Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial.

BACKGROUND: The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy. OBJECTIVE: This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks. METHODS: We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers. RESULTS: We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t41=1.05, P=.30; mean difference=2.3, 95% CI -2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t45=-0.80, P=.43; mean difference=1.3, 95% CI -4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging clinicians in research and their resistance to recruitment: technical difficulties with The Journal, which prevented people logging in easily; difficulty accessing The Journal as it was not available on mobile devices; participants finding some lessons difficult; and participants saying they were too busy to complete the sessions. CONCLUSIONS: The study demonstrated that it is feasible to use a coach in this setting, that people found it helpful, and that it did not conflict with other care that participants were receiving. Future trials need to engage clinicians at an early stage to articulate where Web-based therapies fit into existing clinical pathways; Web-based therapies should be available on mobile devices, and logging in should be easy. The role of the coach should be explored in larger trials. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN): 12613000015741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363351&isReview=true (Archived by WebCite at http://www.webcitation.org/6wEyCc6Ss).

The ACCESS study: Zelen randomised controlled trial of a package of care for people presenting to hospital after self-harm.

BACKGROUND: The problem of people presenting to hospitals with self-harm is important because such presentations are common, there is a clear link to suicide and a high premature mortality. However, the best treatment for this population is unclear. AIMS: To see whether a package of measures, that included regular postcards and problem-solving therapy, improved outcomes at 1 year compared with usual care in people who presented to hospital with self-harm (the ACCESS study: trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000641291). METHOD: The design of the study was a Zelen randomised controlled trial. The primary outcome was re-presentation to hospital with self-harm within 12 months of the index episode. RESULTS: There were no significant differences in the primary outcome and most of the secondary outcomes between the two groups. About half the people offered problem-solving therapy did not receive it, for various reasons. CONCLUSIONS: The package as offered had little effect on the proportion of people re-presenting to hospital with self-harm. The dose of problem-solving therapy may have been too small to have an effect and there was a difficulty engaging participants in active treatment.

Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial.

BACKGROUND: Presentations to hospital with self-harm are common, associated with suicide and have an increased mortality, yet there is no accepted effective intervention. AIMS: To investigate whether problem-solving therapy would improve outcomes in adults presenting to hospital with self-harm, compared with usual care. METHOD: A Zelen randomised controlled trial was conducted in four district health boards in New Zealand. A second hospital presentation with self-harm at 1 year for all episodes, plus separate comparisons of first-time and repeat presentations at the index episode, were the a priori primary outcomes. The trial registration number was ACTRN12605000337673. RESULTS: In an intention-to-treat analysis of all randomised patients (n = 1094) there was no significant difference at 12 months in the proportion of people who had presented again with self-harm when comparing all episodes (intervention 13.4%, usual care 14.1%; relative risk reduction RR = 0.05, 95% CI -0.28 to 0.30, P = 0.79) or where the index episode was the first episode (intervention 13.4%, usual care 9.4%, RR = -0.42, 95% CI -1.17 to 0.08, P = 0.37). Where the index episode was repeated self-harm, those who received therapy were less likely to present again with self-harm (intervention 13.5%, usual care 22.1%, RR = 0.39, 95% CI 0.07 to 0.60, number needed to treat 12, P = 0.03). CONCLUSIONS: Problem-solving therapy is not recommended for everyone who presents to hospital with self-harm. Among adults with a history of self-harm it may be an effective intervention.

The ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self-harm: study protocol for a randomised controlled trial.

BACKGROUND: People who present to hospital after intentionally harming themselves pose a common and important problem. Previous reviews of interventions have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and regular written communications after the self-harm attempt may be an effective treatment. This protocol describes a large pragmatic trial of a package of measures which include problem solving therapy, regular written communication, patient support, cultural assessment, improved access to primary care and a risk management strategy in people who present to hospital after self-harm using a novel design. METHODS: We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enroll a large representative cohort of patients. The main outcome will be hospital attendance following repetition of self-harm, in the 12 months after recruitment with secondary outcomes of self reported self-harm, hopelessness, anxiety, depression, quality of life, social function and hospital use at three months and one year. DISCUSSION: A strength of the study is that it is a pragmatic trial which aims to recruit large numbers and does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. However the primary analysis is a true intention to treat analysis of everyone randomised which includes both those who consent and do not consent to participate in the study. This provides information about how the intervention will work in practice in a representative population which is a major advance in this study compared to what has been done before. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000641291.

Beyond randomized controlled trials in attempted suicide research.

There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We describe the problems of doing randomized controlled trials in attempted suicide and outline the advantages and difficulties of randomized controlled trials, Zelen designs, patient preference designs, and cluster randomized trials in attempted suicide intervention trials. Researchers and consumers should consider other research designs when asking what is effective after self harm.

Epidemiology of intentional self-harm presenting to four district health boards in New Zealand over 12 months, and comparison with official data.

OBJECTIVE: The aim of the present study was to describe the number and characteristics of people presenting with intentional self-harm to four district health boards in New Zealand and to compare this with official data. METHODS: People presenting with self-harm were identified by searching a mixture of electronic and written databases in each DHB. RESULTS: Over 12 months 1633 people presented a total of 2087 times to these four DHBs. The highest rates were in Northland, young women and Maori. Official figures significantly underestimate the number of people who present to hospital with intentional self-harm. CONCLUSION: Considerably more people present to hospital with intentional self-harm in New Zealand than are recorded by official figures. This is important because reducing self-harm is a key part of the New Zealand health strategy. To achieve this, accurate measurement of self-harm rates is required. Encouraging improved reporting by DHBs is unlikely to work. It is suggested that dedicated monitoring sites be set up in representative DHBs to solve the problem of flawed official data collection.

A randomized controlled graded exercise trial for chronic fatigue syndrome: outcomes and mechanisms of change.

The aim of this study was to investigate the potential mechanisms underlying the efficacy of graded exercise therapy for chronic fatigue syndrome (CFS). Forty-nine CFS patients were randomized to a 12-week graded exercise programme or to standard medical care. At the end of treatment the exercise group rated themselves as significantly more improved and less fatigued than the control group. A decrease in symptom focusing rather than an increase in fitness mediated the treatment effect. Graded exercise appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms.