How Does Therapy Harm? A Model of Adverse Process Using Task Analysis in the Meta-Synthesis of Service Users' Experience.

Background: Despite repeated discussion of treatment safety, there remains little quantitative research directly addressing the potential of therapy to harm. In contrast, there are numerous sources of qualitative evidence on clients' negative experience of psychotherapy, which they report as harmful. Objective: To derive a model of process factors potentially leading to negative or harmful effects of therapy, from the clients' perspective, based on a systematic narrative synthesis of evidence on negative experiences and effects of psychotherapy from (a) qualitative research findings and (b) participants' testimony. Method: We adapted Greenberg (2007) task analysis as a discovery-oriented method for the systematic synthesis of qualitative research and service user testimony. A rational model of adverse processes in psychotherapy was empirically refined in two separate analyses, which were then compared and incorporated into a rational-empirical model. This was then validated against an independent qualitative study of negative effects. Results: Over 90% of the themes in the rational-empirical model were supported in the validation study. Contextual issues, such as lack of cultural validity and therapy options together with unmet client expectations fed into negative therapeutic processes (e.g., unresolved alliance ruptures). These involved a range of unhelpful therapist behaviors (e.g., rigidity, over-control, lack of knowledge) associated with clients feeling disempowered, silenced, or devalued. These were coupled with issues of power and blame. Conclusions: Task analysis can be adapted to extract meaning from large quantities of qualitative data, in different formats. The service user perspective reveals there are potentially harmful factors at each stage of the therapy journey which require remedial action. Implications of these findings for practice improvement are discussed.

Risk factors for negative experiences during psychotherapy.

BACKGROUND: It is estimated that between 3% and 15% of patients have a negative experience of psychotherapy, but little is understood about this. AIMS: The aim of this study was to investigate the factors associated with patients' negative therapy experiences. METHOD: The data comprised 185 patient and 304 therapist questionnaires, 20 patient and 20 therapist interviews. Patients reported on an unhelpful or harmful experience of therapy, and therapists on a therapy where they thought the patient they were working with had a poor or harmful experience. These were transcribed and analysed using thematic analysis. RESULTS: There was a Lack of fit between Patient needs, Therapist skills, and Service structures. This could result in Fault Lines, a tension between Safety and containment and Power and control. This tension led to Strain and Poor Engagement, which led to Consequences following the negative therapy experience. CONCLUSIONS: Patients require clear information, choice, involvement in decision-making, explicit contracting and clarity about sessions and progress. Opportunities for patient feedback should be the norm, where the therapist and service are vigilant for signs of deterioration and solutions considered. Clinical and methodological significance of this article: Estimates of "unwanted effects," including long-lasting effects, of psychotherapy have ranged from 3% to 15%. Few empirical studies have been conducted in this area. This study aimed to address this gap and provide clinicians with a model of risk factors for negative therapy effects. The findings of this study indicate the importance of providing patients with a supportive service structure that offers clear information, choice and involvement in decision-making. Explicit contracting at the beginning of therapy and clarity about sessions and progress are also important in managing patient expectations throughout. Opportunities for patient feedback should be provided.

Iatrogenic harm from psychological therapies--time to move on.

The problem of adverse effects of psychotherapy has been recognised for decades, yet research on causes and prevention of harm has failed to progress. There is confusion between different definitions and a lack of systematic recording and reporting. A new framework for moving this field forward is proposed.

Patient experience of negative effects of psychological treatment: results of a national survey†.

BACKGROUND: To make informed choices, patients need information about negative as well as positive effects of treatments. There is little information about negative effects of psychological interventions. AIMS: To determine the prevalence of and risk factors for perceived negative effects of psychological treatment for common mental disorders. METHOD: Cross-sectional survey of people receiving psychological treatment from 184 services in England and Wales. Respondents were asked whether they had experienced lasting bad effects from the treatment they received. RESULTS: Of 14 587 respondents, 763 (5.2%) reported experiencing lasting bad effects. People aged over 65 were less likely to report such effects and sexual and ethnic minorities were more likely to report them. People who were unsure what type of therapy they received were more likely to report negative effects (odds ratio (OR) = 1.51, 95% CI 1.22-1.87), and those that stated that they were given enough information about therapy before it started were less likely to report them (OR = 0.65, 95% CI 0.54-0.79). CONCLUSIONS: One in 20 people responding to this survey reported lasting bad effects from psychological treatment. Clinicians should discuss the potential for both the positive and negative effects of therapy before it starts.

Squaring the circle: a priority-setting method for evidence-based service development, reconciling research with multiple stakeholder views.

BACKGROUND: This study demonstrates a technique to aid the implementation of research findings through an example of improving services and self-management in longer-term depression. In common with other long-term conditions, policy in this field requires innovation to be undertaken in the context of a whole system of care, be cost-effective, evidence-based and to comply with national clinical guidelines. At the same time, successful service development must be acceptable to clinicians and service users and choices must be made within limited resources. This paper describes a novel way of resolving these competing requirements by reconciling different sources and types of evidence and systematically engaging multiple stakeholder views. METHODS: The study combined results from mathematical modelling of the care pathway, research evidence on effective interventions and findings from qualitative research with service users in a series of workshops to define, refine and select candidate service improvements. A final consensus-generating workshop used structured discussion and anonymised electronic voting. This was followed by an email survey to all stakeholders, to achieve a pre-defined criterion of consensus for six suggestions for implementation. RESULTS: An initial list of over 20 ideas was grouped into four main areas. At the final workshop, each idea was presented in person, visually and in writing to 40 people, who assigned themselves to one or more of five stakeholder groups: i) service users and carers, ii) clinicians, iii) managers, iv) commissioners and v) researchers. Many belonged to more than one group. After two rounds of voting, consensus was reached on seven ideas and one runner up. The survey then confirmed the top six ideas to be tested in practice. CONCLUSIONS: The method recruited and retained people with diverse experience and views within a health community and took account of a full range of evidence. It enabled a diverse group of stakeholders to travel together in a direction that converged with the messages coming out of the research and successfully yielded priorities for service improvement that met competing requirements.

Cognitive behavioural intervention for adults with anxiety complications of asthma: prospective randomised trial.

BACKGROUND: High levels of asthma-related fear and panic exacerbate asthma symptoms and complicate the management of asthma. Asthma-specific fear may be reduced by a cognitive behavioural intervention. We aimed to test if there is a reduction in asthma-specific fear after cognitive behavioural intervention compared with routine treatment. METHODS: Adults with asthma registered with family doctors in Sheffield UK were screened for anxiety and 94 highly anxious patients were randomly allocated to receive either a cognitive behavioural intervention to improve self-management of their anxiety (n = 50) or routine clinical care (n = 44). Asthma-specific fear at the end of treatment and at six month follow up were the primary endpoints. Service usage in the six months prior to and six months following the intervention was monitored to allow estimation of costs. Data were analysed by intention to treat. FINDINGS: At the end of treatment, there was a significantly greater reduction in asthma-specific fear for people in the CBT group compared with controls. At six months after treatment the reduction in asthma-specific fear in the CBT group was increased and the difference between treatment and control group was statistically significant. Service use costs were not reduced in the CBT group. INTERPRETATION: A brief cognitive behavioural intervention was found to have efficacy in reducing asthma-specific panic fear immediately after treatment and at 6 months follow up. There was no cost advantage to cognitive behavioural treatment.

Can the impact of public involvement on research be evaluated? A mixed methods study.

BACKGROUND: Public involvement is central to health and social research policies, yet few systematic evaluations of its impact have been carried out, raising questions about the feasibility of evaluating the impact of public involvement. OBJECTIVE: To investigate whether it is feasible to evaluate the impact of public involvement on health and social research. METHODS: Mixed methods including a two-round Delphi study with pre-specified 80% consensus criterion, with follow-up interviews. UK and international panellists came from different settings, including universities, health and social care institutions and charitable organizations. They comprised researchers, members of the public, research managers, commissioners and policy makers, self-selected as having knowledge and/or experience of public involvement in health and/or social research; 124 completed both rounds of the Delphi process. A purposive sample of 14 panellists was interviewed. RESULTS: Consensus was reached that it is feasible to evaluate the impact of public involvement on 5 of 16 impact issues: identifying and prioritizing research topics, disseminating research findings and on key stakeholders. Qualitative analysis revealed the complexities of evaluating a process that is subjective and socially constructed. While many panellists believed that it is morally right to involve the public in research, they also considered that it is appropriate to evaluate the impact of public involvement. CONCLUSIONS: This study found consensus among panellists that it is feasible to evaluate the impact of public involvement on some research processes, outcomes and on key stakeholders. The value of public involvement and the importance of evaluating its impact were endorsed.

Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial.

BACKGROUND: People with multiple sclerosis (MS) are at high risk of depression. We undertook a pilot trial of computerised cognitive behavioural therapy (CCBT) for the treatment of depression in people with MS to test the feasibility of undertaking a full trial. METHODS: Participants with a diagnosis of MS and clinical levels of depression were recruited through out-patient clinics and postal screening questionnaires at two UK centres and randomised to CCBT or usual care. Clinical outcomes included the Beck Depression Inventory (BDI-II) and Multiple Sclerosis Impact Scale (MSIS-29) at baseline, 8 and 21 weeks. Feasibility outcomes included: recruitment rate; reasons for refusal, withdrawal and dropout; feasibility and acceptability of the proposed outcome measures; sample size estimation and variation in and preferences for service delivery. RESULTS: Twenty-four participants were recruited. The recruitment rate, calculated as the proportion of those invited to fill in a screening questionnaire who were consented into the trial, was 4.1%. Recruitment through out-patient clinics was somewhat slower than through screening questionnaire mail-out but the overall recruitment yield was similar. Of the 12 patients in the CCBT arm, 9 (75%) completed at least four, and 6 completed all 8 CCBT sessions. For completers, the median time (IQR) to complete all eight CCBT sessions was 15 (13 to 20) weeks. Participants expressed concern about the face validity of the Beck Depression Inventory II for the measurement of self-reported depression in people with MS. The MSIS-29 was the patient-reported outcome measure which participants felt best reflected their concerns. The estimated sample size for a full trial is between 180 and 390 participants. NHS partners were not delivering CCBT in community facilities and participants preferred to access CCBT at home, with no one expressing a preference for use of CCBT in an alternative location. CONCLUSIONS: A definitive trial, with a recruitment window of one year, would require the participation of around 13 MS centres. This number of centres could be reduced by expanding the eligibility criteria to include either other neurological conditions or people with more severe depression. The MSIS-29 should be used as a patient-important outcome measurement. TRIAL REGISTRATION: ISRCTN: ISRCTN81846800.

The acceptability of computerised cognitive behavioural therapy for the treatment of depression in people with chronic physical disease: a qualitative study of people with multiple sclerosis.

BACKGROUND: People with chronic physical conditions are at elevated risk of depression. Due to a shortage of Cognitive Behavioural Therapy (CBT) practitioners, computerised CBT (CCBT) is recommended for people with mild to moderate depression. We assessed the applicability of CCBT for the treatment of depression in people with multiple sclerosis (MS). METHODS: Depth interviews with 17 people with MS and mild to moderate depression who used one of the two CCBT packages for either eight (Beating the Blues; n = 8) or five (MoodGym; n = 9) weekly sessions were analysed using 'Framework'. RESULTS: Participants found CCBT-use burdensome due to their physical symptoms. In addition to perpetuating social isolation, the lack of human input meant some participants were unable to define problems, set goals or distinguish between events, thoughts and beliefs as required. CCBT did not legitimise their grief over losses concomitant with their MS. They characterised depression symptom inventories as contaminated by somatic symptoms of their MS. One CCBT package (MoodGym) was perceived as using inappropriate case material for people with the symptoms of MS. CONCLUSIONS: It is likely that generic CCBT packages for the treatment of depression will need to be adapted for people with chronic physical conditions to maximise their potential for health benefit.

Health and use of health services: a comparison between Gypsies and Travellers and other ethnic groups.

OBJECTIVES: To examine the health status of adults from black and minority ethnic groups and from a socio-economically mixed White population, all resident in England. DESIGN: A cross-sectional questionnaire survey using validated standardised health measures of a sample of Gypsies and Travellers, Pakistani Muslims, African Caribbean, and White adults living in five geographical locations. Health outcomes included general health, health in the past year, limiting long-term illness, anxiety, depression, respiratory symptoms and angina. RESULTS: Of the 520 recruited age-sex matched sample (260 Gypsies and Travellers matched with 260 Pakistani Muslims, African Caribbean, and White residents), 516 were included in this analysis (173 men, 343 women). There were no differences by age between the four groups but men were approximately four years older than women. There were significant statistical differences in smoking status and educational attendance with more Gypsies and Travellers being current smokers (58% (95% confidence interval (CI) 52, 64) versus 25% (14, 38) or lower in the other groups) and having poorer regular educational attendance (61% (54, 68) versus 89% (77, 96) or higher in the other groups). For all health outcomes examined, Gypsies and Travellers had significantly poorer outcomes (after adjustment for age, sex and smoking status) compared with the White population. The health status of the Pakistani Muslims and African Caribbeans was similar to that of the Gypsies and Travellers for health in the past year, asthma, and depression, but other outcomes (cough, sputum) were significantly less prevalent. There were also significant differences in specific outcomes between African Caribbean and Pakistani Muslim populations. Consultations with various health professionals and use of health services varied between the groups. CONCLUSION: Being a Gypsy or Traveller is associated with even poorer health outcomes than those seen in two other ethnic minority groups resident in England, Pakistani Muslim and African Caribbean, and they in turn have poorer health outcomes than the White residents. More remains to be done to address the health and health service needs of such black and minority ethnic groups.

Anxiety and panic fear in adults with asthma: prevalence in primary care.

BACKGROUND: Patients may find it difficult to distinguish between the symptoms of anxiety and those of asthma. Findings are equivocal on whether there is a specific link between anxiety and asthma. The aims of this study were to i) to identify the prevalence of anxiety, depression and panic fear in adults with asthma compared with that of the general population ii) to investigate whether there is a specific relationship between asthma and anxiety. METHODS: An epidemiological survey of 872 adults with a diagnosis of asthma identified from six General Practices in Sheffield, England. Community postal survey using self-completion questionnaire. RESULTS: The response rate was 59%. People with asthma had higher mean Hospital Anxiety and Depression Scale (HADS) anxiety scores than UK norms with a higher proportion above the clinical cut-off. Mean HADS depression scores were significantly higher than UK norms and norms for a general population sample of people registered with the same practice. These effects were age-related with the relationship between asthma and psychological distress most marked over the age of 45. The prevalence of asthma-specific panic fear was 15.7%. CONCLUSION: A significant minority of people have high levels of panic fear (as measured by the Asthma Symptom Checklist) associated with asthma. However, in adults with asthma there is also high prevalence of both generalised anxiety and depression (as measured by the HADS), suggesting that the link of anxiety to asthma may be part of a broader relationship between psychological distress and chronic disease rather than a specific one.

Psychotherapy and mental health teams.

Mental health teams in different configurations and settings are under increasing pressure to offer formal psychotherapies as well as psychologically informed management to large numbers of 'difficult' patients with severe and complex presentations. This pressure has arisen variously from consumers, governmental agencies and commissioning bodies. Although these teams are an important resource, they receive limited training, supervision or support in models of psychotherapy, especially those incorporating a relational dimension and offering a coherent 'common language'. This commonly results in impairment of collective team function, including the quality and consistency of assessments, and may result in stress, splitting and 'burn out' for team members. This situation is due in part to their burden of casework and responsibility but also to prevailing, largely symptom-based and biomedical, models of mental disorder which tend to minimize the importance of psychosocial dimensions in either aetiology or treatment. Formulating and delivering appropriate, evidence-based and robust models of psychotherapy in generic team settings represents a significantly different challenge from that posed by delivery of psychotherapy in specialist settings. Approaches to this important challenge are discussed and summarized drawing on general considerations and the limited direct research evidence, and are illustrated by a cognitive analytic therapy (CAT)-based training project.