Self-Help Psychotherapy for Premenstrual Disorders

Overseen By Jennifer Gordon, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Regina

Must not be taking: Oral contraceptives

Disqualifiers: Psychotherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a self-help mental health program designed for individuals dealing with premenstrual disorders. It targets those with severe symptoms related to their menstrual cycle, such as premenstrual dysphoric disorder or worsening depression during menstruation. Participants will watch a series of short videos and complete workbook exercises over several months to determine if their symptoms improve. Individuals who have experienced significant mood changes tied to their menstrual cycle and are not currently using oral contraceptives or seeing a therapist might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for menstrual-related mood changes.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does exclude those taking oral contraceptives.

What prior data suggests that this self-help psychotherapy program is safe for individuals with premenstrual disorders?

Research has shown that self-guided therapy programs are generally safe for individuals with premenstrual disorders. Studies on similar online cognitive-behavioral therapy (CBT) programs have found them to be well-tolerated. Most participants complete these programs without major side effects.

These programs assist in managing symptoms by teaching skills to better handle emotions. Although every treatment carries some minor risks, evidence suggests that this therapy is a safe option for those seeking relief from premenstrual symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for premenstrual disorders, which often includes medication like antidepressants or hormonal treatments, this self-directed psychotherapy program offers a unique approach by empowering individuals to take control of their mental health through learning and practicing new skills. This program involves a series of 11 short videos and a workbook, which participants engage with over two menstrual cycles, integrating elements from cognitive behavioral therapy and dialectical behavior therapy. Researchers are excited about this treatment because it provides a non-pharmacological option that can be accessed conveniently from home, potentially reducing the need for medication and its associated side effects.

What evidence suggests that this self-directed psychotherapy program is effective for premenstrual disorders?

Research has shown that self-guided mental health programs can help manage symptoms of premenstrual disorders (PMDs). In this trial, participants will engage with a self-directed psychotherapy program that includes 11 videos and a workbook with exercises. Studies have found that online cognitive behavior therapy (CBT) reduces PMD symptoms by teaching skills like managing emotions and improving communication. These programs often use videos and exercises to help users learn and practice these skills in their daily lives. The self-guided format offers ease and flexibility, allowing individuals to work through the material at their own pace. Overall, these programs show promise in providing relief from the emotional and physical challenges of PMDs. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who experience premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD). Participants will need to track their symptoms for two menstrual cycles before, during, and after completing a self-help mental health program.

Inclusion Criteria

I have severe PMS or my depression gets worse before my period.

Exclusion Criteria

I am currently seeing a therapist for psychotherapy.

I am currently using oral contraceptives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Symptom Tracking

Participants track their daily symptoms for two menstrual cycles before starting the program

2 months

Treatment

Participants engage with the self-directed psychotherapy program, watching 11 videos and completing workbook exercises over two menstrual cycles

2 months

Post-Intervention Symptom Tracking

Participants continue to track their daily symptoms for two additional menstrual cycles after completing the program

2 months

Follow-up

Participants are monitored for changes in symptoms and effectiveness of the program

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Self-directed psychotherapy program for premenstrual disorders

Trial Overview The study is evaluating a self-directed psychotherapy program designed to assist those coping with PMS or PMDD. It involves tracking symptoms over several menstrual cycles to assess the effectiveness of the therapy.

How Is the Trial Designed?

Group I: Self-directed psychotherapy program Experimental Treatment 1 Intervention

The intervention consists of receiving 11 videos that are 10-15 minutes in length along with a workbook containing homework exercises. Participants are instructed to watch the videos over the course of two menstrual cycles: the first 6 during the first cycle and the last 5 during the second cycle. Each module focuses on a different skill inspired by cognitive behavioral therapy and dialectical behavior therapy.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

International Association for Premenstrual Disorders

Collaborator

Trials

1

Recruited

50+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41138050/

Self-Guided Mental Health Interventions for Premenstrual ... Recent research confirms that clinician-guided internet-delivered cognitive behavior therapy is effective for the management of PMD symptoms ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06496139

Emotion Regulation-based Internet-delivered Cognitive ... The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/1/e091649

Emotion regulation-based internet-delivered cognitive ... The current study aims to evaluate the effects and cost-effectiveness of an internet-delivered CBT (ICBT) intervention for PMDD incorporating skills training ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/02703149.2025.2534636?src=

Psychotherapy Modalities for Premenstrual Change All studies reported efficacy and/or effectiveness, yet only seven reported on acceptability. Findings highlight a research gap in client ...

5. researchgate.net researchgate.net/publication/396902389_Self-Guided_Mental_Health_Interventions_for_Premenstrual_Mood_Symptoms

Self-Guided Mental Health Interventions for Premenstrual ... Self-guided psychotherapeutic interventions hold promise for the treatment of PMD symptoms. Integrating such interventions within existing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06648382

Pilot Study of the 'Thriving With PMDs' Program This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12166257/

Patient-identified priorities for a mental health program ... A current project of IAPMD involves developing a PMDD-specific self-guided psychotherapy intervention that addresses the unique challenges of ...

8. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-021-01589-7

Internet-based cognitive-behavioral therapy for premenstrual ... The ICBT could reduce the symptom severity of women suffering from PMS while improving their perimenstrual quality of life.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01961479

Treatment of Premenstrual Syndrome - Internet-based Self ... The therapeutical intervention follows a treatment manual consisting of 14 modules. Patients work on up to two modules every week for eight weeks in a row.