Back to resultsBehavioural Activation (BA) for Postnatal Depression in Blackpool (BA)
Primary Purpose
Postnatal Depression
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behavioural Activation
Sponsored by
About this trial
This is an interventional treatment trial for Postnatal Depression focused on measuring Psychoeducation, Mental Health, Depression, Postnatal
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Score between 10-19 on PhQ9
- Have given birth within the last 6 months
- Willing to engage in a psychological therapy
- Informed, prepared and safe to participate in the programme
- Able to understand spoken and basic written English
Exclusion Criteria:
- Under 18 years old
- Score under 10 or over 19 on the PHQ9
- Receiving another from of psychological treatment for depression
- Unwilling to engage in a psychological therapy
- Another primary area of difficulty which takes precedence over the current programme (e.g.substance dependency disorders, suicidal crises, frequent, serious and deliberate self-harm, acute threat in the form of serious interpersonal violence from a partner or friend or family member, and evidence of more serious mental health disorders which may require additional support, i.e., psychotic disorders, Bipolar Disorder
Sites / Locations
- Centre for Early Child Development
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
Single arm group receiving Behavioural Activation, a facilitated self-help programme delivered by trained Health Visitors as six one hour sessions over four weeks.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire (PHQ9)
The PHQ9 is a 9-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of depression.
Generalised Anxiety Disorder Questionnaire (GAD7)
The GAD7 is a 7-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of anxiety.
Parental Stress Scale (PSS)
The PSS is a self-report scale that intended to assess parental stress. It contains 18 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions).
Maternal Infant Responsiveness Instrument (MIRI)
The MIRI is a 22-item scale designed to measure the parent's feelings about the infant and an appraisal of their infant's responsiveness.
Behavioural Activation for DEpression Scale (BADS)
The BADS is a 25-item scale which can track change in behaviours which are hypothesised to underlie depression which are specifically targeted through Behavioural Activation. It comprises of four subscales; activation, avoidance/rumination, work/school impairment and social impairment.
Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS is a 14-item measure of anhedonia (the degree to which an individual is able to experience pleasure). It comprises of four subscales which measure response/hedonic experiences; interests/past-times, social interaction, sensory experiences, food/drink.
Secondary Outcome Measures
Ages and Stages Questionnaire (ASQ)
Nationally mandated data collected by Health Visitors in the UK to assess children's development. This includes five key areas of development, communication, gross motor, fine motor, problem solving, and personal-social.
Full Information
NCT ID
NCT04183582
First Posted
November 26, 2019
Last Updated
November 28, 2019
Sponsor
National Society for the Prevention of Cruelty to Children
1. Study Identification
Unique Protocol Identification Number
NCT04183582
Brief Title
Behavioural Activation (BA) for Postnatal Depression in Blackpool
Acronym
BA
Official Title
A Two Phase Pilot of a Behavioural Activation (BA) Programme Specifically Adapted to Support Women Experiencing Postnatal Low Mood in Blackpool
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Society for the Prevention of Cruelty to Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Is Behavioural Activation feasible, acceptable and potentially effective for mothers experiencing post natal depression in Blackpool?
Phase 1: A series of single case studies which aim to examine and refine a) the appropriateness of the programme to women in Blackpool b) the suitability of BA as part of a stepped-care approach to perinatal mental health within the Health Visitor pathway and c) the delivery of the programme in practice.
Phase 2: A preliminary single group study examining the quantitative outcomes for participating women (i.e. symptoms of depression, anxiety and general mood, parental stress, responsiveness, and behavioural avoidance and activation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
Psychoeducation, Mental Health, Depression, Postnatal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Experimental Arm - single group study
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Single arm group receiving Behavioural Activation, a facilitated self-help programme delivered by trained Health Visitors as six one hour sessions over four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Activation
Intervention Description
Behavioural Activation is a treatment for depression, the current programme has been adapted to suit the needs of postnatal women Session 1: Getting Started Session 2: Identifying Triggers, Reactions and Avoidance Patterns (TRAPs) Session 3: Turning TRACs in to Triggers, Reactions and Alternative Coping (TRACs) Session 4: Support and Communication Session 5: Being a "Good Enough" Mum Session 6: Staying Well
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ9)
Description
The PHQ9 is a 9-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of depression.
Time Frame
Baseline, 6 weeks, 18 weeks, 1 year
Title
Generalised Anxiety Disorder Questionnaire (GAD7)
Description
The GAD7 is a 7-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of anxiety.
Time Frame
Baseline and 6 weeks
Title
Parental Stress Scale (PSS)
Description
The PSS is a self-report scale that intended to assess parental stress. It contains 18 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions).
Time Frame
Baseline and 6 weeks
Title
Maternal Infant Responsiveness Instrument (MIRI)
Description
The MIRI is a 22-item scale designed to measure the parent's feelings about the infant and an appraisal of their infant's responsiveness.
Time Frame
Baseline and 6 weeks
Title
Behavioural Activation for DEpression Scale (BADS)
Description
The BADS is a 25-item scale which can track change in behaviours which are hypothesised to underlie depression which are specifically targeted through Behavioural Activation. It comprises of four subscales; activation, avoidance/rumination, work/school impairment and social impairment.
Time Frame
Baseline and 6 weeks
Title
Snaith-Hamilton Pleasure Scale (SHAPS)
Description
The SHAPS is a 14-item measure of anhedonia (the degree to which an individual is able to experience pleasure). It comprises of four subscales which measure response/hedonic experiences; interests/past-times, social interaction, sensory experiences, food/drink.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Ages and Stages Questionnaire (ASQ)
Description
Nationally mandated data collected by Health Visitors in the UK to assess children's development. This includes five key areas of development, communication, gross motor, fine motor, problem solving, and personal-social.
Time Frame
Data collected when child is 1 year and 2-2.5years
Other Pre-specified Outcome Measures:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
The EPDS is a 10-item measure which assesses low mood and symptoms of depression. It has been designed specifically for women in the postnatal period.
Time Frame
Baseline, 2 week (x2), 3 weeks (x2), 4 weeks, 5 weeks, 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Score between 10-19 on PhQ9
Have given birth within the last 6 months
Willing to engage in a psychological therapy
Informed, prepared and safe to participate in the programme
Able to understand spoken and basic written English
Exclusion Criteria:
Under 18 years old
Score under 10 or over 19 on the PHQ9
Receiving another from of psychological treatment for depression
Unwilling to engage in a psychological therapy
Another primary area of difficulty which takes precedence over the current programme (e.g.substance dependency disorders, suicidal crises, frequent, serious and deliberate self-harm, acute threat in the form of serious interpersonal violence from a partner or friend or family member, and evidence of more serious mental health disorders which may require additional support, i.e., psychotic disorders, Bipolar Disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miss E Lowrie, PhD
Phone
01253 476611
Email
Emma.CECD@nspcc.org.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mrs C Law, MSc
Phone
01253 476192
Email
Clare.CECD@nspcc.org.uk
Facility Information:
Facility Name
Centre for Early Child Development
City
Blackpool
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Lowrie, PhD
Phone
01253 476611
Email
Emma.CECD@nspcc.org.uk
First Name & Middle Initial & Last Name & Degree
Clare Law, MSc
Phone
01253 476192
Email
Clare.CECD@nspcc.org.uk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To be confirmed with programme developers, research team and potential academic partners
Learn more about this trial
Behavioural Activation (BA) for Postnatal Depression in Blackpool
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