Treatment of Premenstrual Syndrome - Internet-based Self-help (praemensis)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Philipps University Marburg Medical Center
Sponsor:
Collaborator:
Linköping University, Dept. of Behavioural Sciences and Learning
Information provided by (Responsible Party):
Cornelia Weise, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01961479
First received: October 9, 2013
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Premenstrual Syndrome (PMS)
Behavioral: Internet-based CBT for patients with PMS
Other: Waiting list

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Retrospective Screening (Ditzen et al., 2011) [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
    assessment of premenstrual symptoms based on the Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) (self-rating)

  • Prospective PMS-Diary (Kleinstäuber et al., unpublished) [ Time Frame: 6 months; pre-treatment to post-treatment (4 months after admission) ] [ Designated as safety issue: No ]
    prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)

  • Impairment by the premenstrual syndrome (self-developed questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)


Secondary Outcome Measures:
  • Coping with the premenstrual symptoms (self-developed questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of coping strategies (self-rating)

  • Pain Coping Questionnaire (FESV; Geissner, 2003) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of PMS related coping strategies (self-rating)

  • Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of the availability of social support (self-rating)

  • Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of partnership quality (self-rating)

  • Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of work strain (self-rating)

  • Perceived stress scale (PSS, Cohen, 1994) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of stress perception (self-rating)

  • The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008) [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
    assessment of personality

  • Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    assessment of the degree of daily impairment by chronic pain (self-rating)


Estimated Enrollment: 70
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Internet-based CBT for patients with PMS
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.
Other: Waiting list
During the waiting period, participants receive no treatment.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961479

Contacts
Contact: Cornelia Weise, Ph.D. +49-6421-2826738 weise@uni-marburg.de
Contact: Maria Kleinstäuber, Ph.D. +49-6421-2828904 kleinstaeuber@uni-marburg.de

Locations
Germany
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy Recruiting
Marburg, Hessen, Germany, 35037
Contact: Cornelia Weise, Dr.    +49 6421 2826738    weise@uni-marburg.de   
Contact: Maria Kleinstäuber, Dr.    +49 6421 2828904    maria.kleinstaeuber@uni-marburg.de   
Principal Investigator: Cornelia Weise, Ph. D.         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Linköping University, Dept. of Behavioural Sciences and Learning
Investigators
Study Chair: Cornelia Weise, Ph.D. Philipps University Marburg Medical Center
Study Chair: Maria Kleinstäuber, Ph.D. Philipps University Marburg Medical Center
Study Chair: Carolyn Janda, Ph.D.Student Philipps University Marburg Medical Center
Study Chair: Johanna N. Kues, Ph.D.Student Philipps University Marburg Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Cornelia Weise, Dr. rer. nat., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01961479     History of Changes
Other Study ID Numbers: praemensis_2013
Study First Received: October 9, 2013
Last Updated: April 17, 2014
Health Authority: Germany: Department of Psychology, Division of Clinical Psychology

Keywords provided by Philipps University Marburg Medical Center:
Premenstrual syndrome (PMS)
Premenstrual Dysphoric Disorder (PMDD)
Internet-based Therapy
Cognitive Behavioural Therapy (CBT)

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014