LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria (LTP+CaCBT)

• ClinicalTrials.gov Identifier: NCT04644081
• Recruitment Status: Not yet recruiting
• First Posted: November 25, 2020
• Last Update Posted: March 25, 2021
• Sponsor: Nottingham Trent University
• Collaborators: University of Manchester; Teesside University; Sheffield Hallam University; University of Jos
• Information provided by (Responsible Party): Dr Dung Jidong, Nottingham Trent University

Study Description

Brief Summary:

The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.

Condition or disease	Intervention/treatment	Phase
Postnatal Depression	Behavioral: LTP; Behavioral: CaCBT; Drug: TAU	Not Applicable

Detailed Description:

Participants who scored 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS) would be recruited randomly assigned into two groups in each of the four primary health care (PHC) facilities designated for the present study. Groups one will receive the LTP+CaCBT treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). Groups two will receive routine treatment as usual (TAU) currently available in the PHC facilities (e.g. antidepressants) in the selected communities. Each group will comprise of approximately 10 mother-child pairs.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria: A Pilot Randomised Control Trial
• Estimated Study Start Date: September 1, 2021
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: LTP+CaCBT; The LTP+CaCBT intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes) and will deliver two sessions on a weekly basis for six weeks.	Behavioral: LTP; LTP is a low-literacy, sustainable programme that will provide depressed mothers with valuable skills on parenting, improve mother-child relation and mental health self-care. This is a research-based activity that enhances postpartum mental health while simultaneously promoting attachment security through building parents' ability to monitor and be sensitive to their children's cues, and thereby, actively involves in their children's mental and physical development.; Other Name: Learning Through Play; Behavioral: CaCBT; CaCBT adopts 'here and now' problem-solving approach, which involves collaborating with families, active listening techniques, changing negative thinking, and depressive symptoms associated with postnatal depression and other forms of parenting distress.; Other Name: Cultural adapted Cognitive and Behaviour Therapy
Active Comparator: Treatment as Usual (TAU); TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of counselling services).	Drug: TAU; TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of mental health care).; Other Name: Treatment as Usual

Outcome Measures

Primary Outcome Measures :

1. Change in postnatal depression is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
2. Change in postnatal anxiety is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
3. Change in health is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
4. Change in social support is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Primary outcome measures would be assessed using the Oslo Social Support Scale
5. Change in health-related quality of life is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
6. Change in service satisfaction is being assessed [ Time Frame: Change is being assessed at end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
7. Change in child physio-emotional development is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
8. Change in parenting knowledge of child development is being assessed [ Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention ]
   Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 18 years and above
• A mother with a child (0-3 years)
• Able to provide full consent for their participation
• A resident of the trial catchment areas
• Able to complete a baseline assessment
• Score 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS).

Exclusion Criteria:

• Less than 18 years
• Medical disorder that would prevent participation in a clinical trial such as Tuberculosis or heart failure
• Temporary residents are unlikely to be available for follow up
• Active suicidal ideation or any other severe mental disorder
• Non-residents of Jos and environs
• Unable to consent
• Patients currently undergoing severe mental health treatment
• Unable to speak English language fluently
• Other significant physical or learning disability

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Dr Dung Jidong, Senior Lecturer/Lecturer, Nottingham Trent University
• ClinicalTrials.gov Identifier: NCT04644081
• Other Study ID Numbers: 0000-0001-5034-0335
• First Posted: November 25, 2020
• Last Update Posted: March 25, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications