An open-label randomized parallel-group study of the efficacy of app-based cognitive behavioral therapy for premenstrual syndrome (PMS)

JRCT ID: jRCTs052240058

Registered date:10/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Premenstrual Syndrome
• Date of first enrollment: 10/06/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Cognitive behavioural therapy
PMS treatment app.
PMS sham app.

Outcome(s)

Primary Outcome

Change in the 5-day mean of the total DRSP (items 1-21) scores during the late luteal phase (5 days) of the third cycle of treatment period (or at the time of discontinuation) compared to the mean of the pre-treatment observation period.

The late luteal phase shall be the 5 days prior to the onset of menstruation.

Secondary Outcome

1)Change in the 10-day average of the total DRSP (items 1-21) score during the luteal phase (10 days) of the third cycle of the treatment period (or at the time of discontinuation) compared to the average value of the pre-treatment observation period.

Late luteal phase is defined as the 10 days before the onset of menstruation.

2)Evaluate the change in the 5-day average of the total DRSP negative mood score during the late luteal phase (5 days) between the pre-treatment observation period and the third cycle of the treatment period.

DRSP negative mood score:
1a. depressed mood, sadness, depression
1b. Hopelessness
1c. feeling of self-worthlessness/guilt
2. anxiety, nervousness, agitation
3a. mood instability (sudden sadness, tearfulness)
3b. hypersensitivity to rejection, easily hurt feelings
4a. feeling angry or easily offended
4b. interpersonal friction

3)Evaluate the change in the 5-day average of the total score of DRSP dysfunction items in the late luteal phase (5 days) between the pre-treatment observation period and the third cycle of the treatment period.

DRSP dysfunctional items:
1. difficulty getting work, study, or housework done at work, school, or in daily life at home
2. Stopped participating in hobbies, clubs, or social activities or participated in them less frequently.
3. Interfered with relationships with others.

4) Evaluate changes in EQ-5D-5L (EuroQol 5 Dimensions 5 Level) between the pre-treatment observation period and the third cycle of the treatment period.

5) Evaluate changes in the Hospital Anxiety and Depression Scale (HADS) between the pre-treatment observation period and the third cycle of the treatment period.

6) Evaluate changes in CGI-I (Clinical Global Impressions Improvement) between the time of case enrollment and the third cycle of the treatment period.

7)Evaluate the change in CGI-S (Clinical Global Impressions-Severity of illness) between the time of case enrollment and the third cycle of the treatment period.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

1)Female outpatients between the ages of 18 and 45 at the time of obtaining consent.
2)Patients who understand the content of this clinical research and give their written consent to participate in the clinical research.
3)Patients with regular menstrual cycles of 25 to 38 days.
4)Patients with symptoms described in PMS or premenstrual dysphoric mood disorder (PMDD) (DSM-5) as defined by the American College of Obstetricians and Gynecologists at the time of consent and enrollment.
5)Patients who agree to use appropriate contraception on a daily basis from the time consent is obtained through the duration of the clinical study.
6) Patients whose scores as measured by the DRSP during the previous observation period meet the PMS criteria.

Exclude criteria

1)Patients with a history of treatment with antidepressants (tricyclics, tetracyclics, SSRIs, SNRIs, NaSSAs) within 2 weeks prior to obtaining consent.
2)Patients with a history of treatment with herbal medicines for PMS symptoms within 2 weeks prior to obtaining consent. (However, patients who have been taking herbal medicines for PMS symptoms for 2 weeks prior to obtaining consent may continue to receive prescriptions.)
3)Patients with chronic anorexia or bulimia.
4)Patients with poorly controlled hypertension or diabetes mellitus, or chronic diseases such as chronic heart failure, liver cirrhosis, chronic renal failure, chronic pancreatitis, etc.
5)Alcohol abuse or alcohol-dependent patients.
6)Patients with drug abuse or drug dependence.
7)Patients with coexisting malignancy or who have received treatment for malignancy within 5 years prior to obtaining consent (Visit 0).
8)Patients diagnosed with personality disorders.
9)Patients with a diagnosis of schizophrenia, bipolar disorder, a group of depressive disorders other than PMDD, anxiety, or obsessive-compulsive disorder.
10) Menopause or abnormal menstrual cycles.
11)Nursing mothers or patients who wish to become pregnant during the period of this clinical study.
12)Patients who have received any investigational drug within 3 months prior to obtaining consent or who are participating in other clinical trials.
13)Patients who, in the opinion of the principal/participating investigator of the clinical study, are at high risk of poor treatment compliance, inability to complete the clinical study, hindrance in participating in the clinical study, or impact on safety assessment due to self-harm, suicidal ideation, or other symptoms.
14)Patients with a history of treatment with oral contraceptives or sex hormone products containing follicular or progestin hormones such as estrogen/progestin combination drugs within 30 days prior to obtaining consent.
15)Patients using the following medications between the time of consent and the preanalytic period (confirmed at the time of consent and at the time of case enrollment)
Have been using vitamin B6-containing preparations or supplements, dried chestberry extract, oxytocin-containing preparations, folic acid-containing preparations, typical antipsychotics (butyrophenones, phenothiazines, benzamides), anxiolytics (benzodiazepines, serotonergic), sleeping pills (benzodiazepines,benzodiazepines, non-benzodiazepines, melatonin receptor agonists, orexin receptor antagonists)ADHD medications (methylphenidate, atomoxetine, guanfacine).
16)Other patients who are judged by principal investigator or subinvestigator to be inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Takeda Takashi
• Secondary Sponsor: Kawata Yumi,Hedgehog MedTech, Inc.