Open Feasibility Trial Research Articles

Higher adverse childhood experiences interference with targeted early intervention to reduce persistence of adult subacute pain: a feasibility open trial

Higher adverse childhood experiences interference with targeted early intervention to reduce persistence of adult subacute pain: a feasibility open trial

Acceptance and Mindfulness-Based Exposure Therapy for PTSD After Cardiac Arrest: An Open Feasibility Trial.

Acceptance and Mindfulness-Based Exposure Therapy for PTSD After Cardiac Arrest: An Open Feasibility Trial.

Enhancing accessibility and scalability of school-based programs to improve youth attention and behavior: Open feasibility trial of the remote CLS-R-FUERTE program in Mexico.

Enhancing accessibility and scalability of school-based programs to improve youth attention and behavior: Open feasibility trial of the remote CLS-R-FUERTE program in Mexico.

Supplemental Material for Enhancing Accessibility and Scalability of School-Based Programs to Improve Youth Attention and Behavior: Open Feasibility Trial of the Remote CLS-R-FUERTE Program in Mexico

Supplemental Material for Enhancing Accessibility and Scalability of School-Based Programs to Improve Youth Attention and Behavior: Open Feasibility Trial of the Remote CLS-R-FUERTE Program in Mexico

Supporting Families Affected by Adversity: An Open Feasibility Trial of Family Life Skills Triple P

This pilot feasibility study examined the effects of a new trauma-informed parenting program, Family Life Skills Triple P (FLSTP), in an open uncontrolled trial conducted in a regular service delivery context via video conferencing. FLSTP was trialed as a group-delivered 10-session intervention. Program modules target positive parenting skills (4 sessions) and adult life skills including coping with emotions, taking care of relationships, self-care, dealing with the past, healthy living, and planning for the future. Participants were 50 parents with multiple vulnerabilities, due to social disadvantage or adverse childhood experiences, who had children aged 3–9 with early onset behavior problems. Outcomes were assessed across four data collection points: baseline, mid-intervention (after Session 4), post-intervention, and 3-month follow up. Findings show moderate to large intra-group effect sizes for changes in child behavior problems, parenting practices and risk of child maltreatment, and medium effect sizes for parental distress, emotion regulation and self-compassion. Parents and practitioners reported high levels of consumer satisfaction with the program. Parents with lower levels of parental self-efficacy, lower personal agency and higher baseline scores on a measure of child abuse potential were at greater risk of not completing the program. The strength of these preliminary findings indicates that a more rigorous evaluation using a randomized clinical trial is warranted.

Brief adjunctive mindfulness-based cognitive therapy via Telehealth for anxiety during the COVID-19 pandemic

ABSTRACT Background and Objectives While cognitive–behavioral therapy is a highly efficacious treatment for anxiety, additional research is needed to identify adjunctive interventions that may augment treatment outcome. Design In response to the COVID-19 pandemic, we conducted an open feasibility trial of brief (i.e., four 75- to 90-minute sessions) mindfulness-based cognitive therapy (MBCT) for anxiety via telehealth for patients (N = 23) receiving individual CBT at an outpatient specialty clinic. Methods Self-report measures of home practice compliance (weekly), intervention acceptability (post-intervention), mindfulness and self-compassion, anxiety and depressive symptoms, and transdiagnostic processes (pre- and post-intervention) were administered as part of routine clinical practice. Results Results indicated good retention and attendance rates, few technical difficulties, good home practice compliance, and high levels of perceived importance. Participants indicated that they would highly recommend the group to others and also recommended extending the group beyond four sessions. There were significant improvements in mindfulness and self-compassion and reductions in intolerance of uncertainty, anxiety sensitivity, distress intolerance, emotion dysregulation, and anxiety symptoms from pre- to post-intervention. Conclusions Brief MBCT as an adjunctive treatment for anxiety via telehealth is feasible and acceptable, and shows promise in terms of engaging treatment targets and transdiagnostic processes and reducing anxiety symptoms.

Acceptance and Commitment Therapy Group Intervention for Parents of Children with Disabilities (Navigator ACT): An Open Feasibility Trial

Parents of children with autism spectrum disorder and other disabilities report high levels of distress, but systematically evaluated interventions are few. This study aimed to evaluate the feasibility of a novel, manualized Acceptance and Commitment Therapy group intervention (Navigator ACT) in a sample of 94 parents of children with disabilities. Feasibility was measured by treatment completion, credibility, and satisfaction, and preliminary outcomes by using self-rating scales administered at the baseline, post-intervention, and follow-up. The results imply the intervention is feasible in the context of Swedish outpatient habilitation services. A preliminary analysis of the outcome measures suggests that parents experienced significant improvements in well-being. The results indicate that the treatment is feasible and should be evaluated in a randomized controlled trial.

Using 360-degree videos for virtual reality exposure in CBT for panic disorder with agoraphobia: a feasibility study.

Cognitive behavioural therapy (CBT) is an effective treatment for panic disorder with agoraphobia (PDA). However, implementation of some of the procedures involved, particularly in vivo exposure, can be time consuming and taxing for routine health care services. CBT with exposure taking place in virtual reality (VR-CBT) is a more time-efficient option and has shown promising results in the treatment of PDA. However, VR-CBT requires expensive equipment and appropriate virtual environments, which historically has been costly and cumbersome to produce. Thus, access to VR-CBT has been sparse in regular care environments. The aim of this study was to investigate whether VR-CBT using filmed virtual environments produced with a low-cost 360-degree film camera can be a feasible and acceptable treatment for PDA when implemented in a primary care context. This was an open feasibility trial with a within-group design, with assessments conducted at pre-test, post-test, and 6-month follow-up. Participants (n = 12) received a 10-12 week treatment programme of VR-CBT and PDA-related symptoms were assessed by the primary outcome measure The Mobility Inventory for Agoraphobia (MIA) and the Panic-Disorder Severity Scale-Self Rated (PDSS-SR). The results showed that treatment satisfaction was high and participants were significantly improved on PDA-related measures at post-treatment and at 6-month follow-up with large effect sizes (Cohen's d range = 1.46-2.82). All 12 participants completed the treatment. These findings suggest that VR-CBT with 360-degree video virtual environments delivered to primary care patients with PDA is feasible, acceptable, and potentially efficacious.

A Pilot Feasibility Open Trial of an Interpretation Bias Intervention for Parents of Anxious Children

Interpretation bias is a transdiagnostic mechanism underlying anxiety. Theoretical models highlight the role of parental interpretation bias in predicting and maintaining child anxiety. However, very few studies have examined parent interpretation bias as a treatment target. The current pilot study tested the feasibility and acceptability of an interpretation bias intervention delivered by a smartphone app, called HabitWorks, in parents of anxious children who self-reported at least mild symptoms of anxiety and negative interpretation bias.Parents of anxious youth (ages 8 to 16) were recruited from the waitlists of three child anxiety clinics. They were asked to complete interpretation modification exercises via the HabitWorks app 3 times per week for 1 month. Participants completed assessments at pre- and post-intervention and 1-month follow-up to assess changes in interpretation bias, anxiety symptoms, and overall perceptions of HabitWorks.Participants (N = 14) (Mage = 44.36; 14.29% men, 85.71% women) completed an average of 13.29 exercises out of the 12 prescribed. Acceptability ratings were high. Interpretation bias, as measured by an assessment version of the intervention exercise, significantly improved from pre- to posttreatment, and these improvements were maintained at the 1-month follow-up. Anxiety symptoms significantly improved from the “mild” severity range to the “none to minimal” range.In this pilot feasibility study in parents of anxious youth, HabitWorks was a feasible and acceptable low-intensity intervention. These preliminary results support a future controlled trial of HabitWorks for parents. Future studies are also needed to test whether targeting interpretation bias in parents has downstream effects on maladaptive parent behaviors and ultimately, child interpretation bias and anxiety.

A mixed methods pilot and feasibility open trial of internet-delivered cognitive behaviour therapy (iCanADAPT Advanced) for people with advanced cancer with depression and/or anxiety

PurposeEvaluate the feasibility, acceptability and potential efficacy of a form of online therapy for clinical depression and/or anxiety in people living with advanced cancer. MethodsA single-arm open trial of a six-lesson clinician-supervised, internet-delivered cognitive behavioural therapy (iCBT) transdiagnostic intervention (iCanADAPT Advanced) was undertaken. Qualitative (semi-structured telephone interview conducted at 3-months) and quantitative data (questionnaires collected at pre-, post-, and 3-month follow-up) were analysed. Results27 participants partook (26 women, 56% breast cancer, mean age 56yo; average number of mental health diagnoses 1.8, with majority (81%) meeting criteria for generalised anxiety disorder). Feasibility - Unanticipated numbers (48%) of participants had physical health deterioration (cancer progression or death). iCBT had high adherence overall (completion rates: 37% did 6 lessons; 70% did 4 lessons) but adherence was higher for those whose cancer remained stable (completion rates: 43% did 6 lessons; 85% did 4 lessons). Acceptability - the intervention was acceptable to the majority of participants, with high treatment satisfaction. Advisory data was achieved regarding future versions. Potential efficacy - regardless of physical health status, participants who completed the iCBT showed a significant decrease over time in anxiety and depression symptoms. ConclusionsOnline therapies may be useful in assisting those living with advanced cancer dealing with clinical depression and anxiety disorders. The specific modality of clinician supervised iCBT has significant potential to be a suitable modality of online therapy.

Group Psychoeducational Intervention for Grandparents of Young Children with ASD: An Open Feasibility Study

This initial open feasibility trial reports on feasibility and preliminary effectiveness of the manualized, group-based psychoeducational intervention for grandparents of preschool-aged children with ASD provided by the outpatient habilitation services in Stockholm, Sweden. One hundred and twenty non-custodial grandparents participated in a 6-h intervention program. The study demonstrated good feasibility: 114 (95%) grandparents completed both pre- and post-intervention measures and evaluations and reported high intervention acceptability. The results also indicated that grandparents increased their knowledge about ASD from pre-intervention to post-intervention, gained skills about strategies of supporting their grandchildren and adult children, and appreciated the opportunity to meet and share experiences with other grandparents. Follow-up with a randomized controlled trial design is needed to firmly establish efficacy of this intervention.

Concurrent Brainstorming Sessions

Background: Individuals with bipolar disorders (BD) are 5x more likely to be arrested, jailed, or convicted of a criminal offense than those in the general population. BD, in turn, increases risk for adverse outcomes for prisoners post-release, including mood instability, suicide attempts, substance use relapse, and repeat incarceration. Despite these negative sequelae, up to 70% of prisoners with BD do not receive mental health treatment following re-entry. Methods: To address this critical need, we have been piloting the CARE (Community treatment Adherence at Re-Entry) Program, a hybrid in-person/ telephone-based intervention that combines cognitive-behavioral, family, and telephone outreach strategies to promote treatment engagement for prisoners with BD following community re-entry. Results: Prior to the COVID-19 pandemic, we successfully completed an open feasibility trial (N = 12). At the time of the prison lockdown, 11 (out of 40) individuals had been enrolled in the ongoing pilot RCT of CARE vs. TAU, necessitating adjustments to the study protocol so as to safely and ethically retain participants during the pandemic. Other adjustments were made to recruitment and assessment of new participants, given the unique ethical and practical considerations regarding use of telehealth services in the prison setting. Discussion: We will compare and contrast our clinical, operational, and regulatory experiences prior to and during the pandemic, with respect to implementation of this clinical trial to support prisoners with BD around community re-entry.

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

ObjectiveTo establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National...

Internet-Based Cognitive-Behavioral Therapy for Depression: A Feasibility Study for Homecare Older Adults

This pilot study examined the feasibility of delivering internet-based cognitive behavioral therapy (iCBT) to homebound older adults with symptoms of depression who are recipients of non-medical home care. A feasibility open trial was conducted in the homes of homecare older adults (n=26). When possible, home care workers (HCWs) of older adults (n=13) were recruited to provide external support for iCBT usage. In cases where consistent assistance from the same HCW was not feasible, participants were given the choice of working on the program on their own (n=7) or receiving assistance from a research assistant (RA) (n=6). The mean therapy sessions completed was 4.7 out of 8 total sessions. The mean satisfaction rating was 7.7 (SD=2.9) and 86% would recommend the program to others with depressed mood. Significant reductions in depressive symptoms and anxiety symptoms and improvement on a quality of life measure were observed at post-test. The RA-supported group tended to have the best adherence, satisfaction, and reduction in depressive symptoms, followed closely by the HCW-supported group. The self-guided group had the lowest adherence, satisfaction, and symptom reduction. iCBT is a feasible and acceptable treatment modality for homebound older adults with depressive symptoms and potentially effective. Data from the participant exit interviews suggest a need for refining the existing treatment platform to better meet the needs and capabilities of homebound older adults. Future studies are warranted to examine treatment effectiveness as a function of HCW support.

Brief Cognitive-Behavioral Therapy for Suicidal Inpatients

Suicide risk is elevated in psychiatric patients following discharge from inpatient care. Despite this vulnerability, there has been limited research investigating suicide prevention protocols that take into account the unique system characteristics of this setting (e.g., short lengths of stay, crisis stabilization treatment model, multidisciplinary team coordination). Cognitive-behavioral therapy (CBT) has demonstrated efficacy for improving suicide risk in outpatients, but has not been validated with inpatients. The current study was a treatment development and pilot feasibility open trial that modified brief cognitive-behavioral therapy (BCBT) for an inpatient setting (BCBT-I). Key treatment modifications included administering up to 10 sessions (depending on patient length of stay), daily, and in a standardized order, with core crisis management skills introduced during the first three sessions. In addition, coordination with the inpatient treatment team was included in BCBT-I implementation. Six adult inpatients with a recent suicide attempt enrolled and completed an average of 4.67 BCBT-I sessions (SD = 1.36). The treatment was highly acceptable (Client Satisfaction Questionnaire total score M = 3.49, SD = 0.73). Pre- to posttreatment effect sizes demonstrated improvements in suicidal ideation (d = 0.97), depression (d = 1.33), and suicidal implicit associations (d = 1.28). All but one of the participants (83%) completed follow-up assessments 1-, 2-, and 3-months postdischarge. Over follow-up, two participants reported suicidal ideation (both without intent), and none reported suicide attempts, preparatory acts or behaviors, or nonsuicidal self-injury. This study provided preliminary evidence supporting the feasibility of CBT to treat suicidal inpatients. Future research is needed to validate BCBT-I in a larger, randomized controlled trial to determine whether BCBT-I reduces suicide risk beyond that afforded by inpatient treatment alone.

The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK

BackgroundPeople with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.MethodThe RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers.ResultsOf a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22).ConclusionsThe target of 100 participants was not achieved within the study’s timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex.Study registrationISRCTN RegistryISRCTN15747739 prospectively registered 5th July 2016.

A feasibility trial of an internet-delivered psychological intervention to manage mental health and functional outcomes in neurological disorders

ObjectiveMental health and cognitive difficulties are highly prevalent across neurological disorders and significantly contribute to poorer patient outcomes. Unfortunately, access to effective psychological services for these comorbidities are limited. To determine whether a novel transdiagnostic internet-delivered psychological intervention, the Wellbeing Neuro Course, was feasible, acceptable and efficacious a single-group feasibility open trial was employed. MethodsThe Wellbeing Neuro Course, targets mental health and cognitive difficulties, across a variety of neurological disorders. It is comprised of six online lessons, based on Cognitive Behavioural Therapy and Compensatory Cognitive Rehabilitation, delivered over 10 weeks and provided with weekly support from a mental health professional via email and telephone. 105 adults with diagnoses of either epilepsy, multiple sclerosis, Parkinson's disease and/or acquired brain injury, underwent the intervention. ResultsThe intervention was found to be highly acceptable with high intervention completion and levels of satisfaction (>95%). There was evidence of clinically significant improvements in primary outcomes (within-group Cohen's d; average reductions) of depression (d = 0.93; avg. reduction ≥36%), anxiety (ds = 0.66, avg. reduction ≥36%), and disability (ds ≥ 0.49; avg. reduction ≥23%) at post-intervention, maintained at 3-month follow-up. For secondary outcomes there were significant improvements in fatigue severity and perceived cognitive difficulties of attention, planning and prospective memory. Findings were achieved with minimal clinician time, highlighting its public health potential. ConclusionThis open trial provides preliminary evidence the Wellbeing Neuro Course is acceptable and reduces symptoms of depression, anxiety and disability in neurological disorders. Future controlled trials of the intervention are now needed.Trial registration: ACTRN12617000581369.

Internet-Based Cognitive Behavioral Therapy for Depression: A Feasibility Study for Home Care Older Adults

Purpose: The present study examined the feasibility of internet-based cognitive behavioral therapy (iCBT) for home care older adults. Method: A feasibility open trial was conducted with 26 recipients of nonmedical home care with depressive symptoms. When possible, home care workers (HCWs) of older adults ( n = 13) were recruited to provide external support for iCBT usage. Results: The mean therapy sessions completed was 4.7 out of 8, and 86% would recommend the program to others with depressed mood. Participants’ depressive symptoms and anxiety symptoms decreased, whereas their quality of life ratings improved. Discussion: iCBT is a feasible and acceptable treatment modality for home care older adults with depressive symptoms and is potentially effective. Future studies are warranted to refine the existing treatment platform to achieve a better fit between the demands of the program and the needs and capabilities of homebound older adults and to examine treatment effectiveness as a function of HCW support.

Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot.

Delivery of interventions in a group format is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD). We conducted an open feasibility trial of group-based RUBI parent training in 18 children (mean age 6.12 ± 1.95years) with ASD and disruptive behaviors. Parents participated in one of five groups (3 to 4 parents per group). Eighty-three percent of participants completed the 24-week trial. Session attendance was moderate (74.2%). All parents indicated that they would recommend the treatment. Therapists demonstrated 98.8% fidelity to the manual. Eleven of 18 (64.7%) participants were rated as much/very much improved by an independent evaluator at Week 24. Preliminary efficacy findings justify further study.

Digital Cognitive Behavioral Therapy for Insomnia for Adolescents With Mental Health Problems: Feasibility Open Trial.

BackgroundInsomnia in adolescents is common, persistent, and associated with poor mental health including anxiety and depression. Insomnia in adolescents attending child mental health services is seldom directly treated, and the effects of digital cognitive behavioral therapy (CBT) for insomnia (CBTi) on the mental health of adolescents with significant mental health problems are unknown.ObjectiveThis open study aimed to assess the feasibility of adding supported Web-based CBT for insomnia to the usual care of young people aged 14 to 17 years attending specialist child and adolescent mental health services (CAMHS).MethodsA total of 39 adolescents with insomnia aged 14 to 17 years attending specialist CAMHS were assessed and offered digital CBTi. The digital intervention was Sleepio, an evidence-based, self-directed, fully automated CBTi that has proven effective in multiple randomized controlled trials with adults. Self-report assessments of sleep (Sleep Condition Indicator [SCI], Insomnia Severity Scale, and Web- or app-based sleep diaries), anxiety (Revised Child Anxiety and Depression Scale [RCADS]), and depression (Mood and Feelings Questionnaire [MFQ]) were completed at baseline and post intervention. Postuse interviews assessed satisfaction with digital CBTi.ResultsAverage baseline sleep efficiency was very poor (53%), with participants spending an average of 9.6 hours in bed but only 5.1 hours asleep. All participants scored less than 17 on the SCI, with 92% (36/39) participants scoring 15 or greater on the Insomnia Severity Scale, suggesting clinical insomnia. Of the 39 participants, 36 (92%) scored 27 or greater on the MFQ for major depression and 20 (51%) had clinically elevated symptoms of anxiety. The majority of participants (38/49, 78%) were not having any treatment for their insomnia, with the remaining 25% (12/49) receiving medication. Sleepio was acceptable, with 77% (30/39) of the participants activating their account and 54% (21/39) completing the program. Satisfaction was high, with 84% (16/19) of the participants finding Sleepio helpful, 95% (18/19) indicating that they would recommend it to a friend, and 37% (7/19) expressing a definite preference for a digital intervention. Statistically significant pre-post improvements were found in weekly diaries of sleep efficiency (P=.005) and sleep quality (P=.001) and on measures of sleep (SCI: P=.001 and Insomnia Severity Index: P=.001), low mood (MFQ: P=.03), and anxiety (RCADS: P=.005).ConclusionsOur study has a number of methodological limitations, particularly the small sample size, absence of a comparison group and no follow-up assessment. Nonetheless, our findings are encouraging and suggest that digital CBTi for young people with mental health problems might offer an acceptable and an effective way to improve both sleep and mental health.International Registered Report Identifier (IRRID)RR2-10.2196/11324