MoodUP in Improving Psychological Outcomes Among Perinatal Women

National University of Singapore

Status: Completed

Conditions: Perinatal Depression; Prenatal Stress; Pregnancy Related; Sleep Disturbance; Anxiety

Treatments: Other: Usual Care; Behavioral: Internet-based Cognitive Behavioural Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03970057

NUHSRO/2017/054/T1

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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368 participants in 2 patient groups, including a placebo group

MoodUP

Experimental group

Description:

It consisted of six weekly online sessions, homework, and forums. It covered six topics, namely managing mood, psychoeducation, cognitive restructuring, behavioural activation, lifestyle modification, and problem-solving. Each session began with an autoplay video that introduced the session goal and included video and case vignettes, short quizzes, take-home messages, and homework. We also provided an online forum for peer support and regularly monitored it.

Treatment:

Behavioral: Internet-based Cognitive Behavioural Therapy

HealthyMUM

Placebo Comparator group

Description:

It consisted of six weekly online sessions. Each session provided information on essential antenatal care using text and photos. The sessions covered topics such as parenthood, diet, exercise, breastfeeding, rest and sleep, and common problems in pregnancy.

Treatment:

Other: Usual Care