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

Primary Purpose

Premenstrual Syndrome (PMS)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Internet-based CBT for patients with PMS
Waiting list
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome (PMS) focused on measuring Premenstrual syndrome (PMS), Premenstrual Dysphoric Disorder (PMDD), Internet-based Therapy, Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Internet-based CBT for patients with PMS

waiting list

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Prospective PMS-Diary (Kleinstäuber et al., unpublished)
prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)
Impairment by the premenstrual syndrome (self-developed questionnaire)
assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)

Secondary Outcome Measures

Coping with the premenstrual symptoms (self-developed questionnaire)
assessment of coping strategies (self-rating)
Pain Coping Questionnaire (FESV; Geissner, 2003)
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)
assessment of the availability of social support (self-rating)
Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)
assessment of partnership quality (self-rating)
Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)
assessment of work strain (self-rating)
Perceived stress scale (PSS, Cohen, 1994)
assessment of stress perception (self-rating)
The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)
assessment of personality
Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)
assessment of the degree of daily impairment by chronic pain (self-rating)

Full Information

First Posted
October 9, 2013
Last Updated
April 10, 2018
Sponsor
Philipps University Marburg Medical Center
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01961479
Brief Title
Treatment of Premenstrual Syndrome - Internet-based Self-help
Acronym
praemensis
Official Title
Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome (PMS)
Keywords
Premenstrual syndrome (PMS), Premenstrual Dysphoric Disorder (PMDD), Internet-based Therapy, Cognitive Behavioural Therapy (CBT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based CBT for patients with PMS
Arm Type
Experimental
Arm Description
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.
Arm Title
waiting list
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT for patients with PMS
Intervention Description
Internet-based cognitive-behavioural self-help treatment
Intervention Type
Other
Intervention Name(s)
Waiting list
Intervention Description
During the waiting period, participants receive no treatment.
Primary Outcome Measure Information:
Title
Retrospective Screening (Ditzen et al., 2011)
Description
assessment of premenstrual symptoms based on the Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) (self-rating)
Time Frame
pre-treatment
Title
Prospective PMS-Diary (Kleinstäuber et al., unpublished)
Description
prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)
Time Frame
6 months; pre-treatment to post-treatment (4 months after admission)
Title
Impairment by the premenstrual syndrome (self-developed questionnaire)
Description
assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)
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)
Secondary Outcome Measure Information:
Title
Coping with the premenstrual symptoms (self-developed questionnaire)
Description
assessment of coping strategies (self-rating)
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)
Title
Pain Coping Questionnaire (FESV; Geissner, 2003)
Description
assessment of PMS related coping strategies (self-rating)
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)
Title
Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)
Description
assessment of the availability of social support (self-rating)
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)
Title
Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)
Description
assessment of partnership quality (self-rating)
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)
Title
Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)
Description
assessment of work strain (self-rating)
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)
Title
Perceived stress scale (PSS, Cohen, 1994)
Description
assessment of stress perception (self-rating)
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)
Title
The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)
Description
assessment of personality
Time Frame
pre-treatment
Title
Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)
Description
assessment of the degree of daily impairment by chronic pain (self-rating)
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Weise, Ph.D.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Kleinstäuber, Ph.D.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carolyn Janda, Ph.D.Student
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johanna N. Kues, Ph.D.Student
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gudrun Kaiser, Ph.D Student
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18852497
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.
Results Reference
background
PubMed Identifier
9350019
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.
Results Reference
background
PubMed Identifier
11030291
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.
Results Reference
background
PubMed Identifier
12892987
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.
Results Reference
background
PubMed Identifier
12217456
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.
Results Reference
background
PubMed Identifier
19018554
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.
Results Reference
background
PubMed Identifier
18415443
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.
Results Reference
background
PubMed Identifier
22426857
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.
Results Reference
background
Citation
American College of Obstetricians and Gynecologists (ACOG). Premenstrual syndrome. Washington, DC: National Guideline Clearinghouse, 2000.
Results Reference
background
Citation
American Psychiatric Association (APA). Diagnostic and statistical manual for mental disorders (DSM-IV). Washington, DC: American Psychiatric Press, 1994.
Results Reference
background
Citation
Cohen S. Perceived stress scale, 1994. Retrieved August 09, 2012, from http://updates.wcupa.edu/_academics/healthsciences/stressreductioncenter/documents/perceived_stress_scale.pdf
Results Reference
background
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.
Results Reference
background
Citation
Fydrich T, Sommer G, & Brähler E. Fragebogen zur sozialen Unterstützung (F-SozU ). Göttingen: Hogrefe, 2007.
Results Reference
background
Citation
Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe, 2003.
Results Reference
background
Citation
Siffert A, Bodenmann G. Entwicklung eines neuen multidimensionalen Fragebogens zur Erfassung der Partnerschaftsqualität (FPQ). Zeitschrift für Familienforschung, 2010.
Results Reference
background
PubMed Identifier
25467540
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.
Results Reference
derived
Links:
URL
http://www.uni-marburg.de/fb04/ag-klin/forschung/pmsd/index_html
Description
Click here for more information about this study: Treatment of the Premenstrual Syndrome - Internet-based self-help
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-472
Available IPD/Information Comments
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

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Treatment of Premenstrual Syndrome - Internet-based Self-help

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