Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden
Introduction Premenstrual dysphoric disorder (PMDD) is a cyclic mood disorder affecting around 2%–5% of women of reproductive age. Pharmacological interventions exist, but many patients with PMDD experience residual symptoms, discontinue medications or refrain from them due to side effects. Thus, no...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e091649.full |
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| author | Filipa Sampaio Alkistis Skalkidou Gerhard Andersson Cornelia Weise Johanna M. Hoppe Maria Kleinstaeuber Johan Vegelius Erika Comasco Maria Gröndal Elisavet Kaltsouni Felicia Sundström Monica Buhrman |
| author_facet | Filipa Sampaio Alkistis Skalkidou Gerhard Andersson Cornelia Weise Johanna M. Hoppe Maria Kleinstaeuber Johan Vegelius Erika Comasco Maria Gröndal Elisavet Kaltsouni Felicia Sundström Monica Buhrman |
| author_sort | Filipa Sampaio |
| collection | DOAJ |
| description | Introduction Premenstrual dysphoric disorder (PMDD) is a cyclic mood disorder affecting around 2%–5% of women of reproductive age. Pharmacological interventions exist, but many patients with PMDD experience residual symptoms, discontinue medications or refrain from them due to side effects. Thus, non-pharmacological treatments are needed as an alternative or additive treatment strategy. Evidence indicates that cognitive behavioural therapy (CBT) is a promising candidate. However, further research is required to establish its efficacy and identify ways to improve the treatment. Specifically, incorporating components targeting emotional and interpersonal dysregulation could theoretically enhance its effects. Furthermore, increasing the generally low accessibility of CBT for PMDD necessitates scalable and cost-effective ways to deliver treatment. The current study aims to evaluate the effects and cost-effectiveness of an internet-delivered CBT (ICBT) intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness.Methods and analysis The study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided ICBT or a waitlist control condition. Following recruitment and inclusion, 164 individuals aged 18–45 years who fulfil the Diagnostic Manual of Mental Disorders-5 criteria for PMDD will be randomly assigned to the two groups. Primary outcomes are pretreatment to post-treatment group differences in premenstrual symptoms and their impact on everyday life, as well as psychological and functional impairment during the premenstrual phase. Secondary outcomes include treatment effects on quality of life and difficulties in emotion regulation. Long-term treatment effects will be assessed 6 and 12 months postintervention. Data will be analysed using latent Gaussian process modelling and linear mixed models. The economic evaluation will analyse individual-level societal costs and outcomes between trial arms. Recruitment is expected to begin in February 2025, with study completion anticipated by February 2028.Ethics and dissemination The study has been approved by the Swedish Ethical Review Authority (2023-00655-01). Results will be disseminated via presentations and publications in international journals and national outlets for clinicians and patients with PMDD.Protocol version PS2024_v1.Trial registration number NCT06496139. |
| format | Article |
| id | doaj-art-f12eb589606a479d93224583e89247b7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
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| series | BMJ Open |
| spelling | doaj-art-f12eb589606a479d93224583e89247b72025-01-23T06:40:11ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-091649Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in SwedenFilipa Sampaio0Alkistis Skalkidou1Gerhard Andersson2Cornelia Weise3Johanna M. Hoppe4Maria Kleinstaeuber5Johan Vegelius6Erika Comasco7Maria Gröndal8Elisavet Kaltsouni9Felicia Sundström10Monica Buhrman11Department of Public Health and Caring Sciences, Uppsala University, Uppsala, SwedenDepartment of Women`s and Children`s Health, Uppsala University, Uppsala, SwedenDepartment of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, SwedenDepartment of Clinical Psychology and Behavioral Health Technology, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, GermanyDepartment of Psychology, Uppsala University, Uppsala, SwedenDepartment of Psychology, Emma Eccles Jones College of Education and Human Services, Utah State University, Logan, Utah, USADepartment of Medical Sciences, Uppsala University Hospital, Uppsala, SwedenDepartment of Women`s and Children`s Health, Science for Life Laboratory, Uppsala University, Uppsala, SwedenDepartment of Psychology, University of Gothenburg, Gothenburg, SwedenDepartment of Women`s and Children`s Health, Uppsala University, Uppsala, SwedenDepartment of Psychology, Uppsala University, Uppsala, SwedenDepartment of Psychology, Uppsala Universitet, Uppsala, SwedenIntroduction Premenstrual dysphoric disorder (PMDD) is a cyclic mood disorder affecting around 2%–5% of women of reproductive age. Pharmacological interventions exist, but many patients with PMDD experience residual symptoms, discontinue medications or refrain from them due to side effects. Thus, non-pharmacological treatments are needed as an alternative or additive treatment strategy. Evidence indicates that cognitive behavioural therapy (CBT) is a promising candidate. However, further research is required to establish its efficacy and identify ways to improve the treatment. Specifically, incorporating components targeting emotional and interpersonal dysregulation could theoretically enhance its effects. Furthermore, increasing the generally low accessibility of CBT for PMDD necessitates scalable and cost-effective ways to deliver treatment. The current study aims to evaluate the effects and cost-effectiveness of an internet-delivered CBT (ICBT) intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness.Methods and analysis The study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided ICBT or a waitlist control condition. Following recruitment and inclusion, 164 individuals aged 18–45 years who fulfil the Diagnostic Manual of Mental Disorders-5 criteria for PMDD will be randomly assigned to the two groups. Primary outcomes are pretreatment to post-treatment group differences in premenstrual symptoms and their impact on everyday life, as well as psychological and functional impairment during the premenstrual phase. Secondary outcomes include treatment effects on quality of life and difficulties in emotion regulation. Long-term treatment effects will be assessed 6 and 12 months postintervention. Data will be analysed using latent Gaussian process modelling and linear mixed models. The economic evaluation will analyse individual-level societal costs and outcomes between trial arms. Recruitment is expected to begin in February 2025, with study completion anticipated by February 2028.Ethics and dissemination The study has been approved by the Swedish Ethical Review Authority (2023-00655-01). Results will be disseminated via presentations and publications in international journals and national outlets for clinicians and patients with PMDD.Protocol version PS2024_v1.Trial registration number NCT06496139.https://bmjopen.bmj.com/content/15/1/e091649.full |
| spellingShingle | Filipa Sampaio Alkistis Skalkidou Gerhard Andersson Cornelia Weise Johanna M. Hoppe Maria Kleinstaeuber Johan Vegelius Erika Comasco Maria Gröndal Elisavet Kaltsouni Felicia Sundström Monica Buhrman Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden BMJ Open |
| title | Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden |
| title_full | Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden |
| title_fullStr | Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden |
| title_full_unstemmed | Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden |
| title_short | Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden |
| title_sort | emotion regulation based internet delivered cognitive behavioural therapy for premenstrual dysphoric disorder study protocol for a randomised controlled trial in sweden |
| url | https://bmjopen.bmj.com/content/15/1/e091649.full |
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