MoodUP in Improving Psychological Outcomes Among Perinatal Women
NCT ID: NCT03970057
Last Updated: 2024-12-27
Study Results
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Basic Information
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COMPLETED
NA
368 participants
INTERVENTIONAL
2021-06-04
2024-06-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MoodUP
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.
Internet-based Cognitive Behavioural Therapy
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.
HealthyMUM
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.
Usual Care
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.
Interventions
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Internet-based Cognitive Behavioural Therapy
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.
Usual Care
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 medical complications
* severe obstetric complications
* fetal abnormality.
21 Years
FEMALE
Yes
Sponsors
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Ministry of Education, Singapore
OTHER_GOV
National University of Singapore
OTHER
Responsible Party
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Lau Ying
Assistant Professor
Principal Investigators
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Ying Lau, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Cherry
Singapore, , Singapore
Countries
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References
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Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2015 Mar 5;(3):CD011565. doi: 10.1002/14651858.CD011565.
Agius A, Xuereb RB, Carrick-Sen D, Sultana R, Rankin J. The co-existence of depression, anxiety and post-traumatic stress symptoms in the perinatal period: A systematic review. Midwifery. 2016 May;36:70-9. doi: 10.1016/j.midw.2016.02.013. Epub 2016 Mar 4.
Beck AT, Haigh EA. Advances in cognitive theory and therapy: the generic cognitive model. Annu Rev Clin Psychol. 2014;10:1-24. doi: 10.1146/annurev-clinpsy-032813-153734. Epub 2014 Jan 2.
Lau Y, Htun TP, Wong SN, Tam WSW, Klainin-Yobas P. Therapist-Supported Internet-Based Cognitive Behavior Therapy for Stress, Anxiety, and Depressive Symptoms Among Postpartum Women: A Systematic Review and Meta-Analysis. J Med Internet Res. 2017 Apr 28;19(4):e138. doi: 10.2196/jmir.6712.
Webb TL, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res. 2010 Feb 17;12(1):e4. doi: 10.2196/jmir.1376.
Hope DA, Burns JA, Hayes SA, Herbert JD, Warner MD. Automatic Thoughts and Cognitive Restructuring in Cognitive Behavioral Group Therapy for Social Anxiety Disorder. Cognitive Therapy and Research. 2010;34(1):1-12.
Faulconbridge LF, Wadden TA, Thomas JG, Jones-Corneille LR, Sarwer DB, Fabricatore AN. Changes in depression and quality of life in obese individuals with binge eating disorder: bariatric surgery versus lifestyle modification. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):790-6. doi: 10.1016/j.soard.2012.10.010. Epub 2012 Nov 14.
Ebert DD, Lehr D, Boss L, Riper H, Cuijpers P, Andersson G, Thiart H, Heber E, Berking M. Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial. Scand J Work Environ Health. 2014 Nov;40(6):582-96. doi: 10.5271/sjweh.3449. Epub 2014 Aug 13.
Eysenbach G. CONSORT-EHEALTH: implementation of a checklist for authors and editors to improve reporting of web-based and mobile randomized controlled trials. Stud Health Technol Inform. 2013;192:657-61.
Lovibond, S. H., & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales (Second ed.). Sydney: Psychology Foundation of Australia.
Hollon, S. D., & Kendall, P. C. (1980). Cognitive self-statements in depression: Development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4(4), 383-395. doi:10.1007/BF01178214
Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med. 2005 Jan;6(1):41-4. doi: 10.1016/j.sleep.2004.07.006. Epub 2004 Nov 11.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
World Health Organization. (1998). Regional Office for Europe: Wellbeing Measures in Primary Health Care: the Depcare Project. Paper presented at the Report on a WHO Meeting.
Bech, P. (2012). Clinical Psychometrics. Oxford: Wiley-Blackwell.
Other Identifiers
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NUHSRO/2017/054/T1
Identifier Type: -
Identifier Source: org_study_id