MoodUP in Improving Psychological Outcomes Among Perinatal Women

Study Overview
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Brief Summary
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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, 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; 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; 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.

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

Conditions
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Anxiety, Pregnancy Related, Perinatal Depression, Prenatal Stress, Sleep Disturbance

Intervention / Treatment
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* Behavioral: Internet-based Cognitive Behavioural Therapy
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MoodUP<br> | Behavioral: Internet-based Cognitive Behavioural Therapy<br>* MoodUP is an iCBT intervention that is tailored to perinatal women. The core content is presented via different types of devices, such as smartphones, tablets, laptops, or desktops, connected to the internet. The program is designed as an integration of online sessions, self-monitoring, homework, peer support, and therapist support. MoodUP consists of six online sessions focused on CBT skills for improving stress, anxiety, and depressive symptoms among at-risk antenatal women; each session takes between 30 and 40 minutes to complete. The content of the sessions will be as follows: Session 1: Managing mood, Session 2: Psychoeducation, Session 3: Cognitive restructuring, Session 4: Behavioural activation, Session5: Lifestyle modification, Session 6: Problem-solving.<br>* Other names: MoodUP;|
| Placebo Comparator: HealthyMUM<br> | Other: Usual Care<br>* Participants will receive a series of six, weekly online sessions comprising general antenatal education. The content of the sessions will be as follows: Session 1: Parenthood; Session 2: Diet; Session 3: Exercise; Session 4: Breastfeeding; Session 5: Rest and sleep and Session 6: Common pregnancy problems.<br>* Other names: HealthyMUM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antenatal Stress | The DASS-21 is used to rate the frequency and severity of experiencing negative emotions over the previous week (P. F. Lovibond & S. H. Lovibond, 1995). Each of the three DASS-21 scales contains 7 item, divided into sub-scales of stress, anxiety and depressive symptoms (S. H. Lovibond & P. F. Lovibond, 1995). Frequency/severity ratings are made on a series of four-point scales from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores of each sub-scales will be multiplied by 2 to calculate the final score. The total score ranges of each sub-scales from 0 to 42, and a high score on each sub-scale indicates more stress, anxiety and depression. | 2 years | 
| Antenatal Anxiety | The DASS-21 is used to rate the frequency and severity of experiencing negative emotions over the previous week (P. F. Lovibond & S. H. Lovibond, 1995). Each of the three DASS-21 scales contains 7 item, divided into sub-scales of stress, anxiety and depressive symptoms (S. H. Lovibond & P. F. Lovibond, 1995). Frequency/severity ratings are made on a series of four-point scales from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores of each sub-scales will be multiplied by 2 to calculate the final score. The total score ranges of each sub-scales from 0 to 42, and a high score on each sub-scale indicates more stress, anxiety and depression. | 2 years | 
| Antenatal Depressive Symptoms | The DASS-21 is used to rate the frequency and severity of experiencing negative emotions over the previous week (P. F. Lovibond & S. H. Lovibond, 1995). Each of the three DASS-21 scales contains 7 item, divided into sub-scales of stress, anxiety and depressive symptoms (S. H. Lovibond & P. F. Lovibond, 1995). Frequency/severity ratings are made on a series of four-point scales from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores of each sub-scales will be multiplied by 2 to calculate the final score. The total score ranges of each sub-scales from 0 to 42, and a high score on each sub-scale indicates more stress, anxiety and depression. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-item Automatic Thoughts | Measured through Automatic Thoughts Questionnaire. The Automatic Thought Questionnaire (ATQ) is used to measure the occurrence of negative thoughts and related cognitive processes (Hollon & Kendall, 1980). It consisted of 30 statements reflecting negative cognition (Hollon & Kendall, 1980). Respondents are asked to rate the frequency at which each self-statement or a similar self-statement occurred over the course of the past week. The responses are provided on a 5-point scale from 1 (not at all) to 5 (all the time) in order to determine the severity of symptoms. The total score ranges from 30 to 150. A high scores represents more frequent negative thoughts and cognition (Hollon & Kendall, 1980). | 2 years | 
| 5-item Life satisfaction | Measured through The Satisfaction with Life Scale (SWLS) (Diener, Emmons, Larsen, & Griffin, 1985). The five-item Satisfaction with Life Scale (SWLS) is used to assess life satisfaction of the women. Women will rate each item on a seven-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 5 to 35, and a high score on SWLS indicates high life satisfaction. | 2 years | 
| Four-item Sleep Disturbance subscale | Measure through Medical Outcomes Study Sleep Scale (MOSSS). The four-item sleep disturbance sub-scale of the Medical Outcomes Study Sleep Scale (Hays et al., 2005) is used to assess how well women sleep without tapping into other sleep-related medical conditions. Three items related to sleep disturbance are rated on a six-point Likert scale, from 1 (less than 15 minutes) to 6 (none of the time), and one item related to the time needed to fall asleep is assessed on a five-point Likert scale, from 1 (less than 15 minutes) to 5 (more than 60 minutes). Scores are converted to an index that ranged from 0 to 100, with high scores indicating a high level of sleep disturbance. | 2 years | 
| 5-item Mental well-being | Measured through the WHO Well-Being Index (WHOWBI) (Bech, 2012; World Health Organization, 1998). The WHO five-item Well-Being Index is used to measure overall mental well-being. Each item is rated on a six-point Likert scale from 0 (at no time) to 5 (all of the time). The total score ranges from 0 to 25, and a high score represents better well-being. | 2 years | 
| 7-item Client satisfaction | Measured through a self-developed questionnaire to evaluate the clients' satisfaction of website. Client Satisfaction Questionnaire (CSQ) is developed by our research team. Each item is rated on a four-point Likert scale from 1 to 4, and response options differed for the various items. The total score ranges from 7 to 28, and a high score represents better client satisfaction. In addition, we have four open questions to obtain suggestions for improvement. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological outcomes, Internet-based cognitive behavioural therapy, Perinatal women