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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Cognitive Behavioral Therapy | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in depression level | assess changes in Beck Depression Index (BDI) score | at baseline (Week 0), week 3 and Week 6 |
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Inclusion Criteria:
positive (mild to moderate depression)
Exclusion Criteria:
Women postpartum 4 to 24 weeks
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| Name | Affiliation | Role |
|---|---|---|
| Tahir Aris, MD | INSTITUTE FOR PUBLIC HEALTH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Kesihatan Seksyen 7, | Shah Alam | Selangor | 40000 | Malaysia | ||
| Klinik Kesihatan Kuala Lumpur |
data sharing must be requested from Director General of Health Malaysia
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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Participants randomized by offering 2 opaque envelope to group them into either as control or intervention group.
Medical officers were responsible in the management of all participants using standard Clinical Practice Guideline (CPG). Participants from intervention group will see Medical Officer first before being given CBT by nurse
|
| standard management based on Clinical Practice Guideline | Behavioral | Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required |
|
| Kuala Lumpur |
| W.P. Kuala Lumpur |
| 50400 |
| Malaysia |
| Klinik Kesihatan Sg Besi | Kuala Lumpur | WP Kuala Lumpur | 57000 | Malaysia |
| Klinik Kesihatan Presint 11 | Putrajaya | WP Putrajaya | 62000 | Malaysia |
| Klinik Kesihatan Presint 9 | Putrajaya | WP Putrajaya | 62250 | Malaysia |
| Klinik Kesihatan Presint 18 | Putrajaya | WP Putraya | 62602 | Malaysia |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |