AnxietyNCT03970057
MoodUP in Improving Psychological Outcomes Among Perinatal Women
A study testing Internet-based Cognitive Behavioural Therapy in people with Anxiety and Pregnancy Related, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pregnancy Related, Perinatal Depression
- What is being tested?
- Internet-based Cognitive Behavioural Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Jun 2021to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- < 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.
Who cannot join
- severe psychiatric illness
- severe medical complications
- severe obstetric complications
- fetal abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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,
Read more
- 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.
- Being tested
- Internet-based Cognitive Behavioural Therapy, Usual Care
- Keywords
- Psychological outcomes, Internet-based cognitive behavioural therapy, Perinatal women
- Medical subject headings
- Anxiety Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Cognitive Behavioural TherapyBehavioural
Also called MoodUP
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 CareOther
Also called HealthyMUM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start4 Jun 2021
- Primary completion11 Apr 2023
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Principal investigator, Lau Ying, National University of Singapore
- Investigators
- Ying Lau, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970057
- Sponsor's protocol ID
- NUHSRO/2017/054/T1
- Status last verified
- Dec 2024
- First submitted
- 29 May 2019
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25742186Agius 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.
PubMed 27106946Beck 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.
PubMed 24387236Lau 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.
PubMed 28455276Webb 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.
PubMed 20164043Hope 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.
PubMed 23260806Ebert 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.
PubMed 25121986Eysenbach 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.
PubMed 23920638Lovibond, 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.
PubMed 15680294Diener 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.
PubMed 16367493World 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioural Therapy (MoodUP) in Improving Psychological Outcomes Among Perinatal Women: A Prospective Randomised Double-blind Parallel-group Trial
- ClinicalTrials.gov ID
- NCT03970057
- Acronym / sponsor ID
- NUHSRO/2017/054/T1
- Keywords
- Psychological outcomes, Internet-based cognitive behavioural therapy, Perinatal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoodUP | Experimental | Behavioral: Internet-based Cognitive Behavioural TherapyIt 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. |
| HealthyMUM | Placebo comparator | Other: Usual CareIt 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- < 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.
Key exclusion criteria (4 listed)
- severe psychiatric illness
- severe medical complications
- severe obstetric complications
- fetal abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Cognitive Behavioural TherapyAlso: MoodUPMoodUP 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. | Behavioural | MoodUP |
| Usual CareAlso: HealthyMUMParticipants 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 | HealthyMUM |
Primary outcome
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.
5 secondary outcomes
30-item Automatic Thoughts
Time frame: 2 years
5-item Life satisfaction
Time frame: 2 years
Four-item Sleep Disturbance subscale
Time frame: 2 years
5-item Mental well-being
Time frame: 2 years
7-item Client satisfaction
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 25742186Olthuis 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.
- Background: PubMed 27106946Agius 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.
- Background: PubMed 24387236Beck 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.
- Background: PubMed 28455276Lau 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.
- Background: PubMed 20164043Webb 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.
- BackgroundHope 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: PubMed 23260806Faulconbridge 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.
- Background: PubMed 25121986Ebert 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.
- Background: PubMed 23920638Eysenbach 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.
- BackgroundLovibond, S. H., & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales (Second ed.). Sydney: Psychology Foundation of Australia.
- BackgroundHollon, 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: PubMed 15680294Hays 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Lau, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Cognitive Behavioural Therapy in people with Anxiety and Pregnancy Related, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal Stress (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03970057, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.