Acceptance and Commitment Therapy for Premenstrual Dysphoric Disorder

(ACT-PM Trial)

Overseen By Elisabeth Wright, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women's College Hospital

Disqualifiers: Substance use, Suicidal ideation, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Acceptance and Commitment Therapy (ACT) can assist individuals with severe premenstrual mood issues. It specifically targets those with Premenstrual Dysphoric Disorder (PMDD) or mood disorders such as depression or bipolar disorder that worsen before menstruation, known as Premenstrual Exacerbation (PME). The therapy will be delivered online in a group setting to assess its usability and participant satisfaction. Suitable candidates have been diagnosed with PMDD or PME and have regular menstrual cycles. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health support for those with premenstrual mood disorders.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapy is safe for individuals with PMDD and PME?

Research has shown that Acceptance and Commitment Therapy (ACT) is a safe treatment for many mental health issues. Studies have found that most people tolerate it well, with few negative effects. ACT helps individuals accept difficult thoughts and feelings while focusing on personal values and actions. It is typically conducted in a supportive group setting, which many find beneficial.

Although specific research on ACT for Premenstrual Dysphoric Disorder (PMDD) and Premenstrual Exacerbation (PME) is limited, ACT has demonstrated safety in other areas. Since it does not involve medication, there is a lower risk of side effects associated with drugs. Participants often feel more understood and supported, rather than experiencing negative reactions.

Overall, ACT is considered a low-risk therapy. It encourages more flexible thinking, which can improve emotional management. This makes it a promising choice for those seeking to enhance their quality of life and daily functioning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Premenstrual Dysphoric Disorder (PMDD), which often involve medications like antidepressants or hormonal therapies, Acceptance and Commitment Therapy (ACT) offers a psychological approach. ACT is unique because it emphasizes mindfulness and acceptance strategies to help individuals manage their symptoms, rather than trying to eliminate them. Researchers are excited about ACT because it empowers individuals to handle their emotional experiences more effectively, potentially offering a long-term solution without the side effects associated with medication. This therapy could provide a valuable alternative for those seeking non-pharmaceutical options.

What evidence suggests that Acceptance and Commitment Therapy could be an effective treatment for Premenstrual Dysphoric Disorder?

Research has shown that Acceptance and Commitment Therapy (ACT) can help with conditions like Premenstrual Dysphoric Disorder (PMDD). Studies have found that ACT improves emotional management and reduces pain associated with PMDD by enhancing adaptability in dealing with symptoms. One study found that ACT significantly lowers stress levels in women with premenstrual symptoms. These findings suggest that ACT might effectively improve the quality of life for people with PMDD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals in Ontario with severe premenstrual mood symptoms, diagnosed with PMDD or a bipolar/depressive disorder with PME. Participants must have regular menstrual cycles, internet access, a video-enabled device, and be under the care of a physician.

Inclusion Criteria

I have internet and a device that can make video calls.

My menstrual cycles are regular, occurring every 21 to 35 days.

I regularly see a doctor for my health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acceptance and Commitment Therapy (ACT) for PMDD and PME, delivered virtually over 8 weeks

8 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy (ACT) Group

Trial Overview The study is testing Acceptance and Commitment Therapy (ACT) delivered virtually as ACT-Premenstrual (ACT-PM). It aims to see if this therapy is feasible and acceptable for treating severe premenstrual mood symptoms like those seen in PMDD and PME.

How Is the Trial Designed?

Group I: single arm (open label) Experimental Treatment 1 Intervention

all participants will be in pilot psychotherapy group

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06462391

Study Details | NCT06462391 | Adapting and Piloting ... In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT-Premenstrual (ACT-PM) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11974126/

Psychological flexibility as a moderator of the association ... This study aimed to investigate whether psychological flexibility moderates the relationship between premenstrual dysphoric disorder (PMDD) symptoms and ...

3. withpower.com withpower.com/trial/phase-premenstrual-dysphoric-disorder-6-2024-b25d7

Acceptance and Commitment Therapy for Premenstrual ... The study will lay the groundwork for future research to determine if the group is effective. If effective, the intervention could be scaled up to improve ...

4. researchgate.net researchgate.net/publication/316336882_Effects_of_Acceptance_and_Commitment_TherapyACT_on_Premenstrual_Symptoms_Attitudes_about_Menstruation_and_Perceived_Stress_of_Women_with_Premenstrual_Syndrome

Effects of Acceptance and Commitment Therapy(ACT) on ... In perceived stress, acceptance and commitment therapy(ACT) group displayed more significant decrease than the control group and the cognitive ...

5. shefayekhatam.ir shefayekhatam.ir/article-1-2471-en.html

The Effectiveness of Acceptance and Commitment Therapy ... Conclusion: Our data indicate that the ACT can probably improve emotional regulation and reduce the intensity of pain in girls with premenstrual dysphoric ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11576155/

Women with Premenstrual Dysphoric Disorder experiences ... The survey revealed that just under half of women had deliberately harmed themselves during a PMDD crisis, 82% had suicidal thoughts on one or ...

7. trialx.com trialx.com/clinical-trials/listings/324228/adapting-and-piloting-acceptance-and-commitment-therapy-act-for-severe-premenstrual-mood-symptoms/

Premenstrual Exacerbation of Mood Disorder ... In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT- ...

8. app.trialscreen.org app.trialscreen.org/trials/adapting-piloting-acceptance-commitment-therapy-act-severe-premenstrual-trial-nct06462391

Evaluating an Acceptance and Commitment Therapy (ACT) ... This Interventional study is looking for people with Premenstrual Dysphoric Disorder, Premenstrual Exacerbation of Mood Disorder in Toronto Canada to take ...