Postnatal DepressionNCT03196726
Behavioural Interventions for Postnatal Depression: a RCT Study
A study testing Brief Cognitive Behavioral Therapy and standard management based on Clinical Practice Guideline in people with Postnatal Depression, run by Ministry of Health, Malaysia at 6 sites in Malaysia.
Trial summary
Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Brief Cognitive Behavioral Therapy and standard management based on Clinical Practice Guideline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 6 sitesMalaysia
- Study dates
- 2 Mar 2017to 31 Dec 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postpartum 4-24 weeks
- registered with selected primary care clinics
- Edinburgh Postnatal Depression score: 12 or more; and Mini diagnostic interview:
- positive (mild to moderate depression)
- consented to participate
Who cannot join
- severe depression or psychosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Malaysia6 sites
Klinik Kesihatan Kuala Lumpur
Kuala Lumpur, W.P. Kuala Lumpur, 50400
Klinik Kesihatan Sg Besi
Kuala Lumpur, WP Kuala Lumpur, 57000
Klinik Kesihatan Presint 11
Putrajaya, WP Putrajaya, 62000
Klinik Kesihatan Presint 9
Putrajaya, WP Putrajaya, 62250
Klinik Kesihatan Presint 18
Putrajaya, WP Putraya, 62602
Klinik Kesihatan Seksyen 7,
Shah Alam, Selangor, 40000
About this study
Official title: POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2
Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone
Read the detailed description
This was a two-group double-blind randomized controlled trial (RCT) conducted in six primary care clinics at Klang Valley, with 27 subjects in each arms. All post-partum women at 4 to 24 weeks, registered at these clinics, were screened using self-administered Edinburgh Postnatal Depression Scale for symptoms of depression. Those who scored 12 or more and/or positive for question on suicidal behaviour, were interviewed by trained Research Assistants using Mini International Neuropsychiatric Interview, a diagnostic interview tool. Those with mild to moderate depression were invited to join this study, while severe depressed cases were referred to the Family Medicine Specialist for appropriate management. Consented eligible women were randomized into either control group; managed by Medical Officers alone, or intervention group; managed by both Medical Officers and trained nurses. Medical officers were given standard refresher course on Postnatal Depression management based on Clinical Practice Guideline while nurses were trained using brief cognitive-behavioural therapy (CBT) module, which consists of 6 modules for 6 weekly sessions. Depression level and its severity were assessed using self-administered Beck's Depression Index (BDI) and Automatic Thought Questionnaire (ATQ), at Baseline, Week 3 and Week 6.
- Conditions
- Postnatal Depression
- Being tested
- Brief Cognitive Behavioral Therapy, standard management based on Clinical Practice Guideline
- Keywords
- cognitive-behavioral therapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Behavioral TherapyBehavioural
Week 1: Understanding postnatal depression Week 2: Relaxation techniques and tips to reduce stress Week 3: Positive thinking style and Self-Esteem Week 4: Relationship with partner Week 5: Relationship with infant Week 6: Relapse prevention
standard management based on Clinical Practice GuidelineBehavioural
Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. After session with Medical Officer, participants will be seen by Nurse who additionally manage them using brief Cognitive Behavioral Therapy. Participants will be follow-up at weekly basis for 6 weeks. Receives: Behavioral: Brief Cognitive Behavioral Therapy; Behavioral: standard management based on Clinical Practice Guideline |
| Control arm | Placebo comparator | Participants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. Participants will be follow-up at weekly basis for 6 weeks. Receives: Behavioral: standard management based on Clinical Practice Guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in depression level
assess changes in Beck Depression Index (BDI) score
Measured: at baseline (Week 0), week 3 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start2 Mar 2017
- Primary completion30 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Management of postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer in intervention arm, compared to management by Medical Officer alone in control arm.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NOOR ANI AHMAD, Ministry of Health, Malaysia
- Investigators
- Tahir Aris, MD, Study director, INSTITUTE FOR PUBLIC HEALTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196726
- Sponsor's protocol ID
- NMRR-15-2404-26677
- Status last verified
- Mar 2019
- First submitted
- 20 Jun 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data sharing must be requested from Director General of Health Malaysia
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2
- ClinicalTrials.gov ID
- NCT03196726
- Acronym / sponsor ID
- NMRR-15-2404-26677
- Conditions
- Postnatal Depression
- Keywords
- cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Jun 2017 (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.
Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone
Detailed description
This was a two-group double-blind randomized controlled trial (RCT) conducted in six primary care clinics at Klang Valley, with 27 subjects in each arms. All post-partum women at 4 to 24 weeks, registered at these clinics, were screened using self-administered Edinburgh Postnatal Depression Scale for symptoms of depression. Those who scored 12 or more and/or positive for question on suicidal behaviour, were interviewed by trained Research Assistants using Mini International Neuropsychiatric Interview, a diagnostic interview tool. Those with mild to moderate depression were invited to join this study, while severe depressed cases were referred to the Family Medicine Specialist for appropriate management. Consented eligible women were randomized into either control group; managed by Medical Officers alone, or intervention group; managed by both Medical Officers and trained nurses. Medical officers were given standard refresher course on Postnatal Depression management based on Clinical Practice Guideline while nurses were trained using brief cognitive-behavioural therapy (CBT) module, which consists of 6 modules for 6 weekly sessions. Depression level and its severity were assessed using self-administered Beck's Depression Index (BDI) and Automatic Thought Questionnaire (ATQ), at Baseline, Week 3 and Week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Management of postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer in intervention arm, compared to management by Medical Officer alone in control arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Brief Cognitive Behavioral Therapy, Behavioral: standard management based on Clinical Practice GuidelineParticipants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. After session with Medical Officer, participants will be seen by Nurse who additionally manage them using brief Cognitive Behavioral Therapy. Participants will be follow-up at weekly basis for 6 weeks. |
| Control arm | Placebo comparator | Behavioral: standard management based on Clinical Practice GuidelineParticipants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. Participants will be follow-up at weekly basis for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- postpartum 4-24 weeks
- registered with selected primary care clinics
- Edinburgh Postnatal Depression score: 12 or more; and Mini diagnostic interview:
- positive (mild to moderate depression)
- consented to participate
Key exclusion criteria (1 listed)
- severe depression or psychosis
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 |
|---|---|---|
| Brief Cognitive Behavioral TherapyWeek 1: Understanding postnatal depression Week 2: Relaxation techniques and tips to reduce stress Week 3: Positive thinking style and Self-Esteem Week 4: Relationship with partner Week 5: Relationship with infant Week 6: Relapse prevention | Behavioural | Intervention Arm |
| standard management based on Clinical Practice GuidelineMild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required | Behavioural | Control arm, Intervention Arm |
Primary outcome
changes in depression level
Time frame: at baseline (Week 0), week 3 and Week 6
assess changes in Beck Depression Index (BDI) score
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 1 Apr 2019.
- Individual participant dataSharing planned: No. data sharing must be requested from Director General of Health Malaysia
Related trials for Postnatal Depression
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
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.
Tahir Aris, MD study director
INSTITUTE FOR PUBLIC HEALTH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Behavioral Therapy and standard management based on Clinical Practice Guideline in people with Postnatal Depression, run by Ministry of Health, Malaysia at 6 sites in Malaysia.
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 1 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Malaysia. 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?
changes in depression level (time frame: at baseline (Week 0), week 3 and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2019.