Background
Methods
Study design and objectives
Training
Intervention
Comparison
Participants
Recruitment
Assessments
Data analyses
Nested qualitative study
Results
Recruitment of services and training
Recruitment of women during pregnancy and outcome data collection
CBT N = 26 | IPC N = 26 | Overall N = 52 | |
---|---|---|---|
Age, Mean (Std) | 30.1 (4.7) | 32.8 (4.6) | 31.4 (4.8) |
No. of weeks pregnant, Median (Min, Max) | 14 (12, 26) | 16.5 (13, 23) | 15 (12, 26) |
First Pregnancy, N (%) | 14 (54%) | 14 (54%) | 28 (54%) |
Ethnic Group, N (%) | |||
White | 22 (85%) | 25 (96%) | 47 (90%) |
Mixed/ multiple ethnic groups | 2 (8%) | 0 | 2 (4%) |
Asian/ Asian British | 0 | 0 | 0 |
Black/ African/ Caribbean/ Black British | 1 (4%) | 0 | 1 (2%) |
Other Ethnic Group | 1 (4%) | 1 (4%) | 2 (4%) |
Highest Educational Qualification N (%) | |||
No formal qualification | 2 (8%) | 0 | 2 (4%) |
GCSE/ CSE/ O Level | 2 (8%) | 0 | 2 (4%) |
A-Level/ AS level | 5 (19%) | 3 (12%) | 8 (15%) |
Degree | 17 (65%) | 21 (81%) | 38 (73%) |
Other | 0 | 2 (8%) | 2 (4%) |
Marital Status, N (%) | |||
Married/ registered civil partnership | 14 (54%) | 12 (46%) | 26 (50%) |
Living together | 8 (31%) | 14 (54%) | 22 (42%) |
Single | 4 (15%) | 0 | 4 (8%) |
Widowed/ Divorced/ Separated | 0 | 0 | 0 |
No. aged 18+ living in household, N (%) | |||
0 | 1 (4%) | 0 | 1 (2%) |
1 | 23 (88%) | 24 (92%) | 47 (90%) |
2 | 2 (8%) | 2 (8%) | 4 (8%) |
Employment, N (%) | |||
In paid work (full or part time) | 21 (81%) | 26 (100%) | 47 (90%) |
Unemployed | 2 (8%) | 0 | 2 (4%) |
Looking after family or home | 0 | 0 | 0 |
Unable to work | 1 (4%) | 0 | 1 (2%) |
Full-time education/ training | 2 (8%) | 0 | 2 (4%) |
EPDS > 12, N (%) | 20 (77%) | 23 (88%) | 43 (83%) |
CISR Diagnosis | |||
Mild Depression (F32.0) N (%) | 9 (35%) | 7 (27%) | 16 (31%) |
Moderate Depression (F32.1) N (%) | 15 (58%) | 17 (65%) | 32 (62%) |
Mixed anxiety and depression (F41.2) or | 0 | 1 (4%) | 1 (2%) |
Specific Phobias (F40.2) N (%) (recruited in error)a | 2 (4% | 1 (4%) | 3 (6%) |
RDAS Scale, Median (IQR) | N = 25 50 (42, 54) | N = 26 51 (42, 56) | N = 51 51 (42, 55) |
MAAS Scale, Mean (Std) | 68.5 (11.5) | 71.4 (9.0) | 69.9 (10.3) |
EQ-5D-5L, Mean (Std) | 0.730 (0.08) | 0.701 (0.13) | 0.716 (0.11) |
ReQol, Mean (Std) | 24.5 (4.6) | 24.8 (4.6) | 24.7 (4.5) |
Outcomes
Recruitment | N, % | 95% Confidence Interval |
---|---|---|
Potentially Eligible/ Forms returned or referred | ||
By midwife | 19/45 (42%) | (28, 58%) |
At Scanning clinics | 218/1128 (19%) | (17, 22%) |
Total 237/1173 | (20%) | (18, 23%) |
Recruited / Potentially Eligible | ||
By midwife | 6/19 (32%) | (13, 57%) |
At scanning clinics | 46/218 (21%) (38 at 12 week scan, 8 at 20 week scan) | (16, 27%) |
Total | 52/237 (22%) | (17, 28%) |
Recruited/ Randomised (Total) | 52/52 (100%) | (93, 100%) |
Treatment | ||
Randomised/ Clinically Eligible following IAPT assessment | 49/52 (94%) | (84, 99%) |
Randomised to CBT/ Started CBT | 15/26 (58%) | (37, 77%) |
Randomised to IPC / Started IPC | 17/26 (65%) | (44, 83%) |
Randomised to IPC/ Started CBT | 2/26 (8%) | (1, 25%) |
Started IPC / Completed course of treatment to an adequate level | 12/17 (71%) | (44, 90%) |
Randomised to CBT/ Required step-up to high intensity treatment | 1/26 (4%) | (0.1, 20%) |
Randomised to IPC/ Required step-up to high intensity treatment | 1/26 (4%) | (0.1, 20%) |
Follow up data | ||
Randomised/ Completed 12 week EPDS Follow-up | 42/52 (81%) | (67, 90%) |
Randomised/ Provided all 12 week Follow-up measures with no missing data | 37 (71%) (95% CI: 57, 83%) completed all follow-up measures. |
IPC | CBT | Overall | |
---|---|---|---|
No. of weeks from recruitment to starting treatment, Median (IQR) | N = 19 5.0 (3.6, 7.1) | N = 15 7.1 (4.0, 9.0) | N = 34 5.0 (4.0, 8.3) |
No. of weeks from recruitment when follow-up completed, Median (IQR) | N = 21 13.1 (12.7, 14.1) | N = 21 14.4 (13.0, 16.0) | N = 42 13.9 (12.7, 15.3) |
Total Number of sessions attended, Median (IQR) | N = 19 6 (4, 6) | N = 15 6 (3, 7) | N = 34 6 (4, 6) |
No. of partners attending 1 or more sessions, N (%) | 3 (16%) | 0 (0%)a | |
EPDS, Mean (Std | 10.7 (3.9) N = 21 | 11.5 (4.3) N = 21 | 11.1 (4.1) N = 42 |
Change in EPDS score from baseline to 12 week follow-up, Mean (Std) | 4.4 (5.1) | 4.0 (4.8) | 4.2 (4.9) |
EPDS 9/10 cut-off, N(%) with a score of 10+ | 12 (57%) | 14 (67%) | 26 (62%) |
EPDS 12/13 cut-off, N(%) with a score of 13+ | 6 (29%) | 8 (38%) | 14 (33%) |
RDAS Scale, Median (IQR) | 51 (48, 56) N = 21 | 52 (48, 55) N = 19 | 52 (48, 55.5) N = 40 |
MAAS Scale, Mean (Std) | 77.9 (5.6) N = 20 | 76.6 (7.7) N = 20 | 77.2 (6.7) N = 40 |
EQ-5D-5L, Mean (Std) | 0.666 (0.169) | 0.701 (0.11) | 0.683 (0.195) |
ReQoL-10, Mean (Std) | 27.2 (6.0) N = 20 | 27.9 (6.8) N = 19 | 27.5 (6.3) N = 39 |
ReQoL-10 Change Score, Mean (Std) | 1.9 (5.5) | 2.9 (5.4) | 2.4 (5.4) |
Medication use to improve mental health (Yes/No) | 0 | 0 | 0 |
Resource use (societal), mean GBP£ (Std) | 462.83 (1106) | 412.38 (719) | 438.29 (926) |
Health economic measures
Acceptability from qualitative interviews
‘Study was a lifeline’. | |
I think this study is awesome because the therapy I had was amazing and it made a huge difference to my mood and it made me feel so much better about my pregnancy and so much happier, and I think if that hadn’t been there I don’t know how that would have been addressed again…. (1006, site A, primip) | |
Scanning clinics: ‘Space to acknowledge low mood’ | |
That was a good time for me actually to have it, yeah, and actually it’s quite good if you’re giving something while you’re in a waiting area because it’s something to do while you’re waiting rather than when you’re rushing around, so it was quite a good time to look at it. (1034, site A, primip) | |
…it might not have been something I spoke to my midwife about, I might not have….if I hadn’t been directly asked I might not have answered those questions in that respect. This was a confidential way […] that I could do it in my own time to refSlect in how I was feeling’ (1021, site A, multip) | |
The recruitment appointment: ‘Recognising things are not right’. | |
It felt good to just talk about how I had been feeling with someone, actually. I know that you were doing it for the purpose of finding out which help I needed, but even sometimes just sharing your thoughts with someone can help. I have to admit I was nervous about any implications, I was worried whether I would come across as a bad mum or whether it would lead to any intervention from any government bodies, but overall it felt good to be able to share how I was feeling with someone. (1025, site A, primip) | |
Timing of therapy: ‘treatment to start as early as possible’. | |
I remember having my first session with the therapist and then she had some time off or holiday, so there was a bit of a gap between my first and second session,… It was quite difficult juggling it and fitting it in if I’m honest, and in fact I haven’t got on very well with getting to the sessions because I have either been really late or I’ve had problems with childcare. So quite a slow process. (1029, site A, multip, IPC) | |
Delivery mode: ‘face to face is good’ | |
I think face to face is obviously better, you’ve got your eye contact and it just feels different I think face to face, but I am sure telephone will be more helpful than not having it. But I would say face to face is preferable, just to have that rapport as well with the therapist I think helps.(1034, site A, primip, IPC) | |
Content of IPC therapy: asking for help | |
Definitely, I am much better at accepting help now, and to the point where I am trying to make my husband also better at accepting help, because we needed help, and it’s baby steps that I do feel like I’ve come a long way. (1018, site A, multip, IPC) | |
…knowing who is in the support group and [name] reflected on that actually, and there was a chart that she gave me where I could write who it was, my relationship with them, and what good they bring me, and can I rely on them for emotional and physical support, that was really helpful to go through, to know who I had and who I could rely on. (2005, site B, primip, IPC) | |
Junior Mental Health Worker views “IPC approach is ‘more human” | |
There was freedom and a different focus [in IPC therapy], focus still on depression but there was focus on relationship that it’s not really the main thing in CBT, and I think a lot of clients that I worked with found that helpful and having space to talk about things a bit more freely it seemed like it was helpful. (jMHW, Site A) | |
Different [from CBT]… I think the relationship aspect of it was really helpful, who’s in the networks and who is going to support you and… what are you going to do to help… what skills can we develop to help you get that… express your needs, I find that so helpful, especially for pregnant women, and also new babies as well (jMHW site B) |