- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01961479
Treatment of Premenstrual Syndrome - Internet-based Self-help (praemensis)
Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Premenstrual syndrome (PMS) affects millions of women during their reproductive years. The disorder presents with emotional, cognitive, behavioural, and somatic symptoms during the final premenstrual phase and subsiding a few days after menses begins. About 75% of women of reproductive age experience a mild form of PMS (Campbell, Peterkin, O'Grady, & Sanson-Fisher, 1997). The more severe form of PMS, premenstrual dysphoric disorder (PMDD; American Psychiatric Association (APA), 1994) is considered to affect up to 8% of women of reproductive age. This severe form is associated with severe disruptions in normal functioning in work, family, or social relationships (Halbreich, Borenstein, Pearlstein, & Kahn, 2003). The defining characteristics of both-PMS and PMDD- are the cyclic pattern of symptoms, which must be confirmed by prospective daily self ratings of symptoms (PMS-Diary) over two consecutive menstrual cycles (American College of Obstetricians and Gynecologists (ACOG), 2000). PMS and PMDD differ according to the number, severity, duration, and quality of symptoms.
As a first-line intervention, the ACOG suggests pharmacotherapy, in particular selective serotonin reuptake inhibitors (SSRIs; ACOG, 2000). However, the side effects of SSRIs are intolerable to many women, leading to high rates of withdrawal from treatment (Busse et al., 2009; Dimmock, Wyatt, Jones, & O'Brien, 2000). Thus, cognitive behavioural treatments (CBT) have been suggested as an additional treatment approach (Busse et al., 2009). First studies showed promising results for CBT interventions for PMS (Busse et al., 2009; Hunter et al., 2002). However, too few randomized controlled trials have carefully investigated the efficacy of CBT for PMS.
The aim of the current study is thus to develop a CBT-oriented self-help treatment programme for women suffering from PMS or PMDD. The treatment programme consists of psychoeducation (e.g., information about PMS/PMDD and its aetiology), cognitive strategies (e.g., assessing and restructuring dysfunctional cognitions), and suggestions for lifestyle changes (e.g., sports, balanced diet, relaxation). The programme is internet-delivered (iCBT) and participants work on different chapters for eight weeks in a row. In addition to written information, participants receive e-mail feedback from a psychologist on a weekly basis. Participants are required to have sufficient knowledge of German in order to be able to read the treatment materials. After a careful diagnostic assessment (including two months symptom diary), eligible patients are randomly assigned either to the treatment group or a waitlist control group. Participants assigned to the waitlist receive the treatment after the end of the waiting period (eight weeks). Follow-up assessments take place six months after the end of the treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hessen
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Marburg, Hessen, Germany, 35037
- Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fulfilling of particular diagnostic criteria: positive retrospective symptom screening & confirmation of the diagnosis by a prospective PMS-Diary over 2 menstrual cycles
- Age 18-45 years
- Internet access
- Fluency in German
Exclusion Criteria:
- Birth of a child or lactation going back to less than 3 months
- Pregnancy
- Symptoms exist less than three cycles
- Gynaecological diseases: Hysterectomy, Gynaecological cancer, Polycystic ovary syndrome, Endometriosis, Infertility
- Current diagnosis of psychosis or bipolar disorder
- Current diagnosis of eating-disorder
- Current diagnosis of average or severe depression
- Current diagnosis of somatisation disorder
- Acute suicidal tendency
- participation in psychotherapy due to premenstrual syndrome, currently or in the past
- Begin to take antidepressants or a change of the active pharmaceutical ingredient during the last three months
- Begin to take a combined oral contraceptive pill or a change of the preparation during the last three months
- Begin to take hormones or a change of the hormone supplement during the last three months
- The taking of Benzodiazepines/Antipsychotics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Internet-based CBT for patients with PMS
The therapeutical intervention follows a treatment manual consisting of 14 modules.
Patients work on up to two modules every week for eight weeks in a row.
Modules comprise a) psychoeducation (e.g., information about PMS and its treatment); b) cognitive strategies (e.g., identifying and modifying dysfunctional cognitions, or coping with negative affects); and c) suggestions for lifestyle changes (e.g., sports, stress reduction, or balanced diet).
Aim of the iCBT is to improve coping and thus to reduce the impairment due to premenstrual symptoms.
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Internet-based cognitive-behavioural self-help treatment
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Other: waiting list
During the waiting period, patients receive no treatment.
After a waiting time of 2 months, patients of the waitlist receive the same iCBT treatment as the experimental group.
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During the waiting period, participants receive no treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retrospective Screening (Ditzen et al., 2011)
Time Frame: pre-treatment
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assessment of premenstrual symptoms based on the Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) (self-rating)
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pre-treatment
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Prospective PMS-Diary (Kleinstäuber et al., unpublished)
Time Frame: 6 months; pre-treatment to post-treatment (4 months after admission)
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prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)
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6 months; pre-treatment to post-treatment (4 months after admission)
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Impairment by the premenstrual syndrome (self-developed questionnaire)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coping with the premenstrual symptoms (self-developed questionnaire)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of coping strategies (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Pain Coping Questionnaire (FESV; Geissner, 2003)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of PMS related coping strategies (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of the availability of social support (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of partnership quality (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of work strain (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Perceived stress scale (PSS, Cohen, 1994)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of stress perception (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)
Time Frame: pre-treatment
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assessment of personality
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pre-treatment
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Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)
Time Frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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assessment of the degree of daily impairment by chronic pain (self-rating)
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10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Cornelia Weise, Ph.D., Philipps University Marburg Medical Center
- Study Chair: Maria Kleinstäuber, Ph.D., Philipps University Marburg Medical Center
- Study Chair: Carolyn Janda, Ph.D.Student, Philipps University Marburg Medical Center
- Study Chair: Johanna N. Kues, Ph.D.Student, Philipps University Marburg Medical Center
- Study Chair: Gudrun Kaiser, Ph.D Student, Philipps University Marburg Medical Center
Publications and helpful links
General Publications
- Busse JW, Montori VM, Krasnik C, Patelis-Siotis I, Guyatt GH. Psychological intervention for premenstrual syndrome: a meta-analysis of randomized controlled trials. Psychother Psychosom. 2009;78(1):6-15. doi: 10.1159/000162296. Epub 2008 Oct 14.
- Campbell EM, Peterkin D, O'Grady K, Sanson-Fisher R. Premenstrual symptoms in general practice patients. Prevalence and treatment. J Reprod Med. 1997 Oct;42(10):637-46.
- Dimmock PW, Wyatt KM, Jones PW, O'Brien PM. Efficacy of selective serotonin-reuptake inhibitors in premenstrual syndrome: a systematic review. Lancet. 2000 Sep 30;356(9236):1131-6. doi: 10.1016/s0140-6736(00)02754-9.
- Halbreich U, Borenstein J, Pearlstein T, Kahn LS. The prevalence, impairment, impact, and burden of premenstrual dysphoric disorder (PMS/PMDD). Psychoneuroendocrinology. 2003 Aug;28 Suppl 3:1-23. doi: 10.1016/s0306-4530(03)00098-2.
- Hunter MS, Ussher JM, Cariss M, Browne S, Jelley R, Katz M. Medical (fluoxetine) and psychological (cognitive-behavioural therapy) treatment for premenstrual dysphoric disorder: a study of treatment processes. J Psychosom Res. 2002 Sep;53(3):811-7. doi: 10.1016/s0022-3999(02)00338-0.
- Siegrist J, Wege N, Puhlhofer F, Wahrendorf M. A short generic measure of work stress in the era of globalization: effort-reward imbalance. Int Arch Occup Environ Health. 2009 Aug;82(8):1005-13. doi: 10.1007/s00420-008-0384-3. Epub 2008 Nov 19.
- Dillmann U, Nilges P, Saile H, Gerbershagen HU. [Assessing disability in chronic pain patients.]. Schmerz. 1994 Jun;8(2):100-10. doi: 10.1007/BF02530415. German.
- Kleinstauber M, Witthoft M, Hiller W. Cognitive-behavioral and pharmacological interventions for premenstrual syndrome or premenstrual dysphoric disorder: a meta-analysis. J Clin Psychol Med Settings. 2012 Sep;19(3):308-19. doi: 10.1007/s10880-012-9299-y.
- American College of Obstetricians and Gynecologists (ACOG). Premenstrual syndrome. Washington, DC: National Guideline Clearinghouse, 2000.
- American Psychiatric Association (APA). Diagnostic and statistical manual for mental disorders (DSM-IV). Washington, DC: American Psychiatric Press, 1994.
- Cohen S. Perceived stress scale, 1994. Retrieved August 09, 2012, from http://updates.wcupa.edu/_academics/healthsciences/stressreductioncenter/documents/perceived_stress_scale.pdf
- Ditzen B, Nussbeck F, Drobnjak S, Spörri C, Wüest D, Ehlert U. Validierung eines deutschsprachigen DSM-IV-TR basierten Fragebogens zum prämenstruellen Syndrom. Zeitschrift für Klinische Psychologie und Psychotherapie 40(3): 149-159, 2011.
- Fydrich T, Sommer G, & Brähler E. Fragebogen zur sozialen Unterstützung (F-SozU ). Göttingen: Hogrefe, 2007.
- Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe, 2003.
- Siffert A, Bodenmann G. Entwicklung eines neuen multidimensionalen Fragebogens zur Erfassung der Partnerschaftsqualität (FPQ). Zeitschrift für Familienforschung, 2010.
- Kues JN, Janda C, Kleinstauber M, Weise C. Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial. Trials. 2014 Dec 2;15:472. doi: 10.1186/1745-6215-15-472.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- praemensis_2013
Plan for Individual participant data (IPD)
Study Data/Documents
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Study Protocol
Information comments: Kues, J. N., Janda, C., Kleinstaeuber, M., & Weise, C. (2014). Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial. Trials, 15(1), 472. doi:10.1186/1745-6215-15-472
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Questionnaire Validation
Information comments: Kues, J. N., Janda, C., Kleinstäuber, M., & Weise, C. (2015). How to Measure the Impact of Premenstrual Symptoms? Development and Validation of the German PMS-Impact Questionnaire. Women & Health, null-null. doi:10.1080/03630242.2015.1118734
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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