Critical time Intervention for Severely mentally ill Prisoners (CrISP): a randomised controlled trial

BackgroundThe transition from prison to community is difficult for prisoners with mental illness. Critical time intervention (CTI) is designed to provide intensive support to meet health, social care and resettlement needs through close working between client and key worker pre, and up to 6 weeks post, release.ObjectivesTo establish whether or not CTI is effective in (1) improving engagement of discharged male prisoners who have mental illness with community mental health teams (CMHTs) and (2) providing practical support with housing, finance and re-establishing social networks.Trial designA multicentre, parallel-group randomised controlled trial, with follow-up at 6 weeks and at 6 and 12 months. A subset of prisoners and case managers participated in a complementary qualitative study.SettingEight English prisons.ParticipantsOne hundred and fifty adult male prisoners, convicted or remanded, cared for by mental health in-reach teams and diagnosed with severe mental illness, with a discharge date within 6 months of the point of recruitment.InterventionParticipants were randomised to either the intervention or the control (treatment as usual). The intervention group was assigned a case manager who assessed mental and physical health before and following release, made appropriate links to health, housing and financial services and supported the re-establishment of family/peer contact.OutcomeThe primary outcome measure was engagement with a CMHT 6 weeks post discharge. Secondary outcomes included contact with mental health services at 6 and 12 months. A health economic evaluation was undertaken using service contact at the follow-up time points. We were unable to assess the intervention’s effect on reoffending and longer-term health-care use because of study delays.ResultsOne hundred and fifty prisoners were recruited: 72 were randomised to the intervention and 78 were randomised to the control. Engagement with teams at 6 weeks was 53% for the intervention group compared with 27% for the control group [95% confidence interval (CI) 0.13% to 0.78%;p = 0.012]. At 6 months’ follow-up, intervention participants showed continued increase in engagement with teams compared with control participants (95% CI 0.12% to 0.89%;p = 0.029); there were no significant differences at 12 months. Increased engagement resulted in higher levels of service use and costs for the intervention than for the control. Qualitative data showed the intervention group reporting better continuity of care and improved access to services.ConclusionThe intervention significantly improved contact with services at 6 weeks, although at a higher cost than the control. This is important as, in the days and weeks following release, recently released individuals are at a particularly high risk of suicide and drug overdose. Further research is required to establish how teams can better maintain contact with clients when the intervention ends.Future workFurther studies are indicated for groups with different needs, for example women, young prisoners and those in police custody, and at other transition points, for example following arrest and short-term custody, and at points of transition between different mental health services.Trial registrationCurrent Controlled Trials ISRCTN98067793.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 5, No. 8. See the NIHR Journals Library website for further project information.

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Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

European Psychiatry ◽

10.1016/j.eurpsy.2016.12.007 ◽

2017 ◽

Vol 42 ◽

pp. 103-110 ◽

Cited By ~ 39

Author(s):

C.I. Mahlke ◽

S. Priebe ◽

K. Heumann ◽

A. Daubmann ◽

K. Wegscheider ◽

...

Keyword(s):

Mental Illness ◽

Peer Support ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Treatment As Usual ◽

Secondary Outcomes ◽

One To One ◽

Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

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Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.113.128470 ◽

2013 ◽

Vol 203 (5) ◽

pp. 350-357 ◽

Cited By ~ 33

Author(s):

Claire Henderson ◽

Elaine Brohan ◽

Sarah Clement ◽

Paul Williams ◽

Francesca Lassman ◽

...

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Usual Care ◽

Decision Aid ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Full Time ◽

Randomised Controlled

BackgroundMany mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request ‘reasonable adjustments’. There have been no intervention studies to support decisionmaking about disclosure to an employer.AimsTo determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid.MethodIn this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014).ResultsWe recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement −22.7 (s.d. = 15.2) v. −11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03).ConclusionsThe observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.

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Continuity of care for recently released prisoners with mental illness: a pilot randomised controlled trial testing the feasibility of a Critical Time Intervention

Epidemiology and Psychiatric Sciences ◽

10.1017/s2045796011000783 ◽

2012 ◽

Vol 21 (2) ◽

pp. 187-193 ◽

Cited By ~ 34

Author(s):

M. Jarrett ◽

G. Thornicroft ◽

A. Forrester ◽

M. Harty ◽

J. Senior ◽

...

Keyword(s):

Mental Illness ◽

Randomised Controlled Trial ◽

Continuity Of Care ◽

Controlled Trial ◽

Critical Time ◽

Treatment As Usual ◽

Pilot Randomised Controlled Trial ◽

Critical Time Intervention ◽

Randomised Controlled ◽

Face Complex

Aims.Prisoners with mental illness on release from prison often face complex challenges with little support, leading to poor clinical and social outcomes. This feasibility study aimed to see whether a Critical Time Intervention (CTI) in the first weeks post-release effectively connects mentally ill prisoners with social, clinical, housing, and welfare services on leaving prison. The study took place in 2007 and involved local prisons in London and Manchester.Methods.A pilot randomised controlled trial in which CTI was compared to Treatment as Usual (TAU).Results.Sixty prisoners were randomised in the trial, with outcome measures completed on 23. A higher proportion of prisoners in CTI group were in contact with services at follow-up than those receiving TAU. CTI prisoners were significantly more likely to be receiving medication, and be registered with a General Practitioner (GP) than those in the TAU group.Conclusions.Continuity of care for prisoners with severe mental illness can be improved by working with them to identify their needs prior to release, and by assisting them to engage effectively to the necessary agencies in the community.

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A randomised controlled trial of repeated filmed social contact on reducing mental illness-related stigma in young adults

Epidemiology and Psychiatric Sciences ◽

10.1017/s2045796016001050 ◽

2016 ◽

Vol 27 (2) ◽

pp. 199-208 ◽

Cited By ~ 15

Author(s):

S. Koike ◽

S. Yamaguchi ◽

Y. Ojio ◽

K. Ohta ◽

T. Shimada ◽

...

Keyword(s):

Mental Health ◽

Mental Illness ◽

Controlled Trial ◽

Social Contact ◽

Web Based ◽

Related Stigma ◽

Health Related ◽

Randomised Controlled ◽

Intended Behaviour

Aims.Public stigma alters attitudes towards people with mental illness, and is a particular concern for young people since most mental health problems occur in adolescence and young adulthood. However, little is known about the long-term effects of repeated filmed social contact (FSC) on reducing mental health-related stigma among young adults in the general population, compared with self-instructional Internet search (INS) and control interventions.Methods.This study is a parallel-group randomised controlled trial over 12 months conducted in Tokyo, Japan. A total of 259 university students (male n = 150, mean age = 20.0 years, s.d. = 1.2) were recruited from 20 colleges and universities between November 2013 and July 2014, without being provided information about the mental health-related survey or trial. Participants were assigned to one of three groups before completion of the baseline survey (FSC/INS/control = 89/83/87). The FSC group received a computer-based 30-min social contact film with general mental health education and five follow-up web-based FSCs at 2-month intervals. The INS group undertook a 30-min search for mental health-related information with five follow-up web-based reminders for self-instructional searches at 2-month intervals. The control group played PC games and had no follow-up intervention. The main outcome measures were the future (intended behaviour) domain of the Reported and Intended Behaviour Scale at 12 months after the intervention. Analysis was conducted in September 2015.Results.At the 12-month follow-up, 218 participants completed the survey (84.1%, 75:70:73). The FSC group showed the greatest change at the 12-month follow-up (FSC: mean change 2.11 [95% CI 1.49, 2.73], INS: 1.04 [0.29, 1.80], control: 0.71 [0.09, 1.33]; FSC v. INS p = 0.037, FSC v. controls p = 0.004). No adverse events were reported during the follow-up period.Conclusions.FSC was more successful in reducing stigma at 12 months after intervention than INS or control interventions. FSC could be used to reduce stigma in educational lectures and anti-stigma campaigns targeted at young people.Study registration.This study is registered at UMIN-CTR (No. UMIN000012239).

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Effects of biomedical messages and expert-recommended messages on reducing mental health-related stigma: a randomised controlled trial

Epidemiology and Psychiatric Sciences ◽

10.1017/s2045796019000714 ◽

2019 ◽

Vol 29 ◽

Cited By ~ 1

Author(s):

Yasutaka Ojio ◽

Sosei Yamaguchi ◽

Kazusa Ohta ◽

Shuntaro Ando ◽

Shinsuke Koike

Keyword(s):

Mental Health ◽

Mental Illness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Useful Knowledge ◽

Post Test ◽

Related Stigma ◽

Health Related ◽

Randomised Controlled

Abstract Aims Mental health-related stigma is a major challenge associated with the huge mental health treatment gap. It has remained unclear what kind of educational content is effective in reducing the stigma. Whether biomedical messages (BMM) about mental illness are effective or harmful in decreasing stigma is controversial. To investigate whether BMM can improve practically useful knowledge of mental illness, comparably to recommended messages (RCM) advocated by experts, of types such as ‘recovery-oriented’, ‘social inclusion/human rights’ and ‘high prevalence of mental illnesses’ through a randomised controlled trial (RCT). Method This study is an individual-level RCT with a parallel-group design over 1 year, conducted in Tokyo, Japan. A total of 179 participants (males n = 80, mean age = 21.9 years and s.d. = 7.8) were recruited in high schools and universities, and through a commercial internet advertisement in June and July 2017, without any indication that the study appertained to mental health. Participants were allocated to the BMM and RCM groups. They underwent a 10-min intervention, and completed self-report questionnaires during baseline, post-test, 1-month follow-up and 1-year follow-up surveys. The primary outcome measures were practically useful knowledge of mental illness at the post-test survey using the Mental Illness and Disorder Understanding Scale (MIDUS). Analysis was conducted in October 2018. Results Both groups demonstrated improved MIDUS score in the post-test survey, and showed similar intervention effects (F(1, 177) = 160.5, p < 0.001, η2 = 0.48). The effect of the interventions continued until the 1-year follow-up survey (B [95% CI] = −2.56 [−4.27, −0.85], p < 0.01), and showed no difference between groups. The reported adverse effect that BMM increase stigma was not confirmed. Conclusions BMM may have a positive impact on stigma, comparable to RCM. These findings may encourage reconsideration of the content of messages about mental health, as it is indicated that combining BMM and RCM might contribute to an effective anti-stigma programme.

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Peer support for people with severe mental illness versus usual care: study protocol for a pragmatic multicentre randomised controlled trial (UPSIDES-RCT)

10.21203/rs.2.20188/v1 ◽

2020 ◽

Author(s):

Galia Sharon Moran ◽

Jasmine Kalha ◽

Annabel Mueller-Stierlin ◽

Reinhold Kilian ◽

Silvia Krumm ◽

...

Keyword(s):

Mental Health ◽

Mental Illness ◽

Cost Effectiveness ◽

Severe Mental Illness ◽

Peer Support ◽

Social Inclusion ◽

Controlled Trial ◽

Service Users ◽

Randomised Controlled

Abstract Background: Peer support is an established intervention involving a person in recovery from mental illness being engaged to offering support to others with mental illness. Peers are an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at the levels of service users (psychosocial and clinical outcomes), peer support workers (work role, empowerment), services (cost-effectiveness, return on investment), and implementation (adoption, sustainability, organisational change). Methods: UPSIDES-RCT is a pragmatic parallel-group multi-centre randomised controlled trial assessing the effectiveness of UPSIDES at four measurement points over one year (baseline, 4-, 8-, and 12-month follow-up), and embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, United Kingdom, Israel, Uganda, Tanzania, India). The primary outcome is social inclusion of service users with severe mental illness (N= 558; N = 93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (Empowerment Scale), hope (HOPE scale), recovery (Stages of Recovery), and health and social functioning (Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect, and implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers, and policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support. Discussion: By implementing and evaluating a manualized peer support intervention for people with severe mental illness across low-, middle-, and high-income countries, this study will contribute to harmonising core elements of peer support across different cultural and organisational dimensions. The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention. Performance of mental health services will be maximised by actively involving and empowering service users, generating system changes towards user-centeredness, recovery orientation, community participation, and realising mental health as a human right. Trail registration: ISRCTN, ISRCTN26008944. Registered 30 October 2019, http://www.isrctn.com/ISRCTN26008944.

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Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial

Psychotherapy and Psychosomatics ◽

10.1159/000516380 ◽

2021 ◽

pp. 1-14

Author(s):

Nina Reinholt ◽

Morten Hvenegaard ◽

Anne Bryde Christensen ◽

Anita Eskildsen ◽

Carsten Hjorthøj ◽

...

Keyword(s):

Mental Health ◽

Mental Health Services ◽

Health Services ◽

Behavioral Therapy ◽

Controlled Trial ◽

Well Being ◽

Major Depressive ◽

Outpatient Mental Health ◽

End Of Treatment

Introduction: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. Objective: This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. Methods: In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. Results: At end-of-treatment, WHO-5 mean scores for patients in UP (n = 148) were non-inferior to those of patients in dCBT (n = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. Conclusions: This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

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MyCare study: protocol for a controlled trial evaluating the effect of a community-based intervention on psychosocial, clinical outcomes and hospital admission rates for adults with severe mental illness

BMJ Open ◽

10.1136/bmjopen-2020-040610 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040610

Author(s):

Renée O'Donnell ◽

Melissa Savaglio ◽

Debra Fast ◽

Ash Vincent ◽

Dave Vicary ◽

...

Keyword(s):

Mental Health ◽

Mental Illness ◽

Hospital Admission ◽

Clinical Outcomes ◽

Controlled Trial ◽

Community Based ◽

Admission Rates ◽

Mental Health Support ◽

Health Support

IntroductionPeople with serious mental illness (SMI) often fail to receive adequate treatment. To provide a higher level of support, mental health systems have been reformed substantially to integrate mental healthcare into the community. MyCare is one such community-based mental health model of care. This paper describes the study protocol of a controlled trial examining the effect of MyCare on psychosocial and clinical outcomes and hospital admission and duration rates for adults with SMI.Methods and analysisThis is a multisite non-randomised controlled trial with a 3, 6 and 12-month follow-up period. The study participants will be adults (18–64 years of age) with SMI recruited from Hobart, Launceston and the North-West of Tasmania. The treatment group will include adults who receive both the MyCare intervention and standard mental health support; the control group will include adults who receive only standard mental health support. The primary outcome includes psychosocial and clinical functioning and the secondary outcome will examine hospital admission rates and duration of stay. Mixed-effects models will be used to examine outcome improvements between intake and follow-up. This trial will generate the evidence needed to evaluate the effect of a community mental health support programme delivered in Tasmania, Australia. If MyCare results in sustained positive outcomes for adults with SMI, it could potentially be scaled up more broadly across Australia, addressing the inequity and lack of comprehensive treatment that many individuals with SMI experience.Ethics and disseminationThis study has been approved by the Tasmanian Health and Medical Human Research Ethics Committee. The findings will be disseminated to participants and staff who delivered the intervention, submitted for publication in a peer-reviewed journal and shared at academic conferences.Trial registration numberACTRN12620000673943.

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Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol

BMJ Open ◽

10.1136/bmjopen-2019-035895 ◽

2020 ◽

Vol 10 (9) ◽

pp. e035895

Author(s):

Danielle Mazza ◽

Natalie Amos ◽

Cathy J Watson ◽

Kevin McGeechan ◽

Marion Haas ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Accord Study ◽

Contraceptive Choice ◽

Long Acting ◽

Randomised Controlled

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.

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