Katrina M Turner

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial

BACKGROUND Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. METHODS This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. FINDINGS Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). INTERPRETATION Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. FUNDING National Institute for Health Research Health Technology Assessment.

Facilitated physical activity as a treatment for depressed adults: randomised controlled trial

Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care. Design Pragmatic, multicentre, two arm parallel randomised controlled trial. Setting General practices in Bristol and Exeter. Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more. Interventions In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity. Main outcome measures The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up. Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003). Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone. Trial registration Current Controlled Trials ISRCTN16900744.

Adolescent substance use in different social and peer contexts: A social network analysis

This exploratory study investigates whether associations between social network measures and substance use differ according to type of substance and social context. The analyses use data obtained from 13 and 15 year olds (N = 3146) in a school-based survey and focus on three social network measures: sociometric position (e.g. group, dyad, isolate); popularity (friendship nominations received); and expansiveness (nominations made). The study aims to investigate: (i) the patterning of these social network measures by age, gender and school socioeconomic status (SES); and (ii) their relationships with substance use (current smoking, experience of drugs, alcohol in the previous week). Females and those from higher SES schools were more likely to be in groups, more popular and more expansive. Analyses including all three network measures, together with age, gender and school SES found main effects of sociometric position on smoking (lower than average rates among group members, higher than average for pupils in dyads and among isolates), of popularity on drugs and alcohol (highest levels among the most popular pupils) and of expansiveness on alcohol (highest rates among the most expansive). Interactions between the network measures, age, gender, school SES and substance use were also examined. We discuss our results concerning the use of different substances in relation to the mechanisms of selection and influence (as suggested by sociometric position, popularity and expansiveness) in differing social contexts represented by gender and school SES.

Patients with Type 2 diabetes experiences of making multiple lifestyle changes: a qualitative study

OBJECTIVES To explore patients newly diagnosed with Type 2 Diabetes Mellitus (T2DM) experiences of making single (diet) or multiple (diet and physical activity) changes in order to (1) assess whether patients experienced increases in physical activity as supporting or hindering dietary changes and vice versa, and (2) whether patients found making multiple lifestyle changes counterproductive or beneficial. METHODS In-depth interviews with 30 individuals taking part in a randomised controlled trial that aimed to determine the effect of diet and physical activity on T2DM. Interviewees had been randomised to receive usual care, intensive dietary advice, or intensive dietary advice plus information on physical activity. Respondents were interviewed 6 and 9 months post-randomisation. They were asked about their experiences of making lifestyle changes. Data were analysed thematically. RESULTS Findings suggest providing diet and physical activity information together encourages patients to use physical activity in strategic ways to aid disease management and that most patients find undertaking multiple lifestyle changes helpful. CONCLUSION Increasing physical activity can act as a gateway behaviour, i.e. behaviour that produces positive effects in other behaviours. PRACTICE IMPLICATIONS Practitioners should provide diet and physical activity information together to encourage patients to use physical activity strategically to maintain dietary changes.

Women's views and experiences of antidepressants as a treatment for postnatal depression: A qualitative study

BACKGROUND Antidepressants are frequently prescribed by GPs for postnatal depression (PND). Patients, however, may be reluctant to take medication and have concerns that result in poor treatment adherence. Few studies have explored womens views and experiences of antidepressants as a treatment for PND. GPs need to understand womens views and experiences if they are to address their concerns and improve treatment adherence. OBJECTIVE To explore womens views and experiences of antidepressants as a treatment for PND. METHODS In-depth interviews with 27 women in three UK cities who had been diagnosed with PND and taken part in a randomized controlled trial. During the trial, participants could receive antidepressants and/or non-directive counselling. Data were analysed thematically. RESULTS Most participants stated that they had held negative views towards antidepressants at the time of randomization. Some participants reported that, over the course of their illness, through time and contact with others, including health professionals, their views towards antidepressants had changed and that they had gone on to take medication. Most interviewees who had taken antidepressants reported benefits, although some remained concerned about taking medication. CONCLUSION Womens views of antidepressants can change in response to their treatment options and experiences, the views of friends and relatives and their contact with health professionals. GPs should assess womens concerns about antidepressants prior to prescribing them for PND and should provide regular follow-up for women on medication. This should lead to greater treatment adherence and thus earlier resolution of symptoms.

A pragmatic randomised controlled trial to compare antidepressants with a community-based psychosocial intervention for the treatment of women with postnatal depression: the RESPOND trial.

OBJECTIVES To evaluate clinical effectiveness at 4 weeks of antidepressant therapy for mothers with postnatal depression (PND) compared with general supportive care; to compare outcome at 18 weeks of those randomised to antidepressant therapy with those randomised to listening visits as the first intervention (both groups were to be allowed to receive the alternative intervention after 4 weeks if the woman or her doctor so decided); and to assess acceptability of antidepressants and listening visits to users and health professionals. DESIGN A pragmatic two-arm individually randomised controlled trial. SETTING Participants were recruited from 77 general practices: 21 in Bristol, 21 in south London and 35 in Manchester. PARTICIPANTS A total of 254 women who fulfilled International Classification of Diseases version 10 criteria for major depression in the first 6 postnatal months were recruited and randomised. INTERVENTIONS Women were randomised to receive either an antidepressant, usually a selective serotonin reuptake inhibitor prescribed by their general practitioner (GP), or non-directive counselling (listening visits) from a specially trained research health visitor (HV). The trial was designed to compare antidepressants with general supportive care for the first 4 weeks, after which women allocated to listening visits commenced their sessions. It allowed for women to receive the alternative intervention if they had not responded to their allocated intervention or wished to change to, or add in, the alternative intervention at any time after 4 weeks. MAIN OUTCOME MEASURES The duration of the trial was 18 weeks. Primary outcome, measured at 4 weeks and 18 weeks post randomisation, was the proportion of women improved on the Edinburgh Postnatal Depression Scale (EPDS), that is scoring < 13. Secondary outcomes were the EPDS measured as a continuous variable at 4 and 18 weeks, and scores on various other questionnaires. RESULTS At 4 weeks, women were more than twice as likely to have improved if they had been randomised to antidepressants compared with listening visits, which started after the 4-week follow-up, i.e. after 4 weeks of general supportive care [primary intention-to-treat (ITT), 45% versus 20%; odds ratio (OR) 3.4, 95% confidence interval (CI) 1.8 to 6.5, p < 0.001]. Explanatory analyses emphasised these findings. At 18 weeks, ITT analysis revealed that the proportion of women improving was 11% greater in the antidepressant group, but logistic regression analysis showed no clear benefit for one group over the other [62% versus 51%, OR 1.5 (95% CI 0.8 to 2.6), p = 0.19]. Overall, there was a difference between the groups in favour of the antidepressant group of about 25 percentage points at 4 weeks, which reduced at 18 weeks. No statistical support existed for a benefit of antidepressants at 18 weeks, but 95% CIs could not rule out a clinically important benefit. It was difficult for GPs not to prescribe antidepressants to women randomised to listening visits after the initial 4 weeks, so many women received both interventions in both groups by 18 weeks and consequently power was reduced. Qualitative interviews with women revealed a preference for listening visits but an acceptance that antidepressants might be necessary. They wished to be reassured that their GP and HV were offering continuity of care focusing on their particular set of circumstances. Interviews with GPs and HVs revealed lack of collaboration in managing care for women with PND; neither professional group was willing to assume responsibility. CONCLUSIONS At 4 weeks, antidepressants were significantly superior to general supportive care. Trial design meant that by 18 weeks many of the women initially randomised to listening visits were also receiving antidepressants, and more vice versa. The lack of evidence for differences at 18 weeks is likely to reflect a combination of reduced power and the considerable degree of switching across the two interventions. Qualitative study revealed that women found both antidepressants and listening visits effective depending on their circumstances and preferences. The trial indicates that early treatment with antidepressants leads to clinical benefit for women with PND.

A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial.

OBJECTIVE The TREAting Depression with physical activity (TREAD) study investigated the cost-effectiveness of a physical activity intervention, in addition to usual general practitioner care, as a treatment for people with depression. DESIGN An individually randomised, pragmatic, multicentre randomised controlled trial with follow-up at 4, 8 and 12 months. A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention. SETTING General practices in the Bristol and Exeter areas. PARTICIPANTS Aged 18-69 years with an International Statistical Classification of Diseases and Related Health Problems, 10th Edition (ICD-10) diagnosis of depression and scoring ≥ 14 on the Beck Depression Inventory (BDI). Those who were unable to complete self-administered questionnaires in English, with medical contraindications to physical activity or with psychosis, bipolar disorder or serious drug abuse were excluded. INTERVENTIONS We devised an intervention designed to encourage choice and autonomy in the adoption of physical activity. It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period. MAIN OUTCOME MEASURES The primary outcome was the BDI score measured at 4 months. Secondary outcomes included depressive symptoms over the 12 months and quality of life, antidepressant use and level of physical activity. RESULTS The study recruited 361 patients, with 182 randomised to the intervention arm and 179 to the usual care arm; there was 80% retention at the 4-month follow-up. The intervention group had a slightly lower BDI score at 4 months [-0.54, 95% confidence interval (CI) -3.06 to 1.99] but there was no evidence that the intervention improved outcome for depression. Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants. However, the amount of physical activity undertaken by those who had received the intervention was increased (odds ratio 2.3, 95% CI 1.3 to 3.9) and was sustained beyond the end of the intervention. From a health-care perspective, the intervention group was more costly than the usual care group, with the cost of the intervention £220 per person on average. It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds. CONCLUSIONS This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression. Previous research has reported some benefit and there are three possible reasons for this discrepancy: first, even though the intervention increased self-reported physical activity, the increase in activity was not sufficiently large to lead to a measurable influence; second, only more vigorous activity might be of benefit; and third, previous studies had recruited individuals with a pre-existing commitment to physical activity. Future research is needed to identify and explain the mechanisms by which depression might be effectively treated, including, in particular, specific guidance on the optimum type, intensity and duration of physical activity required to produce a therapeutic effect. TRIAL REGISTRATION Current Controlled Trials ISRCTN16900744. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 10. See the HTA programme website for further project information.

Parents’ views on child physical activity and their implications for physical activity parenting interventions: a qualitative study

BackgroundEstablishing healthy physical activity (PA) behaviours in early childhood is important for future PA behaviours. Parents play a central role in young children’s PA. However, there is currently little research on parenting interventions to increase child PA. This study was formative work to inform the content of a pilot randomised-controlled trial.MethodsIn-depth telephone interviews were carried out with 32 parents of 6 to 8 year old children residing in two areas that varied in their socio-economic characteristics, in Bristol, UK. Data were analysed thematically using a framework approach.ResultsMost parents described their child as being active or very active and indicated that they did not perceive a need for an increase in their child’s PA. Parents used a variety of visual cues to make this judgement, the most common being that they perceived their child as having lots of energy or that they did not view them as overweight. Parents reported environmental factors such as monetary cost, time constraints, lack of activity provision and poor weather as the main barriers to their child’s PA. Parental support and child’s enjoyment of PA appeared to be important facilitators to children participating in PA.ConclusionImproving parents’ knowledge of the PA recommendations for children, and increasing their awareness of the benefits of PA beyond weight status may be an important first step for a parenting PA intervention. Although parents commonly perceive environmental factors as the main barriers to their child’s PA, parental concern about low levels of child PA, their capacity to support behaviour change, child motivation, self confidence and independence may be key areas to address within an intervention to increase child PA. Effective methods of helping parents address the latter have been developed in the context of generic parenting programmes.

Women's experiences of health visitor delivered listening visits as a treatment for postnatal depression: A qualitative study

OBJECTIVE To explore womens experiences of health visitor delivered listening visits as a treatment for postnatal depression. METHODS In-depth interviews with 22 women who had received listening visits as a treatment for postnatal depression. RESULTS All the women reported the visits as beneficial, although many of them had required additional intervention to manage their symptoms. Women who had a previous history of depression and women whose depression was not attributed to events in the postnatal period perceived the listening visits to be less beneficial. Receiving visits from a research health visitor, rather than their practice health visitor, was felt to be advantageous. CONCLUSION Women with postnatal depression may report listening visits as helpful but insufficient to manage their depression. The extent to which women report listening visits as beneficial appears to be linked to the causes of their depression, the way in which the visits are delivered and by whom. PRACTICE IMPLICATIONS Practitioners managing women with postnatal depression should discuss possible causes and previous episodes of depression before suggesting listening visits as a treatment. They need to explain what the visits will entail, ensure that additional types of treatment remain available and encourage women to utilise other forms of support.

How children from disadvantaged areas keep safe

Purpose – The paper sets out to describe how children from disadvantaged areas perceive their communities and actively negotiate threats in their lives.Design/methodology/approach – A total of 60 interviews and 16 discussions groups were held with 8 to 14‐year‐olds sampled from four deprived communities located in the West of Scotland. Participants were asked about their local area and how they kept safe. Data were coded thematically and area, age and gender differences examined.Findings – Children mentioned both positive and negative aspects of their local area. Positive elements primarily related to being near friends and important adults. The negatives were linked to local youth gangs, adults, litter and graffiti, traffic, and drug and alcohol misuse. Participants used both preventive and reactive strategies to keep safe.Research limitations/implications – Owing to the strategies used to sample areas and participants, the extent to which findings can be generalised is limited. Thus, the study should be...