Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000553471
Ethics application status
Approved
Date submitted
19/05/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Trial of Brief Tailored Online Therapy for Rumination and Worry in Adults with Premenstrual Dysphoric Disorder
Scientific title
Pilot Trial of Brief Tailored Online Therapy for Rumination and Worry in Adults with Premenstrual Dysphoric Disorder
Secondary ID [1] 314340 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual Dysphoric Disorder 337313 0
Premenstrual Syndrome 337314 0
Condition category
Condition code
Mental Health 333697 333697 0 0
Other mental health disorders
Mental Health 333698 333698 0 0
Depression
Mental Health 333699 333699 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being investigated is a 4-module online CBT program delivered with clinician support over 4 weeks, called the Managing Overthinking in PMDD Program.

Program content was informed by several evidence-based strategies for rumination including Rumination-Focused CBT, Mindfulness-Based Cognitive Therapy, and concreteness training. Each lesson provides psychoeducation and/or introduces skills for participants to practise over the coming week. Content includes psychoeducation (about PMDD and treatment options, rumination and worry, and their link with PMDD symptoms), menstrual cycle and symptom tracking, self-monitoring of rumination/worry, activity planning, structured problem-solving, skills to disengage from rumination and worry (e.g., shifting attention), managing rumination and worry at night, shifting to Specific Thinking, and relapse prevention.

The program comprises four lessons, delivered via a learning management platform, that participants complete over a period of four weeks. Participants receive the intervention individually in a remote setting (e.g., anywhere they can access the program via the internet from a personal device). Program content consists of written information and interactive exercises. The program is self-paced; one sequential lesson is made available each week, encouraging participants to revise and practice the previous lesson’s skills before accessing the next module. Each lesson will take approximately 30-40 minutes to read. Participants will have access to summaries of each lesson, homework exercises and extra resources for each lesson. A lesson is considered complete once all lesson content has been viewed and the lesson summary/activity plan downloaded. Participants are advised to spend at least 3-4 hours a week working through the lesson material and practicing the skills.

Clinician guidance will be provided to all participants in the form of phone and/or email contact from the study clinicians (Clinical Psychologists, and Clinical Psychology Registrars or Provisional Psychologists who have received tertiary-level qualifications and training in the assessment and treatment of clinical disorders). After the completion of Lesson 1 and 3, participants will be contacted via phone by a study clinician for a brief, semi-structured check-in call to help summarise lesson content, troubleshoot difficulties, answer questions, provide encouragement, and assist with skill implementation, estimated to last from 10 to 30 minutes in length. A brief email check-in will be conducted after Lesson 2 with the option for participants to elect for a check-in phone call. All participant contact (attempts, number, duration, and type of each contact) will be logged on the Redcap platform.

Participants will also receive automatic email notifications via the online platform to complete lessons, questionnaires, and practise skills between lessons. Additional email and/or phone contact will also be initiated from clinical staff if participants fail to complete lessons or questionnaires after these reminders.

To monitor participants' safety throughout the program, they will complete a brief measure of distress (the DQ-5) prior to each lesson, as well as during the pre-intervention, post-intervention, and follow-up questionnaires. Clinicians will initiate phone and/or email contact in response to significant deterioration in participants’ scores on the DQ-5, or if participant feedback about the previous lesson indicates the presence of or an increase in risk via suicidal ideation or high distress. A risk assessment will be conducted and direction to further support resources provided if necessary.

Participants will be able to initiate email contact with the study team for technical enquiries or to seek further clinical support throughout the trial, and will be responded to by email or phone during business hours.

After screening, participants will complete a telephone interview with a study clinician assessing PMDD diagnostic criteria, and qualitative questions around their lived experience of PMDD, and treatment needs and preferences. All participants will then complete measures of PMDD symptom severity, repetitive negative thinking, rumination and worry, depression symptoms, anxiety symptoms, distress, wellbeing, and functioning at baseline (immediately prior to Lesson 1; Week 1), post-treatment (within one week after Lesson 4; Week 5), and two five-week follow-up periods (Weeks 10 and 15, to capture at least two menstrual cycles following treatment completion). All questionnaires will be completed online. Before each lesson, participants will also complete short measures of repetitive negative thinking and distress (DQ-5), and answer some brief engagement questions about the previous lesson (i.e., how many minutes spent reading the lesson, and practising the strategies discussed). Up to 15 participants will also be randomly selected to be invited to complete an optional post-treatment feedback qualitative interview at week 10 to obtain further feedback on the treatment.

Automated email reminders and close monitoring of participant engagement (via lesson completion) by the study clinicians will be used to monitor participant adherence to the program. Treatment adherence will be assessed according to number of modules completed and engagement by participants’ self-reported time spent reading the modules and practicing the skills.
Intervention code [1] 330950 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341294 0
Changes in self-reported Premenstrual Dysphoric Disorder (PMDD) symptom severity
Timepoint [1] 341294 0
Baseline (week 1), post-treatment (week 5), follow-up 1 (week 10) and follow-up 2 (week 15 ). Primary timepoint is post-treatment (week 5).
Secondary outcome [1] 447041 0
Changes in self-reported psychological distress
Timepoint [1] 447041 0
Baseline (week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [2] 447052 0
Treatment adherence
Timepoint [2] 447052 0
Number of modules completed in total assessed at post-treatment (week 5)
Secondary outcome [3] 447047 0
Changes in self-reported mental wellbeing
Timepoint [3] 447047 0
Baseline (Week 1), post-treatment (week 5) and follow-up (weeks 10 and 15). Primary timepoint is post-treatment (week 5).
Secondary outcome [4] 447048 0
Changes in self-reported functional impairment
Timepoint [4] 447048 0
Baseline (Week 1), post-treatment (week 5) and follow-up (weeks 10 and 15). Primary timepoint is post-treatment (week 5).
Secondary outcome [5] 448063 0
Treatment engagement.
Timepoint [5] 448063 0
Self-reported time spent engaging with previous lesson material assessed before Lessons 2, 3 and 4 and post-Lesson 4. This will be assessed via a self-report question (online) at the beginning of Lessons 2, 3 and 4, and at the end of Lesson 4.
Secondary outcome [6] 447039 0
Changes in self-reported repetitive negative thinking frequency
Timepoint [6] 447039 0
Baseline (week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [7] 447043 0
Changes in self-reported suicidality (frequency of suicidal thinking)
Timepoint [7] 447043 0
Baseline (week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [8] 447050 0
Treatment satisfaction
Timepoint [8] 447050 0
All participants complete TSQ at post-treatment (week 5) Subset of participants complete optional qualitative interview at follow-up 1 (week 10)
Secondary outcome [9] 447044 0
Changes in self-reported worry
Timepoint [9] 447044 0
Baseline (week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [10] 447042 0
Changes in self-reported depression symptom severity
Timepoint [10] 447042 0
Baseline (week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [11] 447049 0
Changes in self-reported days out of role (partial and full)
Timepoint [11] 447049 0
Baseline (Week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [12] 447045 0
Changes in self-reported rumination
Timepoint [12] 447045 0
Baseline (Week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).
Secondary outcome [13] 447046 0
Changes in self-reported anxiety
Timepoint [13] 447046 0
Baseline (Week 1), post-treatment (week 5) and follow-up (weeks 10 and 15).

Eligibility
Key inclusion criteria
Inclusion criteria for entry into the study include:
1. Aged 18 years or over
2. Lives in Australia
3. Proficient in English language
4. Access to an internet-connected device sufficient to access the online program
5. Able to provide demographic information and the details of their General Practitioner (GP)
6. Female sex or Assigned Female At Birth (AFAB)
7. Not menopausal, pregnant, or have undergone a hysterectomy
8. Experiencing elevated premenstrual distress (according to a score of least ‘Moderate PMS’ on the Premenstrual Symptom Screening Test, PSST)
9. Experiencing elevated levels of rumination and/or worry (score of 28 or above on the Repetitive Thinking Questionnaire 10-item/RTQ-10).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
1. Insufficient severity of premenstrual distress, according to scoring less than ‘Moderate PMS’ on the PSST
2. Insufficient frequency of rumination and/or worry according to RTQ-10 score of 27 or below.
3. Self-reported diagnosis of schizophrenia, psychosis or bipolar disorder.
4. Current daily suicidal ideation as indicated by a score of 3 on item 9 of the PHQ-9, active suicidal intent or acute suicide risk as determined by clinician interview
5. Commencement of medication (or changing dosage of medication) for depression, anxiety or PMDD within the two months prior to screening (e.g., antidepressants, hormonal treatments).
6. Currently receiving CBT for depression, anxiety or PMDD
7. Completed an online CBT program for rumination or worry in the year prior to screening.
8. Unwilling to provide GP details for risk management purposes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The planned sample size is 35 subjects, based on the following sample size calculation. Conservatively, 26 people would be needed to detect a an expected effect size for the pre-post treatment changes in PMDD symptoms (d=0.8, 80% power, alpha=.05, two-tailed test); we will recruit up to 35 people to account for attrition (approximately 25%).

All analyses will be undertaken using intention to treat linear mixed model analyses. Relationships between observations at different occasions will be modelled with the appropriate covariance matrix. This analytic approach is the preferred method for analysing repeated measures as it more effectively manages missing data and better accounts for the correlation between the repeated measurements on the same subject inherent in pre post, pre-follow-up design pilot trials. This analysis will be conducted after all data has been collected, and no interim analyses are planned. Planned contrasts will be used to compare changes between pre-treatment and post-treatment, and follow-up. Effect sizes will be calculated (Hedges g) to measure the size of the within group changes on primary and secondary outcome measures. Independent samples t tests and chi square analyses will be conducted to compare the sample of participants who completed treatment (4 out of 4 modules) versus those who did not complete treatment on symptom severity (e.g., PSST), as well as sociodemographic characteristics (e.g., age). The same analyses will also be used to compare those who dropped out of the study versus those who remained in the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
8/09/2025
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318861 0
Government body
Name [1] 318861 0
National Health and Medical Research Council (NHMRC) Investigator Grant Fellowship (GNT2008839) awarded to Jill Newby.
Country [1] 318861 0
Australia
Funding source category [2] 318859 0
Government body
Name [2] 318859 0
Australian Research Training Program Scholarship awarded to Emily Upton from the Australian Government Department of Education
Country [2] 318859 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 321319 0
None
Name [1] 321319 0
Address [1] 321319 0
Country [1] 321319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317475 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 317475 0
Ethics committee country [1] 317475 0
Australia
Date submitted for ethics approval [1] 317475 0
15/02/2025
Approval date [1] 317475 0
11/04/2025
Ethics approval number [1] 317475 0
iRECS7982

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141166 0
Prof Jill Newby
Address 141166 0
Black Dog Institute, Prince of Wales Hospital, Hospital Road, Randwick NSW 2031
Country 141166 0
Australia
Phone 141166 0
+61 2 9065 9108
Fax 141166 0
Email 141166 0
[email protected]
Contact person for public queries
Name 141167 0
Emily Upton
Address 141167 0
Black Dog Institute, Prince of Wales Hospital, Hospital Road, Randwick NSW 2031
Country 141167 0
Australia
Phone 141167 0
+61 2 9065 7751
Fax 141167 0
Email 141167 0
[email protected]
Contact person for scientific queries
Name 141168 0
Emily Upton
Address 141168 0
Black Dog Institute, Prince of Wales Hospital, Hospital Road, Randwick NSW 2031
Country 141168 0
Australia
Phone 141168 0
+61 2 9065 7751
Fax 141168 0
Email 141168 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.