Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496139
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-29
Brief Title:
Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder A Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Premensis-s
Brief Summary:
Premenstrual dysphoric disorder PMDD is a debilitating cyclic mental disorder affecting about 2-5 of women of reproductive age PMDD is characterised by recurring emotional behavioural cognitive and somatic symptoms that arise during the luteal premenstrual phase of the menstrual cycle and remit shortly after the onset of menses Although pharmacological interventions are available many women experience residual symptoms discontinue treatment or refrain from them because of side effects Therefore non-pharmacological treatment options are needed
Preliminary evidence suggests that internet-delivered cognitive behavioural therapy ICBT is a promising candidate but further research is warranted Also there is room for treatment improvement Specifically it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial RCT
Preliminary evidence suggests that internet-delivered cognitive behavioural therapy ICBT is a promising candidate but further research is warranted Also there is room for treatment improvement Specifically it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial RCT
Detailed Description:
The study is a parallel two-group RCT with 11 allocation to 8 weeks of a therapist-guided self-help ICBT for PMDD or a waitlist control group Approximately 164 women age 18-45 fulfilling the DSM-5 diagnostic criteria for PMDD will be randomly assigned
Recruitment
Participants will be recruited from the general population using the following screening procedure
1 Web-based screening for PMDD Premenstrual Screening Tool and other eligibility criteria
2 Clinical diagnostic telephone interview assessing preliminary PMDD diagnosis and psychiatric comorbidity
3 Prospective daily ratings of premenstrual symptoms during two consecutive menstrual cycles using the Daily Report of Severity of Problems DRSP
Outcomes and Expected Results
Primary outcomes are pre- to post-treatment group differences in premenstrual symptoms and their impact on everyday life prospective daily ratings two menstrual cycles pre- and post-treatment and PMDD-related psychological and functional impairment retrospective ratings Participants in the treatment group vs waiting list are expected to report a reduction in primary outcomes during the luteal premenstrual phase after treatment vs baseline No group differences in outcomes are expected during the follicular post-menstrual phase
Secondary outcomes include treatment effects on quality of life QoL and difficulties in emotion regulation Participants in the treatment group are expected to report higher QoL and lower levels of difficulties in emotion regulation after treatment vs baseline than the waitlist control group To assess long-term treatment effects follow-up assessments will be conducted 6 and 12 months after treatment
Health economic data will be collected for future health economic evaluations of the treatment
Analysis
All randomised participants will be included in the intention-to-treat ITT population regardless of whether they received or completed treatment The per-protocol PP population will be a subgroup of the ITT population containing all participants without a major protocol violation Sensitivity analyses will also be conducted with 1 participants who have completed at least four mandatory modules modules 1-4 and 2 participants who have completed at least four mandatory modules and at least one of the optional lifestyle modules To further explore potential differential effects of ICBT exploratory analyses will be conducted for different symptom clusters eg affective symptoms and symptom trajectories in terms of onset andor in combination with severity and severity peak The relationship between difficulties in emotion regulation and improvement in primary outcomes will also be explored
Recruitment
Participants will be recruited from the general population using the following screening procedure
1 Web-based screening for PMDD Premenstrual Screening Tool and other eligibility criteria
2 Clinical diagnostic telephone interview assessing preliminary PMDD diagnosis and psychiatric comorbidity
3 Prospective daily ratings of premenstrual symptoms during two consecutive menstrual cycles using the Daily Report of Severity of Problems DRSP
Outcomes and Expected Results
Primary outcomes are pre- to post-treatment group differences in premenstrual symptoms and their impact on everyday life prospective daily ratings two menstrual cycles pre- and post-treatment and PMDD-related psychological and functional impairment retrospective ratings Participants in the treatment group vs waiting list are expected to report a reduction in primary outcomes during the luteal premenstrual phase after treatment vs baseline No group differences in outcomes are expected during the follicular post-menstrual phase
Secondary outcomes include treatment effects on quality of life QoL and difficulties in emotion regulation Participants in the treatment group are expected to report higher QoL and lower levels of difficulties in emotion regulation after treatment vs baseline than the waitlist control group To assess long-term treatment effects follow-up assessments will be conducted 6 and 12 months after treatment
Health economic data will be collected for future health economic evaluations of the treatment
Analysis
All randomised participants will be included in the intention-to-treat ITT population regardless of whether they received or completed treatment The per-protocol PP population will be a subgroup of the ITT population containing all participants without a major protocol violation Sensitivity analyses will also be conducted with 1 participants who have completed at least four mandatory modules modules 1-4 and 2 participants who have completed at least four mandatory modules and at least one of the optional lifestyle modules To further explore potential differential effects of ICBT exploratory analyses will be conducted for different symptom clusters eg affective symptoms and symptom trajectories in terms of onset andor in combination with severity and severity peak The relationship between difficulties in emotion regulation and improvement in primary outcomes will also be explored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None