Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

The role of lifetime stressors in adult fibromyalgia: systematic review and meta-analysis of case-control studies.

BACKGROUND: Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain. Although accumulating evidence suggests that exposure to stressful events increases the risk for this complex disorder, this is the first meta-analysis to compare the impact of a full range of lifetime stressors (e.g. physical trauma through to emotional neglect) on adult fibromyalgia. METHODS: This review was performed in accordance with PRISMA guidelines. Random-effects models examined associations between different stressor exposures and fibromyalgia status with meta-regression investigating the effects of publication year and study quality on effect sizes. RESULTS: Nineteen studies were included in the meta-analysis. Significant associations with fibromyalgia status were observed for all six exposure types examined: odds ratios (OR) were highest for physical abuse (OR 3.23, 95% confidence interval 1.99-5.23) and total abuse (3.06, 1.71-5.46); intermediate for sexual abuse (2.65, 1.85-3.79) and smaller for medical trauma (1.80, 1.19-2.71), other lifetime stressors (1.70, 1.31-2.20), and emotional abuse (1.52, 1.27-1.81). Results were not significantly changed when childhood, as opposed to adult, exposures were used in studies that reported both. Meta-regression analyses demonstrated no effect of publication year or study quality on effect sizes. CONCLUSIONS: This study confirmed a significant association between stressor exposure and adult fibromyalgia with the strongest associations observed for physical abuse. Limitations related to current available literature were identified; we provide several suggestions for how these can be addressed in future studies. Stressors are likely to be one of many risk factors for fibromyalgia which we argue is best approached from a biopsychosocial perspective.

Exploration of the influence of insecure attachment and parental maltreatment on the incidence and course of adult clinical depression.

BACKGROUND: Both childhood maltreatment and insecure attachment are known to be associated with depression in adulthood. The extent insecure attachment increases the risk of adult clinical depression over that of parental maltreatment among women in the general population is explored, using those at high risk because of their selection for parental maltreatment together with an unselected sample. METHODS: Semi-structured interviews and investigator-based measures are employed. RESULTS: Insecure attachment is highly associated with parental maltreatment with both contributing to the risk of depression, with attachment making a substantial independent contribution. Risk of depression did not vary by type of insecure attachment, but the core pathways of the dismissive and enmeshed involved the whole life course in terms of greater experience of a mother's physical abuse and their own anger as an adult, with both related to adult depression being more often provoked by a severely threatening event involving humiliation rather than loss. By contrast, depression of the insecure fearful and withdrawn was more closely associated with both current low self-esteem and an inadequately supportive core relationship. In terms of depression taking a chronic course, insecure attachment was again a key risk factor, but with this now closely linked with the early experience of a chaotic life style but with this involving only a modest number of women. CONCLUSIONS: Both insecure attachment and parental maltreatment contribute to an increased risk of depression with complex effects involving types of insecure attachment.

Functional polymorphism in the brain-derived neurotrophic factor gene interacts with stressful life events but not childhood maltreatment in the etiology of depression.

BACKGROUND: We test the hypothesis that the functional Val66Met polymorphism of BDNF interacts with recent life events to produce onset of new depressive episodes. We also explore the possibility that the Met allele of this polymorphism interacts with childhood maltreatment to increase the risk of chronic depression. METHODS: In a risk-enriched combined sample of unrelated women, childhood maltreatment and current life events were measured with the Childhood Experience of Care and Abuse, and Life Events and Difficulties Schedule interviews. Chronic episodes of depression (12 months or longer) during adulthood and onset of a major depressive episode during a 12-month follow-up were established with the Schedules for Clinical Assessment in Neuropsychiatry interview. RESULTS: Met alleles of BDNF moderated the relationship between recent life events and adult onsets of depression in a significant gene-environment interaction (interaction risk difference 0.216, 95% CI 0.090-0.342; P =.0008). BDNF did not significantly influence the effect of childhood maltreatment on chronic depression in the present sample. CONCLUSIONS: The Met allele of BDNF increases the risk of a new depressive episode following a severe life event. The BDNF and the serotonin transporter gene length polymorphism (5-HTTLPR) and BDNF may contribute to depression through distinct mechanisms involving interactions with childhood and adulthood adversity respectively, which may, in combination, be responsible for a substantial proportion of depression burden in the general population.

Serotonin transporter length polymorphism, childhood maltreatment, and chronic depression: a specific gene-environment interaction.

BACKGROUND: Key questions about the interaction between the serotonin transporter length polymorphism (5-HTTLPR) and stress in the etiology of depression remain unresolved. We test the hypotheses that the interaction is restricted to childhood maltreatment (as opposed to stressful events in adulthood), and leads to chronic depressive episodes (as opposed to any onset of depression), using gold-standard assessments of childhood maltreatment, severe life events, chronic depression, and new depressive onsets. METHOD: In a risk-enriched sample of 273 unrelated women, childhood maltreatment was retrospectively assessed with the Childhood Experience of Care and Abuse (CECA) interview and 5-HTTLPR was genotyped. A subset of 220 women was followed prospectively for 12 months with life events assessed with the Life Events and Difficulties (LEDS) interview. Any chronic episode of depression (12 months or longer) during adulthood and onset of a major depressive episode during a 12-month follow-up were established with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview. RESULTS: The short alleles of 5-HTTLPR moderated the relationship between childhood maltreatment and chronic depression in adulthood, reflected in a significant gene-environment interaction (RD = 0.226, 95% CI: 0.076-0.376, P = .0032). 5-HTTLPR did not moderate the effects of either childhood maltreatment or severe life events on new depressive onsets. CONCLUSIONS: The short variant of the serotonin transporter gene specifically sensitizes to the effect of early-life experience of abuse or neglect on whether an adult depressive episode takes a chronic course. This interaction may be responsible for a substantial proportion of cases of chronic depression in the general population.

Interrogating intervention delivery and participants' emotional states to improve engagement and implementation: A realist informed multiple case study evaluation of Engager.

BACKGROUND: 'Engager' is an innovative 'through-the-gate' complex care intervention for male prison-leavers with common mental health problems. In parallel to the randomised-controlled trial of Engager (Trial registration number: ISRCTN11707331), a set of process evaluation analyses were undertaken. This paper reports on the depth multiple case study analysis part of the process evaluation, exploring how a sub-sample of prison-leavers engaged and responded to the intervention offer of one-to-one support during their re-integration into the community. METHODS: To understand intervention delivery and what response it elicited in individuals, we used a realist-informed qualitative multiple 'case' studies approach. We scrutinised how intervention component delivery lead to outcomes by examining underlying causal pathways or 'mechanisms' that promoted or hindered progress towards personal outcomes. 'Cases' (n = 24) were prison-leavers from the intervention arm of the trial. We collected practitioner activity logs and conducted semi-structured interviews with prison-leavers and Engager/other service practitioners. We mapped data for each case against the intervention logic model and then used Bhaskar's (2016) 'DREIC' analytic process to categorise cases according to extent of intervention delivery, outcomes evidenced, and contributing factors behind engagement or disengagement and progress achieved. RESULTS: There were variations in the dose and session focus of the intervention delivery, and how different participants responded. Participants sustaining long-term engagement and sustained change reached a state of 'crises but coping'. We found evidence that several components of the intervention were key to achieving this: trusting relationships, therapeutic work delivered well and over time; and an in-depth shared understanding of needs, concerns, and goals between the practitioner and participants. Those who disengaged were in one of the following states: 'Crises and chaos', 'Resigned acceptance', 'Honeymoon' or 'Wilful withdrawal'. CONCLUSIONS: We demonstrate that the 'implementability' of an intervention can be explained by examining the delivery of core intervention components in relation to the responses elicited in the participants. Core delivery mechanisms often had to be 'triggered' numerous times to produce sustained change. The improvements achieved, sustained, and valued by participants were not always reflected in the quantitative measures recorded in the RCT. The compatibility between the practitioner, participant and setting were continually at risk of being undermined by implementation failure as well as changing external circumstances and participants' own weaknesses. TRIAL REGISTRATION NUMBER: ISRCTN11707331, Wales Research Ethics Committee, Registered 02-04-2016-Retrospectively registered https://doi.org/10.1186/ISRCTN11707331.

Depression and the serotonin transporter 5-HTTLPR polymorphism: a review and a hypothesis concerning gene-environment interaction.

Studies of the interaction of the serotonin transporter genotype and environment upon adult depression (G x E) have suggested a role for both childhood maltreatment and stressful life events. This paper deals with two main issues. First, do both contribute? Evidence that G x E with childhood maltreatment plays a role is much stronger than that for G x E with life events occurring close to onset, although that for G x E with life events occurring over a 5-year period before the presence of the recorded depression is stronger. However, non-genetic research shows that life events occurring so long before onset as 5 years have little or no relationship with adult depression once childhood maltreatment is taken into account, suggesting they serve as a marker for childhood maltreatment rather than making a direct contribution to G x E. Second, genetic research has dealt only with the presence of depression and taking account of course may radically change ideas about the point at which G x E occurs. Two findings from non-genetic research concerning childhood maltreatment are relevant. Childhood maltreatment is associated with a particularly high risk of an adult onset of depression taking a chronic course (i.e. lasting 12 months or more). Moreover such maltreatment makes a substantial direct contribution - i.e. its link with course is independent of all other childhood and adult risk factors. This is consistent with early changes in brain function associated with the polymorphism in the context of childhood maltreatment explaining the link of such maltreatment with adult chronic episodes. It also follows that restricting analysis to such episodes would increase current estimates of G x E.

Parental maltreatment and proximal risk factors using the Childhood Experience of Care & Abuse (CECA) instrument: a life-course study of adult chronic depression - 5.

BACKGROUND: This is the final paper of a series concerning parental maltreatment and chronic depression in women. It extends the scope of the analysis to take account of proximal risk factors, present within at most six months of an onset. It deals with the contribution of factors influencing onset of a depressive episode as well as those related to whether this takes a chronic course. Once a two-stage model dealing with both sets of risk factors has been developed we explore how far distal factors (more than at least one year earlier) influence each stage. METHODS: Three studies are employed. All take account of parental maltreatment. Two prospective studies deal with proximal risk factors, and a retrospective one with distal and proximal factors. RESULTS: For the first stage of the model concerning onset the influence of parental maltreatment and its correlated risk factors (e.g. conduct problems) are almost entirely mediated by proximal factors (e.g. quality of core relationships). However, for the second stage concerning course parental maltreatment makes a direct contribution that is independent of all other risk factors. LIMITATIONS: The retrospective nature of some of the data may introduce bias (But see the second paper in the present series [Brown, G.W., Craig, T.K.J., Harris, T.O., Handley, R.V., Harvey, A.L., 2007b. Validity of retrospective measures of early maltreatment and depressive episodes using the Childhood Experience of Care & Abuse (CECA) instrument - a life-course study of adult chronic depression - 2. J. Affect. Dis., 103, 217-224]). Only females have been considered. CONCLUSIONS: The influence of parental maltreatment on the onset of adult depression is largely indirect and the mechanisms involved are reasonably clear. However, the mechanisms involved in the substantial direct contribution of maltreatment to course are as yet unclear. Some interplay of maltreatment and early brain development is one of a number of interesting possibilities.

Parental maltreatment and adulthood cohabiting partnerships: a life-course study of adult chronic depression--4.

BACKGROUND: This fourth paper of a series of five concerning depression in women considers: i. why parental maltreatment increases risk of highly aversive ('very poor') partnerships, and ii. how far these relationships explain the link of such maltreatment with adult chronic depression. METHODS: Data was collected retrospectively by semi-structured interviews and only women living at some point with a partner included. RESULTS: Parental maltreatment was indirectly linked to chronic depression via highly aversive partnerships. This was partly mediated by childhood conduct problems. However, a broader range of behaviour in late adolescence and early adulthood such as early risky sexual behaviour among those without conduct problems was also involved. In addition parental maltreatment was directly linked to chronic depression, judged by a substantial remaining association when other risk factors were controlled. Highly aversive partnerships were less common by the late 20s while this was matched by an increase of 'very poor' circumstances among those no longer living with a partner. This increase often involved lone motherhood, an established risk factor for chronic depression. LIMITATIONS: These findings should be seen as tentative given the retrospective nature of many of the measures (But see the second paper in the present series [Brown, G.W., Craig, T.K.J., Harris, T.O., Handley, R.V., & Harvey, A.L. (2007b). Validity of retrospective measures of early maltreatment and depressive episodes using CECA (Childhood Experience of Care & Abuse)--A life-course study of adult chronic depression--2. J. Affect. Disord., 103, 217-224]. Only women were studied. CONCLUSIONS: Parental maltreatment relates indirectly to adult chronic episodes of depression with highly aversive partnerships playing an important mediating role. Parental maltreatment also has a direct link. While these results are broadly consistent with earlier research a more complete understanding of the mechanisms acting across the life-course requires an assessment of a wider range of factors around the time of an onset of depression. This is the task of our next and final paper.

The feasibility of following up prisoners, with mental health problems, after release: a pilot trial employing an innovative system, for engagement and retention in research, with a harder-to-engage population.

BACKGROUND: Following up released prisoners is demanding, particularly for those prisoners with mental health problems, for whom stigma and chaotic lifestyles are problematic. Measurement of mental health outcomes after release is challenging. To evaluate mental healthcare for offender populations, using high-quality randomised controlled trials, evidenced-based methods must be developed to engage them while in custody, to locate and re-interview them after release, and to collect potentially stigmatising mental health outcomes data. METHODS: We developed an initial theoretical model and operational procedures for collecting baseline and follow-up data informed by a literature search, focus groups, and case studies. Male prisoners from five prisons in two sites were invited to participate. The inclusion criteria included individuals who were above threshold on nine-item Patient Health Questionnaire, seven-item Generalized Anxiety Disorder, or post-traumatic stress disorder scales, or who had reported mental health problems in the past 2 years or had been assessed with a likely personality disorder. Potential participants were interviewed to generate baseline data and were re-contacted before their release. We then contacted them for a follow-up interview, which included repeating the earlier data collection measures 2-8 weeks after release. A qualitative formative process evaluation produced and refined a model procedure for the recruitment and retention of male prison leavers in trials, identified the mechanisms which promoted engagement and retention, and mapped these against a theoretical behaviour change model. RESULTS: We developed a flexible procedure which was successful in recruiting male prison leavers to a pilot trial: 185/243 (76%, 95% confidence interval (CI) 70-81%) of those approached agreed to participate. We also retained 63% (95% CI 54-71%) of those eligible to participate in a follow-up interview 2-8 weeks after release. Mental health outcomes data was collected at both these time points. CONCLUSIONS: It is possible to design acceptable procedures to achieve sustained engagement critical for delivering and evaluating interventions in prison and in the community and to collect mental health outcomes data. These procedures may reduce attrition bias in future randomised controlled trials of mental health interventions for prison leavers. This procedure has been replicated and successfully delivered in a subsequent pilot trial and a definitive randomised controlled trial.

Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

BACKGROUND: Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial. METHODS: Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported. RESULTS: Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release. CONCLUSIONS: This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based on this pilot study and some minor changes to the trial design and intervention, a full two-centre randomised trial assessing the clinical and cost-effectiveness of the ENGAGER intervention is currently underway.

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.

Validity of retrospective measures of early maltreatment and depressive episodes using the Childhood Experience of Care and Abuse (CECA) instrument -- A life-course study of adult chronic depression - 2.

BACKGROUND: A previous paper, using data collected retrospectively from sister pairs, reported substantial associations of adult depressive episodes lasting at least 12 months with childhood maltreatment [Brown, G.W., Craig, T.K.J., Harris, T.O. Handley, R.V. & Harvey, A.L. 2007a-this issue. Development of a retrospective interview measure of parental maltreatment using the Childhood Experience of Care & Abuse (CECA) instrument - a life-course study of adult chronic depression - 1. J. Affect. Disord. doi:10.1016/j.jad.2007.05.022]. Risk was far less when depressive episodes of any duration were considered. This paper considers how much scientific weight can be placed on these findings in the light of doubt often expressed about retrospective collection of childhood and adult data. METHODS: The retrospectively gathered material was obtained from adult sister pairs within 5 years of age, comprising a high-risk series (n = 118) where the first sister was selected as likely to have experienced childhood abuse or neglect, and a comparison series (n = 80) where she was selected at random. Current age ranged between early 20s and 50s. Data was collected by semi-structured interviews, using investigator-based ratings covering a wide range of parental behaviour and childhood behaviour. RESULTS: A series of analyses failed to reveal evidence of significant bias in the collection of material about adult depression or parental maltreatment. There was, however, some evidence of under reporting. LIMITATIONS: Conclusions from such analyses can only be judged in terms of degree of plausibility. CONCLUSIONS: Nothing emerged to suggest the presence of significant bias in the aetiological findings of our earlier paper. There is evidence of some underreporting of both early adverse experience and adult depressive episodes, but this is unlikely to threaten the conclusions drawn about the link of parental maltreatment with adult chronic depressive episodes.

Development of a retrospective interview measure of parental maltreatment using the Childhood Experience of Care and Abuse (CECA) instrument -- A life-course study of adult chronic depression - 1.

BACKGROUND: Childhood maltreatment among women is related to risk of adult depression and particularly an episode taking a chronic course. This paper explores the aspects of parental behaviour involved. METHODS: An expanded version of CECA (Childhood Experiences of Care and Abuse), a retrospective interview-based instrument covering neglect as well as various forms of abuse is used to develop a new index of parental maltreatment. Data are derived from an enquiry of sister pairs between early 20s and 50s, comprising a high-risk series (n=118) where the first sister was selected as likely to have experienced childhood abuse or neglect, and a comparison series (n=80) where she was selected at random. RESULTS: Adverse maternal behaviour emerges as of critical importance for the link with adult chronic depression. Maternal lack of affection ('neglect') and maternal rejection ('emotional abuse') form the core of an index of parental maltreatment, and it is concluded that persistent rejection, particularly from a mother, appears to be the core experience of importance. The findings of behavioural genetics that the experience of siblings of parents in ordinary families often differs have been found to hold for the more extreme behaviour involved in maltreatment. Difference between siblings in risk of later chronic depression is entirely related to such experience. LIMITATIONS: The study is based on retrospective questioning of adult women. Our next paper considers the possible threats to validity involved [Brown, G.W., Craig, T.K.J., Harris, T.O., Handley, R.V., Harvey, A.L., 2007a. Validity of retrospective measures of early maltreatment and depressive episodes using CECA (Childhood Experience of Care and Abuse) - a life-course study of adult chronic depression - 2. J. Affect. Disord. doi:10.1016/j.jad.2007.06.003]. CONCLUSIONS: Parental maltreatment emerges as a critical determinant of later chronic depressive episodes among adult women.

Child-specific and family-wide risk factors using the retrospective Childhood Experience of Care & Abuse (CECA) instrument: a life-course study of adult chronic depression - 3.

BACKGROUND: An earlier paper [Brown, G.W., Craig, T.K.J., Harris, T.O., Handley, R.V., Harvey, A.L., 2007a-this issue. Development of a retrospective interview measure of parental maltreatment using the Childhood Experience of Care & Abuse (CECA) instrument - a life-course study of adult chronic depression - 1. J. Affect. Disord. doi:10.1016/j.jad.2007.05.022] documented an association between parental maltreatment and risk of adult chronic depression. This paper explores the contribution of other child-specific factors (e.g. conduct problems) and family-wide factors (e.g. parental discord). METHODS: Data are derived from an enquiry of 198 women largely comprising of adult sister pairs. Data was collected by semi-structured interviews covering a wide range of parental behaviour and childhood behaviour. RESULTS: Parental maltreatment emerged as channelling the effect of family-wide factors on risk of adult chronic depression, but with a child's conduct problems and shame-withdrawal partly mediating this link. A child's depression before 17, although correlated with parental maltreatment, did not appear to play a significant role in adult depression. This core model is supplemented by analyses exploring the mechanisms involved. A mother's rejection/physical abuse and her depression via her lax control, for example, account for the link of parental maltreatment with conduct problems. Also 'rebelliousness' of a child relates to the chances of her low affection moving to rejection. "Rebelliousness" also appears to play a role in why the paired sisters so often had a different experience of maltreatment. LIMITATIONS: The data is collected retrospectively - but see [Brown, G.W., Craig, T.K.J., Harris, T.O., Handley, R.V., Harvey, A.L., 2007b-this issue. Validity of retrospective measures of early maltreatment and depressive episodes using the Childhood Experience of Care and Abuse (CECA) instrument - A life-course study of adult chronic depression - 2. J. Affect. Disord. doi:10.1016/j.jad.2007.06.003]. CONCLUSIONS: Child-specific factors play a major role in the origins of adult chronic depressive episodes. This, however, is fully consistent with an equally significant contribution from family-wide factors. The crucial point is that the link of the latter with such depression appears to be indirect and mediated very largely by parental maltreatment.

Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study).

BACKGROUND: Depression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. OBJECTIVES: The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. The specific objectives were to confirm methods for practice recruitment and the ability to recruit patients via the proposed approaches; to determine the acceptability of the study interventions and outcome measures; to assess contamination; to confirm the randomisation method for main trial and the level of participant attrition; and to check the robustness of data collection systems. DESIGN: An adaptive, parallel, two-group multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation. Both individual- and cluster (general practice)-level were was used in the pilot phase to assign participants to intervention or control groups. SETTING: General practices in England and Wales. PARTICIPANTS: Individuals were included who were aged ≥ 18 years, scored ≥ 14 on the Beck Depression Inventory II and self-identified as having debt worries. The main exclusion criteria were being actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; having a severe addiction to alcohol/illicit drugs; being unable/unwilling to give written informed consent; currently participating in other research including follow-up phases; having received Citizens Advice Bureau (CAB) debt advice in the past year; and not wanting debt advice via a general practice. INTERVENTIONS: The participants in the intervention group were given debt advice provided by the CAB and shared biopsychosocial assessment, in addition to treatment as usual (TAU) and two debt advice leaflets. The participants in the control group were given advice leaflets provided by the general practitioner and TAU only. MAIN OUTCOME MEASURES: (1) Outcomes of the pilot trial - the proportion of eligible patients who consented, the number of participants recruited compared with target, assessment of contamination, and assessment of patient satisfaction with intervention and outcome measures. (2) Participant outcomes - primary - Beck Depression Inventory II; secondary - psychological well-being, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties, and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and at 4 months post randomisation. Other data sources - qualitative interviews were conducted with participants, clinicians and CAB advisors. RESULTS: Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 in the intervention group and 29 in the control group). All participants provided baseline outcomes and 52 provided the primary outcome at 4 months' follow-up (14.7% dropout). Seventeen participants allocated to the intervention saw a CAB advisor. Descriptive statistics are reported for participants with complete outcomes at baseline and 4 months' follow-up. Our qualitative findings suggest that the relationship between debt and depression is complex, and the impact of each on the other is compounded by other psychological, social and contextual influences. CONCLUSIONS: As a result of low recruitment, this trial was terminated at the internal pilot phase and was too small for inferential statistical analysis. We recommend ways to reduce this risk when conducting complex trials among vulnerable populations recruited in community settings. These cover trial design, the design and delivery of interventions, recruitment strategies and support for sites. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79705874. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 35. See the NIHR Journals Library website for further project information. Mark Gabbay and Adele Ring are part-funded by NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) North West Coast and Richard Byng and Rod S Taylor, Vashti Berry and Elizabeth Shaw part-funded by NIHR CLAHRC South West Peninsula.

Effects of social support during weekend leave on cortisol and depression ratings: a pilot study.

BACKGROUND: The biological mechanism by which social support influences the course of a depressive episode may involve the stress response which is reflected and/or mediated by cortisol. The study took advantage of the weekend leave that inpatients receive towards the end of an admission to investigate the inter-relationship between social support, cortisol secretion, and the severity of depression. METHOD: For 23 inpatients with a major depressive episode (DSM IV) differences between ward and home in social support, depression ratings, and cortisol secretion were compared. The effect of hassles on cortisol secretion was also assessed. RESULTS: An inverse linear relationship was found between changes in social support and depression ratings across the two settings. No relationship was found between changes in the other two sets of variables. Hassles resulted in increased cortisol secretion. LIMITATIONS: The small sample limits the analysis of hypotheses of interest. Findings are restricted to an inpatient tertiary referral sample. CONCLUSIONS: Weekend leave is an appropriate paradigm to study the effect of social influences on cortisol secretion, and the severity of depression. It is feasible for depressed inpatients to accurately collect timed saliva samples both on the ward and when at home, and for research workers to measure social support provided by a ward. The relationship between social support and depression has clinical implications in terms of interpreting mood changes following weekend leave. Hassles are associated with increased secretion of cortisol in depressed patients, which extends similar previous findings in normal subjects.

Preliminary evidence that sub-chronic citalopram triggers the re-evaluation of value in intimate partnerships.

Depression frequently involves disrupted inter-personal relationships, while treatment with serotonergic anti-depressants can interfere with libido and sexual function. However, little is known about how serotonin activity influences appraisals of intimate partnerships. Learning more could help to specify how serotonergic mechanisms mediate social isolation in psychiatric illness. Forty-four healthy heterosexual adults, currently in romantic relationships, received 8 days treatment with the selective serotonin re-uptake inhibitor citalopram (N = 21; 10 male) or placebo (N = 23; 12 male). Participants viewed photographs of unknown, heterosexual couples and made a series of judgements about their relationships. Participants also indicated the importance of relationship features in their own close partnerships, and close partnerships generally. Citalopram reduced the rated quality of couples' physical relationships and the importance attributed to physical and intimate aspects of participants' own relationships. In contrast, citalopram also enhanced the evaluated worth of mutual trust in relationships. Amongst males, citalopram was associated with judgements of reduced turbulence and bickering in others' relationships, and increased male dominance. These data constitute preliminary evidence that enhancing serotonin activity modulates cognitions about sexual activity as part of a re-appraisal of sources of value within close intimate relationships, enhancing the judged importance of longer-term benefits of trust and shared experiences.

'Watchful waiting' or 'active monitoring' in depression management in primary care: exploring the recalled content of general practitioner consultations.

BACKGROUND: Current NICE depression guidelines recommend a period of 'active monitoring' prior to commencing treatment with antidepressants. The content of consultations during active monitoring or supportive care has not been previously prescribed. METHODS: As part of a randomised trial of supportive care versus supportive care plus SSRI consultation content was measured through patient recall for the purpose of testing equity in content between trial arms. An exploratory analysis of the consultation content measure is presented together with a measure of consultation satisfaction (MISS) and depression severity (HMRD). A score for 'psychoactive consultation content' (PSAC) was generated to enable comparison between groups. RESULTS: 220 patients were randomised in the study. The majority of participants recalled a discussion of practical problems they faced and many reported some element of problem solving; a significant minority reported discussions about changing the way they thought, addressing relationships or talking to trusted friends or family. Consultation content was unrelated to depression outcome although in multivariate analysis it was strongly related to consultation satisfaction. LIMITATIONS: This is a secondary analysis based on patient recall of consultation content. CONCLUSIONS: Supportive care is not a passive process as patients report several potentially therapeutic discussions within the consultation and these occur regardless of whether antidepressants are prescribed. It is not known whether these discussions do have any therapeutic value in this context. Consultation content was unrelated to outcome in this study but did predict satisfaction with the consultation. Further work is required to validate the patient report of consultation content and to identify what if any consultation strategies have therapeutic effect.