Clinical trial NCT01961479: Treatment of Premenstrual Syndrome - Internet-based Self-help
Official title: Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome (PMS)
Keywords: Premenstrual syndrome (PMS)
Premenstrual Dysphoric Disorder (PMDD)
Internet-based Therapy
Cognitive Behavioural Therapy (CBT)
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2013-10-11
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retrospective Screening (Ditzen et al., 2011)
timeFrame: pre-treatment
measure: Prospective PMS-Diary (Kleinstäuber et al., unpublished)
timeFrame: 6 months; pre-treatment to post-treatment (4 months after admission)
measure: Impairment by the premenstrual syndrome (self-developed questionnaire)
timeFrame: 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:
measure: Coping with the premenstrual symptoms (self-developed questionnaire)
timeFrame: 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)
measure: Pain Coping Questionnaire (FESV; Geissner, 2003)
timeFrame: 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)
measure: Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)
timeFrame: 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)
measure: Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)
timeFrame: 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)
measure: Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)
timeFrame: 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)
measure: Perceived stress scale (PSS, Cohen, 1994)
timeFrame: 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)
measure: The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)
timeFrame: pre-treatment
measure: Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)
timeFrame: 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)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Cornelia Weise, Ph.D.
role: STUDY_CHAIR
affiliation: Philipps University Marburg
name: Maria Kleinstäuber, Ph.D.
role: STUDY_CHAIR
affiliation: Philipps University Marburg
name: Carolyn Janda, Ph.D.Student
role: STUDY_CHAIR
affiliation: Philipps University Marburg
name: Johanna N. Kues, Ph.D.Student
role: STUDY_CHAIR
affiliation: Philipps University Marburg
name: Gudrun Kaiser, Ph.D Student
role: STUDY_CHAIR
References:
citation: 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.
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.
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. doi: 10.1016/s0140-6736(00)02754-9.
citation: 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.
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. doi: 10.1016/s0022-3999(02)00338-0.
citation: 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.
citation: 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.
citation: 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.
citation: American College of Obstetricians and Gynecologists (ACOG). Premenstrual syndrome. Washington, DC: National Guideline Clearinghouse, 2000.
citation: American Psychiatric Association (APA). Diagnostic and statistical manual for mental disorders (DSM-IV). Washington, DC: American Psychiatric Press, 1994.
citation: Cohen S. Perceived stress scale, 1994. Retrieved August 09, 2012, from http://updates.wcupa.edu/_academics/healthsciences/stressreductioncenter/documents/perceived_stress_scale.pdf
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.
citation: Fydrich T, Sommer G, & Brähler E. Fragebogen zur sozialen Unterstützung (F-SozU ). Göttingen: Hogrefe, 2007.
citation: Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe, 2003.
citation: Siffert A, Bodenmann G. Entwicklung eines neuen multidimensionalen Fragebogens zur Erfassung der Partnerschaftsqualität (FPQ). Zeitschrift für Familienforschung, 2010.
citation: 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.