Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT).

BACKGROUND: People with psychosis have a reduced life expectancy of 10-20 years, largely due to cardiovascular disease. This trial aimed to determine the effectiveness of a modular health promotion intervention (IMPaCT Therapy) in improving health and reducing cardiovascular risk in psychosis. METHODS: A multicentre, two arm, parallel cluster RCT was conducted across five UK mental health NHS trusts. Community care coordinators (CC) were randomly assigned to training and supervision in delivering IMPaCT Therapy or treatment as usual (TAU) to current patients with psychosis (cluster). The primary outcome was the physical and mental health subscales of the Short form-36 (SF-36) questionnaire. RESULTS: Of 104 care coordinators recruited, 52 (with 213 patients) were randomised to deliver IMPaCT therapy and 52 (with 193 patients) randomised to TAU. Of 406 patients, 318 (78%) and 301 (74%) attended 12- and 15-month follow-up respectively. IMPaCT therapy showed no significant effect on the physical or mental health component SF-36 scores versus TAU at 12 or 15 months. No effect was observed for cardiovascular risk indicators, except for HDL cholesterol, which improved more with IMPACT therapy than TAU (Treatment effect (95% CI); 0.085 (0.007 to 0.16); p = 0.034). The 22% of patients who received >180 min of IMPACT Therapy in addition to usual care achieved a greater reduction in waist circumference than did controls, which was clinically significant. CONCLUSION: Training and supervising community care coordinators to use IMPaCT therapy in patients with psychosis is insufficient to significantly improve physical or mental health quality of life. The search for effective, pragmatic interventions deliverable in health care services continues. TRIAL REGISTRATION: The trial was retrospectively registered with ISRCTN registry on 23/4/2010 at ISRCTN58667926 ; recruitment started on 01/03/2010 with first randomization on 09.08.2010 ISRCTN58667926 .

Randomised controlled trial to improve health and reduce substance use in established psychosis (IMPaCT): cost-effectiveness of integrated psychosocial health promotion.

BACKGROUND: There is mounting evidence that people with severe mental illness have unhealthy lifestyles, high rates of cardiovascular and metabolic diseases, and greater risk of early mortality. This study aimed to assess the cost-effectiveness of a health promotion intervention seeking to improve physical health and reduce substance use in people with psychosis. METHODS: Participants with a psychotic disorder, aged 18-65 years old and registered on an enhanced care approach programme or equivalent were recruited from community mental health teams in six mental health trusts in England. Participants were randomisation to either standard community mental health team care (treatment as usual) or treatment as usual with an integrated health promotion intervention (IMPaCT). Cost-effectiveness and cost-utility analyses from health and social care and societal perspectives were conducted alongside a cluster randomised controlled trial. Total health and social care costs and total societal costs at 12 and 15 months were calculated as well as cost-effectiveness (incremental cost-effectiveness ratios and cost-effectiveness acceptability curves) at 15 months based on quality of life (SF-36 mental and physical health components, primary outcome measures) and quality adjusted life years (QALYs) using two measures, EQ-5D-3 L and SF-36. Data were analysed using bootstrapped regressions with covariates for relevant baseline variables. RESULTS: At 12-15 months 301 participants had full data needed to be included in the economic evaluation. There were no differences in adjusted health and social care costs (£95, 95% CI -£1410 to £1599) or societal costs (£675, 95% CI -£1039 to £2388) between the intervention and control arms. Similarly, there were no differences between the groups in the SF-36 mental component (-0.80, 95% CI -3.66 to 2.06), SF-36 physical component (-0.68, 95% CI -3.01 to 1.65), QALYs estimated from the SF-36 (-0.00, -0.01 to 0.00) or QALYs estimated from the EQ-5D-3 L (0.00, 95% CI -0.01 to 0.02). Cost-effectiveness acceptability curves for all four outcomes and from both cost perspectives indicate that the probability of the health promotion intervention being cost-effective does not exceed 0.4 for willingness to pay thresholds ranging from £0-£50,000. CONCLUSIONS: Alongside no evidence of additional quality of life/clinical benefit, there is also no evidence of cost-effectiveness. TRIAL REGISTRATION: ISRCTN58667926 . Date retrospectively registered: 23/04/2010. Recruitment start date: 01/03/2010.

Computer-assisted therapy for medication-resistant auditory hallucinations: proof-of-concept study.

BACKGROUND: One in four patients with schizophrenia responds poorly to antipsychotic medication, continuing to hear persecutory auditory hallucinations. Patients who are able to sustain a dialogue with their persecutor feel much more in control. AIMS: To develop a computerised system that enables the patient to create an avatar of their persecutor. To encourage them to engage in a dialogue with the avatar, which the therapist is able to control so that the avatar progressively yields control to the patient. METHOD: Avatar therapy was evaluated by a randomised, single blind, partial crossover trial comparing the novel therapy with treatment as usual (TAU). We used three main outcome measures: (a) the Psychotic Symptom Rating Scale (PSYRATS), hallucinations section; (b) the Omnipotence and Malevolence subscales of the Revised Beliefs About Voices Questionnaire (BAVQ-R); and (c) the Calgary Depression Scale (CDS). RESULTS: The control group showed no change over time in their scores on the three assessments, whereas the novel therapy group showed mean reductions in the total PSYRATS score (auditory hallucinations) of 8.75 (P = 0.003) and in the BAVQ-R combined score of omnipotence and malevolence of the voices of 5.88 (P = 0.004). There was no significant reduction in the CDS total score for depression. For the crossover control group, comparison of the period of TAU with the period of avatar therapy confirmed the findings of the previous analysis. The effect size of the therapy was 0.8. CONCLUSIONS: Avatar therapy represents a promising treatment for medication-resistant auditory hallucinations. Replication with a larger sample is required before roll-out to clinical settings.

Improving physical health and reducing substance use in psychosis--randomised control trial (IMPACT RCT): study protocol for a cluster randomised controlled trial.

BACKGROUND: Cardiovascular morbidity and mortality is increased in individuals with severe mental illnesses.We set out to establish a multicentre, two arm, parallel cluster randomized controlled trial (RCT) of a health promotion intervention (HPI), IMPACT Therapy. The patient-tailored IMPACT Therapy aims to target one or more health behaviours from a pre-defined list that includes cannabis use; alcohol use; other substance use; cigarette smoking; exercise; diet and diabetic control, prioritising those identified as problematic by the patient, taking a motivational interviewing and CBT approach. METHODS: Impact therapy will be delivered by care coordinators in the community to the treatment group and will be compared to treatment as usual (TAU). The main hypothesis is that the addition of IMPACT Therapy (HPI) to TAU will be more effective than TAU alone in improving patients' quality of life as measured by the Short Form-36, including mental health and physical health subscales on completion of the intervention at 12 months post randomisation. A subsidiary hypothesis will be that addition of IMPACT Therapy (HPI) will be more cost-effective than TAU alone in improving health in people with SMI 12 months from baseline. The IMPACT therapy patient groups' improvement in quality of life, as well as its cost effectiveness, is hypothesised to be maintained at 15 months. Outcomes will be analyzed on an intention-to-treat (ITT) basis. DISCUSSION: The results of the trial will provide information about the effectiveness of the IMPACT therapy programme in supporting community mental health teams to address physical comorbidity in severe mental illness. TRIAL REGISTRATION: ISRCTN58667926.

Avatar therapy for persecutory auditory hallucinations: What is it and how does it work?

We have developed a novel therapy based on a computer program, which enables the patient to create an avatar of the entity, human or non-human, which they believe is persecuting them. The therapist encourages the patient to enter into a dialogue with their avatar, and is able to use the program to change the avatar so that it comes under the patient's control over the course of six 30-min sessions and alters from being abusive to becoming friendly and supportive. The therapy was evaluated in a randomised controlled trial with a partial crossover design. One group went straight into the therapy arm: "immediate therapy". The other continued with standard clinical care for 7 weeks then crossed over into Avatar therapy: "delayed therapy". There was a significant reduction in the frequency and intensity of the voices and in their omnipotence and malevolence. Several individuals had a dramatic response, their voices ceasing completely after a few sessions of the therapy. The average effect size of the therapy was 0.8. We discuss the possible psychological mechanisms for the success of Avatar therapy and the implications for the origins of persecutory voices.