Judith Gellatly

Improving outcomes for COPD patients with mild-to-moderate anxiety and depression: A systematic review of cognitive behavioural therapy

PURPOSE Anxiety and depression are highly prevalent in patients with chronic obstructive pulmonary disease (COPD) and are associated with lower levels of self-efficacy, impaired health status, poorer treatment outcomes and reduced survival following emergency admission. Cognitive behavioural therapy (CBT) may be effective for treating anxiety and depression in COPD patients but evidence for this is uncertain. METHODS A systematic review of controlled trials that evaluated the effectiveness of CBT for treating mild-to-moderate anxiety or depression in adults with clinically stable COPD. Ovid electronic bibliographic databases were searched from inception to May 2006; all content held by the Cochrane Library Issue 3, 2006 was also searched. RESULTS One small randomized controlled trial (RCT) of moderate quality showed that CBT, when given with exercise training and education, was associated with large and significant treatment effects for both anxiety (-1.39 (95% CIs -2.19, -0.59)) and depression (-0.86 (95% CIs -1.61, -0.11)). Additionally, a larger RCT of higher quality demonstrated that CBT, when given with exercise and education, was associated with large and significant treatment effects for depression (-0.76 (95% CIs -1.34, -0.17)), but not for anxiety. No other included study reported significant reductions in either anxiety or depression in COPD patients given CBT. CONCLUSION There is only limited evidence that CBT, when used with exercise and education, can contribute to significant reductions in anxiety and depression in COPD patients. There is scope for a well-powered RCT to evaluate the effectiveness and acceptability of CBT among this patient population.

Developing guided self-help for depression using the Medical Research Council complex interventions framework: A description of the modelling phase and results of an exploratory randomised controlled trial

BackgroundCurrent guidelines for the management of depression suggest the use of guided self-help for patients with mild to moderate disorders. However, there is little consensus concerning the optimal form and delivery of this intervention. To develop acceptable and effective interventions, a phased process has been proposed, using a modelling phase to examine and develop an intervention prior to preliminary testing in an exploratory trial. This paper (a) describes the modelling phase used to develop a guided self-help intervention for depression in primary care and (b) reports data from an exploratory randomised trial of the intervention.MethodsA guided self-help intervention was developed following a modelling phase which involved a systematic review, meta synthesis and a consensus process. The intervention was then tested in an exploratory randomised controlled trial by examining (a) fidelity using analysis of taped guided self-help sessions (b) acceptability to patients and professionals through qualitative interviews (c) effectiveness through estimation of the intervention effect size.ResultsFifty eight patients were recruited to the exploratory trial. Seven professionals and nine patients were interviewed, and 22 tapes of sessions analysed for fidelity. Generally, fidelity to the intervention protocol was high, and the professionals delivered the majority of the specific components (with the exception of the use of feedback). Acceptability to both professionals and patients was also high. The effect size of the intervention on outcomes was small, and in line with previous analyses showing the modest effect of guided self-help in primary care. However, the sample size was small and confidence intervals around the effectiveness estimate were wide.ConclusionThe general principles of the modelling phase adopted in this study are designed to draw on a range of evidence, potentially providing an intervention that is evidence-based, patient-centred and acceptable to professionals. However, the pilot outcome data did not suggest that the intervention developed was particularly effective. The advantages and disadvantages of the general methods used in the modelling phase are discussed, and possible reasons for the failure to demonstrate a larger effect in this particular case are outlined.

The effectiveness of self-care support interventions for children and young people with long-term conditions: A systematic review

Childrens health policy has highlighted the need to develop self-care programmes. However, there is a lack of evidence on which to base the development of such programmes. This paper reviews the published research on the effectiveness of self-care support interventions for children and young people with asthma, cystic fibrosis and diabetes. A systematic search was conducted of a range of electronic databases, supplemented by searching the reference lists of retrieved papers and published reviews. Retrieved studies were assessed against quality and eligibility criteria by two independent reviewers. The results were narratively synthesized to examine the effectiveness of self-care support interventions on health status, psycho-social well-being, condition-related knowledge, health service use and participant satisfaction. The search strategy identified 4261 papers which were screened against the review inclusion criteria. A total of 194 papers were assessed as being potentially eligible for inclusion with 15 papers being judged as adequate to include in the review. There is strong evidence of the effectiveness of interventions that target children/young people; use e-health or group-based methods; that are delivered in community settings. There is no evidence that interventions that focus on parents alone or are delivered only in hospital settings are effective. While there is some evidence to inform the development of self-care support programmes, there is a need for well-designed trials of interventions that are feasible to transfer into real-life settings and which involve parents and children in their development.

Obsessive Compulsive Treatment Efficacy Trial (OCTET) comparing the clinical and cost effectiveness of self-managed therapies: study protocol for a randomised controlled trial.

BackgroundUK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach. Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help (GSH) to more intensive psychological and pharmacological interventions. Cognitive behavioural therapy (CBT), including exposure and response prevention, is the recommended psychological treatment. However, whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective, a more robust evidence base of their clinical and cost effectiveness and acceptability is required.Methods/DesignOur proposed study will test two different self-help treatments for OCD: 1) computerised CBT (cCBT) using OCFighter, an internet-delivered OCD treatment package; and 2) GSH using a book. Both treatments will be accompanied by email or telephone support from a mental health professional. We will evaluate the effectiveness, cost and patient and health professional acceptability of the treatments.DiscussionThis study will provide more robust evidence of efficacy, cost effectiveness and acceptability of self-help treatments for OCD. If cCBT and/or GSH prove effective, it will provide additional, more accessible treatment options for people with OCD.Trial registrationCurrent Controlled Trials: ISRCTN73535163. Date of registration: 5 April 2011

Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of obsessive-compulsive disorder: the Obsessive-Compulsive Treatment Efficacy randomised controlled Trial (OCTET).

BACKGROUND The Obsessive-Compulsive Treatment Efficacy randomised controlled Trial emerged from a research recommendation in National Institute for Health and Care Excellence obsessive-compulsive disorder (OCD) guidelines, which specified the need to evaluate cognitive-behavioural therapy (CBT) treatment intensity formats. OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of two low-intensity CBT interventions [supported computerised cognitive-behavioural therapy (cCBT) and guided self-help]: (1) compared with waiting list for high-intensity CBT in adults with OCD at 3 months; and (2) plus high-intensity CBT compared with waiting list plus high-intensity CBT in adults with OCD at 12 months. To determine patient and professional acceptability of low-intensity CBT interventions. DESIGN A three-arm, multicentre, randomised controlled trial. SETTING Improving Access to Psychological Therapies services and primary/secondary care mental health services in 15 NHS trusts. PARTICIPANTS Patients aged ≥ 18 years meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria for OCD, on a waiting list for high-intensity CBT and scoring ≥ 16 on the Yale-Brown Obsessive Compulsive Scale (indicative of at least moderate severity OCD) and able to read English. INTERVENTIONS Participants were randomised to (1) supported cCBT, (2) guided self-help or (3) a waiting list for high-intensity CBT. MAIN OUTCOME MEASURES The primary outcome was OCD symptoms using the Yale-Brown Obsessive Compulsive Scale - Observer Rated. RESULTS Patients were recruited from 14 NHS trusts between February 2011 and May 2014. Follow-up data collection was complete by May 2015. There were 475 patients randomised: supported cCBT (n = 158); guided self-help (n = 158) and waiting list for high-intensity CBT (n = 159). Two patients were excluded post randomisation (one supported cCBT and one waiting list for high-intensity CBT); therefore, data were analysed for 473 patients. In the short term, prior to accessing high-intensity CBT, guided self-help demonstrated statistically significant benefits over waiting list, but these benefits did not meet the prespecified criterion for clinical significance [adjusted mean difference -1.91, 95% confidence interval (CI) -3.27 to -0.55; p = 0.006]. Supported cCBT did not demonstrate any significant benefit (adjusted mean difference -0.71, 95% CI -2.12 to 0.70). In the longer term, access to guided self-help and supported cCBT, prior to high-intensity CBT, did not lead to differences in outcomes compared with access to high-intensity CBT alone. Access to guided self-help and supported cCBT led to significant reductions in the uptake of high-intensity CBT; this did not seem to compromise patient outcomes at 12 months. Taking a decision-making approach, which focuses on which decision has a higher probability of being cost-effective, rather than the statistical significance of the results, there was little evidence that supported cCBT and guided self-help are cost-effective at the 3-month follow-up compared with a waiting list. However, by the 12-month follow-up, data suggested a greater probability of guided self-help being cost-effective than a waiting list from the health- and social-care perspective (60%) and the societal perspective (80%), and of supported cCBT being cost-effective compared with a waiting list from both perspectives (70%). Qualitative interviews found that guided self-help was more acceptable to patients than supported cCBT. Professionals acknowledged the advantages of low intensity interventions at a population level. No adverse events occurred during the trial that were deemed to be suspected or unexpected serious events. LIMITATIONS A significant issue in the interpretation of the results concerns the high level of access to high-intensity CBT during the waiting list period. CONCLUSIONS Although low-intensity interventions are not associated with clinically significant improvements in OCD symptoms, economic analysis over 12 months suggests that low-intensity interventions are cost-effective and may have an important role in OCD care pathways. Further research to enhance the clinical effectiveness of these interventions may be warranted, alongside research on how best to incorporate them into care pathways. TRIAL REGISTRATION Current Controlled Trials ISRCTN73535163. 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. 37. See the NIHR Journals Library website for further project information.

Low-intensity cognitive-behaviour therapy interventions for obsessive-compulsive disorder compared to waiting list for therapist-led cognitive-behaviour therapy: 3-arm randomised controlled trial of clinical effectiveness

Background Obsessive-compulsive disorder (OCD) is prevalent and without adequate treatment usually follows a chronic course. “High-intensity” cognitive-behaviour therapy (CBT) from a specialist therapist is current “best practice.” However, access is difficult because of limited numbers of therapists and because of the disabling effects of OCD symptoms. There is a potential role for “low-intensity” interventions as part of a stepped care model. Low-intensity interventions (written or web-based materials with limited therapist support) can be provided remotely, which has the potential to increase access. However, current evidence concerning low-intensity interventions is insufficient. We aimed to determine the clinical effectiveness of 2 forms of low-intensity CBT prior to high-intensity CBT, in adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD. Methods and findings This study was approved by the National Research Ethics Service Committee North West–Lancaster (reference number 11/NW/0276). All participants provided informed consent to take part in the trial. We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-care United Kingdom mental health services. All patients were on a waiting list for therapist-led CBT (treatment as usual). Four hundred and seventy-three eligible patients were recruited and randomised. Patients had a median age of 33 years, and 60% were female. The majority were experiencing severe OCD. Patients received 1 of 2 low-intensity interventions: computerised CBT (cCBT; web-based CBT materials and limited telephone support) through “OCFighter” or guided self-help (written CBT materials with limited telephone or face-to-face support). Primary comparisons concerned OCD symptoms, measured using the Yale-Brown Obsessive Compulsive Scale–Observer-Rated (Y-BOCS-OR) at 3, 6, and 12 months. Secondary outcomes included health-related quality of life, depression, anxiety, and functioning. At 3 months, guided self-help demonstrated modest benefits over the waiting list in reducing OCD symptoms (adjusted mean difference = −1.91, 95% CI −3.27 to −0.55). These effects did not reach a prespecified level of “clinically significant benefit.” cCBT did not demonstrate significant benefit (adjusted mean difference = −0.71, 95% CI −2.12 to 0.70). At 12 months, neither guided self-help nor cCBT led to differences in OCD symptoms. Early access to low-intensity interventions led to significant reductions in uptake of high-intensity CBT over 12 months; 86% of the patients allocated to the waiting list for high-intensity CBT started treatment by the end of the trial, compared to 62% in supported cCBT and 57% in guided self-help. These reductions did not compromise longer-term patient outcomes. Data suggested small differences in satisfaction at 3 months, with patients more satisfied with guided self-help than supported cCBT. A significant issue in the interpretation of the results concerns the level of access to high-intensity CBT before the primary outcome assessment. Conclusions We have demonstrated that providing low-intensity interventions does not lead to clinically significant benefits but may reduce uptake of therapist-led CBT. Trial registration International Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN73535163.

Low intensity interventions for Obsessive-Compulsive Disorder (OCD): a qualitative study of mental health practitioner experiences

BackgroundObsessive-compulsive disorder (OCD) is a debilitating mental health disorder that can substantially impact upon quality of life and everyday functioning. Guidelines recommend pharmacological and psychological treatments, using a cognitive behaviour therapy approach (CBT) including exposure and response prevention, but access has generally been poor. Low intensity psychological interventions have been advocated. The evidence base for these interventions is emerging but there is a paucity of information regarding practitioners’ perceptions and experiences of supporting individuals with OCD using this approach.MethodsQualitative interviews were undertaken with psychological wellbeing practitioners (PWPs) (n = 20) delivering low intensity psychological interventions for adults with OCD within the context of a large pragmatic effectiveness trial. Interviews explored the feasibility and acceptability of delivering two interventions; guided self-help and supported computerised cognitive behaviour therapy (cCBT), within Improving Access to Psychological Therapies (IAPT) services in NHS Trusts. Interviews were recorded with consent, transcribed and analysed using thematic analysis.ResultsPWPs acknowledged the benefits of low intensity psychological interventions for individuals experiencing OCD symptoms on an individual and population level. Offering low intensity support provided was perceived to have the opportunity to overcome existing service barriers to access treatment, improve patient choice and flexibility. Professional and service relevant issues were also recognised including self-beliefs about supporting people with OCD and personal training needs. Challenges to implementation were recognised in relation to practitioner resistance and intervention delivery technical complications.ConclusionsThis study has provided insight into the implementation of new low intensity approaches to the management of OCD within existing mental health services. Benefits from a practitioner, service and patient perspective are identified and potential challenges highlighted.Trial registrationCurrent Controlled Trials: ISRCTN73535163. Date of registration: 5 April 2011.

The experiences of help-seeking in people with obsessive compulsive disorder: an internet survey

Obsessive compulsive disorder (OCD) is a debilitating mental health disorder, with prevalence in adults of around 3.1%. The social and economic consequences of OCD are high for patients and their families. It is unlikely to improve without treatment. Help-seeking for treatment is often delayed and studies have found an average treatment gap of up to 17 years. This study aimed to explore the factors that influenced how, when and why people sought help and to identify any issues that they faced during help-seeking. Individuals experiencing OCD were invited to complete a web-based survey hosted on a national OCD charity website over a 3-month period. Eighty-eight individuals took part. Most had sought help from their general practitioner (GP), while others accessed websites and private services. Lack of awareness and understanding by health professionals was reported as a problem, as was the speed of referral or getting the right treatment. There is a need for further training and education for health professionals and GPs. Education and awareness campaigns for the general public, with more focus on how help can be sought, and on the different types of OCD may contribute to improving recognition of symptoms and accessing timely help.

Psychological interventions in obsessive compulsive disorder.

Obsessive compulsive disorder (OCD) is a common mental health problem associated with poor quality of life, impaired functioning and increased risk of suicide. Improvement is unlikely and symptoms will remain chronic unless adequate treatment is provided. National Institute for Health and Care Excellence (2006a) guidelines on the management of OCD, recommend the use of psychological treatments that are based on cognitive behavioural therapy (CBT). Brief treatment forms of CBT are recommended initially and more intensive forms are offered when health gain is not apparent. While the presentation of OCD can be complex, nurses can assist in the recognition and treatment of OCD through additional training or current skills.

Learning from OCTET – exploring the acceptability of clinical trials management methods

BackgroundConducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high-quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring and closure. Lessons are also frequently learnt during the development and conduct of trials but rarely shared for the benefit of others.For the wider research team, the key focus will always be on the execution and delivery of a study. The aim of this study was to evaluate the acceptability of clinical trials management methods, focussing on study execution and monitoring, as implemented in the National Institute for Health Research Health Technology Assessment Programme-funded Obsessive Compulsive Treatment Efficacy Trial (OCTET).MethodsWorkshops, questionnaires and semi-structured interviews were used to explore acceptability of trial management methods with members of the OCTET Trial research team. Nine members participated in the focus group, 10 completed a questionnaire and 20 were interviewed as part of qualitative work for the main OCTET study. Data was collected and analysed using thematic analysis.ResultsSix key themes were identified: support; communication; processes; resources; training and ethos. Clear and open communication, enthusiasm and accessibility of the trial managers and chief investigator were consistently noted as an important facet of the successful running of the trial. Clear resources and training materials were also found to be crucial in helping staff to work within the trial setting. Constructive suggestions were also made for improvement of these resources; for example, including both checklists and flowcharts within trial processes.ConclusionOrganisation, openness and positivity are crucial for executing a trial successfully, whilst clear and focussed processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study.Trial registrationClinical Trial Registry, ID: ISRCTN73535163. Registered prospectively on 5 April 2011.