ICD-11: GA34. 41 Premenstrual Dysphoric Disorder (PMDD) N94.3
Conditions
Interventions
Group 1: Intervention + Treatment-as-usual (Belle + TAU): Participants have access to a mobile app (Belle App) that provides a self-help program . The program is based on cognitive-behavioral therapy
Sponsors
FAU Erlangen-Nürnberg, Institut für Psychologie, Klinische Psychologie und Behavioral Health Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Access to a smartphone with internet access 2. Diagnosis of Premenstrual Dysphoric Disorder (PMDD; ICD-11: GA34.41), symptom pattern confirmed by a prospective symptom diary (Janda et al., 2017) of two consecutive menstrual cycles 3. Be able to understand and read German 4. German resident ___________ 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 impact of symptoms of the Premenstrual Dysphoric Disorder (PMDD) How is it measured: Validated questionnaire in German Symptom impact: PMS Impact Questionnaire (PMS-I; Kues et al., 2016): When is it measured: Always in participants' individual luteal phase - Before the Intervention starts (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: 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. Symptom Severity: Questionnaire for the Screening of Premenstrual Symptoms (Ditzen et al., 2011) - Screening before Randomization; Before the Intervention starts (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 2. PMS Symptom Disability (German Version of the Pain Disability Index adjusted for PMDD; PDI; Dilmann, 1994) - Before the Intervention starts (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 3. Self-Perceived Self-Efficacy (German Version of the Pain Self-Efficacy Questionnaire adjusted for PMDD; Mangels et al., 2009) - Before the Intervention starts (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 4. Symptoms of Depression, Anxiety Symptoms, Stress perception (German Version of the Depression Anxiety Stress Scale 21; DASS-21; Nilges & Essau, 2021) - Before the Intervention starts (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 5. 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) - Before the Intervention starts (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 6. Quality of Life (EQ-5 | — |
Countries
Germany
Contacts
Public ContactIsabella Hebel
FAU Erlangen-Nürnberg, Lehrstuhl Klinische Psychologie und Behavioral Health Technology
Outcome results
None listed