Treatment of Premenstrual Syndrome - Internet-based Self-help

Premenstrual Syndrome (PMS) Clinical Trial

— praemensis  

Official title:

Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961479
• Other study ID #: praemensis_2013
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: April 10, 2018
• Start date: July 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Premenstrual Syndrome (PMS)
• Syndrome

Intervention

Behavioral:
• Internet-based CBT for patients with PMS
Internet-based cognitive-behavioural self-help treatment

Other:
• Waiting list
During the waiting period, participants receive no treatment.

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Linkoeping University

Country where clinical trial is conducted

Germany, 

References & Publications (15)

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.

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. — View Citation

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. — View Citation

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

Dillmann U, Nilges P, Saile H, Gerbershagen HU. [Assessing disability in chronic pain patients.]. Schmerz. 1994 Jun;8(2):100-10. German. — View Citation

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. — View Citation

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.

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. Review. — View Citation

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. — View Citation

Kleinstäuber M, Witthöft 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. Review. — View Citation

Siegrist J, Wege N, Pühlhofer 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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	Coping with the premenstrual symptoms (self-developed questionnaire)	assessment of coping strategies (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	Pain Coping Questionnaire (FESV; Geissner, 2003)	assessment of PMS related coping strategies (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	Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)	assessment of the availability of social support (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	Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)	assessment of partnership quality (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	Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)	assessment of work strain (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	Perceived stress scale (PSS, Cohen, 1994)	assessment of stress perception (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	The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)	assessment of personality	pre-treatment
Secondary	Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)	assessment of the degree of daily impairment by chronic pain (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)

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