Common use of Procedure Clause in Contracts

Procedure. During an online screening, potential participants were identified through a retrospective screening for PMS using a self-report questionnaire – the German PMS Inventory (Ditzen et al., 2011b). Furthermore, a screening for other mental disorders using the Brief Web-Based Screening Questionnaire for Mental Disorders, (WSQ; ▇▇▇▇▇▇ et al., 2009) was conducted. Results of the German PMS Inventory (Ditzen et al., 2011b) were necessary to pre-check early in the study procedure if women would be eligible for participating either in the control or in the PMS group (see detailed criteria for this screening in Table 6.1). When this screening indicated that a participant potentially did not meet inclusion criteria (e.g., there was suspicion of a mental disorder), further exploration through a telephone interview followed. Concerning the check for other mental disorders, the well-validated International Diagnostic Checklists for ICD-10 (IDCL; Janca & ▇▇▇▇▇▇, 1996) were applied. Second, only women with PMS (but not non-PMS controls) completed daily records in a symptom diary to measure premenstrual complaints and the functional impairment attributable to these symptoms (symptoms are listed in the Note of Table 1). The diary is based on the German PMS Inventory (Ditzen et al., 2011b), which was already used during the initial screening procedure as a retrospective questionnaire and was applied as a prospective symptom diary in this step of the study procedure. The items of the German PMS Inventory cover all psychological and physical symptoms that are part of the diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD) (American Psychiatric Association, 2013). For the purpose of transforming the questionnaire to a diary, original statements of this German PMS Inventory (Ditzen et al., 2011b) were slightly modified: only the single term of the symptom instead of the complete item wordings (e.g., “hopelessness” instead of “I feel more hopeless”) was used. Items were rated by participants on a four-point Likert scale. The first day of measurement was the first day of the next menses and lasted for two menstrual cycles. Participants were excluded whose diaries were incomplete on those days of the menstrual cycle that were important for checking eligibility criteria of PMS symptom severity and disability (see Table 1). Moreover, by analyzing the daily records, women who did not fulfill the specified cut-off values confirming premenstrual symptomatology (see Table 1) were excluded. After completing the daily records, two experimental sessions followed. These sessions included an online version of the affect misattribution procedure (AMP), the German PMS Inventory (Ditzen et al., 2011b), and the German version of the Cognitive Emotion Regulation Questionnaire (CERQ, Garnefski & ▇▇▇▇▇▇, ▇▇▇▇; ▇▇▇▇ et al., 2011). Women again completed the German PMS Inventory (Ditzen et al., 2011b) immediately before each experimental session in order to assess the severity of premenstrual symptoms on the day of the experiment. This was done in order to validate that participants really had stronger PMS symptoms during the luteal phase and no symptoms during the follicular phase. The two dates for the experimental sessions were calculated based on information regarding the dates and duration of the previous menstrual cycles (from the prospective daily ratings); For the luteal phase, the session had to take place during the three days before the expected start of the next menses and for the other assessment, a date around the mean of the follicular phase was estimated. For this reason, an adjustment of the follicular phase of the menstrual cycle was made. Weschler (2002) explains that the follicular phase (determined as days 6–10 for a cycle length of 28 days) can vary between individuals. Therefore, the relevant follicular phase was adjusted in accordance with the individual length of the menstrual cycle. After the experimental assessments were completed, we recorded the starting point of the following menses in order to reconfirm the dates of experimental assessments during the follicular and luteal phases. Whether participants had their first assessment in the follicular or in the luteal phase was randomly assigned. During the experimental sessions, the principal investigator instructed the participants via telephone regarding how to start and complete the experimental task. Afterwards, we screened for deviations in the duration of experiments for each participant. There was no hint of systematic errors or deviations. Both experimental sessions were conducted remotely at the participants’ home. The group of non-PMS control participants was matched to the PMS group according to age and education. We first assessed the PMS group, creating percentiles of the distribution of age and educational level. Second, we recruited participants for the control group according to the percentiles of the PMS group. Women in the control group received 50 Euro and women in the PMS group received 100 Euro for their participation.

Procedure. During an An initial retrospective online screening, screening was carried out to identify potential participants were identified through a retrospective screening for PMS with PMS, using a self-report questionnaire – the (German PMS Inventory (Ditzen Inventory; ▇▇▇▇▇▇ et al., 2011b). Furthermore, a screening for The existence of other mental disorders was also assessed using the Brief Web-Based Screening Questionnaire for Mental Disorders, Disorders (WSQ; ▇▇▇▇▇▇ et al., 2009) was conducted). Results Based on the results of the German PMS Inventory (Ditzen et al., 2011b) were necessary to pre-check early in ), the study procedure if women would be eligible for participating either in who fulfilled the control or in the PMS group (see detailed criteria for this screening in Table 6.1). When this screening indicated that a participant potentially did not meet inclusion criteria (e.g.see Table 1) were assigned to either the control group or the PMS group. Depending on the screening results, there was suspicion of a mental disorder), further exploration through by a telephone interview followed. Concerning For women who affirmed any of the check for other mental disordersWSQ-items, the well-well validated International Diagnostic Checklists for ICD-10 (IDCL; Janca & ▇▇▇▇▇▇, 1996Zaudig, & Mombour, 2004) were appliedapplied in order to check participants for any other mental disorders in addition to PMS. SecondIn a next step, only women with PMS (but not non-PMS controls) completed daily records in a symptom diary to measure of premenstrual complaints and the functional impairment attributable to these symptoms (symptoms are listed in the Note footnote of Table 1)5.1) and the associated impairment of social functioning had to be completed over two menstrual cycles by women suffering from PMS. The diary is daily record was based on the German PMS Inventory (Ditzen et al., 2011b), which was already ) that we used during the initial screening procedure as a retrospective questionnaire and was applied as a prospective symptom diary in this step of the study procedure. It was provided as an Excel® file in which participants entered their symptoms every day. The items of the German PMS Inventory cover all psychological and physical symptoms that are part of the diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD) (American Psychiatric Association, 2013). For the purpose of transforming the questionnaire to a diary, original statements of this German PMS Inventory (Ditzen et al., 2011b) questionnaire were slightly modified: modified using only the single term of the symptom instead of the complete item wordings (e.g., “hopelessness” instead of “I feel more hopeless”) was used). Items were rated by participants on a four4-point Likert scale. The first day of measurement was assessment began on the first day of the next menses and lasted for two menstrual cycles. Participants were excluded whose diaries were incomplete on those the days of the menstrual cycle that were important substantial for checking eligibility criteria of PMS symptom severity and disability (see Table 1)5.1) were excluded. Moreover, by analyzing the daily records, women who did not fulfill the specified cut-off values confirming premenstrual symptomatology a PMS (see Table 15.1) were excluded. After completing the daily recordsdiary, two experimental sessions followed. These sessions included an online version versions of the affect misattribution procedure emotional Stroop task (AMP), the EST) and German PMS Inventory (Ditzen et al., 2011b), and the German version of the Cognitive Emotion Regulation Questionnaire (CERQ, Garnefski & ▇▇▇▇▇▇, ▇▇▇▇; ▇▇▇▇ et al., 2011). Women again completed the German PMS Inventory (Ditzen et al., 2011b) immediately before each experimental session in order to assess the severity of premenstrual symptoms on the day of the experiment. This The latter was done in order used to validate that participants really had stronger PMS symptoms during the luteal phase and no symptoms during group assignment done by daily ratings in the follicular phasediary. The two dates for the experimental sessions were calculated based on information regarding of the dates and duration of the previous former menstrual cycles (from the prospective daily ratings); cycles: For the luteal phase, the session had to take place during the three days before the expected start of the next menses and for the other assessment, a date around in the mean middle of the follicular phase was estimated. For this reason, an adjustment of the follicular phase of the menstrual cycle was made. Weschler (2002) explains that Since the follicular phase (determined as days 6–10 for 6-10 regarding a cycle length of 28 days) can vary between individuals. Thereforeindividuals (Weschler, the relevant follicular phase 2002) it was adjusted in accordance with dependence on the individual length of the menstrual cycle. Whether participants had their first measure in the follicular or in the luteal phase was randomly assigned. The participants were instructed by the principal investigator via telephone how to start and complete the experimental task. Afterwards we screened if there were deviations in the duration of experiments for each participants. There was no hint for systematic errors or deviations. Figure 5.1 gives an overview of all steps of study procedure. After the experimental assessments were completed, had been accomplished we recorded the starting point of the following menses in order to reconfirm the dates of experimental assessments during the follicular and luteal phases. Whether participants had their first assessment in the follicular or in the luteal phase was randomly assigned. During the experimental sessions, the principal investigator instructed the participants via telephone regarding how to start and complete the experimental task. Afterwards, we screened for deviations in the duration of experiments for each participant. There was no hint of systematic errors or deviationsphase. Both experimental sessions were conducted remotely at the participants’ home. The group of non-PMS control participants was matched to the PMS group according to age and education. We first assessed the PMS group, creating percentiles of the distribution of age and educational level. Second, we recruited participants for the control group according to the percentiles of the PMS group. Women in the control group received 50 Euro and women in the PMS PMS- group received 100 Euro for their participation.