Treatment of Premenstrual Syndrome - Internet-based Self-help

Study Overview
=================
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.

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

Conditions
-----------------
Premenstrual Syndrome (PMS)

Intervention / Treatment
-----------------
* Behavioral: Internet-based CBT for patients with PMS
* Other: Waiting list


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT for patients with PMS<br>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<br>* Internet-based cognitive-behavioural self-help treatment<br>|
| Other: waiting list<br>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<br>* During the waiting period, participants receive no treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premenstrual syndrome (PMS), Premenstrual Dysphoric Disorder (PMDD), Internet-based Therapy, Cognitive Behavioural Therapy (CBT)