Depression, PostpartumROSHNI-DNCT01838889
Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
A study testing Culturally adapted psychological intervention (Positive Health Programme) in people with Depression, Postpartum and Postnatal Depression in British South Asian Women, run by Lancashire Care NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is an exploratory randomized controlled trial (RCT) of a group psychological intervention for postnatal depression in British mother's of south Asian origin. The aim is to evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Postnatal Depression in British South Asian Women
- What is being tested?
- Culturally adapted psychological intervention (Positive Health Programme)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Oct 2013
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- self-ascribed British women of South Asian origin as defined by UK Office of -National Statistics,
- over the age of 16 years
- living with their babies,
- who meet the criteria for ICD-10 depression
Who cannot join
- women with diagnosed physical or learning disability,
- post-partum or other psychosis,
- severely depressed
- actively suicidal.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Primary Care; Mother and Baby Clinics
Borough of Blackburn With Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester
About this study
Official title: Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
This study is an exploratory randomized controlled trial (RCT) of a group psychological intervention for postnatal depression in British mother's of south Asian origin. The aim is to evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is that depressed British women of South Asian origin receiving the group intervention will show significant improvements in terms of severity of depression as compared to the treatment as usual (TAU) control group.
- Being tested
- Culturally adapted psychological intervention (Positive Health Programme)
- Keywords
- Culturally adapted, Group psychological intervention, British South Asian women, CBT
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted psychological intervention (Positive Health Programme)Behavioural
Also called PHP
This study will evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted psychological intervention (PHP) | Experimental | Depressed Mothers randomized to experimental arm will undergo a 12 week group psychological intervention on the 'positive health programme'. Receives: Behavioral: Culturally adapted psychological intervention (Positive Health Programme) |
| Treatment as usual (TAU) | No intervention | Depressed mothers randomized to TAU arm will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).
Secondary outcomes (7)
EuroQoL-5 Dimensions (EQ-5D)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
The Parenting Stress Index (PSI)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Dyadic Adjustment Scale (DAS)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Home Inventory (HI)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Hamilton Rating Scale for Depression (HRSD)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Client Service Receipt Inventory (CSRI)
Measured: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMar 2011
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancashire Care NHS Foundation Trust
- Sponsor type
- Research network
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838889
- Sponsor's protocol ID
- 47847
- Other IDs
- PB-PG-1208-18087
- Acronym
- ROSHNI-D
- Status last verified
- Dec 2014
- First submitted
- 14 Apr 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Husain N, Lunat F, Lovell K, Sharma D, Zaidi N, Bokhari A, Syed A, Tomenson B, Islam A, Chaudhry N, Waheed W. Exploratory RCT of a group psychological intervention for postnatal depression in British mothers of South Asian origin - ROSHNI-D. Acta Psychol (Amst). 2023 Aug;238:103974. doi: 10.1016/j.actpsy.2023.103974. Epub 2023 Jul 4.
PubMed 37413896Masood Y, Lovell K, Lunat F, Atif N, Waheed W, Rahman A, Mossabir R, Chaudhry N, Husain N. Group psychological intervention for postnatal depression: a nested qualitative study with British South Asian women. BMC Womens Health. 2015 Nov 25;15:109. doi: 10.1186/s12905-015-0263-5.
PubMed 26603604
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
- ClinicalTrials.gov ID
- NCT01838889
- Acronym / sponsor ID
- ROSHNI-D / 47847
- Keywords
- Culturally adapted, Group psychological intervention, British South Asian women, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Lancashire Care NHS Foundation TrustResearch network
- Collaborators
- University of Manchester
- Study start
- Mar 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Apr 2013 (estimated)
- 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.
This study is an exploratory randomized controlled trial (RCT) of a group psychological intervention for postnatal depression in British mother's of south Asian origin. The aim is to evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is that depressed British women of South Asian origin receiving the group intervention will show significant improvements in terms of severity of depression as compared to the treatment as usual (TAU) control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted psychological intervention (PHP) | Experimental | Behavioral: Culturally adapted psychological intervention (Positive Health Programme)Depressed Mothers randomized to experimental arm will undergo a 12 week group psychological intervention on the 'positive health programme'. |
| Treatment as usual (TAU) | No intervention | –Depressed mothers randomized to TAU arm will receive treatment as usual. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- self-ascribed British women of South Asian origin as defined by UK Office of -National Statistics,
- over the age of 16 years
- living with their babies,
- who meet the criteria for ICD-10 depression
Key exclusion criteria (4 listed)
- women with diagnosed physical or learning disability,
- post-partum or other psychosis,
- severely depressed
- actively suicidal.
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 |
|---|---|---|
| Culturally adapted psychological intervention (Positive Health Programme)Also: PHPThis study will evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women. | Behavioural | Culturally adapted psychological intervention (PHP) |
Primary outcome
Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).
7 secondary outcomes
EuroQoL-5 Dimensions (EQ-5D)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
The Parenting Stress Index (PSI)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Dyadic Adjustment Scale (DAS)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Home Inventory (HI)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Hamilton Rating Scale for Depression (HRSD)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Client Service Receipt Inventory (CSRI)
Time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Derived from this study: PubMed 37413896Husain N, Lunat F, Lovell K, Sharma D, Zaidi N, Bokhari A, Syed A, Tomenson B, Islam A, Chaudhry N, Waheed W. Exploratory RCT of a group psychological intervention for postnatal depression in British mothers of South Asian origin - ROSHNI-D. Acta Psychol (Amst). 2023 Aug;238:103974. doi: 10.1016/j.actpsy.2023.103974. Epub 2023 Jul 4.
- Derived from this study: PubMed 26603604Masood Y, Lovell K, Lunat F, Atif N, Waheed W, Rahman A, Mossabir R, Chaudhry N, Husain N. Group psychological intervention for postnatal depression: a nested qualitative study with British South Asian women. BMC Womens Health. 2015 Nov 25;15:109. doi: 10.1186/s12905-015-0263-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted psychological intervention (Positive Health Programme) in people with Depression, Postpartum and Postnatal Depression in British South Asian Women, run by Lancashire Care NHS Foundation Trust 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987) (time frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838889, which also lists 2 linked publications.
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 8 Dec 2014.