Postnatal DepressionBANCT04183582
Behavioural Activation (BA) for Postnatal Depression in Blackpool
A study testing Behavioural Activation in people with Postnatal Depression, run by National Society for the Prevention of Cruelty to Children at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Behavioural Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Early Child Development
Blackpool
Emma Lowrie, PhD, 01253 476611, Emma.CECD@nspcc.org.uk
Clare Law, MSc, 01253 476192, Clare.CECD@nspcc.org.uk
About this study
Official title: A Two Phase Pilot of a Behavioural Activation (BA) Programme Specifically Adapted to Support Women Experiencing Postnatal Low Mood in Blackpool
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.
- Conditions
- Postnatal Depression
- Being tested
- Behavioural Activation
- Keywords
- Psychoeducation, Mental Health, Depression, Postnatal
- Medical subject headings
- Depression, Postpartum, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural ActivationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Single arm group receiving Behavioural Activation, a facilitated self-help programme delivered by trained Health Visitors as six one hour sessions over four weeks. Receives: Behavioral: Behavioural Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 18 weeks, 1 year
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.
Measured: Baseline and 6 weeks
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).
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
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.
Measured: Data collected when child is 1 year and 2-2.5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental Arm - single group study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Society for the Prevention of Cruelty to Children
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183582
- Sponsor's protocol ID
- BBS001
- Acronym
- BA
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be confirmed with programme developers, research team and potential academic partners
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Phase Pilot of a Behavioural Activation (BA) Programme Specifically Adapted to Support Women Experiencing Postnatal Low Mood in Blackpool
- ClinicalTrials.gov ID
- NCT04183582
- Acronym / sponsor ID
- BA / BBS001
- Conditions
- Postnatal Depression
- Keywords
- Psychoeducation, Mental Health, Depression, Postnatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Society for the Prevention of Cruelty to ChildrenUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental Arm - single group study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Behavioural ActivationSingle arm group receiving Behavioural Activation, a facilitated self-help programme delivered by trained Health Visitors as six one hour sessions over four weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural ActivationBehavioural 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 | Behavioural | Intervention Group |
Primary outcome
Patient Health Questionnaire (PHQ9)
Time frame: Baseline, 6 weeks, 18 weeks, 1 year
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)
Time frame: Baseline and 6 weeks
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)
Time frame: Baseline and 6 weeks
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)
Time frame: Baseline and 6 weeks
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)
Time frame: Baseline and 6 weeks
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)
Time frame: Baseline and 6 weeks
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.
1 secondary outcome
Ages and Stages Questionnaire (ASQ)
Time frame: Data collected when child is 1 year and 2-2.5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No. To be confirmed with programme developers, research team and potential academic partners
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation in people with Postnatal Depression, run by National Society for the Prevention of Cruelty to Children at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miss E Lowrie, PhD (01253 476611, Emma.CECD@nspcc.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ9) (time frame: Baseline, 6 weeks, 18 weeks, 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.