Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis.

BACKGROUND: Individuals with psychosis report favourable attitudes towards psychological interventions delivered via smartphone apps. Evidence for acceptability, safety, feasibility and efficacy is promising but in-depth reporting of app engagement in trials is sparse. AIMS: To examine how people with psychosis engaged with the cognitive behaviour therapy (CBT)-informed Actissist app over a 12-week intervention period, and to examine factors associated with app engagement. METHODS: Secondary data from participants in the intervention arm (n = 24) of a proof-of-concept randomised controlled trial of the Actissist app were analysed. The app prompted participants to engage with app-based CBT-informed material in five domains (voices, socialization, cannabis use, paranoia, perceived criticism) at pseudo-random intervals (three notifications per day, six days per week). Participants could self-initiate use any time. App use was financially incentivised. RESULTS: Participants responded to 47% of app notifications. Most app engagements (87%) were app-initiated rather than self-initiated. Participants engaged most with the voices domain, then paranoia. Age and employment status were significantly associated with overall app engagement. CONCLUSION: Individuals with psychosis engaged well with Actissist, particularly with areas focussing on voice-hearing and paranoia. App-generated reminders successfully prompted app engagement. As financial incentives may have increased app engagement, future studies of non-incentivized engagement in larger samples are needed.

Ethnicity and impact on the receipt of cognitive-behavioural therapy in people with psychosis or bipolar disorder: an English cohort study.

OBJECTIVES: (1) To explore the role of ethnicity in receiving cognitive-behavioural therapy (CBT) for people with psychosis or bipolar disorder while adjusting for differences in risk profiles and symptom severity. (2) To assess whether context of treatment (inpatient vs community) impacts on the relationship between ethnicity and access to CBT. DESIGN: Cohort study of case register data from one catchment area (January 2007-July 2017). SETTING: A large secondary care provider serving an ethnically diverse population in London. PARTICIPANTS: Data extracted for 30 497 records of people who had diagnoses of bipolar disorder (International Classification of Diseases (ICD) code F30-1) or psychosis (F20-F29 excluding F21). Exclusion criteria were: <15 years old, missing data and not self-defining as belonging to one of the larger ethnic groups. The sample (n=20 010) comprised the following ethnic groups: white British: n=10 393; Black Caribbean: n=5481; Black African: n=2817; Irish: n=570; and 'South Asian' people (consisting of Indian, Pakistani and Bangladeshi people): n=749. OUTCOME ASSESSMENTS: ORs for receipt of CBT (single session or full course) as determined via multivariable logistic regression analyses. RESULTS: In models adjusted for risk and severity variables, in comparison with White British people; Black African people were less likely to receive a single session of CBT (OR 0.73, 95% CI 0.66 to 0.82, p<0.001); Black Caribbean people were less likely to receive a minimum of 16-sessions of CBT (OR 0.83, 95% CI 0.71 to 0.98, p=0.03); Black African and Black Caribbean people were significantly less likely to receive CBT while inpatients (respectively, OR 0.76, 95% CI 0.65 to 0.89, p=0.001; OR 0.83, 95% CI 0.73 to 0.94, p=0.003). CONCLUSIONS: This study highlights disparity in receipt of CBT from a large provider of secondary care in London for Black African and Caribbean people and that the context of therapy (inpatient vs community settings) has a relationship with disparity in access to treatment.

Developing a Theory-Informed Smartphone App for Early Psychosis: Learning Points From a Multidisciplinary Collaboration.

Background: Actissist is a smartphone app designed to deliver an intervention grounded in cognitive behavior therapy for early psychosis. Actissist was developed by a multidisciplinary team of academics, clinicians, experts by experience and software engineers. Actissist has been tested in two trials, the first a proof-of-concept trial where Actissist was safe, acceptable and feasible, the second, a powered randomized controlled trial. Objective: This article describes how our multidisciplinary team designed and developed Actissist. This article describes: (i) how Actissist was informed by initial qualitative interviews and focus groups and an expert reference group; (ii) refinements made to the app based on ongoing user feedback; (iii) successes and challenges encountered; and (iv) learning points and recommendations for involving stakeholders in digital health interventions. Methods: Expert reference group meetings informed the development of Actissist and design of subsequent trials, which included individuals with lived experience of psychosis, clinicians, academics, computer scientists and software engineers. Person-centered stakeholder involvement was promoted using focus groups and qualitative interviews prior to the development of the app, which informed version one of Actissist. Interviews were carried out with participants who had used Actissist. Two further versions of Actissist were developed following additional rounds of testing. Results: Multidisciplinary working throughout the Actissist project led to the development, inclusion and improvement of the app design and content. These changes and features included non-directive and compassionate content, co-designed recovery videos, relaxation exercises, psychoeducation material, ability to "favorite" areas of the app that users found helpful, and goal-setting. Challenges to collaborative working included discrepancies between what stakeholders want and what is technically possible to deliver, resource pressures, trying to deliver desired features within the boundaries of fundamental trial design considerations, and power imbalances associated with multidisciplinary working. Conclusions: The involvement of stakeholders in the design and development and delivery of Actissist has been fundamental to our development approach. Through this collaborative process, we have identified different perspectives and ideas that would have not been generated by the research team alone. Clinical Trial Registrations: Proof-of-concept trial: http://www.isrctn.com/ISRCTN34966555 Fully-powered randomized controlled trial: https://www.isrctn.com/ISRCTN76986679.

"They Are Not Hard-to-Reach Clients. We Have Just Got Hard-to-Reach Services." Staff Views of Digital Health Tools in Specialist Mental Health Services.

Background: Digital health products designed to help people with severe mental health problems appear to be feasible, acceptable, and efficacious. The challenge facing the digital mental health field is implementing digital tools in routine service delivery. To date, there has been a paucity of qualitative research exploring staff views of digital health solutions in the context of mental healthcare. Engaging and involving frontline staff in the design and rollout of new technology to improve utilization is imperative for successful uptake and adoption of digital tools. The aim of the current study is to explore frontline staff views regarding the utility and appropriateness of using digital tools in the healthcare pathway for people accessing specialist secondary care mental health services. Method: Qualitative study using framework analysis was used with 48 mental health staff working in early intervention for psychosis services. Six groups comprising 5-10 early intervention service staff members in each group were conducted across the Northwest of England. Robust measures were used to develop a stable framework, including member checking, triangulation, and consensus meetings. Results: Three themes were identified a priori: i) perceived barriers to adopting smartphone apps for early psychosis; ii) acceptability of digital health tools for early psychosis patients; and iii) data security, safety, and risk. Alongside exploring the a priori topics, one theme was generated a posteriori: iv) relationships. Conclusions: Staff working in specialist early intervention for psychosis services found digital tools on the whole acceptable in mental health service provision, but raised a number of concerns that will likely affect implementation of such systems into routine service delivery and practice. Thirteen recommendations are made in this paper as a result of the themes generated in these data. Implementing of digital systems needs to be simple and uncomplicated and improve clinical workflows for staff rather than hinder and increase clinical workflows. Furthermore, organizational support with a clear plan for implementing technological innovations is required for successful adoption of digital systems. Consideration of staff views around digital systems is important if successful adoption and implementation of such systems are to occur. Clinical Trial Registration: http://www.isrctn.com, identifier ISRCTN34966555.

Early Psychosis Service User Views on Digital Technology: Qualitative Analysis.

BACKGROUND: Digital technology has the potential to improve outcomes for people with psychosis. However, to date, research has largely ignored service user views on digital health interventions (DHIs). OBJECTIVE: The objective of our study was to explore early psychosis service users' subjective views on DHIs. METHODS: Framework analysis was undertaken with data obtained from 21 semistructured interviews with people registered with early intervention for psychosis services. Robust measures were used to develop a stable framework, including member checking, triangulation, independent verification of themes, and consensus meetings. RESULTS: The following 4 themes were established a priori: acceptability of technology in psychosis and mental health; technology increasing access to and augmenting mental health support; barriers to adopting DHIs; and concerns about management of data protection, privacy, risk, and security of information. The following 2 themes were generated a posteriori: blending DHIs with face-to-face treatment and empowerment, control, and choice. DHIs were also viewed as potentially destigmatizing, overcoming barriers faced in traditional service settings, facilitating communication, and empowering service users to take active control of their health care. CONCLUSIONS: In the first study of its kind, early psychosis service users' were largely positive about the potential use of DHIs supporting and managing mental health. Overall, service users felt that DHIs were a progressive, modern, and relevant platform for health care delivery. Concerns were expressed around privacy and data security and practical barriers inherent within DHIs, all of which require further attention. Future research should explore whether findings transfer to other service user groups, other technology delivery formats, and across a range of treatment modalities.

Assessing Therapeutic Alliance in the Context of mHealth Interventions for Mental Health Problems: Development of the Mobile Agnew Relationship Measure (mARM) Questionnaire.

BACKGROUND: Digital health interventions in the form of smartphone apps aim to improve mental health and enable people access to support as and when needed without having to face the stigma they may experience in accessing services. If we are to evaluate mobile health (mHealth) apps and advance scientific understanding, we also need tools to help us understand in what ways mHealth interventions are effective or not. The concept of therapeutic alliance, a measure of the quality of the relationship between a health care provider and a service user, is a key factor in explaining the effects of mental health interventions. The Agnew Relationship Measure (ARM) is a well-validated measure of therapeutic alliance in face-to-face therapy. OBJECTIVE: This study presented the first attempt to (1) explore service users' views of the concept of relationship within mHealth mental health interventions and (2) adapt a well-validated face-to-face measure of therapeutic alliance, the Agnew Relationship Measure (ARM), for use with mHealth interventions. METHODS: In stage 1, we interviewed 9 mental health service users about the concept of therapeutic alliance in the context of a digital health intervention and derived key themes from interview transcripts using thematic analysis. In stage 2, we used rating scales and open-ended questions to elicit views from 14 service users and 10 mental health staff about the content and face validity of the scale, which replaced the word "therapist" with the word "app." In stage 3, we used the findings from stages 1 and 2 to adapt the measure with the support of a decision-making algorithm about which items to drop, retain, or adapt. RESULTS: Findings suggested that service users do identify relationship concepts when thinking about mHealth interventions, including forming a bond with an app and the ability to be open with an app. However, there were key differences between relationships with health professionals and relationships with apps. For example, apps were not as tailored and responsive to each person's unique needs. Furthermore, apps were not capable of portraying uniquely human-like qualities such as friendliness, collaboration, and agreement. We made a number of changes to the ARM that included revising 16 items; removing 4 items due to lack of suitable alternatives; and adding 1 item to capture a key theme derived from stage 1 of the study ("The app is like having a member of my care team in my pocket"). CONCLUSIONS: This study introduces the mHealth version of the ARM, the mARM, that has good face and content validity. We encourage researchers to include this easy-to-use tool in digital health intervention studies to gather further data about its psychometric properties and advance our understanding of how therapeutic alliance influences the efficacy of mHealth interventions. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 34966555; http://www.isrctn.com/ISRCTN34966555 (Archived by WebCite at http://www.webcitation.org/6ymBVwKif).

Actissist: Proof-of-Concept Trial of a Theory-Driven Digital Intervention for Psychosis.

Background: Timely access to intervention for psychosis is crucial yet problematic. As such, health care providers are forming digital strategies for addressing mental health challenges. A theory-driven digital intervention that monitors distressing experiences and provides real-time active management strategies could improve the speed and quality of recovery in psychosis, over and above conventional treatments. This study assesses the feasibility and acceptability of Actissist, a digital health intervention grounded in the cognitive model of psychosis that targets key early psychosis domains. Methods: A proof-of-concept, single, blind, randomized controlled trial of Actissist, compared to a symptom-monitoring control. Thirty-six early psychosis patients were randomized on a 2:1 ratio to each arm of the trial. Actissist was delivered via a smartphone app over 12-weeks; clinical and functional assessment time-points were baseline, post-treatment and 22-weeks. Assessors' blind to treatment condition conducted the assessments. Acceptability was examined using qualitative methods. Results: Actissist was feasible (75% participants used Actissist at least once/day; uptake was high, 97% participants remained in the trial; high follow-up rates), acceptable (90% participants recommend Actissist), and safe (0 serious adverse events), with high levels of user satisfaction. Treatment effects were large on negative symptoms, general psychotic symptoms and mood. The addition of Actissist conferred benefit at post-treatment assessment over routine symptom-monitoring and treatment as usual. Conclusions: This is the first controlled proof-of-concept trial of a theory-driven digital health intervention for early psychosis. Actissist is feasible and acceptable to early psychosis patients, with a strong signal for treatment efficacy. Trial Registration: ISRCTN: 34966555.

Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.

BACKGROUND: Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. METHODS/DESIGN: We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. DISCUSSION: To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care. TRIAL REGISTRATION: ISRCTN34966555. Date of first registration: 12 June 2014.