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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective in reducing the impairment caused by premenstrual symptoms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based CBT for patients with PMS | Experimental | 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. |
|
| waiting list | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based CBT for patients with PMS | Behavioral | Internet-based cognitive-behavioural self-help treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | pre-treatment |
| Prospective PMS-Diary (Kleinstäuber et al., unpublished) | prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating) | 6 months; pre-treatment to post-treatment (4 months after admission) |
| Impairment by the premenstrual syndrome (self-developed questionnaire) | assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating) | 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 | Description | Time Frame |
|---|---|---|
| Coping with the premenstrual symptoms (self-developed questionnaire) | assessment of coping strategies (self-rating) | 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) |
| Pain Coping Questionnaire (FESV; Geissner, 2003) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Weise, Ph.D. | Philipps University Marburg | Study Chair |
| Maria Kleinstäuber, Ph.D. | Philipps University Marburg | Study Chair |
| Carolyn Janda, Ph.D.Student | Philipps University Marburg | Study Chair |
| Johanna N. Kues, Ph.D.Student | Philipps University Marburg | Study Chair |
| Gudrun Kaiser, Ph.D Student | Philipps University Marburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy | Marburg | Hesse | 35037 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18852497 | Background | 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. | |
| 9350019 | Background | 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. |
| Label | URL |
|---|---|
| Click here for more information about this study: Treatment of the Premenstrual Syndrome - Internet-based self-help | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 15, 2022 | |
| Reset | Oct 18, 2023 | |
| Release | Nov 30, 2023 | |
| Reset | May 3, 2024 | |
| Release | Aug 21, 2024 | |
| Reset | Nov 6, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 15, 2022 | Oct 18, 2023 | |||
| Nov 30, 2023 |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D013050 | Spectrometry, Fluorescence |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
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| Waiting list | Other | During the waiting period, participants receive no treatment. |
|
assessment of PMS related coping strategies (self-rating) |
| 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) |
| 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) | 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) |
| Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010) | assessment of partnership quality (self-rating) | 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) |
| Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009) | assessment of work strain (self-rating) | 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) |
| Perceived stress scale (PSS, Cohen, 1994) | assessment of stress perception (self-rating) | 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) |
| The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008) | assessment of personality | pre-treatment |
| Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994) | assessment of the degree of daily impairment by chronic pain (self-rating) | 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) |
| 11030291 | Background | 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. |
| 12892987 | Background | 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. |
| 12217456 | Background | 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. |
| 19018554 | Background | 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. |
| 18415443 | Background | 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. |
| 22426857 | Background | 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. |
| Background | American College of Obstetricians and Gynecologists (ACOG). Premenstrual syndrome. Washington, DC: National Guideline Clearinghouse, 2000. |
| Background | American Psychiatric Association (APA). Diagnostic and statistical manual for mental disorders (DSM-IV). Washington, DC: American Psychiatric Press, 1994. |
| Background | Cohen S. Perceived stress scale, 1994. Retrieved August 09, 2012, from http://updates.wcupa.edu/_academics/healthsciences/stressreductioncenter/documents/perceived_stress_scale.pdf |
| 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. |
| Background | Fydrich T, Sommer G, & Brähler E. Fragebogen zur sozialen Unterstützung (F-SozU ). Göttingen: Hogrefe, 2007. |
| Background | Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe, 2003. |
| Background | Siffert A, Bodenmann G. Entwicklung eines neuen multidimensionalen Fragebogens zur Erfassung der Partnerschaftsqualität (FPQ). Zeitschrift für Familienforschung, 2010. |
| 25467540 | Derived | 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. |
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 |
| May 3, 2024 |
| Aug 21, 2024 | Nov 6, 2024 |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D008919 |
| Investigative Techniques |
| D013057 | Spectrum Analysis |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |