Dataset Information

Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial.

ABSTRACT:

Objectives

To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.

Design

A two-arm unblinded feasibility RCT.

Setting

Six NHS EIP services in England.

Participants

Adults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).

Interventions

Participants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users' discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.

Primary and secondary outcome measures

Feasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.

Results

83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.

Conclusions

Recruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.

Trial registration

ISRCTN10004994.

SUBMITTER: Steare T

PROVIDER: S-EPMC7451533 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial.

Steare Thomas T O'Hanlon Puffin P Eskinazi Michelle M Osborn David D Lloyd-Evans Brynmor B Jones Rebecca R Rostill Helen H Amani Sarah S Johnson Sonia S

BMJ open 20200826 8

<h4>Objectives</h4>To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.<h4>Design</h4>A two-arm unblinded feasibility RCT.<h4>Setting</h4>Six NHS EIP services in England.<h4>Participants</h4>Adults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).<h4>Interventions</h4>Participants were randomise ...[more]

PMID: 32847902

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Project description:IntroductionMental health interventions delivered through digital technology have potential applications in promoting recovery and improving outcomes among people in the early stages of psychosis. Self-management approaches are recommended for the treatment of psychosis and could be delivered via applications (apps) installed on Smartphones to provide low-cost accessible support. We describe the protocol for a feasibility trial investigating a self-management Smartphone app intervention for adults using Early Intervention in Psychosis (EIP) services.Methods and analysisIn this feasibility randomised controlled trial, 40 participants will be recruited from EIP services in London and Surrey. Twenty participants will be randomised to receive a supported self-management Smartphone app (My Journey 3) plus Treatment As Usual (TAU), while the other 20 participants will receive TAU only. The primary objective of this study is to evaluate the feasibility of conducting a full-scale trial of this intervention in EIP services. Participant data will be collected at baseline and at two follow-up assessments conducted 4 months and 12 months post-baseline. Analysed outcome measures will include relapse of psychosis (operationalised as admission to a hospital or community acute alternative), mental health and well-being, recovery, quality of life and psychopathology. Semi-structured interviews with participants and EIP service clinicians will additionally explore experiences of using My Journey 3 and participating in the trial and suggestions for improving the intervention.Ethics and disseminationThe App to support Recovery in Early Intervention Services study has been reviewed and approved by the National Research Ethics Service Committee London-Brent (Research Ethics Committee reference: 15/LO/1453). The findings of this study will be disseminated through peer-reviewed scientific journals and conferences, magazines and web publications.Trial registration numberISRCTN10004994.

Project description:BackgroundThough olfactory deficits are well-documented in schizophrenia, fewer studies have examined olfactory performance profiles across the psychosis spectrum. The current study examined odor identification, discrimination, and detection threshold performance in first-episode psychosis (FEP) patients diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depression with psychotic features, and other psychotic conditions.MethodFEP patients (n = 97) and healthy adults (n = 98) completed birhinal assessments of odor identification, discrimination, and detection threshold sensitivity for lyral and citralva. Participants also completed measures of anticipatory pleasure, anhedonia, and empathy. Differences in olfactory performances were assessed between FEP patients and controls and within FEP subgroups. Sex-stratified post hoc analyses were employed for a complete analysis of sex differences. Relationships between self-report measures and olfactory scores were also examined.ResultsIndividuals with psychosis had poorer scores across all olfactory measures when compared to the control group. Within the psychosis cohort, patients with schizophrenia-associated psychosis had poorer odor identification, discrimination, and citralva detection threshold scores relative to controls. In schizophrenia patients, greater olfactory disturbance was associated with increased negative symptomatology, greater self-reported anhedonia, and lower self-reported anticipatory pleasure. Patients with mood-associated psychosis performed comparable to controls though men and women in this cohort showed differential olfactory profiles.ConclusionsThese findings indicate that olfactory deficits extend beyond measures of odor identification in FEP with greater deficits observed in schizophrenia-related subgroups of psychosis. Studies examining whether greater olfactory dysfunction confers greater risk for developing schizophrenia relative to other forms of psychosis are warranted.

Dataset Information

Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial.

Objectives

Design

Setting

Participants

Interventions

Primary and secondary outcome measures

Results

Conclusions

Trial registration

Publications

Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial.

Similar Datasets

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