Community perinatal mental health teams and associations with perinatal mental health and obstetric and neonatal outcomes in pregnant women with a history of secondary mental health care in England: a national population-based cohort study.

BACKGROUND: Women with a pre-existing severe mental disorder have an increased risk of relapse after giving birth. We aimed to evaluate associations of the gradual regional implementation of community perinatal mental health teams in England from April, 2016, with access to mental health care and with mental health, obstetric, and neonatal outcomes. METHODS: For this cohort study, we used the national dataset of secondary mental health care provided by National Health Service England, including mental health-care episodes from April 1, 2006, to March 31, 2019, linked at patient level to the Hospital Episode Statistics, and birth notifications from the Personal Demographic Service. We included women (aged ≥18 years) with an onset of pregnancy from April 1, 2016, who had given birth to a singleton baby up to March 31, 2018, and who had a pre-existing mental disorder, defined as contacts with secondary mental health care in the 10 years immediately before pregnancy. The primary outcome was acute relapse, defined as psychiatric hospital admission or crisis resolution team contact in the postnatal period (first year after birth). Secondary outcomes included any secondary mental health care in the perinatal period (pregnancy and postnatal period) and obstetric and neonatal outcomes. Outcomes were compared according to whether a community perinatal mental health team was available before pregnancy, with odds ratios (ORs) adjusted for time trends and maternal characteristics (adjORs). FINDINGS: Of 807 798 maternity episodes in England, we identified 780 026 eligible women with a singleton birth, of whom 70 323 (9·0%) had a pre-existing mental disorder. A postnatal acute relapse was found in 1117 (3·6%) of 31 276 women where a community perinatal mental health team was available and in 1745 (4·5%) of 39 047 women where one was unavailable (adjOR 0·77, 95% CI 0·64-0·92; p=0·0038). Perinatal access to any secondary mental health care was found in 9888 (31·6%) of 31 276 women where a community perinatal mental health team was available and 10 033 (25·7%) of 39 047 women where one was not (adjOR 1·35, 95% CI 1·23-1·49; p<0·0001). Risk of stillbirth and neonatal death was higher where a community perinatal mental health team was available (165 [0·5%] of 30 980 women) than where it was not (151 [0·4%] of 38 693 women; adjOR 1·34, 95% CI 1·09-1·66; p=0·0063), as was the risk of a baby small for gestational age (2227 [7·2%] of 31 030 women vs 2542 [6·6%] of 38 762 women; adjOR 1·10, 1·02-1·20; p=0·016), whereas preterm birth risk was lower (3167 [10·1%] of 31 206 women vs 4341 [11·1%] of 38 961; adjOR 0·86, 0·74-0·99; p=0·032). INTERPRETATION: The regional availability of community perinatal mental health teams reduced the postnatal risk of acute relapse and increased the overall use of secondary mental health care. Community perinatal mental health teams should have close links with maternity services to avoid intensive psychiatric support overshadowing obstetric and neonatal risks. FUNDING: The National Institute for Health and Care Research.

User-Centered Design of a Gamified Mental Health App for Adolescents in Sub-Saharan Africa: Multicycle Usability Testing Study.

BACKGROUND: There is an urgent need for scalable psychological treatments to address adolescent depression in low-resource settings. Digital mental health interventions have many potential advantages, but few have been specifically designed for or rigorously evaluated with adolescents in sub-Saharan Africa. OBJECTIVE: This study had 2 main objectives. The first was to describe the user-centered development of a smartphone app that delivers behavioral activation (BA) to treat depression among adolescents in rural South Africa and Uganda. The second was to summarize the findings from multicycle usability testing. METHODS: An iterative user-centered agile design approach was used to co-design the app to ensure that it was engaging, culturally relevant, and usable for the target populations. An array of qualitative methods, including focus group discussions, in-depth individual interviews, participatory workshops, usability testing, and extensive expert consultation, was used to iteratively refine the app throughout each phase of development. RESULTS: A total of 160 adolescents from rural South Africa and Uganda were involved in the development process. The app was built to be consistent with the principles of BA and supported by brief weekly phone calls from peer mentors who would help users overcome barriers to engagement. Drawing on the findings of the formative work, we applied a narrative game format to develop the Kuamsha app. This approach taught the principles of BA using storytelling techniques and game design elements. The stories were developed collaboratively with adolescents from the study sites and included decision points that allowed users to shape the narrative, character personalization, in-app points, and notifications. Each story consists of 6 modules ("episodes") played in sequential order, and each covers different BA skills. Between modules, users were encouraged to work on weekly activities and report on their progress and mood as they completed these activities. The results of the multicycle usability testing showed that the Kuamsha app was acceptable in terms of usability and engagement. CONCLUSIONS: The Kuamsha app uniquely delivered BA for adolescent depression via an interactive narrative game format tailored to the South African and Ugandan contexts. Further studies are currently underway to examine the intervention's feasibility, acceptability, and efficacy in reducing depressive symptoms.

Obstetric and neonatal outcomes in pregnant women with and without a history of specialist mental health care: a national population-based cohort study using linked routinely collected data in England.

BACKGROUND: Pregnant women with pre-existing mental illnesses have increased risks of adverse obstetric and neonatal outcomes compared with pregnant women without pre-existing mental illnesses. We aimed to estimate these differences in risks according to the highest level of pre-pregnancy specialist mental health care, defined as psychiatric hospital admission, crisis resolution team (CRT) contact, or specialist community care only, and the timing of the most recent care episode in the 7 years before pregnancy. METHODS: Hospital and birth registration records of women with singleton births between April 1, 2014, and March 31, 2018 in England were linked to records of babies and records from specialist mental health services provided by the England National Health Service, a publicly funded health-care system. We compared the risks of adverse pregnancy outcomes, including fetal and neonatal death, preterm birth, and babies being born small for gestational age (SGA; birthweight <10th percentile), and composite indicators for neonatal adverse outcomes and maternal morbidity, between women with and without a history of contact with specialist mental health care. We calculated odds ratios adjusted for maternal characteristics (aORs), using logistic regression. FINDINGS: Of 2 081 043 included women (mean age 30·0 years; range 18-55 years; 77·7% White, 11·4% South Asian, 4·7% Black, and 6·2% mixed or other ethnic background), 151 770 (7·3%) had at least one pre-pregnancy specialist mental health-care contact. 7247 (0·3%) had been admitted to a psychiatric hospital, 29 770 (1·4%) had CRT contact, and 114 753 (5·5%) had community care only. With a pre-pregnancy mental health-care contact, risk of stillbirth or neonatal death within 7 days of birth was not significantly increased (0·45-0·49%; aOR 1·11, 95% CI 0·99-1·24): risk of preterm birth (<37 weeks) increased (6·5-9·8%; aOR 1·53, 1·35-1·73), as did risk of SGA (6·2- 7·5%; aOR 1·34, 1·30-1·37) and neonatal adverse outcomes (6·4-8·4%; aOR 1·37, 1·21-1·55). With a pre-pregnancy mental health-care contact, risk of maternal morbidity increased slightly from 0·9% to 1·0% (aOR 1·18, 1·12-1·25). Overall, risks were highest for women who had a psychiatric hospital admission any time or a mental health-care contact in the year before pregnancy. INTERPRETATION: Information about the level and timing of pre-pregnancy specialist mental health-care contacts helps to identify women at increased risk of adverse obstetric and neonatal outcomes. These women are most likely to benefit from dedicated community perinatal mental health teams working closely with maternity services to provide integrated care. FUNDING: National Institute for Health Research.

Digital delivery of behavioural activation therapy to overcome depression and facilitate social and economic transitions of adolescents in South Africa (the DoBAt study): protocol for a pilot randomised controlled trial.

INTRODUCTION: Scalable psychological treatments to address depression among adolescents are urgently needed. This is particularly relevant to low-income and middle-income countries where 90% of the world's adolescents live. While digital delivery of behavioural activation (BA) presents a promising solution, its feasibility, acceptability and effectiveness among adolescents in an African context remain to be shown. METHODS AND ANALYSIS: This study is a two-arm single-blind individual-level randomised controlled pilot trial to assess the feasibility, acceptability and initial efficacy of digitally delivered BA therapy among adolescents with depression. The intervention has been coproduced with adolescents at the study site. The study is based in the rural northeast of South Africa in the Bushbuckridge subdistrict of Mpumalanga province. A total of 200 adolescents with symptoms of mild to moderately severe depression on the Patient Health Questionnaire Adolescent Version will be recruited (1:1 allocation ratio). The treatment group will receive BA therapy via a smartphone application (the Kuamsha app) supported by trained peer mentors. The control group will receive an enhanced standard of care. The feasibility and acceptability of the intervention will be evaluated using a mixed methods design, and signals of the initial efficacy of the intervention in reducing symptoms of depression will be determined on an intention-to-treat basis. Secondary objectives are to pilot a range of cognitive, mental health, risky behaviour and socioeconomic measures; and to collect descriptive data on the feasibility of trial procedures to inform the development of a further larger trial. ETHICS AND DISSEMINATION: This study has been approved by the University of the Witwatersrand Human Research Ethics Committee (MED20-05-011) and the Oxford Tropical Research Ethics Committee (OxTREC 34-20). Study findings will be published in scientific open access peer-reviewed journals, presented at scientific conferences and communicated to participants, their caregivers, public sector officials and other relevant stakeholders. TRIAL REGISTRATION NUMBERS: This trial was registered on 19 November 2020 with the South African National Clinical Trials Registry (DOH-27-112020-5741) and the Pan African Clinical Trials Registry (PACTR202206574814636).

Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): report of a feasibility randomized controlled trial.

BACKGROUND: We investigated the acceptability and feasibility of a new brief intervention for maternal prenatal anxiety within maternity services in London and Exeter, UK. METHODS: One hundred fourteen pregnant individuals attending their 12-week scan at a prenatal clinic with elevated symptoms of anxiety (GAD-7 score of ≥7) were randomly assigned to either the ACORN intervention + Treatment as usual (TAU) (n = 57) or to usual care only (n = 57). The ACORN intervention consisted of 3 2-h group sessions, led by a midwife and psychological therapist, for pregnant individuals and their partners. The intervention included psychoeducation about anxiety, strategies for problem-sovling and tolerating uncertainty during pregnancy, including communicating about these with others, and mindfulness exercises. RESULTS: Engagement rates with ACORN met or exceeded those in primary care services in England. In the intervention arm, 77% (n = 44) of participants attended at least one session, 51% (n = 29) were adherent, defined as attending two or more sessions. Feedback was positive, and participants in the ACORN treatment group demonstrated evidence of a larger drop in their levels of anxiety than the participants in the TAU-only group (Cohen's d = 0.42). CONCLUSION: The ACORN intervention was acceptable to pregnant individuals and their partners and resulted in reductions in anxiety. With further evaluation in a larger-scale trial with child outcomes, there is significant potential for large scale public health benefit.

'Asking for help': a qualitative interview study exploring the experiences of interpersonal counselling (IPC) compared to low-intensity cognitive behavioural therapy (CBT) for women with depression during pregnancy.

BACKGROUND: Treating depression early in pregnancy can improve health outcomes for women and their children. Current low-intensity psychological therapy for perinatal depression is a supported self-help approach informed by cognitive behavioural therapy (CBT) principles. Interpersonal counselling (IPC) may be a more appropriate low-intensity talking therapy for addressing the problems experienced by pregnant women with depression. A randomised feasibility trial (ADAGIO) has compared the acceptability of offering IPC for mild-moderate antenatal depression in routine NHS services compared to low-intensity CBT. This paper reports on a nested qualitative study which explored women's views and expectations of therapy, experiences of receiving IPC, and Psychological Wellbeing Practitioners (PWPs - junior mental health workers) views of delivering the low-intensity therapy. METHODS: A qualitative study design using in-depth semi-structured interviews and focus groups. Thirty-two pregnant women received talking therapy within the ADAGIO trial; 19 contributed to the interview study from July 2019 to January 2020; 12 who had IPC and seven who had CBT. All six PWPs trained in IPC took part in a focus group or interview. Interviews and focus groups were recorded, transcribed, anonymised, and analysed using thematic methods. RESULTS: Pregnant women welcomed being asked about their mental health in pregnancy and having the chance to have support in accessing therapy. The IPC approach helped women to identify triggers for depression and explored relationships using strategies such as 'promoting self-awareness through mood timelines', 'identifying their circles of support', 'developing communication skills and reciprocity in relationships', and 'asking for help'. PWPs compared how IPC differed from their prior experiences of delivering low-intensity CBT. They reported that IPC included a useful additional emotional component which was relevant to the perinatal period. CONCLUSIONS: Identifying and treating depression in pregnancy is important for the future health of both mother and child. Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners in routine NHS primary care services in England are acceptable to pregnant women with mild-moderate depression. The strategies used in IPC to manage depression, including identifying triggers for low mood, and communicating the need for help, may be particularly appropriate for the perinatal period. TRIAL REGISTRATION: ISRCTN 11513120. 02/05/2019.

A comparison of the effects of sudden gains and depression spikes on short- and long-term depressive symptoms in a randomized controlled trial of behavioral activation and cognitive behavioural therapy.

OBJECTIVE: The aim of this study was to examine the effects of sudden gains and depression spikes in a randomized controlled trial of cognitive behavioral therapy (CBT) and behavioral activation (BA) for depression (COBRA trial). METHOD: This is a secondary analysis of 300 adults with major depressive disorder (MDD) who received CBT (n = 156) or BA (n = 144) (Richards et al., 2016). The Patient Health Questionnaire (PHQ-9) and Structured Clinical Interview Schedule (SCID) were used to measure depression symptoms at 6-, 12-, and 18-month follow-up. RESULTS: One-hundred and ten (37%) individuals experienced sudden gains, and 77 (26%) experienced depression spikes. There were no differences in rates of gains or spikes between treatments. Individuals with sudden gains had lower PHQ-9 scores across follow-up and were less likely to meet SCID criteria than those without a sudden gain. Generalized estimating equation (GEE) models demonstrated that individuals who had a sudden gain and were in CBT had lower PHQ-9 scores at 6 and 18 months than those in BA. Conversely, individuals who had a depression spike and were in CBT had higher PHQ-9 scores across follow-up compared to those without a depression spike and also a greater chance of meeting SCID criteria for MDD at 18 months than those who received BA. CONCLUSIONS: The short- and long-term impact of discontinuous change varied by type of treatment package. Identifying strategies within treatment packages and client processes that are associated with gains and spikes may help to inform treatment planning and clinical decision-making. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy.

INTRODUCTION: One in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study. METHODS AND ANALYSIS: A two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women's mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study. ETHICS AND DISSEMINATION: Study results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol. TRIAL REGISTRATION NUMBER: ISRCTN11513120.

Trajectories of Change in a Group Behavioral Activation Treatment for Severe, Recurrent Depression.

Depression is a common and costly problem. Behavioral Activation (BA) is an effective treatment for depression when delivered 1:1, but group treatments often do not perform as well as 1:1 treatments. One way to begin to understand how group treatments perform is to assess the process of change during treatment. This study examined trajectories of change across 10-session group BA for individuals with severe, chronic, or recurrent forms of depression. We also tested whether individuals who had associated sudden gains or depression spikes had better outcomes than those who did not have these change patterns. We examined psychological and sociodemographic predictors of the patterns of change. Participants were 104 individuals who met diagnostic criteria for major depressive disorder and participated in one of 10 BA groups, provided over a 2-year period. A linear, but not quadratic or cubic, rate of change fit the data and the effect size for the change in mood symptoms from baseline to posttreatment was large, Cohen's d = 1.25. Although 34% (26 of the 77 who provided outcome data) of individuals had a sudden gain and 10% (7/77) had a depression spike, neither sudden gains nor depression spikes predicted posttreatment outcomes. None of the demographic or psychological factors (rumination, behavioral activation) predicted the pattern of change. These results suggest that although group BA may help to reduce depressive symptoms in individuals with severe, recurrent, and/or chronic forms of depression, the overall linear pattern of change is different from quadratic patterns of change reported for 1:1 BA.

Shape of change in internet based behavioral activation treatment for depression.

Shape of change, sudden gains and depression spikes were examined in an online 12-session Behavioral Activation (BA) treatment for depression. Client and therapist factors related to sudden gains were examined to investigate processes associated with outcome. METHODS: Participants were postpartum Women with Major Depressive Disorder (n=42) who received online BA supported in 30-minute telephone sessions by a mental health worker. Depression symptoms were assessed at each session and number of sessions completed were recorded by the online program. Therapist records were rated for client stressful life event and therapist concrete focus. A quadratic pattern provided the best fit with the data; a cubic pattern was a poor fit. Sudden gains, but not depression spikes, predicted lower depression scores at 17-week outcome. Women who had higher baseline social functioning, did not experience a stressful life event during therapy, and completed more online modules, but not more telephone sessions, were more likely to have a sudden gain. A concrete therapist focus was associated with sudden gains. These results extend research on trajectories of change and sudden gains to an online BA treatment and to postpartum depression, and suggest important client and therapist factors associated with sudden gains.

Cost and outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): a qualitative process evaluation.

OBJECTIVE: To explore participant views on acceptability, mechanisms of change and impact of behavioural activation (BA) delivered by junior mental health workers (MHWs) versus cognitive behavioural therapy (CBT) delivered by professional psychotherapists. DESIGN: Semistructured qualitative interviews analysed using a framework approach. PARTICIPANTS: 36 participants with major depressive disorder purposively sampled from a randomised controlled trial of BA versus CBT (the COBRA trial). SETTING: Primary care psychological therapies services in Devon, Durham and Leeds, UK. RESULTS: Elements of therapy considered to be beneficial included its length and regularity, the opportunity to learn and not dwelling on the past. Homework was an important, although challenging aspect of treatment. Therapists were perceived as experts who played an important role in treatment. For some participants the most important element of therapy was having someone to talk to, but for others the specific factors associated with BA and CBT were crucial, with behavioural change considered important for participants in both treatments, and cognitive change unsurprisingly discussed more by those receiving CBT. Both therapies were considered to have a positive impact on symptoms of depression and other areas of life including feelings about themselves, self-care, work and relationships. Barriers to therapy included work, family life and emotional challenges. A subset (n=2) of BA participants commented that therapy felt too simple, and MHWs could be perceived as inexperienced. Many participants saw therapy as a learning experience, providing them with tools to take away, with work on relapse prevention essential. CONCLUSIONS: Despite barriers for some participants, BA and CBT were perceived to have many benefits, to have brought about cognitive and behavioural change and to produce improvements in many domains of participants' lives. To optimise the delivery of BA, inexperienced junior MHWs should be supported through good quality training and ongoing supervision. TRIAL REGISTRATION NUMBER: ISRCTN27473954, 09/12/2011.

Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial.

BACKGROUND: National guidelines in the UK, United States of America, Canada, and Australia have recently stressed the importance of identifying and treating antenatal anxiety and depression. However, there is little research into the most effective and acceptable ways of helping women manage their symptoms of anxiety and stress during pregnancy. Research indicates the necessity to consider the unique needs and concerns of perinatal populations to ensure treatment engagement, highlighting the need to develop specialised treatments which could be integrated within routine antenatal healthcare services. This trial aims to develop a brief intervention for antenatal anxiety, with a focus on embedding the delivery of the treatment within routine antenatal care. METHODS/DESIGN: This study is a two-phase feasibility trial. In phase 1 we will develop and pilot a brief intervention for antenatal anxiety, blended with group support, to be led by midwives. This intervention will draw on cognitive behavioural principles and wider learning from existing interventions that have been used to reduce anxiety in expectant mothers. The intervention will then be tested in a pilot randomised controlled trial in phase 2. The following outcomes will be assessed: (1) number of participants meeting eligibility criteria, (2) number of participants consenting to the study, (3) number of participants randomised, (4) number of sessions completed by those in the intervention arm, and (5) number of participants completing the post-intervention outcome measures. Secondary outcomes comprise: detailed feedback on acceptability, which will guide further development of the intervention; and outcome data on symptoms of maternal and paternal anxiety and depression, maternal quality of life, quality of couple relationship, mother-child bonding, infant temperament and infant sleep. DISCUSSION: The study will provide important data to inform the design of a future full-scale randomised controlled trial of a brief intervention for anxiety during pregnancy. This will include information on its acceptability and feasibility regarding implementation within current antenatal services, which will inform whether ultimately this provision could be rolled out widely in healthcare settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95282830 . Registered on 29 October 2014.

The association between childhood maltreatment and emotion regulation: two different mechanisms contributing to depression?

BACKGROUND: Childhood maltreatment is an established distal risk factor for later emotional problems, although research suggests this relationship is mediated by proximal factors. However, it is unclear if different forms of childhood maltreatment are related to unique emotion regulation strategies. In this study, we examined whether avoidance and rumination, two emotion regulation strategies strongly associated with depression, were associated with different forms of childhood maltreatment, and whether these strategies, in turn, mediated the relationship between childhood maltreatment and current depressive symptoms. METHODS: Participants were a community sample of pregnant, primarily low-income women, 55 of whom met criteria for Major Depressive Disorder (MDD) and 85 who had elevated levels of depressive symptoms but did not meet criteria for MDD. RESULTS: Significant rates of childhood maltreatment were reported. Childhood emotional neglect was related to behavioural avoidance, and childhood emotional abuse was related to rumination. In path analyses, behavioural avoidance mediated the relationship between childhood emotional neglect and depression. Rumination was a partial mediator of childhood emotional abuse and depression. LIMITATIONS: The data were correlational in nature, and replication with a larger sample will help validate the model. DISCUSSION: In a clinical, community-based sample different types of childhood maltreatment are related to unique emotion regulation strategies. Implications for understanding the developmental antecedents of emotion regulation and depression are discussed.

Rumination decreases parental problem-solving effectiveness in dysphoric postnatal mothers.

BACKGROUND: Postnatal depression is associated with poorer parenting quality, but there are few studies examining maternal-specific cognitive processes that may impact on parenting quality. In this study, we examined the impact of rumination on parental problem-solving effectiveness in dysphoric and non-dysphoric postnatal mothers. METHODS: Fifty-nine mothers with a infant aged 12 months and under, 20 of whom had a Beck Depression Score II (BDI-II) score ≥ 14, and 39 who scored less than 14 on the BDI-II were randomly assigned to either a rumination or distraction condition. Problem-solving effectiveness was assessed post-induction with the "Postnatal Parental Problem-Solving Task" (PPST), which was adapted from the Means Ends Problem-solving task. Parental problem-solving confidence was also assessed. RESULTS: Dysphoric ruminating mothers exhibited poorer problem-solving effectiveness and poorer confidence regarding their problem-solving compared to dysphoric distracting, non-dysphoric distracting, and non-dysphoric ruminating mothers. LIMITATIONS: A self-report measure of depressed mood was used. CONCLUSIONS: Rumination may be a key mechanism associated with both depressive mood and maternal parenting quality during the postnatal period.

Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial.

BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. METHODS/DESIGN: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. DISCUSSION: The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954.

Radically open-dialectical behavior therapy for adult anorexia nervosa: feasibility and outcomes from an inpatient program.

BACKGROUND: Anorexia Nervosa (AN) is a highly life-threatening disorder that is extremely difficult to treat. There is evidence that family-based therapies are effective for adolescent AN, but no treatment has been proven to be clearly effective for adult AN. The methodological challenges associated with studying the disorder have resulted in recommendations that new treatments undergo preliminary testing prior to being evaluated in a randomized clinical trial. The aim of this study was to provide preliminary evidence on the effectiveness of a treatment program based on a novel adaptation of Dialectical Behavior Therapy (DBT) for adult Anorexia Nervosa (Radically Open-DBT; RO-DBT) that conceptualizes AN as a disorder of overcontrol. METHODS: Forty-seven individuals diagnosed with Anorexia Nervosa-restrictive type (AN-R; mean admission body mass index = 14.43) received the adapted DBT inpatient program (mean length of treatment = 21.7 weeks). RESULTS: Seventy-two percent completed the treatment program demonstrating substantial increases in body mass index (BMI; mean change in BMI = 3.57) corresponding to a large effect size (d = 1.91). Thirty-five percent of treatment completers were in full remission, and an additional 55% were in partial remission resulting in an overall response rate of 90%. These same individuals demonstrated significant and large improvements in eating-disorder related psychopathology symptoms (d = 1.17), eating disorder-related quality of life (d = 1.03), and reductions in psychological distress (d = 1.34). CONCLUSIONS: RO-DBT was associated with significant improvements in weight gain, reductions in eating disorder symptoms, decreases in eating-disorder related psychopathology and increases in eating disorder-related quality of life in a severely underweight sample. These findings provide preliminary support for RO-DBT in treating AN-R suggesting the importance of further evaluation examining long-term outcomes using randomized controlled trial methodology.

Internet-based behavioral activation--treatment for postnatal depression (Netmums): a randomized controlled trial.

BACKGROUND: Despite the high prevalence of postnatal depression (PND), few women seek help. The internet may increase timely access to treatment. We report a randomized controlled trial of a minimal intervention internet Behavioral Activation (iBA) treatment modified to address postnatal specific concerns (Postnatal-iBA). METHODS: Women (n=910) recruited via a popular UK parenting site, Netmums.com, scoring above 12 on the Edinburgh Postnatal Depression Scale (EPDS) were randomly assigned to receive either Postnatal-iBA delivered or treatment-as-usual (TAU). We investigated the feasibility (recruitment, trial and treatment adherence) and effectiveness (depression status EPDS >12) of the intervention. RESULTS: Recruitment was excellent; 1261 women, 961 of whom met inclusion criteria, signed up to the trial within two 2-week recruitment periods. Thirty-eight percent (343/910) of women completed the 15-week outcome assessment. Of those who completed 15-week assessment, fewer exceeded the depression cutoff in the Postnatal-iBA group (n=66/181) compared to TAU (n=91/162). Assuming all non-respondents remained depressed, the Postnatal-iBA effect was reduced. LIMITATIONS: The study suffered from high attrition and future trials need to consider strategies for improving outcome completion. Some women reported struggles "keeping up" with the treatment. CONCLUSIONS: A minimal support, widely accessible internet Behavioral Activation program for PND is feasible to deliver to community populations when embedded within popular parenting sites. For women who provide outcome data, postnatal-iBA offers promise as an effective treatment for PND. The addition of support may reduce women's struggles to keep pace with the treatment.

Stigma and depression during pregnancy: does race matter?

Rates of depression treatment are low in pregnant women, particularly Black women. Stigma is an important barrier to treatment, but little research has examined how depression stigma differs in Blacks and Whites; a key purpose of this study. Participants were 532 pregnant women recruited in obstetrics settings, who responded to measures of stigma and mood. Black women reported more depression stigma than White women, regardless of their depression status, and were more likely to endorse the view that depression should be kept secret, than White women. In White women, stigma increased as a function of depression status (current, past, never). White women's perceptions of depression stigma were positively correlated with their beliefs about keeping depression secret. Secrecy and depression stigma were uncorrelated in Black women. There are important racial differences in the way depression stigma functions in pregnant women. Implications for engaging women in mental health treatment are discussed.

Patient preferences for clinician interactional style in treatment of perinatal depression.

Most women with depression around the time of childbearing are not treated adequately, or at all. Clinical practice guidelines focus primarily on provision of information rather than on interaction factors. In this study, we explored clinician interactional style characteristics contributing to patient response to perinatal depression referral and treatment. Stratified purposeful sampling resulted in 23 participants selected by pregnancy, socioeconomic, and depression status. Participants completed semistructured interviews exploring their experiences with and preferences for clinician interactional style characteristics in the context of obstetrics-setting referral and delivery of depression treatment. Thematic analysis revealed a central theme related to interactional cues that influence women's reactions to clinical encounters, summarized by the question, "Can this person help me?" Women evaluated this question in four domains: feeling heard, developing trust in the clinician, perceiving technical competence in the clinician, and feeling that the intervention focus is effectively chosen and communicated. Our results imply that, in addition to informational factors, the way in which clinicians interact with patients about depression might strongly influence patient responses.

Illness perceptions associated with perinatal depression treatment use.

The relationship between psychological beliefs about depression and depression treatment use was examined in depressed pregnant and postpartum women using the Common Sense Model as a framework (CSM; Leventhal H, Nerenz DR, Steele DF (1984) A handbook of psychology and health illness representations and coping with health threats. Hillsdale, NJ: Erlbaum.). Pregnant women who screened >/ 10 on the Edinburgh Postnatal Depression Scale (EPDS; Cox et al. Br J Psychiatry 150:782-786, 1987) completed measures of depression symptoms, perceptions and treatment at three time points through 6 weeks postpartum. Understanding modifiable beliefs may be useful in improving low rates of perinatal depression treatment use.