MoodUP in Improving Psychological Outcomes Among Perinatal Women

August 27, 2023 updated by: Lau Ying, National University of Singapore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MoodUP
Behavioral: 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.

Other Names:
  • MoodUP
Placebo Comparator: HealthyMUM
Other: 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 Names:
  • HealthyMUM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antenatal Stress
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Singapore

Collaborators

Ministry of Education, Singapore

Investigators

  • Principal Investigator: Ying Lau, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUHSRO/2017/054/T1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Internet-based Cognitive Behavioural Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe