N94.3
Conditions
Interventions
Group 1: Intervention group (IG): Participants have access to a mobile app (Belle App) that provides a self-help program. The program is based on cognitive-behavioral therapy (CBT) and is completed in
Sponsors
Philipps-Universität Marburg, Fachbereich Psychologie, AG Klinische Psychologie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Be between the age of 18 and 45 2. Have access to a smartphone with internet access 3. Diagnosis of Premenstrual Dysphoric Disorder (PMDD), symptom pattern confirmed by a prospective symptom diary (Janda et al., 2017) of two consecutive menstrual cycles: ICD-10-Code N94.3 4. Be able to understand and read German 5. Demonstrate sufficient cognitive capacities to attend and complete the treatment ___________ Reference: Janda, C., Kues, J. N., Andersson, G., Kleinstäuber, M., & Weise, C. (2017). A symptom diary to assess severe premenstrual syndrome and premenstrual dysphoric disorder. Women & health, 57(7), 837-854.
Exclusion criteria
Exclusion criteria: 1. Indication of acute suicidal behavior 2. Bipolar and/or psychotic disorder 3. Pregnancy and/or lactation at the moment or within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What is measured: Reduction of the severity and impact of symptoms of the Premenstrual Dysphoric Disorder (PMDD) How is it measured: Two validated questionnaires in German 1. Symptom severity: Premenstrual Symptom Screening Questionnaire (Ditzen et al., 2011) 2. Symptom impact: PMS Impact Questionnaire (PMS-I; Kues et al., 2016): When is it measured: Always in participants' individual luteal phase - Before the Intervention Begins (pre/baseline) = t0 - First luteal phase following the start of training (mitd-training) = t1 - First luteal phase following the end of intervention (post) = t2 - Third luteal phase following the post-assessment (FU) = t3 References: Ditzen, B., Nussbeck, F., Drobnjak, S., Spörri, C., Wüest, D., & Ehlert, U. (2011). Validierung eines deutschsprachigen DSM-IV-TR basierten Fragebogens zum prämenstruellen Syndrom. Zeitschrift für Klinische Psychologie und Psychotherapie. Kues, J. N., Janda, C., Kleinstäuber, M., & Weise, C. (2016). How to measure the impact of premenstrual symptoms? Development and validation of the German PMS-Impact Questionnaire. Women & health, 56(7), 807-826. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PMS Symptom Disability (German Version of the Pain Disability Index adjusted for PMDD; PDI; Dilmann, 1994) 2. Self-Perceived Self-Efficacy (German Version of the Pain Self-Efficacy Questionnaire adjusted for PMDD; Mangels et al., 2009) 3. Symptoms of Depression (German Version of the Depression Anxiety Stress Scale 21; DASS-21; Nilges & Essau, 2021) 4. Anxiety Symptoms (German Version of the Depression Anxiety Stress Scale 21; DASS-21; Nilges & Essau, 2021) 5. Stress perception (German Version of the Depression Anxiety Stress Scale 21; DASS-21; Nilges & Essau, 2021) 6. Health literacy: Understanding of the biopsychosocial model of PMDD (Patients' Endorsement of a Biopsychosocial Model of Pain Scale adapted for PMDD; PEB-Scale; Kleinstäuber et al., 2024) 7. Quality of Life (EQ-5D-3L; Graf et al., 1998) 9. Number of work absence days (based on Sleed et al., 2005) 9. Satisfaction with the intervention (Client Satisfaction Questionnaire translated to German; CSQ-8; Attkisson & Zwick, 1982) ___________ References: Attkisson, C. C., & Zwick, R. (1982). The Client Satisfaction Questionnaire: Psychometric properties and correlations with service utilization and psychotherapy outcome. Evaluation and program planning, 5(3), 233-237. Dillmann, U., Nilges, P., Saile, H. & Gerbershagen, H. U. (1994). Behinderungseinschätzung bei chronischen Schmerzpatienten. Der Schmerz, 8 (2), 100-110. Graf, J. M., Claes, C., Greiner, W., & Uber, A. (1998). The German version of the EuroQol questionnaire. Zeitschrift für Gesundheitswissenschaften= .Journal of public health, 6, 3-20. Mangels, M., Schwarz, S., Sohr, G., Holme, M., & Rief, W. (2009). Der Fragebogen zur Erfassung der schmerzspezifischen Selbstwirksamkeit (FESS) Eine Adaptation des Pain Self-Efficacy Questionnaire für den deutschen Sprachraum. Diagnostica, 55(2), 84-93. Nilges, P. & Essau, C. (2021). DASS. Depressions-Angst-Stress-Skalen - deutschsprachige Kurzfassung [Verfahrensdokumentation und Fragebo | — |
Countries
Germany
Contacts
Public ContactIsabella Hebel
FAU Erlangen-Nürnberg, Institut für Psychologie, Klinische Psychologie und Behavioral Health Technology
Outcome results
None listed