Fear of Progression G20 G35
Conditions
Interventions
Group 1: Fear of progression specific cognitive-behavioral intervention (4 sessions of 60 minutes over 2 weeks)
After study phase 1 (feasibility): Extension of the intervention up to 4 sessions of 90
Sponsors
Medizinische Psychologie | Neuropsychologie und Gender StudiesCentrum für Neuropsychologische Diagnostik und Intervention (CeNDI), Medizinische Fakultät und Uniklinik Köln, Universität zu Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inpatients of the neurological rehabilitation centre Godeshöhe e.V. Bonn; Clinical PD or MS diagnosis; Affirmation of item 1 and 3 of the psychosocial 3-item requirement analysis: 1. Do you often suffer from the fear of the progression of your disease in everyday life? 2. If so, how strongly does the fear of progression affect your everyday life? (Numeric analogue scale from 0 to 10) 3. Would you like to have support in dealing with this fear?; The patients are able to follow instructions; Unrestricted or sufficiently corrected sight and hearing; German as mother tongue or sufficiently good knowledge of German After study phase 1 (feasiblity): recruitment of outpatients only (time points of measurements for pre-, post-, and follow-up assessments as well as intervention sessions take part at the University Hospital Cologne)
Exclusion criteria
Exclusion criteria: Severe cognitive impairment (Montreal Cognitive Assessment (MoCa) = 12 points, cut-off value between mild cognitive impairment and Alzheimer's dementia according to Nasreddine et al., 2005) and therefore a limited or missing capacity for consent; Presence of major depression (assessed by the General Depression Scale (ADS-K), cut-off value = 17 according to Radloff, 1977) and/or acute suicidal tendencies (assessed by the responsible psychologists of the Neurological Rehabilitation Centre Godeshöhe e.V. or information on patient record); Severe neurological and psychiatric or life-threatening comorbidities (e.g., acute episodes of affective disorders, personality disorders, psychoses or somatoform disorders; in each case assessed by the responsible psychologists of the Neurological Rehabilitation Centre Godeshöhe e.V. or information on patient records)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the first study phase the feasibility of the fear of progression cognitive-behavioral intervention will be examined, defined by the quality of the structure, process and outcome of the intervention. The following parameters are to be collected for this analysis: Structural quality (equipment, personnel, spatial, financial aspects, group size and structure); process quality (participant satisfaction with the procedure, content, exercises and homework; employee satisfaction, complications/disturbance-free implementation); outcome quality (participant satisfaction with the intervention, subjective assessment of usefulness, drop-out rate). The following methods are used for the survey: Recording of the presence of the participants (for study phase 1 & 2); filling out an anxiety diary between the intervention sessions (for study phases 1 & 2); semi-standardized questionnaire to record the motivation and to investigate the extent to which the critical examination of the meeting topics was successful (for study phases 1 & 2); semi-standardized questionnaire to evaluate the subjective benefit, content fit and formal design of the intervention at the end of the intervention (for study phases 1 & 2); qualitative interviews with all study participants to assess the possible need for modification of the fear of progression cognitive-behavioral intervention (for study phase 1); qualitative interviews with staff members of the rehabilitation center (n = 4) to assess the structural feasibility of such an intervention ("How can such a program be implemented in everyday rehabilitation? “) (for study phase 1). The objective of the second study phase is to identify the effectiveness of the fear of progression specific cognitive-behavioral intervention based on the outcome fear of progression anxiety. This will be done using the Fear of Progressio Questionnaire (PA-F long version) at T1 (pre-testing), T2 (post-testing) and T3 (follow-up after 3 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the management of fear of progression (questionnaire developed by the authors for the study); depression (ADS); anxiety (State Trait Anxiety Inventory, STAI); fatigue (PD- and MS-specific fatigue scales; coping with generally problematic feelings and specifically with feelings of stress and anxiety (questionnaire for emotionally specific self-evaluation of emotional competencies, SEK-27; subscale Stress and Anxiety of the SEK-ES); coping (coping inventory for dealing with stress situations, CISS); quality of life (for PD: Parkinson's Disease Questionnaire-8, PDQ-8; for MS: SF-12); disease perception (Illness Perception Questionnaire, short form of IPQ-R); sleep quality (Pittsburgh Sleep Quality Index, PSQI); sense of coherence (Sense of Coherence-Scale, SOC); hope (Herth Hope Index, HHI-D); Coping, self-observation, self verbalization, social support, change motivation: Questionnaire for recording resources and self-management skills (FERUS); Partnership quality (Questionnaire for partnership quality, FPD). For possible predictive analyses, the following additional domains are recorded: motor skills (for PD: Hoehn and Yahr stage, UPDRS-III; for MS: EDSS); activities of daily living (for PD: UPDRS-II); pain (visual analogue scale); global cognition (MoCA); personality (NEO-FFI); health literacy (HLS-EU-Q47). After study phase 1 (feasibility): Reduction of the secondary outcome parameters: Depression, Anxiety, Fatigue, Coping, Quality of Life, Well-being, Sleep quality; FERUS-subscales coping, self-observation, self verbalization, social support, change motivation | — |
Countries
Germany
Contacts
Public ContactAnn-Kristin Folkerts
Medizinische Psychologie | Neuropsychologie und Gender StudiesCentrum für Neuropsychologische Diagnostik und Intervention (CeNDI), Medizinische Fakultät und Uniklinik Köln, Universität zu Köln
Outcome results
None listed