Clinical trial NCT03970057: MoodUP in Improving Psychological Outcomes Among Perinatal Women
Official title: Internet-based Cognitive Behavioural Therapy (MoodUP) in Improving Psychological Outcomes Among Perinatal Women: A Prospective Randomised Double-blind Parallel-group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pregnancy Related
Perinatal Depression
Prenatal Stress
Sleep Disturbance
Keywords: Psychological outcomes
Internet-based cognitive behavioural therapy
Perinatal women
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Singapore
First posted: 2019-05-31
Enrollment: 368
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dramatic physiological, psychological, and social changes during the antenatal period may significantly affect a woman's psychosocial and physical conditions, thereby resulting in stress, anxiety, and depressive symptoms. Cognitive behavior therapy (CBT) is a well-established effective psychotherapy to modify thoughts, beliefs, and perceptions, as well as change the behavioral patterns under numerous conditions. However, at-risk women that need access to CBT are challenged by many issues, such as insufficient therapists, stigmatization, long waiting times, and high costs. Preventive strategies may offer a more acceptable means of addressing the problem. Internet-based CBT can help overcome some barriers to improve psychological well-being by providing a timely and efficacious intervention that is customizable, cost-effective, and flexible in terms of time and geography.

Hypotheses Compared with the control group,

1. Women who completed an internet-based CBT (MoodUP) will have significantly lower scores for stress, anxiety, and depressive symptoms immediately post-intervention and at 12 weeks post-intervention;
2. Women who completed MoodUP will reduce the frequency of negative automatic thoughts, achieve a better sleep quality, life satisfaction, and mental health immediately post-intervention and at 12 weeks post-intervention;
3. Women who completed MoodUP will have better client satisfaction.

Approach A two-stage research design will be used for 3 years. Stage I will consist of the development and validation of MoodUP based on theoretical and empirical rationales. The development of MoodUP will be guided by a combination of the basic principles from behavioral and cognitive psychology. Essential components, teaching strategies, and technical elements of MoodUP will be established according to literature review and a meta-analysis by the principal investigator and her team. Ethical and quality standards will be assessed using the Health on the Net code of conduct and the Health-Related Website Evaluation Form, respectively.

Stage II will be used to evaluate the efficacy of MoodUP among 143 antenatal women using a randomized controlled trial, two-armed parallel group pretest, and repeated post-test following the Consolidated Standards of Report Trials guidelines for an internet-based intervention. Primary outcomes will be the presence and severity of antenatal stress, anxiety, and depressive symptoms using the 21-item Depression Anxiety Stress Scale. Secondary outcomes will be automatic thoughts, sleep disturbance, life satisfaction, mental well-being, and client satisfaction, as determined by the 30-item Automatic Thoughts Questionnaires, four-item Sleep Disturbance subscale of the Medical Outcomes Study Sleep Scale, the five-item Satisfaction with Life Scale, the WHO five-item Well-Being Index, and the seven-item Client Satisfaction Questionnaire, respectively. Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three-time points through Wilks's lambda test. The data will be analyzed according to the intention-to-treat principle with baseline values imputed for missing follow-up data.


Eligibility criteria: Inclusion Criteria:

* \< 18 weeks of gestation (the upper limit of \< 18 weeks allows time to complete six sessions and follow-up questionnaires prior to delivery)
* 21 years of age or older
* ability to speak and read English
* plan to deliver baby in Singapore
* can access the internet.

Exclusion Criteria:

* severe psychiatric illness
* severe medical complications
* severe obstetric complications
* fetal abnormality.

Primary outcomes:
measure: Antenatal Stress
timeFrame: 2 years
measure: Antenatal Anxiety
timeFrame: 2 years
measure: Antenatal Depressive Symptoms
timeFrame: 2 years
Secondary outcomes:
measure: 30-item Automatic Thoughts
timeFrame: 2 years
measure: 5-item Life satisfaction
timeFrame: 2 years
measure: Four-item Sleep Disturbance subscale
timeFrame: 2 years
measure: 5-item Mental well-being
timeFrame: 2 years
measure: 7-item Client satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Cherry
Study officials:
affiliation: Chinese University of Hong Kong
name: Ying Lau, PhD
role: PRINCIPAL_INVESTIGATOR
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