Questionnaire Revised (CFQ-R): The CFQ-R assesses the impact on overall health, perceived well-being and symptoms (T0,T1,T2). Self- Report Behavioural Automaticity Index (SRBAI): The SRBAI measures habit strength, perceptions of treatment adherence, perceived effort of nebuliser treatments, and subjective adherence (T0,T1,T2). Rosenberg Self-Esteem Scale (RSES): The RSES is a questionnaire assessing patients self-esteem (T0,T1,T2). Client satisfaction questionnaire (CSQ): The CSQ is a questionnaire for assessing patients’ satisfaction with the treatment. (T1). Subjective appraisal of MukoHelp: The questionnaire assesses the subjective appraisal of MukoHelp adapted from Jelinek, Zielke et al. (2018) (T1). Questionnaire on other treatments: The questionnaire on other treatments assesses at which therapies (e.g., cognitive behavioral therapy) patients participated during the study (T1). Treatment Adherence Perception Questionnaire (TAPQ): The TAPQ assesses the adherence to the learned psychological strategies. The questionnaire was originally designed to assess therapy adherence for the adherence to the intake of medication but was adapted to the assessment of adherence to psychological interventions for this study (T1, T2). Adherence for the use of the manual: The adherence to the use of the manual is assessed by the help of different parameters, as for example the number of modules worked on | — |
Countries
Germany
Contacts
Public ContactFranziska Miegel
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed