Addition of testosterone to endocrine care for transgender women: a dose-finding and feasibility trial.

OBJECTIVE: Transgender women who underwent gonadectomy have lower serum testosterone concentrations than cisgender women. There is uncertainty regarding the dosing and side effects of supplementation of testosterone in transgender women. This study aimed to assess the feasibility of dosing testosterone to the cisgender female physiological range in transgender women. In addition, we explored changes in cardiovascular parameters, virilizing side effects, and clinical symptoms. DESIGN: This is an open-label, single-arm feasibility study. Participants initially went through a dose-titration phase with 2-week intervals of 0.07-0.09-0.13 mL (277-318-403 µg bioavailable testosterone) testosterone 2% gel to establish a dose leading to serum testosterone concentrations between 1.5 and 2.5 nmol/L. This dose was then continued for 8 weeks. METHODS: Participants applied daily transdermal testosterone 2% gel (Tostran®) at the prescribed dosage. Testosterone was measured every 2-4 weeks. Laboratory analyses, side effects, and clinical symptoms were evaluated. RESULTS: In total, 12 participants were included. Most participants required a dose of 0.07 mL (277 µg bioavailable testosterone) or 0.09 mL (318 µg bioavailable testosterone) to reach serum testosterone concentrations of 1.5-2.5 nmol/L. Continuing this dose, testosterone concentrations remained stable throughout the study. Changes in clinical outcomes were in the desired direction, and side effects were mild. CONCLUSIONS: The use of testosterone supplementation in transgender women seems feasible and safe in the short term. Although dosing requires personalized titration, stable testosterone levels can be established. A blinded, placebo-controlled, randomized clinical trial is needed to study the clinical benefit.

Mindfulness-based group intervention for adolescents with type 1 diabetes: initial findings from a pilot and feasibility randomized controlled trial.

OBJECTIVE: To evaluate feasibility/acceptability of a virtual, group mindfulness-based intervention (MBI) adapted for pediatric type 1 diabetes (T1D). METHODS: This two-way controlled trial randomized adolescents 1:1 to MBI (n = 20) or health education (HE; n = 22) groups lasting 6-7 weeks. Eligibility included 12-17 years, T1D ≥ 1 year, and elevated scores on PROMIS depression or anxiety measures. Recruitment, retention, and session attendance were tracked to measure feasibility. Acceptability was measured via youth-reported post-session surveys. Adolescents completed depression, anxiety, and diabetes-specific surveys at baseline, immediately post-program, and 3 months post-program completion. HbA1c values approximating these timeframes were obtained from chart review. RESULTS: 55% of screened participants were eligible to participate, and 100% of eligible youth enrolled. There was 93% study retention and 96% session attendance rates. Survey data were 100% complete at baseline, and 93% complete at post-program and 3-month follow-ups; 83% and 78% of MBI participants rated sessions as at least somewhat enjoyable and helpful, respectively, and 91% and 82% of HE participants rated sessions as at least somewhat enjoyable and helpful, respectively. Mean scores showed declines in depression, anxiety, disordered eating, diabetes distress, and HbA1c in both groups across time, with trends toward potential greater reductions in depression and HbA1c in MBI. CONCLUSIONS: This pilot provides preliminary evidence that virtual MBI and HE groups adapted for adolescents with T1D are feasible to deliver and acceptable, with potential improvement in psychosocial, behavioral, and diabetes-specific outcomes. Whether MBI is more effective for targeting negative affect and glycemic control in the context of adolescent T1D requires testing in a full-scale efficacy trial.

Network of doctors for multimorbidity and diabetes - the NOMAD intervention: protocol for feasibility trial of multidisciplinary team conferences for people with diabetes and multimorbidity.

BACKGROUND: The prevalence of diabetes and coexisting multimorbidity rises worldwide. Treatment of this patient group can be complex. Providing an evidence-based, coherent, and patient-centred treatment of patients with multimorbidity poses a challenge in healthcare systems, which are typically designed to deliver disease-specific care. We propose an intervention comprising multidisciplinary team conferences (MDTs) to address this issue. The MDT consists of medical specialists in five different specialities meeting to discuss multimorbid diabetes patients. This protocol describes a feasibility test of MDTs designed to coordinate care and improve quality of life for people with diabetes and multimorbidity. METHODS: A mixed-methods one-arm feasibility test of the MDT. Feasibility will be assessed through prospectively collected data. We will explore patient perspectives through patient-reported outcomes (PROs) and assess the feasibility of electronic questionnaires. Feasibility outcomes are recruitment, PRO completion, technical difficulties, impact of MDT, and doctor preparation time. During 17 months, up to 112 participants will be recruited. We will report results narratively and by the use of descriptive statistics. The collected data will form the basis for a future large-scale randomised trial. DISCUSSION: A multidisciplinary approach focusing on better management of diabetic patients suffering from multimorbidity may improve functional status, quality of life, and health outcomes. Multimorbidity and diabetes are highly prevalent in our healthcare system, but we lack a solid evidence-based approach to patient-centred care for these patients. This study represents the initial steps towards building such evidence. The concept can be efficiency tested in a randomised setting, if found feasible to intervention providers and receivers. If not, we will have gained experience on how to manage diabetes and multimorbidity as well as organisational aspects, which together may generate hypotheses for research on how to handle multimorbidity in the future. ADMINISTRATIVE INFORMATION: Protocol version: 01 TRIAL REGISTRATION: NCT05913726 - registration date: 21 June 2023.

Integrating Virtual Mindfulness-Based Stress Reduction Into Inflammatory Bowel Disease Care: Mixed Methods Feasibility Trial.

BACKGROUND: Individuals with inflammatory bowel disease (IBD) experience cycles of aggressive physical symptoms including abdominal pain, diarrhea, and fatigue. These acute symptoms regress and return, and chronic symptoms and complications often linger. The nature of the disease can also cause individuals to experience psychological distress including symptoms of anxiety and depression; however, unlike the physical symptoms of IBD, these psychological symptoms often remain untreated. OBJECTIVE: This study aims to evaluate the feasibility, acceptability, and effectiveness of virtual mindfulness-based stress reduction (v-MBSR) for adults with IBD. METHODS: IBD patients with self-reported anxiety or depression were recruited from clinics in Alberta, Canada to participate in an 8-week v-MSBR intervention. Eligible patients participated in v-MBSR delivered by psychiatrists using a videoconferencing platform. Primary feasibility outcomes included trial uptake, adherence, attendance, and attrition rates. Secondary effectiveness outcomes included measures of anxiety, depression, quality of life (QoL), and mindfulness. Effectiveness data were collected at 3 time points: baseline, at intervention completion, and 6 months after completion. To further assess feasibility and acceptability, participants were invited to participate in a semistructured interview after completing v-MBSR. RESULTS: A total of 16 of the 64 (25%) referred patients agreed to participate in v-MBSR with the most common reason for decline being a lack of time while 7 of the 16 (43.8%) participants completed the program and experienced encouraging effects including decreased anxiety and depression symptoms and increased health-related QoL with both improvements persisting at 6-month follow-up. Participants described improved coping strategies and disease management techniques as benefits of v-MBSR. CONCLUSIONS: Patients with IBD were interested in a psychiatrist-led virtual anxiety management intervention, but results demonstrate v-MBSR may be too time intensive for some patients with IBD patients. v-MBSR was acceptable to those who completed the intervention, and improvements to anxiety, depression, and QoL were promising and sustainable. Future studies should attempt to characterize the patients with IBD who may benefit most from interventions like v-MBSR.

Mellow Babies: A Randomised Feasibility Trial of an Intervention to Improve the Quality of Parent-Infant Interactions and Parental Mental Wellbeing.

Mellow Babies aims to improve mothers' mental wellbeing and the quality of their interactions with their baby. The feasibility of a definitive trial of Mellow Babies was assessed using a waiting-list randomised pilot trial (Clinicaltrials.gov: NCT02277301). Mothers with substantial health/social care needs and a child aged <13 months were randomly allocated either to a 14-week Mellow Babies programme or to receive usual care whilst on a waiting list for the intervention. Rates of recruitment and retention as well as participants' views of their experience in this study were recorded. Outcomes were parenting behaviour, assessed by the blind-rated Mellow Parenting Observation System (primary) and self-report maternal wellbeing pre- and post-intervention/waiting period. We recruited 38 eligible participants: 36 (95%; 18 intervention, 18 control) completed baseline measures, and 28 (74%; 15 intervention, 13 control) provided post-intervention data. Two practitioners took part in feedback interviews. Intervention participants had significantly more positive interactions with their babies at post-intervention compared to those in the control group (p = 0.019), adjusted for pre-intervention scores. There was no significant improvement in mothers' mental wellbeing on any measure. A definitive trial of Mellow Babies is feasible and should include longer follow up of mothers and the opportunity for fathers to take part.

Study on Gamma sensory flicker for Insomnia.

OBJECTIVES: Insomnia has been the subject of much systematic research because it is a risk factor for a variety of diseases. There is some evidence that gamma sensory stimulation therapy has also been demonstrated to improve sleep quality for people with Alzheimer's disease. However, it is unclear whether this method is effective for treating insomnia. The principal objective of this project was to investigate the efficacy and safety of gamma sensory flicker in improving the sleep quality of insomnia patients. METHODS: Thirty-seven participants with insomnia were recruited for this prospective observational study. For a duration of 8 weeks, participants were exposed to flicker stimulation through a light and sound device. RESULTS: During the main phase of the study, adherence rates averaged 92.21%. Additionally, no severe adverse events were reported for flicker treatment. Analysis of sleep diaries indicated that 40 Hz flickers can enhance sleep quality by reducing sleep onset latencies, and arousals, and increasing total sleep duration. CONCLUSIONS: Gamma sensory flicker improves sleep quality in people suffering from insomnia.

Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study.

BACKGROUND: One in five patients experience chronic pain 1 year after total knee arthroplasty (TKA), highlighting the need for enhanced treatment strategies to improve outcomes. This feasibility trial aimed to optimize the content and delivery of a complex intervention tailored to osteoarthritis (OA) patients at risk of poor outcome after TKA and assess the feasibility of initiating a full-scale multicenter randomized controlled trial (RCT). METHODS: Patients scheduled for TKA were included between August 2019 and June 2020 and block-randomized into one of three groups: (a) 12-week exercise therapy and education (ExE) and 10-module internet-delivered cognitive behavioral therapy (iCBT), (b) TKA followed by ExE and iCBT and (c) TKA and standard postoperative care. Outcomes were (i) recruitment and retention rate, (ii) compliance to the intervention and follow-up, (iii) crossover, and (iv) adverse events, reported by descriptive statistics. RESULTS: Fifteen patients were included in the study. Only 1 out of 146 patients screened for eligibility was included during the first 4 months. During the next 3 months, 117 patients were not included since they lived too far from the hospital. To increase the recruitment rate, we made three amendments to the inclusion criteria; (1) at-risk screening of poor TKA outcome was removed as an eligibility criterion, (2) patients across the country could be included in the study and (3) physiotherapists without specific certification were included, receiving thorough information and support. No patients withdrew from the study or crossed over to surgery during the first year. Nine out of 10 patients completed the ExE program and six out of 10 completed the iCBT program. Fourteen out of 15 patients completed the 1-year follow-up. One minor adverse event was registered. CONCLUSIONS: Except for recruitment and compliance to iCBT, feasibility was demonstrated. The initial recruitment process was challenging, and necessary changes were made to increase the recruitment rate. The findings informed how a definitive RCT should be undertaken to test the effectiveness of the complex intervention. TRIAL REGISTRATION: The MultiKnee RCT, including the feasibility study, is pre-registered at ClinicalTrials.gov: NCT03771430 11/12/2018.

A pilot, single-arm feasibility study of an integrated cognitive-behavioral treatment for anxiety in young autistic children.

OBJECTIVE: Anxiety is prevalent in young autistic children under 7 years of age. Yet there is a paucity of empirically based interventions for this age group. DINO Strategies for Anxiety and Uncertainty Reduction (DINOSAUR) is an innovative cognitive behavioral intervention that seeks to optimize treatment response in young autistic children by targeting anxiety and the contributing mechanisms of intolerance of uncertainty and parental accommodation using a telehealth delivery model. This pilot, single-arm study examines the preliminary feasibility of DINOSAUR. METHODS: Fourteen autistic children ages 4-6 years with average language and cognitive skills and their parents received the intervention. Quantitative and qualitative data pertaining to parent satisfaction and treatment outcomes were collected. RESULTS: Attendance, retention, and parent satisfaction ratings offer preliminary support for the feasibility of the treatment model. Change in clinical severity ratings on a semi-structured parent interview of anxiety and parents' qualitative report suggests the potential to benefit young autistic children. CONCLUSIONS: Results support future study of the DINOSAUR model in a larger, randomized controlled trial.

Severe COVID anxiety among adults in the United Kingdom: cohort study and nested feasibility trial.

BACKGROUND: People with severe COVID anxiety have poor mental health and impaired functioning, but the course of severe COVID anxiety is unknown and the quality of evidence on the acceptability and impact of psychological interventions is low. METHODS: A quantitative cohort study with a nested feasibility trial. Potential participants aged 18 and over, living in the UK with severe COVID anxiety, were recruited online and from primary care services. We examined levels of COVID anxiety in the six months after recruitment, and factors that influenced this, using linear regression. Those scoring above 20 on the short Health Anxiety Inventory were invited to participate in a feasibility trial of remotely delivered Cognitive Behavioural Therapy for Health Anxiety (CBT-HA). Exclusion criteria were recent COVID-19, current self-isolation, or current receipt of psychological treatment. Key outcomes for the feasibility trial were the level of uptake of CBT-HA and the rate of follow-up. RESULTS: 204 (70.2%) of 285 people who took part in the cohort study completed the six month follow-up, for whom levels of COVID anxiety fell from 12.4 at baseline to 6.8 at six months (difference = -5.5, 95% CI = -6.0 to -4.9). Reductions in COVID anxiety were lower among older people, those living with a vulnerable person, those with lower baseline COVID anxiety, and those with higher levels of generalised anxiety and health anxiety at baseline. 36 (90%) of 40 participants enrolled in the nested feasibility trial were followed up at six months. 17 (80.9%) of 21 people in the active arm of the trial received four or more sessions of CBT-HA. We found improved mental health and social functioning among those in the active, but not the control arm of the trial (Mean difference in total score on the Work and Social Adjustment Scale between baseline and follow up, was 9.7 (95% CI = 5.8-13.6) among those in the active, and 1.0 (95% C.I. = -4.6 to 6.6) among those in the control arm of the trial. CONCLUSIONS: While the mental health of people with severe COVID anxiety appears to improve over time, many continue to experience high levels of anxiety and poor social functioning. Health anxiety is highly prevalent among people with severe COVID anxiety and may provide a target for psychological treatment. TRIAL REGISTRATION: Retrospectively registered at ISRCTN14973494 on 09/09/2021.

Ketamine for postoperative avoidance of depressive symptoms: the K-PASS feasibility randomised trial.

Background: Surgical patients with previous depression frequently experience postoperative depressive symptoms. This study's objective was to determine the feasibility of a placebo-controlled trial testing the impact of a sustained ketamine infusion on postoperative depressive symptoms. Methods: This single-centre, triple-blind, placebo-controlled randomised clinical trial included adult patients with depression scheduled for inpatient surgery. After surgery, patients were randomly allocated to receive ketamine (0.5 mg kg-1 over 10 min followed by 0.3 mg kg-1 h-1 for 3 h) or an equal volume of normal saline. Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale. On post-infusion day 1, participants guessed which intervention they received. Feasibility endpoints included the fraction of patients approached who were randomised, the fraction of randomised patients who completed the study infusion, and the fraction of scheduled depression assessments that were completed. Results: In total, 32 patients were allocated a treatment, including 31/101 patients approached after a protocol change (31%, 1.5 patients per week). The study infusion was completed without interruption in 30/32 patients (94%). In each group, 7/16 participants correctly guessed which intervention they received. Depression assessments were completed at 170/192 scheduled time points (89%). Between baseline and post-infusion day 4 (pre-specified time point of interest), median depressive symptoms decreased in both groups, with difference-in-differences of -1.00 point (95% confidence interval -3.23 to 1.73) with ketamine compared with placebo. However, the between-group difference did not persist at other time points. Conclusions: Patient recruitment, medication administration, and clinical outcome measurement appear to be highly feasible, with blinding maintained. A fully powered trial may be warranted. Clinical trial registration: NCT05233566.

Cognitive-behavioral therapy for patients with post-COVID-19 condition (CBT-PCC): a feasibility trial.

BACKGROUND: The post-COVID-19 condition describes the persistence or onset of somatic symptoms (e.g. fatigue) after acute COVID-19. Based on an existing cognitive-behavioral treatment protocol, we developed a specialized group intervention for individuals with post-COVID-19 condition. The present study examines the feasibility, acceptance, and effectiveness of the program for inpatients in a neurological rehabilitation setting. METHODS: The treatment program comprises eight sessions and includes psychoeducational and experience-based interventions on common psychophysiological mechanisms of persistent somatic symptoms. A feasibility trial was conducted using a one-group design in a naturalistic setting. N = 64 inpatients with a history of mild COVID-19 that fulfilled WHO criteria for post-COVID-19 condition were enrolled. After each session, evaluation forms were completed and psychometric questionnaires on somatic and psychopathological symptom burden were collected pre- and post-intervention. RESULTS: The treatment program was well received by participants and therapists. Each session was rated as comprehensible and overall satisfaction with the sessions was high. Pre-post effect sizes (of standard rehabilitation incl. new treatment program; intention-to-treat) showed significantly reduced subjective fatigue (p < 0.05, dav = 0.33) and improved disease coping (ps < 0.05, dav = 0.33-0.49). CONCLUSIONS: Our results support the feasibility and acceptance of the newly developed cognitive-behavioral group intervention for individuals with post-COVID-19 condition. Yet, findings have to be interpreted cautiously due to the lack of a control group and follow-up measurement, the small sample size, and a relatively high drop-out rate.

Promoting Alcohol Reduction in Non-Treatment Seeking parents (PAReNTS): a pilot feasibility cluster randomized controlled trial of brief alcohol interventions with parents in contact with child safeguarding services.

Many parents who come into contact with early help and children's social care services are risky drinkers. This study aimed to investigate the feasibility and acceptability of conducting a trial of brief alcohol interventions within this setting. We conducted a three-arm pilot feasibility cluster randomised controlled trial in the North-East of England. The additive interventions were: i) screening and a healthy lifestyle leaflet (control); ii) brief advice; iii) extended brief intervention. The trial was later reduced to two-arm due to the extended brief intervention being infeasible. Of the 1769 parents that were approached, 429 consented to be screened (24%), the majority were eligible to participate (n = 415; 97%), 147 of which (35%) scored ≥5 on the AUDIT-C screening tool. There were 108 parents (74%) who consented to participate in the trial (n = 50 control; n = 58 brief advice). Follow-up rates at 6 and 12-months were 61% and 43%. The TLFB30 was found to be a suitable tool to measure the primary outcome of heavy episodic drinking. Qualitative data showed that parents and practitioners largely found trial procedures to be acceptable, however, care should be taken when discussing alcohol risk with parents in this setting. Most of the a-priori success criteria were met in this pilot feasibility trial. The findings suggest that it may be feasible to conduct a two-arm randomised controlled trial of brief alcohol interventions to parents in contact with early help and social care. The TLFB30 was found to be a suitable tool to measure the primary outcome of heavy episodic drinking.

Feasibility and acceptability of a low-resource-intensive, transdiagnostic intervention for children with social-communication challenges in early childhood education settings.

ABSTRACT: Preschool classrooms provide a unique context for supporting the development of children with social-communication challenges. This study is an uncontrolled clinical trial of an adapted professional development intervention for preschool teachers (Social Emotional Engagement-Knowledge & Skills-Early Childhood). Social Emotional Engagement-Knowledge & Skills-Early Childhood is a low-resource-intensive, transdiagnostic intervention to address the learning needs of children with social-communication challenges and consists of four asynchronous online modules and three synchronous coaching sessions. The current research evaluated the feasibility and acceptability of intervention and research procedures, implemented in authentic early childhood education settings. Participants included one teacher and one target child with social-communication challenges from 25 preschool classrooms, sampled to maximize variability. Overall, the current research revealed high levels of feasibility, with 9 out of 10 benchmarks met: (a) procedures for participant recruitment reliably identified a neurodiverse sample of children with teacher-reported social-communication challenges; (b) teachers showed high levels of program engagement and Social Emotional Engagement-Knowledge & Skills-Early Childhood completion (76%); and (c) results revealed a robust pattern of gains in Social Emotional Engagement-Knowledge & Skills-Early Childhood classrooms and associations among key outcome measures (including active engagement, student teacher relationship, social-communication competencies). Implications for the design of a subsequent, larger effectiveness-implementation hybrid trial (Type 1) are discussed.

Enhancing Adherence to Antiretroviral Therapy Among Adolescents Living With HIV Through Group-Based Therapeutic Approaches in Uganda: Findings From a Pilot Cluster-Randomized Controlled Trial.

OBJECTIVE: We examine the preliminary impact of group-cognitive behavioral therapy (G-CBT) versus a family-strengthening intervention delivered via multiple family group (MFG) in improving ART adherence among adolescents living with HIV (ALHIV) in Uganda. METHODS: We analyzed data from a pilot cluster-randomized trial (2020-2022) conducted in 9 clinics in Uganda among 89 participants, who were eligible out of the 147 ALHIV screened. Participants were eligible if they were aged 10-14 years, HIV positive, taking ART, and living with a family. Adolescents were randomized, at the clinic level, to receive the usual care (n = 29), MFG (n = 34), or G-CBT (n = 26). The interventions were delivered over 3 months. Overall, the mean percentage attendance for the 10 G-CBT and MFG sessions was 87.7% and 90.2%, respectively. Three ALHIV were lost to follow-up, while 1 child died. Adherence was assessed using pharmacy records collected at baseline and 4 additional pharmacy visits. We used mixed-effects logistic regression analysis to examine the effect of the interventions on ART adherence. RESULTS: We found statistically significant main effects for the intervention, χ2(2) = 7.76, p = .021, time, χ2(2) = 39.67, p < .001, and intervention-time interaction effect χ2(6)= 27.65, p < .001. Pairwise comparisons showed increasing adherence in the MFG group compared to usual care at visit 3 (odds ratio [OR] = 4.52 [1.01-20.11], p = .047) and visit 5 (OR = 3.56 [1.42-8.91], p = .007). Also, compared to usual care, participants who received G-CBT showed higher adherence at visit 4 (OR = 2.69 [1.32-5.50], p = .007). CONCLUSIONS: Our study showed preliminary evidence that G-CBT and MFG might have contributed to improved ART adherence among ALHIV. Moreover, G-CBT is a low-cost alternative to expensive individual therapy, especially in low-resource settings. The results warrant the need for more extensive studies to better understand the role of these interventions in the routine care of ALHIV. The trial is registered at ClinicalTrials.Gov (#NCT04528732).

Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): results from a randomised controlled pilot feasibility trial for low mood in acquired brain injury.

BACKGROUND: Acquired brain injury (ABI) is linked to increased depression risk. Existing therapies for depression in ABI (e.g., cognitive behavioural therapy) have mixed efficacy. Behavioural activation (BA), an intervention that encourages engaging in positively reinforcing activities, shows promise. The primary aims were to assess feasibility, acceptability, and potential efficacy of two 8-week BA groups. METHODS: Adults (≥ 18 years) recruited from local ABI services, charities, and self-referral via social media were randomised to condition. The Activity Planning group (AP; "traditional" BA) trained participants to plan reinforcing activities over 8 weeks. The Activity Engagement group (AE; "experiential" BA) encouraged engagement in positive activities within session only. Both BA groups were compared to an 8-week Waitlist group (WL). The primary outcomes, feasibility and acceptability, were assessed via recruitment, retention, attendance, and qualitative feedback on groups. The secondary outcome, potential efficacy, was assessed via blinded assessments of self-reported activity levels, depression, and anxiety (at pre- and post-intervention and 1 month follow-up) and were compared across trial arms. Data were collected in-person and remotely due to COVID-19. RESULTS: N = 60 participants were randomised to AP (randomised n = 22; total n = 29), AE (randomised n = 22; total n = 28), or re-randomised following WL (total n = 16). Whether in-person or remote, AP and AE were rated as similarly enjoyable and helpful. In exploring efficacy, 58.33% of AP members had clinically meaningful activity level improvements, relative to 50% AE and 38.5% WL. Both AP and AE groups had depression reductions relative to WL, but only AP participants demonstrated anxiety reductions relative to AE and WL. AP participants noted benefits of learning strategies to increase activities and learning from other group members. AE participants valued social discussion and choice in selecting in-session activities. CONCLUSIONS: Both in-person and remote group BA were feasible and acceptable in ABI. Though both traditional and experiential BA may be effective, these may have different mechanisms. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03874650. Protocol version 2.3, May 26 2020.

Twice-Weekly Outpatient Rehabilitation Intervention for Young Children With Spinal Muscular Atrophy Treated With Genetic-Based Therapies: Protocol for a Feasibility Study.

BACKGROUND: Spinal muscular atrophy (SMA) is a progressive neuromuscular disorder that causes muscle weakness and is the leading genetic cause of infant mortality worldwide. While no definitive cure exists, the approval of 3 genetic-based therapies in Canada since 2018 has led to significant improvements in muscle function for children with SMA. With that, there are no evidence-based rehabilitation interventions and minimal evidence on the combined effects of genetic-based therapies and rehabilitation. OBJECTIVE: This protocol describes the methodology to assess the feasibility of a twice-weekly outpatient rehabilitation intervention focusing on gross and fine motor function to inform the methodology and sample size of a definitive clinical trial. METHODS: We will conduct a single-center nonrandomized pilot and feasibility trial to explore an outpatient rehabilitation intervention for children aged 6 months to 3 years with SMA treated with genetic-based therapies. Participation in the study will occur over a 25-week period, with a baseline assessment visit followed by a 12-week intervention period and a 12-week nonintervention period. The rehabilitation intervention comprises weekly physical and occupational therapy for 11 weeks. Assessments will occur at baseline (week 0), end of intervention or early withdrawal (week 12), and follow-up (week 24). Predetermined feasibility indicators will evaluate study feasibility across process (recruitment rates, eligibility criteria, adherence rates, retention rates, questionnaire suitability, and acceptability), resource (time, implementation, and execution), management (materials and data), and scientific (safety, tolerability, and preliminary efficacy) domains. RESULTS: This project was funded in March 2022, and data will be collected between March 2023 and December 2023. Data analysis will occur between January 2024 and March 2024, with publication expected in the fall of 2024. The protocol for the feasibility trial will be considered successful if it meets the success criteria set out for the feasibility indicators. Indicators of specific interest include all process indicators, as well as time. Exploratory indicators will be reported. Pragmatically, the results of the feasibility trial will inform changes to the protocol and the start-up of a definitive multisite trial. CONCLUSIONS: This novel twice-weekly outpatient rehabilitation intervention will be the first step toward filling the need for an evidence-based rehabilitation intervention for children with SMA treated with genetic-based therapies. It is expected that consistent and intensive rehabilitation therapy will augment functional gains being observed in this population. In the future, a definitive trial will measure the efficacy of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05638750; https://clinicaltrials.gov/study/NCT05638750. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46363.

Behavioral Activation for Comorbid Depression in People With Noncommunicable Disease in India: Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: The increasing burden of depression and noncommunicable disease (NCD) is a global challenge, especially in low- and middle-income countries, considering the resource constraints and lack of trained human resources in these settings. Effective treatment of depression in people with NCDs has the potential to enhance both the mental and physical well-being of this population. It will also result in the effective use of the available health care resources. Brief psychological therapies, such as behavioral activation (BA), are effective for the treatment of depression. BA has not been adapted in the community health care services of India, and the feasibility of using BA as an intervention for depression in NCD and its effectiveness in these settings have not been systematically evaluated. OBJECTIVE: Our objective is to adapt BA for the Indian NCD context and test the acceptability, feasibility, and implementation of the adapted BA intervention (BEACON intervention package [BIP]). Additionally, we aim to test the feasibility of a randomized controlled trial evaluation of BIP for the treatment of depression compared with enhanced usual care. METHODS: Following well-established frameworks for intervention adaptation, we first adapted BA (to fit the linguistic, cultural, and resource context) for delivery in India. The intervention was also adapted for potential remote delivery by telephone. In a randomized controlled trial, we will be testing the acceptability, feasibility, and implementation of the adapted BA intervention (BIP). We shall also test if a randomized controlled feasibility trial can be delivered effectively and estimate important parameters (eg, recruitment and retention rates and completeness of follow-up) needed to design a future definitive trial. RESULTS: Following the receipt of approval from all the relevant agencies, the development of the BIP was started on November 28, 2020, and completed on August 18, 2021, and the quantitative data collection was started on August 23, 2021, and completed on December 10, 2021. Process evaluation (qualitative data) collection is ongoing. Both the qualitative and quantitative data analyses are ongoing. CONCLUSIONS: This study may offer insights that could help in closing the gap in the treatment of common mental illness, particularly in nations with limited resources, infrastructure, and systems such as India. To close this gap, BEACON tries to provide BA for depression in NCDs through qualified NCD (BA) counselors integrated within the state-run NCD clinics. The results of this study may aid in understanding whether BA as an intervention is acceptable for the population and how feasible it will be to deliver such interventions for depression in NCD in South Asian countries such as India. The BIP may also be used in the future by Indian community clinics as a brief intervention program. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2020/05/025048; https://tinyurl.com/mpt33jv5. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41127.

iJobs - An online implementation of the JOBS II program for fostering reemployment: A feasibility and acceptability study.

The current study aimed to test the feasibility and acceptability of iJobs, an online adaptation of the JOBS II program (Curran et al., 1999). iJobs is a two-week internet intervention for the unemployed, consisting of five modules. This study is an open-label trial with an uncontrolled, within-group, pre-posttest, and follow-up design. Out of the 56 participants allocated to the intervention, 36 completed (Mage = 25 years; 57.1 % females) the post-test (36 % dropout), and 34 the three months follow-up. The protocol-compliant participants followed the modules with great engagement (mean quality of assignments completion above 4 points out of 5 for each module). The online platform's usability was high (84.86 points out of 100). Participants reported high overall satisfaction with the program. Our results suggest that iJobs is a feasible intervention and was accepted by its beneficiaries. Relative to baseline, inoculation against setbacks (d = 0.64), job search self-efficacy (d = 0.50), and self-esteem (d = 0.28) increased significantly, while future career anxiety in the COVID-19 context decreased significantly (d = 0.34). No significant differences were found for depression, anxiety, and job-search behaviors. At three months follow-up, 55.9 % of the participants found employment, 5.9 % were in a job selection process, and 38.2 % were still unemployed. Job satisfaction was high among the employed.

Transient Elastography and Video Recovery Narrative Access to Support Recovery From Alcohol Misuse: Development of a Novel Intervention for Use in Community Alcohol Treatment Services.

BACKGROUND: Mortality from alcohol-related liver disease has risen significantly for 3 decades. Transient elastography (TE) is a noninvasive test providing a numerical marker of liver disease. Preliminary evidence suggests that TE can reduce alcohol consumption. The KLIFAD (does knowledge of liver fibrosis affect high-risk drinking behavior?) study has developed a complex intervention wherein people receiving alcohol treatment are provided with access to TE, accompanied by scripted feedback tailored to their disease state, and access to video narratives describing alcohol misuse recovery after receiving TE. Recovery narratives are included due to preliminary evidence from mental health studies which suggest that access to digital narratives describing recovery from mental health problems can help people affected by mental health problems, including through mechanisms with the potential to be transferable to an alcohol treatment setting, for example, by increasing hope for the future, enabling learning from the experience of others, or promoting help-seeking behaviors. OBJECTIVE: We aimed to develop the KLIFAD intervention to the point that it could be delivered in a feasibility trial and to produce knowledge relevant to clinicians and researchers developing interventions making use of biomarkers of disease. METHODS: In research activity 1, standardized scripted feedback was developed by this study, and then iterated through focus groups with people who had experienced alcohol misuse and TE, and key alcohol workers with experience in delivering TE. We report critical design considerations identified through focus groups, in the form of sensitizing concepts. In research activity 2, a video production guide was coproduced to help produce impactful video-based recovery narratives, and a patient and public involvement (PPI) panel was consulted for recommendations on how best to integrate recovery narratives into an alcohol treatment setting. We report PPI recommendations and an overview of video form and content. RESULTS: Through research activity 1, we learnt that patient feedback has not been standardized in prior use of TE, that receiving a numeric marker can provide an objective target that motivates and rewards recovery, and that key alcohol workers regularly tailor information to their clients. Through research activity 2, we developed a video production guide asking narrators what recovery means to them, what helped their recovery, and what they have learned about recovery. We produced 10 recovery narratives and collected PPI recommendations on maximizing impact and safety. These led to the production of unplanned videos presenting caregiver and clinician perspectives, and a choice to limit narrative availability to alcohol treatment settings, where support is available around distressing content. These choices have been evaluated through a feasibility randomized controlled trial [ISRCTN16922410]. CONCLUSIONS: Providing an objective target that motivates and rewards recovery is a candidate change mechanism for complex interventions integrating biomarkers of disease. Recovery narratives can contain distressing content; intervention developers should attend to safe usage. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-054954.

Feasibility of pain informed movement program for people with knee osteoarthritis.

Objective: To establish the feasibility of an intervention consisting of neuromuscular exercise, mind-body techniques, and pain neuroscience education (PNE), referred to as Pain Informed Movement in people with knee Osteoarthritis (KOA). This program has the potential to improve our understanding of intrinsic pain modulation and its role in the management of chronic pain. Methods: This was a single-arm feasibility trial with a nested qualitative component. Primary outcome: complete follow-up. Inclusion criteria: age ≥40 years, KOA clinical diagnosis or meeting KOA NICE criteria, and pain intensity ≥3/10. The program consisted of 8-week in-person and at-home exercise sessions. PNE and mind-body techniques were provided as videos and integrated into the exercise sessions. Participants completed questionnaires and physical assessments including blood draws at baseline and program completion. Secondary feasibility outcomes: acceptability of the intervention, burden, rates of recruitment, compliance and adherence, and adverse events. A priori success criteria were identified. Participants were invited to an online focus group. Results: 19 participants were enrolled, with a complete follow-up rate of 74% (mean age 63.3 years (SD 10.5), 73% female), indicating modifications were necessary to proceed. All other success criteria were met. The focus groups revealed that the video content pertaining to the mind-body techniques would benefit from on screen demonstrations. Conclusion: The Pain Informed Movement program is deemed feasible, with minor modifications needed to proceed. A pilot two-arm RCT will be conducted to establish the feasibility and explore potential effects of Pain Informed Movement compared to conventional neuromuscular exercise and standard OA education.