Pilot Trial of Brief Tailored Online Therapy for Rumination and Worry in Adults with Premenstrual Dysphoric Disorder

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.