Behavioural Interventions for Postnatal Depression: a RCT Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

Conditions
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Postnatal Depression

Intervention / Treatment
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* Behavioral: Brief Cognitive Behavioral Therapy
* Behavioral: standard management based on Clinical Practice Guideline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: severe depression or psychosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Behavioral: Brief Cognitive Behavioral Therapy<br>* 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<br>Behavioral: standard management based on Clinical Practice Guideline<br>* Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required<br>|
| Placebo Comparator: Control arm<br>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. | Behavioral: standard management based on Clinical Practice Guideline<br>* Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavioral therapy