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Completed

NCT Number: NCT03196726

Behavioural Interventions for Postnatal Depression: a RCT Study

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Kesihatan Seksyen 7,, Shah Alam, Selangor, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

standard management based on Clinical Practice Guideline

Behavioral

Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Primary outcomes

  1. changes in depression level

    Time frame: at baseline (Week 0), week 3 and Week 6

    assess changes in Beck Depression Index (BDI) score

Sponsors and collaborators

Lead sponsor

Ministry of Health, Malaysia

Other Gov

Registry information

Official study title

POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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