AzTrials
AzTrials

Premenstrual Syndrome (PMS)praemensisNCT01961479

Treatment of Premenstrual Syndrome - Internet-based Self-help

A study testing Internet-based CBT for patients with PMS and Waiting list in people with Premenstrual Syndrome (PMS), run by Philipps University Marburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Premenstrual Syndrome (PMS)
What is being tested?
Internet-based CBT for patients with PMS and Waiting list
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteGermany
Study dates
Jul 2013to Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Marburg, Hesse, 35037

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
Internet-based CBT for patients with PMS, Waiting list
Keywords
Premenstrual syndrome (PMS), Premenstrual Dysphoric Disorder (PMDD), Internet-based Therapy, Cognitive Behavioural Therapy (CBT)
Medical subject headings
Premenstrual Syndrome, Premenstrual Dysphoric Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based CBT for patients with PMSBehavioural

    Internet-based cognitive-behavioural self-help treatment

  • Waiting listOther

    During the waiting period, participants receive no treatment.

Study groups in NCT01961479
Study groupRoleWhat they receive
Internet-based CBT for patients with PMSExperimentalThe 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.
Receives: Behavioral: Internet-based CBT for patients with PMS
waiting listOtherDuring 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.
Receives: Other: Waiting list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: pre-treatment

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

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

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

  3. Impairment by the premenstrual syndrome (self-developed questionnaire)

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

    Measured: 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)

  1. Coping with the premenstrual symptoms (self-developed questionnaire)

    assessment of coping strategies (self-rating)

    Measured: 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)

  2. Pain Coping Questionnaire (FESV; Geissner, 2003)

    assessment of PMS related coping strategies (self-rating)

    Measured: 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)

  3. 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)

    Measured: 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)

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

    assessment of partnership quality (self-rating)

    Measured: 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)

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

    assessment of work strain (self-rating)

    Measured: 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)

  6. Perceived stress scale (PSS, Cohen, 1994)

    assessment of stress perception (self-rating)

    Measured: 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)

  7. The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)

    assessment of personality

    Measured: pre-treatment

  8. Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)

    assessment of the degree of daily impairment by chronic pain (self-rating)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2017
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01961479
Sponsor's protocol ID
praemensis_2013
Acronym
praemensis
Status last verified
Apr 2018
First submitted
9 Oct 2013
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 18852497

  • 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.

    PubMed 9350019

  • 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.

    PubMed 11030291

  • 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.

    PubMed 12892987

  • 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.

    PubMed 12217456

  • 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.

    PubMed 19018554

  • 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.

    PubMed 18415443

  • 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.

    PubMed 22426857

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based CBT for patients with PMS and Waiting list in people with Premenstrual Syndrome (PMS), run by Philipps University Marburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retrospective Screening (Ditzen et al., 2011) (time frame: pre-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01961479, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in