Treatment of Premenstrual Syndrome - Internet-based Self-help

NCT ID: NCT01961479

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-04-30

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.

Conditions

Premenstrual Syndrome (PMS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-based CBT for patients with PMS

Intervention Type: BEHAVIORAL

Internet-based cognitive-behavioural self-help treatment

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.

Group Type: OTHER

Waiting list

Intervention Type: OTHER

During the waiting period, participants receive no treatment.

Interventions

Internet-based CBT for patients with PMS

Internet-based cognitive-behavioural self-help treatment

Intervention Type: BEHAVIORAL

Waiting list

During the waiting period, participants receive no treatment.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Cornelia Weise

Dr. rer. nat.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cornelia Weise, Ph.D.

Role: STUDY_CHAIR

Philipps University Marburg

Maria Kleinstäuber, Ph.D.

Role: STUDY_CHAIR

Philipps University Marburg

Carolyn Janda, Ph.D.Student

Role: STUDY_CHAIR

Philipps University Marburg

Johanna N. Kues, Ph.D.Student

Role: STUDY_CHAIR

Philipps University Marburg

Gudrun Kaiser, Ph.D Student

Role: STUDY_CHAIR

Philipps University Marburg

Locations

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

Marburg, Hesse, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 18852497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9350019 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11030291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12892987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12217456 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19018554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18415443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22426857 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 25467540 (View on PubMed)

Study Documents

Document Type: Study Protocol

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

View Document

Related Links

http://www.uni-marburg.de/fb04/ag-klin/forschung/pmsd/index_html

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

Other Identifiers

praemensis_2013

Identifier Type: -

Identifier Source: org_study_id