Treatment of Premenstrual Syndrome - Internet-based Self-help

NCT01961479 | Completed

• 1 other identifier: praemensis_2013
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective in reducing the impairment caused by premenstrual symptoms.

Conditions

Premenstrual Syndrome (PMS)

Keywords

Premenstrual syndrome (PMS); Premenstrual Dysphoric Disorder (PMDD); Internet-based Therapy; Cognitive Behavioural Therapy (CBT)

Outcome Measures

Primary Outcomes (3)

• Retrospective Screening (Ditzen et al., 2011)

  assessment of premenstrual symptoms based on the Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) (self-rating)

  pre-treatment

• Prospective PMS-Diary (Kleinstäuber et al., unpublished)

  prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)

  6 months; pre-treatment to post-treatment (4 months after admission)

• Impairment by the premenstrual syndrome (self-developed questionnaire)

  assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)

  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)

Secondary Outcomes (8)

• Coping with the premenstrual symptoms (self-developed questionnaire)

  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)

• Pain Coping Questionnaire (FESV; Geissner, 2003)

  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)

• Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)

  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)

• Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)

  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)

• Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)

  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)

Study Arms (2)

Internet-based CBT for patients with PMS

EXPERIMENTAL

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.

Behavioral: Internet-based CBT for patients with PMS

waiting list

OTHER

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.

Other: Waiting list

Interventions

Internet-based CBT for patients with PMS BEHAVIORAL

Internet-based cognitive-behavioural self-help treatment

Internet-based CBT for patients with PMS

Waiting list OTHER

During the waiting period, participants receive no treatment.

waiting list

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Linkoeping University: collaborator

Study Sites (1)

Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35037, Germany

Location

Related Publications (16)

• 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.

  PMID: 18852497 BACKGROUND

• 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.

  PMID: 9350019 BACKGROUND

• 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.

  PMID: 11030291 BACKGROUND

• 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.

  PMID: 12892987 BACKGROUND

• 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.

  PMID: 12217456 BACKGROUND

• 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.

  PMID: 19018554 BACKGROUND

• 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.

  PMID: 18415443 BACKGROUND

• 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.

  PMID: 22426857 BACKGROUND

• American College of Obstetricians and Gynecologists (ACOG). Premenstrual syndrome. Washington, DC: National Guideline Clearinghouse, 2000.

  BACKGROUND

• American Psychiatric Association (APA). Diagnostic and statistical manual for mental disorders (DSM-IV). Washington, DC: American Psychiatric Press, 1994.

  BACKGROUND

• Cohen S. Perceived stress scale, 1994. Retrieved August 09, 2012, from http://updates.wcupa.edu/_academics/healthsciences/stressreductioncenter/documents/perceived_stress_scale.pdf

  BACKGROUND

• 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.

  BACKGROUND

• Fydrich T, Sommer G, & Brähler E. Fragebogen zur sozialen Unterstützung (F-SozU ). Göttingen: Hogrefe, 2007.

  BACKGROUND

• Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe, 2003.

  BACKGROUND

• Siffert A, Bodenmann G. Entwicklung eines neuen multidimensionalen Fragebogens zur Erfassung der Partnerschaftsqualität (FPQ). Zeitschrift für Familienforschung, 2010.

  BACKGROUND

• 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.

  PMID: 25467540 DERIVED

Related Links

• Click here for more information about this study: Treatment of the Premenstrual Syndrome - Internet-based self-help

MeSH Terms

Conditions

Premenstrual Syndrome; Premenstrual Dysphoric Disorder

Interventions

Spectrometry, Fluorescence; Waiting Lists

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Cornelia Weise, Ph.D.

  Philipps University Marburg

  STUDY CHAIR

• Maria Kleinstäuber, Ph.D.

  Philipps University Marburg

  STUDY CHAIR

• Carolyn Janda, Ph.D.Student

  Philipps University Marburg

  STUDY CHAIR

• Johanna N. Kues, Ph.D.Student

  Philipps University Marburg

  STUDY CHAIR

• Gudrun Kaiser, Ph.D Student

  Philipps University Marburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

DE (1)