MoodUP in Improving Psychological Outcomes Among Perinatal Women

NCT03970057 | Completed

• 1 other identifier: NUHSRO/2017/054/T1
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Women who completed MoodUP will have better client satisfaction.

Conditions

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

Keywords

Psychological outcomes; Internet-based cognitive behavioural therapy; Perinatal women

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 30-item Automatic Thoughts

  2 years

• 5-item Life satisfaction

  2 years

• Four-item Sleep Disturbance subscale

  2 years

• 5-item Mental well-being

  2 years

• 7-item Client satisfaction

  2 years

Study Arms (2)

MoodUP

EXPERIMENTAL

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.

Behavioral: Internet-based Cognitive Behavioural Therapy

HealthyMUM

PLACEBO COMPARATOR

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.

Other: Usual Care

Interventions

Internet-based Cognitive Behavioural Therapy BEHAVIORAL

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.

Also known as: MoodUP

MoodUP

Usual Care OTHER

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.

Also known as: HealthyMUM

HealthyMUM

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Singapore: lead
• Ministry of Education, Singapore: collaborator

Study Sites (1)

Cherry

Singapore, Singapore

Location

Related Publications (15)

• 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.

  PMID: 25742186 BACKGROUND

• 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.

  PMID: 27106946 BACKGROUND

• 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.

  PMID: 24387236 BACKGROUND

• 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.

  PMID: 28455276 BACKGROUND

• 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.

  PMID: 20164043 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23260806 BACKGROUND

• 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.

  PMID: 25121986 BACKGROUND

• 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.

  PMID: 23920638 BACKGROUND

• Lovibond, S. H., & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales (Second ed.). Sydney: Psychology Foundation of Australia.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15680294 BACKGROUND

• 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.

  PMID: 16367493 BACKGROUND

• 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.

  BACKGROUND

• Bech, P. (2012). Clinical Psychometrics. Oxford: Wiley-Blackwell.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ying Lau, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomisation algorithm on the HappyMUM website automatically assigned women to either the intervention (MoodUP) group or the control (HealthyMum) group in a 1:1 allocation ratio. A computer-generated message notified women of their group assignment. We aimed to blind women to use the active nature of the control condition. Due to the computer-based randomisation, the researchers and research assistants were unaware of the group assignment before allocation and remained blinded to the participants' group allocation throughout the trial, which ensured allocation concealment. We also blinded the group assignment to data collectors and analysts.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: June 4, 2021
• Primary Completion: April 11, 2023
• Study Completion: June 27, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

SG (1)