MoodUP in Improving Psychological Outcomes Among Perinatal Women

Anxiety Clinical Trial

Official title: Internet-based Cognitive Behavioural Therapy (MoodUP) in Improving Psychological Outcomes Among Perinatal Women: A Prospective Randomised Double-blind Parallel-group Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anxiety
• Dyssomnias
• Parasomnias
• Perinatal Depression
• Pregnancy Related
• Prenatal Stress
• Sleep Disturbance

• NCT number: NCT03970057
• Study type: Interventional
• Source: National University of Singapore
• Contact: Ying Lau, PhD
• Phone: (852)59180547
• Email: yinglau@cuhk.edu.hk
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Completion date: December 2023