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Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial.

Kues JN, Janda C, Kleinstäuber M, Weise C - Trials (2014)

Bottom Line: Impairment can be as serious as that of dysthymic disorders.Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks).The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstr, 18, 35032 Marburg, Germany. kuesj@uni-marburg.de.

ABSTRACT

Background: With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.

Methods/design: The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.

Discussion: So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

Trial registration: ClinicalTrials.gov: NCT01961479, 9 October 2013.

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Related in: MedlinePlus

Study process. t = measurement points: t0 = screening for basic inclusion criteria. t1 = first assessment of primary and secondary outcome in luteal phase, first and second cycle of the symptom diary. t2 = second assessment in luteal phase, third and fourth cycle of the symptom diary, approximately 2 months after admission. t3 = for the wait-list group only, third assessment of primary and secondary outcome in luteal phase, fifth and sixth cycle of the symptom diary, approximately 6 months after admission. t4 = for the treatment group: third assessment of primary and secondary outcome in luteal phase, approximately 10 months after admission; for the wait-list group: fourth assessment of primary and secondary outcome in luteal phase, approximately 14 months after admission.
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Fig1: Study process. t = measurement points: t0 = screening for basic inclusion criteria. t1 = first assessment of primary and secondary outcome in luteal phase, first and second cycle of the symptom diary. t2 = second assessment in luteal phase, third and fourth cycle of the symptom diary, approximately 2 months after admission. t3 = for the wait-list group only, third assessment of primary and secondary outcome in luteal phase, fifth and sixth cycle of the symptom diary, approximately 6 months after admission. t4 = for the treatment group: third assessment of primary and secondary outcome in luteal phase, approximately 10 months after admission; for the wait-list group: fourth assessment of primary and secondary outcome in luteal phase, approximately 14 months after admission.

Mentions: Eligible participants undergo four assessments (see Figure 1). In the first assessment (t0-assessment), participants fill out a retrospective screening of premenstrual symptoms[50] according to the DSM-5 criteria[7]. If participants fulfil the basic inclusion criteria and primary DSM-5 criteria (that is, five premenstrual symptoms including at least one affective symptom), a structured clinical interview regarding comorbid disorders is conducted via telephone. Afterwards, principally eligible participants are invited to complete a daily symptom rating during two consecutive menstrual cycles, as requested by the DSM-5 and ACOG criteria. During one of the premenstrual (luteal) phases within these two cycles, the participants fill in the pre-treatment assessment (t1-assessment) including primary (impairment of premenstrual symptoms) and secondary outcome measures (coping with premenstrual symptoms, social support, quality of partnership, level of stress). If the participants fulfil the diagnostic criteria of a severe PMS or PMDD with regard to the daily symptom rating, they are randomly assigned to either the treatment or the wait-list control group. In addition, they are randomized to one of two psychologists who will be the responsible psychologist throughout the study.Figure 1


Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial.

Kues JN, Janda C, Kleinstäuber M, Weise C - Trials (2014)

Study process. t = measurement points: t0 = screening for basic inclusion criteria. t1 = first assessment of primary and secondary outcome in luteal phase, first and second cycle of the symptom diary. t2 = second assessment in luteal phase, third and fourth cycle of the symptom diary, approximately 2 months after admission. t3 = for the wait-list group only, third assessment of primary and secondary outcome in luteal phase, fifth and sixth cycle of the symptom diary, approximately 6 months after admission. t4 = for the treatment group: third assessment of primary and secondary outcome in luteal phase, approximately 10 months after admission; for the wait-list group: fourth assessment of primary and secondary outcome in luteal phase, approximately 14 months after admission.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4265499&req=5

Fig1: Study process. t = measurement points: t0 = screening for basic inclusion criteria. t1 = first assessment of primary and secondary outcome in luteal phase, first and second cycle of the symptom diary. t2 = second assessment in luteal phase, third and fourth cycle of the symptom diary, approximately 2 months after admission. t3 = for the wait-list group only, third assessment of primary and secondary outcome in luteal phase, fifth and sixth cycle of the symptom diary, approximately 6 months after admission. t4 = for the treatment group: third assessment of primary and secondary outcome in luteal phase, approximately 10 months after admission; for the wait-list group: fourth assessment of primary and secondary outcome in luteal phase, approximately 14 months after admission.
Mentions: Eligible participants undergo four assessments (see Figure 1). In the first assessment (t0-assessment), participants fill out a retrospective screening of premenstrual symptoms[50] according to the DSM-5 criteria[7]. If participants fulfil the basic inclusion criteria and primary DSM-5 criteria (that is, five premenstrual symptoms including at least one affective symptom), a structured clinical interview regarding comorbid disorders is conducted via telephone. Afterwards, principally eligible participants are invited to complete a daily symptom rating during two consecutive menstrual cycles, as requested by the DSM-5 and ACOG criteria. During one of the premenstrual (luteal) phases within these two cycles, the participants fill in the pre-treatment assessment (t1-assessment) including primary (impairment of premenstrual symptoms) and secondary outcome measures (coping with premenstrual symptoms, social support, quality of partnership, level of stress). If the participants fulfil the diagnostic criteria of a severe PMS or PMDD with regard to the daily symptom rating, they are randomly assigned to either the treatment or the wait-list control group. In addition, they are randomized to one of two psychologists who will be the responsible psychologist throughout the study.Figure 1

Bottom Line: Impairment can be as serious as that of dysthymic disorders.Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks).The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstr, 18, 35032 Marburg, Germany. kuesj@uni-marburg.de.

ABSTRACT

Background: With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.

Methods/design: The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.

Discussion: So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

Trial registration: ClinicalTrials.gov: NCT01961479, 9 October 2013.

Show MeSH
Related in: MedlinePlus