Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study.

BACKGROUND: According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices. OBJECTIVES: This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace. METHOD: The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance. RESULTS: Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19. CONCLUSIONS: The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity. TRIAL REGISTRATION NUMBER: ISRCTN14582090.

Erratum: A community health volunteer delivered problem-solving therapy mobile application based on the Friendship Bench 'Inuka Coaching' in Kenya: A pilot cohort study - CORRIGENDUM.

[This corrects the article DOI: 10.1017/gmh.2021.3.].

Developing a framework for evaluation: a Theory of Change for complex workplace mental health interventions.

BACKGROUND: There is a gap between the necessity of effective mental health interventions in the workplace and the availability of evidence-based information on how to evaluate them. The available evidence outlines that mental health interventions should follow integrated approaches combining multiple components related to different levels of change. However, there is a lack of robust studies on how to evaluate multicomponent workplace interventions which target a variety of outcomes at different levels taking into account the influence of different implementation contexts. METHOD: We use the MENTUPP project as a research context to develop a theory-driven approach to facilitate the evaluation of complex mental health interventions in occupational settings and to provide a comprehensive rationale of how these types of interventions are expected to achieve change. We used a participatory approach to develop a ToC involving a large number of the project team representing multiple academic backgrounds exploiting in tandem the knowledge from six systematic reviews and results from a survey among practitioners and academic experts in the field of mental health in SMEs. RESULTS: The ToC revealed four long-term outcomes that we assume MENTUPP can achieve in the workplace: 1) improved mental wellbeing and reduced burnout, 2) reduced mental illness, 3) reduced mental illness-related stigma, and 4) reduced productivity losses. They are assumed to be reached through six proximate and four intermediate outcomes according to a specific chronological order. The intervention consists of 23 components that were chosen based on specific rationales to achieve change on four levels (employee, team, leader, and organization). CONCLUSIONS: The ToC map provides a theory of how MENTUPP is expected to achieve its anticipated long-term outcomes through intermediate and proximate outcomes assessing alongside contextual factors which will facilitate the testing of hypotheses. Moreover, it allows for a structured approach to informing the future selection of outcomes and related evaluation measures in either subsequent iterations of complex interventions or other similarly structured programs. Hence, the resulting ToC can be employed by future research as an example for the development of a theoretical framework to evaluate complex mental health interventions in the workplace.

Working alliance in low-intensity internet-based cognitive behavioral therapy for depression in primary care in Spain: A qualitative study.

Introduction: Psychotherapies delivered via the Internet have been promoted as an alternative for improving access to psychological treatments. A conceptual working alliance model of blended (i.e., traditional face-to-face consultation combined with Internet-delivered psychotherapy) cognitive-behavioral therapy (b-CBT) for depression has been developed in the UK. However, little is known about how this important therapeutic process, namely the working alliance (WA), is developed and maintained in Internet-delivered cognitive-behavioral therapy without face-to-face consultation (i-CBT). The aim of this study was to evaluate the validity of the WA model of b-CBT in Spanish patients with depression receiving i-CBT. Methods: Forty-one patients suffering from mild-moderate depression were interviewed to assess their experiences of an i-CBT program. Interviews were conducted with participants who received a self-guided application (n = 9), and low-intensity support (n = 10). Three group interviews were also conducted with patients who either did not start the program (n = 8) or did not complete it (n = 6), and with patients who did complete it (n = 8). Results: Qualitative thematic content analysis was performed using the constant comparative method, which revealed four main themes: "bond," "goals," "task," and "usability heuristics," all consistent with the existing literature. However, a new subcategory emerged, called "anonymity," which may highlight the social stigma that mental illness still has in the Spanish context. Conclusion: Results suggest that the development and maintenance of the WA through i-CBT could offer a better experience of the therapeutic process and improve the clinical impact. Clinical Trial Registration: Clinicaltrials.gov, identifier: NCT01611818.

A Digital Mental Health Intervention (Inuka) for Common Mental Health Disorders in Zimbabwean Adults in Response to the COVID-19 Pandemic: Feasibility and Acceptability Pilot Study.

BACKGROUND: Common mental health disorders (CMDs) are leading causes of disability globally. The ongoing COVID-19 pandemic has further exacerbated the burden of CMDs. COVID-19 containment measures, including lockdowns, have disrupted access to in-person mental health care. It is therefore imperative to explore the utility of digital mental health interventions to bridge the treatment gap. Mobile health technologies are effective tools for increasing access to treatment at a lower cost. This study explores the utility of Inuka, a chat-based app hinged on the Friendship Bench problem-solving therapy intervention. The Inuka app offers double anonymity, and clients can book or cancel a session at their convenience. Inuka services can be accessed either through a mobile app or the web. OBJECTIVE: We aimed to explore the feasibility of conducting a future clinical trial. Additionally, we evaluated the feasibility, acceptability, appropriateness, scalability, and preliminary effectiveness of Inuka. METHODS: Data were collected using concurrent mixed methods. We used a pragmatic quasiexperimental design to compare the feasibility, acceptability, and preliminary clinical effectiveness of Inuka (experimental group) and WhatsApp chat-based counseling (control). Participants received 6 problem-solving therapy sessions delivered by lay counselors. A reduction in CMDs was the primary clinical outcome. The secondary outcomes were health-related quality of life (HRQoL), disability and functioning, and social support. Quantitative outcomes were analyzed using descriptive and bivariate statistics. Finally, we used administrative data and semistructured interviews to gather data on acceptability and feasibility; this was analyzed using thematic analysis. RESULTS: Altogether, 258 participants were screened over 6 months, with 202 assessed for eligibility, and 176 participants were included in the study (recruitment ratio of 29 participants/month). The participants' mean age was 24.4 (SD 5.3) years, and most participants were female and had tertiary education. The mean daily smartphone usage was 8 (SD 3.5) hours. Eighty-three users signed up and completed at least one session. The average completion rate was 3 out of 4 sessions. Inuka was deemed feasible and acceptable in the local context, with connectivity challenges, app instability, expensive mobile data, and power outages cited as potential barriers to scale up. Generally, there was a decline in CMDs (F2,73=2.63; P=.08), depression (F2,73=7.67; P<.001), and anxiety (F2,73=2.95; P=.06) and a corresponding increase in HRQoL (F2,73=7.287; P<.001) in both groups. CONCLUSIONS: Study outcomes showed that it is feasible to run a future large-scale randomized clinical trial (RCT) and lend support to the feasibility and acceptability of Inuka, including evidence of preliminary effectiveness. The app's double anonymity and structured support were the most salient features. There is a great need for iterative app updates before scaling up. Finally, a large-scale hybrid RCT with a longer follow-up to evaluate the clinical implementation and cost-effectiveness of the app is needed.

Practitioners' experience of the working alliance in a blended cognitive-behavioural therapy intervention for depression: qualitative study of barriers and facilitators.

BACKGROUND: Digital technologies have been widely acknowledged as a potentially useful resource for increasing mental healthcare access. The working alliance is a key influence on outcomes in conventional psychotherapy, but little is known about therapists' experiences of forming an effective working alliance in blended interventions that involve in-person psychotherapy and a digital programme. AIMS: To investigate psychological well-being practitioners' (PWPs') experiences of the working alliance in a trial of blended cognitive-behavioural therapy (b-CBT) for depression. Trial registration ISRCTN12388725. METHOD: Semi-structured qualitative interviews were conducted with 13 PWPs who delivered b-CBT in a two-arm, non-inferiority randomised controlled trial investigating the effectiveness of b-CBT compared with face-to-face CBT. Thematic analysis was used to analyse the data. RESULTS: Participants reported four facilitating factors when building and maintaining a working alliance in b-CBT: having more time to deliver treatment, access to a wider toolkit, capacity to tailor components of b-CBT and receiving appropriate training and support. Participants also identified four barriers to building and maintaining a working alliance: time and resource constraints, usability challenges, limited flexibility to tailor the digital programme to patients' needs and lack of confidence in delivering b-CBT. CONCLUSIONS: Our study is the first specifically to investigate practitioners' perceived facilitators and barriers to forming a working alliance in b-CBT for depression. Findings suggest that PWPs' experiences of the working alliance can be improved by: accounting for the time required to deliver b-CBT in service workflows to reduce time pressures; increasing opportunities to tailor the digital programme through offering transdiagnostic tools and adaptable features; and providing appropriate b-CBT training and technical support.

Organizational Readiness for Implementing an Internet-Based Cognitive Behavioral Therapy Intervention for Depression Across Community Mental Health Services in Albania and Kosovo: Directed Qualitative Content Analysis.

BACKGROUND: The use of digital mental health programs such as internet-based cognitive behavioral therapy (iCBT) holds promise in increasing the quality and access of mental health services. However very little research has been conducted in understanding the feasibility of implementing iCBT in Eastern Europe. OBJECTIVE: The aim of this study was to qualitatively assess organizational readiness for implementing iCBT for depression within community mental health centers (CMHCs) across Albania and Kosovo. METHODS: We used qualitative semistructured focus group discussions that were guided by Bryan Weiner's model of organizational readiness for implementing change. The questions broadly explored shared determination to implement change (change commitment) and shared belief in their collective capability to do so (change efficacy). Data were collected between November and December 2017. A range of health care professionals working in and in association with CMHCs were recruited from 3 CMHCs in Albania and 4 CMHCs in Kosovo, which were participating in a large multinational trial on the implementation of iCBT across 9 countries (Horizon 2020 ImpleMentAll project). Data were analyzed using a directed approach to qualitative content analysis, which used a combination of both inductive and deductive approaches. RESULTS: Six focus group discussions involving 69 mental health care professionals were conducted. Participants from Kosovo (36/69, 52%) and Albania (33/69, 48%) were mostly females (48/69, 70%) and nurses (26/69, 38%), with an average age of 41.3 years. A directed qualitative content analysis revealed several barriers and facilitators potentially affecting the implementation of digital CBT interventions for depression in community mental health settings. While commitment for change was high, change efficacy was limited owing to a range of situational factors. Barriers impacting "change efficacy" included lack of clinical fit for iCBT, high stigma affecting help-seeking behaviors, lack of human resources, poor technological infrastructure, and high caseload. Facilitators included having a high interest and capability in receiving training for iCBT. For "change commitment," participants largely expressed welcoming innovation and that iCBT could increase access to treatments for geographically isolated people and reduce the stigma associated with mental health care. CONCLUSIONS: In summary, participants perceived iCBT positively in relation to promoting innovation in mental health care, increasing access to services, and reducing stigma. However, a range of barriers was also highlighted in relation to accessing the target treatment population, a culture of mental health stigma, underdeveloped information and communications technology infrastructure, and limited appropriately trained health care workforce, which reduce organizational readiness for implementing iCBT for depression. Such barriers may be addressed through (1) a public-facing campaign that addresses mental health stigma, (2) service-level adjustments that permit staff with the time, resources, and clinical supervision to deliver iCBT, and (3) establishment of a suitable clinical training curriculum for health care professionals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883.

A community health volunteer delivered problem-solving therapy mobile application based on the Friendship Bench 'Inuka Coaching' in Kenya: A pilot cohort study.

BACKGROUND: Sub-Saharan Africa (SSA) has the largest care gap for common mental disorders (CMDs) globally, heralding the use of cost-cutting approaches such as task-shifting and digital technologies as viable approaches for expanding the mental health workforce. This study aims to evaluate the effectiveness of a problem-solving therapy (PST) intervention that is delivered by community health volunteers (CHVs) through a mobile application called 'Inuka coaching' in Kenya. METHODS: A pilot prospective cohort study recruited participants from 18 health centres in Kenya. People who self-screened were eligible if they scored 8 or higher on the Self-Reporting Questionnaire-20 (SRQ-20), were aged 18 years or older, conversant in written and spoken English, and familiar with the use of smart mobile devices. The intervention consisted of four PST mobile application chat-sessions delivered by CHVs. CMD measures were administered at baseline, 4-weeks (post-treatment), and at 3-months follow-up assessment. RESULTS: In all, 80 participants consented to the study, of which 60 participants (female, n = 38; male, n = 22) completed their 4-week assessments, and 52 participants completed their 3-month follow-up assessment. The results showed a significant improvement over time on the Self-Reporting Questionnaire-20 (SRQ-20). Higher-range income, not reporting suicidal ideation, being aged over 30 years, and being male were associated with higher CMD symptom reduction. CONCLUSION: To our knowledge, this report is the first to pilot a PST intervention that is delivered by CHVs through a locally developed mobile application in Kenya, to which clinically meaningful improvements were found. However, a randomised-controlled trial is required to robustly evaluate this intervention.

Lay-delivered talk therapies for adults affected by humanitarian crises in low- and middle-income countries.

BACKGROUND: Published by the World Health Organization (WHO) and United Nations High Commissioner for Refugees (UNHCR) in 2015, the mental health Gap Action Programme Humanitarian Intervention Guide (mhGAP-HIG) recommends brief versions of structured psychological interventions for people experiencing symptoms of common mental disorders (CMDs). mhGAP-HIG acknowledges a growing body of evidence suggesting these interventions can be delivered by lay workers to people affected by humanitarian crises in low- and middle-income countries (LMICs). However, there has not yet been a systematic review and synthesis of this evidence. This paper reports the results of a systematic review of qualitative, quantitative, and mixed-methods studies assessing the implementation and/or effectiveness of talk therapies for CMDs when provided by lay workers in LMICs to adults who have survived or are currently living in humanitarian situations. METHODS: Seven electronic databases were searched: MEDLINE, Embase, PsycINFO, PsycEXTRA, Global Health, Cochrane Library, and ClinicalTrials.gov . We also hand-searched the contents pages of three academic journals, reference lists of 30 systematic reviews, and online resource directories of two mental health networks. A preliminary list of included studies was circulated to topical experts for review, and all included studies were backward and forward searched. All titles, abstracts, and full-texts were independently double-screened. Quality appraisal and data extraction were carried out by a single reviewer and checked by a second reviewer, using standardised tools. Any disagreements were discussed and referred to a third reviewer as needed. RESULTS: We identified 23 unique studies and carried out a narrative synthesis of patient and implementation outcome data. Every evaluation of the effectiveness of lay-delivered talk therapies for adults affected by humanitarian crises in LMICs showed some treatment effect for at least one CMD, and often multiple CMDs. Implementation research generally found these interventions to be acceptable, appropriate and feasible to implement, with good fidelity to manualised therapies. CONCLUSION: Although results are promising, particularly for individually-delivered talk therapies based on cognitive behavioural therapy techniques, there is a high degree of heterogeneity in this literature. We make several recommendations on how to improve the quality and generalisability of research on this topic, to facilitate further evidence synthesis. TRIAL REGISTRATION: PROSPERO registration number: CRD42017058287 .

Towards a conceptual framework of the working alliance in a blended low-intensity cognitive behavioural therapy intervention for depression in primary mental health care: a qualitative study.

OBJECTIVES: To examine and adapt a conceptual framework of the working alliance (WA) in the context of a low-intensity blended (psychological well-being practitioner (PWP) plus computerised program) cognitive behavioural therapy intervention (b-CBT) for depression. DESIGN: Patient involvement was enlisted to collaboratively shape the design of the project from the onset, before data collection. In-depth semi-structured interviews were carried out with participants who experienced b-CBT as part of the E-compared trial. A thematic analysis was conducted using a constant comparative method informed by grounded theory. SETTING: Recruitment was carried out in four psychological primary care services across the UK. PARTICIPANTS: Nineteen trial participants with major depressive disorder who completed at least one computerised program and face-to-face session with a PWP in the b-CBT arm were recruited to the study. RESULTS: Qualitative interviews that were guided by WA theory and patient involvement, revealed four themes: (1) a healthcare provider (PWP and computerised program) with good interpersonal competencies for building a working relationship with the client ('bond'); (2) collaborative efforts between the client and the provider to appropriately identify what the client hopes to achieve through therapy ('goals'); (3) the selection of acceptable therapeutic activities that address client goals and the availability of responsive support ('task') and (4) the promotion of active engagement and autonomous problem solving ('usability heuristics'). Participants described how the PWP and computerised program uniquely and collectively contributed to different WA needs. CONCLUSIONS: This study is the first to offer a preliminary conceptual framework of WA in b-CBT for depression, and how such demands can be addressed through blended PWP-computerised program delivery. These findings can be used to promote WA in technological design and clinical practice, thereby promoting engagement to b-CBT interventions and effective deployment of practitioner and program resources. TRIAL REGISTRATION NUMBER: ISRCTN12388725.

Added value or added burden? A qualitative investigation of blending internet self-help with face-to-face cognitive behaviour therapy for depression.

Objectives: Numerous studies and reviews have explored the value of adding therapist support to internet self-help for improving client adherence and outcomes. This study is different as it explores the value of adding internet self-help to face-to-face therapy, from the perspective of practitioners who used both. This study explores practitioners' experiences of whether-and how-internet self-help blended with face-to-face therapy may confer an added value or become an added burden to their routine practice. Methods: Using a structured topic guide, we collected narrative data via 3 focus groups and 1 telephone interview from 11 practitioners across two sites in England. We carried out a thematic analysis within two domains, "value vs. burden". Results: Practitioners reported that internet self-help can confer added value to face-to-face therapy by: fostering client engagement with face-to-face sessions; making therapy ubiquitous beyond sessions; and preventing therapeutic drift between sessions. Conversely, internet self-help can add burden to face-to-face therapy when it is experienced as disruptive, overwhelming and time-consuming. Conclusions: Recognizing and mitigating factors that can turn internet self-help from an added value to an added burden will help practitioners adopt and make the most out of blended therapy.

Views From the Street Pilot Study: Constraints and Difficulties of Using Photographs in Research of a Complex Nature Such as Homelessness.

Homeless people experience a unique set of challenges leading to pervasive health and social problems. An increasing number of researchers have harnessed photographic data to gain a unique perspective of marginalised groups. The aim of the study is to explore the feasibility of using photographs in research to understand the complex environment experienced by homeless people, with a special interest in mental health. Individuals who frequently attend homeless facilities in London were sensitively approached and asked if they would be interested in taking part in the 'Views From the Street' pilot study. Once agreement was confirmed through a formal consenting procedure, participants were asked to visually capture and upload their own digital photos, along with a brief description. The collection of data highlighted a number of barriers to engagement and acceptability, including issues around the level of familiarity with the recruiter, practicalities of participation, public perception of phone use, poor technical literacy, anonymity, and disassociation with the 'homeless' label. Recommendations are made for future research utilising photographic participatory designs with the homeless population.

The PCL as a brief screen for posttraumatic stress disorder within schizophrenia.

OBJECTIVES: To assess the utility of using the posttraumatic checklist (PCL) as a screening measure for identifying posttraumatic stress disorder (PTSD) in individuals diagnosed with a psychotic disorder. METHODS: The PCL was administered to 165 participants as part of a clinical trial. Those scoring 44 or above on the PCL underwent further assessment using the clinician administered PTSD scale (CAPS). RESULTS: Overall 18.2% of the sample exhibited a diagnostic level of PTSD symptoms, as indicated by the CAPS assessment. Only 29.7% of those who scored above the PCL threshold were diagnostic of PTSD. CONCLUSIONS: The use of PCL for identifying PTSD within this population is not recommended.

Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation.

BACKGROUND: Most patients with chest pain have nothing wrong with their cardiac function. Psychological forms of treatment for this condition are more likely to be successful than others. METHODS/DESIGN: A two-arm parallel controlled randomized trial of standard care versus a modified form of cognitive behaviour therapy for chest pain (CBT-CP) in patients who have attended emergency hospital services. Inclusion criteria include (i) emergency attendance more than once in the previous year with chest pain when no physical pathology has been found, (ii) aged between 16 and 75, (iii) signed consent to take part in the study. Exclusion criteria are (i) under current psychiatric care, (ii) those who have had new psychotropic drugs prescribed within the last two months, (iii) are receiving or about to receive a formal psychological treatment. Those satisfying these criteria will be randomized to 4-10 sessions of CBT-CP or to continue with standard care. Participants are randomized using a remote web-based system using permuted stacked blocks stratified by study centre. Assessment is carried out at baseline by researchers subsequently masked to allocation and at 6 months and 1 year after randomization. The primary outcome is the Health Anxiety Inventory score at 6 months, and secondary outcomes are generalised anxiety and depressive symptoms, the Lucock Health Anxiety Questionnaire adapted for chest pain, visual analogue scales for chest pain and discomfort (Inskip Scale), the Schedule for Evaluating Persistent Symptoms (SEPS), health related quality of life, social functioning and medical resource usage. Intention to treat analyses will be carried out with clinical and functioning data, and a cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D. The data will also be linked to another parallel study in New Zealand where 126 patients with the same inclusion criteria have been treated in a similar trial; the form of analysis of the combined data has yet to be determined. DISCUSSION: The morbidity and costs of non-cardiac chest pain are substantial and if a simple psychological treatment given by health professionals working in medical departments is beneficial it should prove to be of great value. Combining data with a similar study in New Zealand is an additional asset. TRIAL REGISTRATION: ISRCTN14711101 (registered 05/03/2015).