Table 1 The study characteristics of feasibility studies, stratified by study design
Feasibility/Pilot randomized controlled trial(s) (n = 3)a | |||||||
Author, year, country | Participants | Setting | Aim | Control/comparator condition | Follow up | Outcome measure(s) | |
Rotondi, 2005, [54•] USA | - Persons with schizophrenia (PWS): aged 14 or older and diagnosed with schizophrenia or schizoaffective disorder - Support persons: aged 18 or older | In- and outpatient psychiatric care units and rehabilitation centres | To assess the feasibility and preliminary efficacy of providing a psychoeducational program to participants’ homes via the Internet. | Intervention vs. treatment as usual (TAU) control | Long-term follow up: 3-and 6-month post-baseline | - Social isolation outcomes (for PWS and support persons): perceived social support via Perceived Support Scale (PSS) and Medical Outcomes Study Social Support Survey (MOS-SSS) - Feasibility outcomes: helpfulness, value, understandability and ease of use via Website Evaluation Instrument (WEI) - Other outcomes: perceived stress | |
O’Mahen, 2014, [55•] UK | Mothers with postnatal depression symptoms and had given birth to a live baby last year | Netmums website and newsletter | To (1) establish recruitment and trial adherence rates; (2) determine treatment adherence and predictors of modules and telephone sessions; (3) assess the preliminary effectiveness of NetmumsHWD on depressive and anxious symptoms, work and social impairment, perceived support, and maternal self-reported bonding with her infant in order to help inform future sample size calculations; and (4) gather data on health care utilization at baseline and at post-treatment in preparation for a health economic assessment. | Intervention vs. TAU control | - End of treatment: 17-week - Long-term follow up: 6-month | Social isolation outcomes: perceived availability of support via Social Provision Scale (SPS) - Feasibility outcomes: treatment adherence and attrition - Other outcomes: depression, anxiety, work and social impairment, postnatal bonding and health service utilization \ | |
Hanssen, 2020, [56•] Netherlands | Adults (aged 18–60 years) with a schizophrenia spectrum disorders diagnosis | Community mental health treatment teams, hospitals, iand patient- and relative associations | To find out whether using an interactive smartphone application is feasible in a schizophrenia sample and whether providing personalised ESM-derived feedback can ameliorate symptoms and improve social functioning. | SMARTapp provided feedback according to the participants’ daily ESM entries vs. SMARTapp included only ESM questionnaires without personalised feedback. | End of treatment: 3-week | - Social isolation outcomes: loneliness measured by daily ESM questionnaire - Feasibility outcomes: usage and evaluation of SMARTapp - Other outcomes: positive and negative psychotic symptoms, social functioning, intelligence | |
Feasibility/Pilot non-randomized trial(s) (n = 1)b | |||||||
Author, year, country | Participants | Setting | Aim | Control/comparator condition | Follow up | Outcome measure(s) | |
Pfeiffer, 2017, [57•] USA | Individuals with an inpatient diagnosis of depression | VA Ann Arbor Healthcare System | To assess the acceptability and feasibility of enhanced social support with automated telephone monitoring for patients with depression discharged from psychiatric inpatient stays. | Social support provided by a family/friend VS social support provided by a trained peer specialist | - Mid-term follow up: 3-months - End of treatment: 6-month | - Social isolation outcomes: perceived social support via Multidimensional Scale of Perceived Social Support (MSPSS) - Feasibility outcomes: acceptability and satisfaction with the program - Other outcomes: depression severity, depression symptoms, anxiety, suicidal ideation, functioning, hopelessness, antidepressant adherence, readmission to inpatient psychiatry, outpatient mental health visits | |
Feasibility/Pilot single-group study(s) (n = 7)c | |||||||
Author, year, country | Participants | Setting | Aim | Follow up | Outcome measure(s) | ||
Van Voorhees, 2005, [58•] USA | Adolescents (ages 18–24) with at least one risk factor for developing depression | Primary care settings in the USA (urban primary care and university health clinic) | To evaluate the acceptability, potential adverse effects, and potential benefits (i.e., reduction of risk factors for depression) of the intervention. | Time elapsed from enrolment to follow-up interview (completers) ranged from 1 to 6 weeks | - Social isolation outcomes: social support questionnaire-short form (SSQ-6) - Feasibility outcomes: acceptability (performance, satisfaction ratings) - Other outcomes: adverse effects, depressive symptoms, dysfunctional thinking | ||
Rice, 2020, [59•] Australia | Young people (aged 12–25 years) with “probable” social phobia | Headspace early intervention centres in north-western Melbourne, Australia | To examine the acceptability, feasibility, safety and potential clinical benefit (according to both clinical and social measures) of a novel digital intervention for young people with social anxiety. In addition to Entourage demonstrating acceptability, feasibility and safety, the intervention was expected to be associated with improved clinical (e.g., social anxiety, mood, wellbeing) and social functioning (e.g., social support, connectedness) outcomes between baseline and post-treatment. | End of treatment: 12-week | - Social isolation outcomes: social support network via LSNS, social connectedness via Abbreviated Duke Social Support Index (DSSI), Revised University of California, Los Angeles Loneliness Scale (UCLA-LS), Social Connectedness Scale (SCS) and Interpersonal Needs Questionnaire (INQ) - Feasibility outcomes: acceptability (participants’ use of the system), feasibility (capacity to recruit and retain young people in Entourage) and safety (monitoring the occurrence of adverse events and symptom deterioration) - Other outcomes: depression, wellbeing, social anxiety, self-esteem, emotion regulation, self-compassion, experiential avoidance, public speaking cognitions, guilt and shame. | ||
Rice, 2018, [60•] Australia | Young people (aged 15–24 years) with diagnosis of Major Depressive Disorder (MDD); either in partial remission or full remission | Early intervention clinics in Melbourne, Australia | To evaluate the acceptability, feasibility, usability and safety of an innovative moderated online social therapy (MOST) for depression relapse prevention in young people. | - End of treatment: 12-week | - Social isolation outcomes: social connectedness via MOS-SSS, social support via the 2-Way Social Support Scale - Feasibility outcomes: acceptability (user experience via Website Analysis and Measurement Inventory), feasibility, usability (frequency ratings and patterns of use) - Other outcomes: MDD diagnoses, depression symptom rating, strengths use, worry and anxiety | ||
Price, 2014, [61•] USA | Individuals (aged younger than 55 years) who presented for an injury that would satisfy a diagnosis criterion of PTSD | Recovery ward of a Level 1 Trauma Center | To determine the proportion of trauma patients that would consent to receiving daily text messages assessing mental health, determine response rates to daily text messages among trauma patients, identify predictors of higher rates of responding, assess patient satisfaction, and determine provider burden. | Long-term follow up: 1-month, 3-month | - Social isolation outcomes: MOS-SSS - Feasibility outcomes: satisfaction with the intervention - Other outcomes: depressive symptoms, PTSD symptoms, illness intrusiveness rating Scale, injury severity score. | ||
Ludwig, 2020, [62•] USA | Individuals (aged 18–35 years) with schizophrenia spectrum disorder and with a maximum of 5 lifetime years of treatment with antipsychotic medication | - Recruited from First Episode Psychosis clinics in North Carolina. | To examine the feasibility and acceptability of Horyzons for American clients receiving care at three FEP clinics in North Carolina. | - Mid-term follow up: 6-week - End of treatment: 12-week - Long-term follow up: 16-week | - Social isolation outcomes: loneliness via UCLA-LS, perceived social support and relationship quality via Social Provisions Scale (SPS) - Feasibility outcomes: usage (site logins) and satisfaction (perceived benefits or challenges of intervention) - Other outcomes: well-being, positive and negative emotions, subjective self-worth, psychosis-related symptoms, depressive symptoms, social/ occupational functioning | ||
Bailey, 2020, [63•] Australia | Young people (aged 16–25 years) with suicidal intent | Tertiary-level outpatient mental health service | To (1) evaluate the safety, feasibility, and acceptability of a MOST intervention (“Affinity”) among a sample of young people who were receiving treatment for major depressive disorder and had also experienced past-four-week suicidal ideation, (2) explore changes in cognitive and interpersonal targets of the Affinity intervention, as well as changes in self-reported depression and suicidal ideation. | End of treatment: 8-week | - Social isolation outcomes: Social Connectedness Scale-Revised (SCS-R) - Feasibility outcomes: safety, feasibility, acceptability - Other outcomes: suicidal ideation, depressive symptoms, perceived burdensomeness and thwarted belongingness, mindful attention awareness, self-compassion, problem solving, suicide severity rating, self-harm risk | ||
Alvarez-Jimenez, 2018, [64•] Australia | Young people (aged 15–25 years) of ultra-high risk (UHR) for psychosis | Specialised UHR research clinic (the PACE clinic) | To conduct an initial evaluation of MOMENTUM regarding its acceptability, safety and potential to improve social functioning in UHR young people | - Baseline and 2-month follow up | - Social isolation outcomes: perceived social isolation and social support via SPS and University of California, Los Angeles Loneliness Scale (UCLA-LS-3) - Feasibility outcomes: feasibility, acceptance (participants’ usage) and safety (adverse events) - Other outcomes: social functioning, subjective well-being, self-efficacy self-esteem, depressed mood, perceived stress, mindfulness, strengths use | ||
Feasibility/Pilot mixed-methods study(s) (n = 5) | |||||||
Author, year, country | Participants | Setting | Aim | Control group | Follow up | Data collection method | |
Quantitative: outcome measure(s) | Qualitative | ||||||
Lim, 2020, [65•] Australia | Young people (aged 16–25 years) with diagnosis of psychotic disorder | Early psychosis services in Melbourne, Australia | To (1) develop a pilot digital smartphone application to target loneliness that is feasible and acceptable to young people with early psychosis, (2) develop an app that is usable to young people as one necessary step to reducing the likelihood of poor engagement, a common problem with mental health smartphone apps | None | - End of treatment: after participants complete at least 33 days of +Connect (T2) - Long-term follow up: 3-month post-treatment (T3) | - Social isolation outcomes: loneliness via Revised UCLA-LS - Feasibility outcomes: acceptability, feasibility, usability (content helpfulness, satisfaction ratings, completion rates, etc) - Other outcomes: social interaction anxiety, psychological well-being, positive and negative symptoms, depressive symptoms | - Semi-structured qualitative interview at T2 regarding participants’ experiences using the app |
Lim, 2019, [66•] Australia | - Young people (aged 18–23 years) with Social Anxiety Disorder (SAD) - Young people (aged 18–23 years) with no diagnosable mental health disorder (recruited as control participants | - SAD participants: Local youth health service - Control participants: Australian university | To examine the acceptability, feasibility, and safety of +Connect in young people with or without social anxiety disorder. | SAD participants vs. control participants | - End of treatment: after participants complete at least 33 days of +Connect (T2) - Long-term follow up: 3-month post-treatment (T3) | - Social isolation outcomes: loneliness via Revised UCLA-LS - Feasibility outcomes: acceptability, feasibility, usability (content helpfulness, satisfaction ratings, completion rates, etc) - Other outcomes: social interaction anxiety, depressive symptoms | Semi-structured qualitative interview at T2 regarding participants’ experiences using the app |
Gjerdingen, 2013, [67•] USA | Mothers aged above 16 years with postpartum depression | St. Paul hospitals, local practices, mothering Web sites and mid-wife referrals | To pilot a peer support intervention trial for mothers with postpartum depressive symptoms. Specifically, to test the feasibility of recruiting postpartum doulas, peer telephone supporters, and depressed mothers for a trial, and began to evaluate the impact of postpartum doula and peer telephone support as adjunctive treatments for depressive symptoms. | Postpartum doula vs. peer telephone support vs. no treatment control | - End of treatment: 3-month - Long-term follow up: 6-month | - Social isolation outcomes: social support via a 7-item scale: available Support, Importance of Support and satisfaction with support - Other outcomes: mental health history, health status | - Open-ended questions or opportunities for making further comments. |
Dow, 2008, [68•] Australia | Individuals (aged 65 years or above) with mild depression, provide personal care for a co-resident relative, live in the Pyrenees subregion | Local newspapers, word of mouth and carer support groups | To test the feasibility of a computer intervention for promoting the health of rural carers in Australia. | None | Long-term follow up: 3-month | - Social isolation outcomes: loneliness via UCLA-LS - Other outcomes: depressive symptoms, carer burden | - Semi-structured interview regarding participants’ experiences using the computer and intentions regarding future use. - Group discussion about their experiences of the computer intervention |
Campbell, 2019, [69•] Australia | Young people (aged 13–25 years) with mild-to-moderate depression or anxiety; contacting or previously engaged with Kids Helpline (KHL) for counselling; seeking support for issues related to family discord | Kids Helpline counselling service and Webchat | To develop the evidence base to validate the proof of concept for KHL Circles: a purpose-built, private, and secure SNS, designed to provide 24/7 group counseling to young people in Australia experiencing family discord. | None | - Mid-term follow up: 2-, 4- and 6-week - End of treatment: 8-week | - Social isolation outcomes: MSPSS - Other outcomes: depressive symptoms, anxiety, self-esteem, | Mid-term and final surveys asked for indications of helpfulness, whether participants would return to KHL Circles, what issues they would be comfortable discussing, what they considered to be the most important features of a social media peer-support site, and other feedback |