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Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada.

ABSTRACT: INTRODUCTION:HIV-associated neurocognitive disorder (HAND) may affect 30%-50% of people ageing with HIV. HAND may increase stress and anxiety, and impede coping. Psychosocial group therapy may ameliorate HAND's symptoms, yet the ideal intervention is unclear. This protocol outlines a pilot randomised controlled trial (RCT)-designed using community-based participatory research-to pilot cognitive remediation group therapy (CRGT) against an active comparator. METHODS AND ANALYSIS:This is a pilot, parallel design, two-arm RCT that will recruit participants diagnosed with the mild neurocognitive disorder form of HAND from a neurobehavioural research unit at a tertiary care hospital in Toronto, Canada. Eligibility criteria include age ?40 years, known HIV status for 5+ years, English fluency, able to consent and able to attend 8?weeks of group therapy. Eligible participants will be randomised to one of two treatment arms, each consisting of eight-session group interventions delivered once weekly at 3?hours per session. Arm 1 (novel) is CRGT, combining mindfulness-based stress reduction with brain training activities. Arm 2 (active control) is mutual aid group therapy. The primary outcomes are feasibility, measured by proportions of recruitment and completion, and acceptability, determined by a satisfaction questionnaire. The secondary outcome is intervention fidelity, where content analysis will be used to assess facilitator session reports. A between-group analysis will be conducted on exploratory outcomes of stress, anxiety, coping and use of intervention activities that will be collected at three time points. ETHICS AND DISSEMINATION:Ethical approval was obtained from the Research Ethics Boards of St. Michael's Hospital and the University of Toronto. Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study could provide insight into design (eg, recruitment, measures) and intervention considerations (eg, structure, content) for a larger trial to lessen the burden of cognitive decline among people ageing with HIV. TRIAL REGISTRATION NUMBER:NCT03483740; Pre-results.

SUBMITTER: Eaton AD

PROVIDER: S-EPMC6830703 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada.

Eaton Andrew David AD Walmsley Sharon L SL Craig Shelley L SL Rourke Sean B SB Sota Teresa T McCullagh John W JW Fallon Barbara A BA

BMJ open 20191031 10

<h4>Introduction</h4>HIV-associated neurocognitive disorder (HAND) may affect 30%-50% of people ageing with HIV. HAND may increase stress and anxiety, and impede coping. Psychosocial group therapy may ameliorate HAND's symptoms, yet the ideal intervention is unclear. This protocol outlines a pilot randomised controlled trial (RCT)-designed using community-based participatory research-to pilot cognitive remediation group therapy (CRGT) against an active comparator.<h4>Methods and analysis</h4>Thi ...[more]

PMID: 31676660

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Project description:IntroductionMajor depressive disorder (MDD) affects 163 million people globally every year. Individuals who experience subsyndromal depressive symptoms during remission (ie, partial remission of MDD) are especially at risk for a return to a depressive episode within an average of 4 months. Simultaneously, partial remission of MDD is associated with work and (psycho)social impairment and a lower quality of life. Brief psychological interventions such as preventive cognitive therapy (PCT) can reduce depressive symptoms or relapse for patients in partial remission, although achieving full remission with treatment is still a clinical challenge. Treatment might be more effective if cognitive functioning of patients is targeted as well since cognitive problems are the most persisting symptom in partial remission and predict poor treatment response and worse functioning. Studies show that cognitive functioning of patients with (remitted) MDD can be improved by online neurocognitive remediation therapy (oNCRT). Augmenting oNCRT to PCT might improve treatment effects for these patients by strengthening their cognitive functioning alongside a psychological intervention.Methods and analysisThis study will examine the effectiveness of augmenting oNCRT to PCT in a pragmatic national multicentre superiority randomised controlled trial. We will include 115 adults partially remitted from MDD with subsyndromal depressive symptoms defined as a Hamilton Depression Rating Scale score between 8 and 15. Participants will be randomly allocated to PCT with oNCRT, or PCT only. Primary outcome measure is the effect on depressive symptomatology over 1 year. Secondary outcomes include time to relapse, cognitive functioning, quality of life and healthcare costs. This first dual approach study of augmenting oNCRT to PCT might facilitate full remission in partially remitted individuals as well as prevent relapse over time.Ethics and disseminationEthical approval was obtained by Academic Medical Center, Amsterdam. Outcomes will be made publicly available.Trial registration numberNL9582.

Project description:BACKGROUND:Improving the quality of patient care through the use of mobile devices is one of the hot topics in the health care field. In unwanted situations like an accident, ambulances and rescuers often require a certain amount of time to arrive at the scene. Providing immediate cardiopulmonary resuscitation (CPR) to patients might improve survival. OBJECTIVE:The primary objective of this study was to evaluate the feasibility of an emergency and mutual-aid app model in Taiwan and to provide a reference for government policy. METHODS:A structured questionnaire was developed as a research tool. All questionnaires were designed according to the technology acceptance model, and a Likert scale was used to measure the degree of agreement or disagreement. Moreover, in-depth interviews were conducted with six experts from medical, legal, and mobile app departments. Each expert was interviewed once to discuss feasible countermeasures and suggestions. Statistical Package for the Social Sciences (SPSS version 19; IBM Corp, Armonk, New York) was used to perform all statistical analyses, including descriptive statistics, independent sample t-tests, variance analysis, and Pearson correlation analysis. RESULTS:We conducted this study between October 20, 2017, and November 10, 2017, at the Taipei Medical University Hospital. Questionnaires were distributed to medical personnel, visiting guests, family members, and volunteers. A total of 113 valid questionnaires were finally obtained after the exclusion of incomplete questionnaires. Cronbach α values for self-efficacy (perceived ease of use), use attitude (perceived usefulness), and use willingness and frequency were above .85, meeting the criterion of greater than .70. We observed that the reliability of each subquestion was acceptable and the values for use attitude (perceive usefulness) and use willingness and frequency were more than .90. CONCLUSIONS:The findings suggest that perceived ease of use and perceived usefulness of the app model affect use willingness. However, perceived usefulness had an intermediary influence on use willingness. Experts in law, medical, and technology fields consider that an emergency and mutual-aid model can be implemented in Taiwan. Along with the development of an emergency and mutual-aid app model, we recommend an increase in the number of automated external defibrillators per region and promotion of correct knowledge about CPR in order to decrease morbidity and mortality.

Project description:BackgroundPatients with anorexia nervosa (AN) experience difficulties in neurocognitive functioning in the acute phase of illness which might be related to clinical presentation, but also in the apparently remitted state after weight recovery. Among the most commonly reported persistent deficits is cognitive inflexibility, which can be interpreted as a vulnerability trait or a "neuropsychological scar" reflecting the detrimental effect of prolonged semi-starvation in patients with a long duration of illness. Studies of adolescent samples with a relatively short clinical course may enable avoiding the effect of prolonged illness and help to determine whether neuropsychological deficits are trait or state dependent. The aim of this study is to assess cognitive functioning in adolescents with AN before and after the inpatient treatment programme, including cognitive remediation therapy (CRT).MethodsForty-seven adolescent female inpatients with AN diagnosed according to DSM-5 and fifty healthy female adolescents matched for the education level and age were recruited. The patients underwent a multimodal treatment including a ten-week CRT. The standardized and cross-validated neuropsychological (Trail Making Test - TMT A and B, Color-Word Stroop Task - CWST, Ruff Figural Fluency Test - RFFT) and clinical measurements (Beck Depression Inventory - BDI, Eating Attitude Test - EAT-26, Yale-Brown Obsessive Compulsive Scale - Y-BOCS) were used to assess both clinical (in the acute phase and after partial weight recovery) and control subjects.ResultsInitially, AN patients performed significantly worse compared to the controls, but afterwards, inpatient treatment improvement was noted on all examined measures. In a few subtests (TMT, CWST) performance of AN patients after the programme was still significantly poorer than in HC.ConclusionsCognitive inflexibility in adolescent AN patients, as measured with TMT, CWST, and RFFT tends to improve after therapy. Nevertheless, a few neuropsychological subtests which did not show complete normalization may warrant attention in subsequent studies. Further research including control intervention is needed to conclude whether CRT intervention affects the outcome.

Dataset Information

Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada.

Publications

Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada.

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