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出境医 / 临床实验 / MoodUP in Improving Psychological Outcomes Among Perinatal Women

MoodUP in Improving Psychological Outcomes Among Perinatal Women

Study Description
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. 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 204 antenatal at-risk women using a stratified 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.


Condition or disease Intervention/treatment Phase
Anxiety Pregnancy Related Perinatal Depression Prenatal Stress Sleep Disturbance Behavioral: Internet-based Cognitive Behavioural Therapy Other: Usual Care Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Internet-based Cognitive Behavioural Therapy (MoodUP) in Improving Psychological Outcomes Among Perinatal Women: A Prospective Randomised Double-blind Parallel-group Trial
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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 Name: 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 Name: HealthyMUM

Outcome Measures
Primary Outcome Measures :
  1. 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. 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.


  3. 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.



Secondary Outcome Measures :
  1. 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. 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.


  3. 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.


  4. 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.


  5. 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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ying Lau, PhD +6566011603 nurly@nus.edu.sg

Locations
Layout table for location information
Singapore
National University Hospital
Singapore, Singapore, 119074
Contact: Lau Ying, PhD    +6566011603    nurly@nus.edu.sg   
Sponsors and Collaborators
National University, Singapore
Ministry of Education, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Ying Lau, PhD National University, Singapore
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date March 4, 2021
Estimated Study Start Date  ICMJE July 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Antenatal Stress [ Time Frame: 2 years ]
    Measured through the 21-item DASS21. The DASS21 is used to rate the frequency and severity of experiencing negative emotions over the previous week. Frequency/severity ratings are made on a series of four-point scales (from 0 which indicates the parameter does not apply to me at all to 3 which indicates the parameter applied to me very much or most of the time).
  • Antenatal Anxiety [ Time Frame: 2 years ]
    Measured through the 21-item DASS21. The DASS21 is used to rate the frequency and severity of experiencing negative emotions over the previous week. Frequency/severity ratings are made on a series of four-point scales (from 0 which indicates the parameter does not apply to me at all to 3 which indicates the parameter applied to me very much or most of the time).
  • Antenatal Depressive Symptoms [ Time Frame: 2 years ]
    Measured through the 21-item DASS21. The DASS21 is used to rate the frequency and severity of experiencing negative emotions over the previous week. Frequency/severity ratings are made on a series of four-point scales (from 0 which indicates the parameter does not apply to me at all to 3 which indicates the parameter applied to me very much or most of the time).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Four-item Sleep Disturbance subscale [ Time Frame: 2 years ]
    Measure through Medical Outcomes Study Sleep Scale (MOSSS).
  • 30-item Automatic Thoughts [ Time Frame: 2 years ]
    Measured through Automatic Thoughts Questionnaire.
  • 5-item Life satisfaction [ Time Frame: 2 years ]
    Measured through The Satisfaction with Life Scale (SWLS).
  • 5-item Mental well-being [ Time Frame: 2 years ]
    Measured through the WHO Well-Being Index (WHOWBI)
  • 7-item Client satisfaction [ Time Frame: 2 years ]
    Measured through a self-developed questionnaire to evaluate the clients' satisfaction of website
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MoodUP in Improving Psychological Outcomes Among Perinatal Women
Official Title  ICMJE Internet-based Cognitive Behavioural Therapy (MoodUP) in Improving Psychological Outcomes Among Perinatal Women: A Prospective Randomised Double-blind Parallel-group Trial
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. 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 204 antenatal at-risk women using a stratified 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Anxiety
  • Pregnancy Related
  • Perinatal Depression
  • Prenatal Stress
  • Sleep Disturbance
Intervention  ICMJE
  • 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 Name: MoodUP
  • 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 Name: HealthyMUM
Study Arms  ICMJE
  • Experimental: MoodUP
    Intervention: Behavioral: Internet-based Cognitive Behavioural Therapy
  • Placebo Comparator: HealthyMUM
    Intervention: Other: Usual Care
Publications *
  • 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. Review. Update in: Cochrane Database Syst Rev. 2016;3: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. Review.
  • 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. Review.
  • 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. Review.
  • 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. Review.
  • 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. 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
364
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ying Lau, PhD +6566011603 nurly@nus.edu.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970057
Other Study ID Numbers  ICMJE NUHSRO/2017/054/T1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lau Ying, National University, Singapore
Study Sponsor  ICMJE National University, Singapore
Collaborators  ICMJE Ministry of Education, Singapore
Investigators  ICMJE
Principal Investigator: Ying Lau, PhD National University, Singapore
PRS Account National University, Singapore
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP