Mobile CBT for Middle Aged and Older Adults
Anxiety Disorders and SymptomsDepressive Symptoms1 moreThis study aims to assess a mobile iPhone app called MAYA for use in middle-aged and older adults with anxiety or mood disorders. The MAYA app is designed to teach coping skills for anxiety and depression that are drawn from cognitive behavioral therapy. Participants will be asked to use the app for at least two days a week, 20 minutes on each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up). During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app. The main hypotheses of the study are that participants will complete most of the assigned sessions and that they will rate their impressions of the app highly. The secondary hypotheses are that symptoms of depression and anxiety will decrease with use of the MAYA app.
SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities...
SchizophreniaSchizoaffective Disorder9 moreAlthough psychotic disorders typically affect less than 1% of the population, they are a significant cause of disability worldwide. Psychotic symptoms such as hallucinations, delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily living. However, the social consequences of psychosis are often even more troubling than the symptoms. For example, people with psychosis have a high risk of experiencing violence, poverty, homelessness, incarceration, and unemployment, among other adverse outcomes. There is a need for a range of accessible, appropriate interventions for people with psychosis to be delivered to those in the most vulnerable situations, including in low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part of the formative research for SUCCEED identified 10 studies evaluating the impact of interventions for people with psychosis in Africa, most of which had a strongly clinical focus. The review concluded that there was a need for further research involving people with lived experience of psychosis in designing and evaluating holistic interventions that meet their diverse needs, within and beyond the health sector. SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought together people with lived experience of psychosis and people with professional experience (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone, Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of Change-driven approach. The SUCCEED intervention takes the World Health Organisation's (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people living with psychosis and other psychosocial disabilities, and how best to meet these needs by mobilising the resources of individuals and families affected, as well as their broader communities. This protocol describes a pilot study in which the SUCCEED intervention will be delivered and evaluated on a small scale, in preparation for a larger multi-country research evaluation using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe and observational studies in Malawi and Sierra Leone, respectively. The main outcome of interest is change in subjective quality of life among participants with lived experience of psychosis who are offered the intervention over a four-month follow up period.
LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients...
Systemic Lupus ErythematosusDepressionThe purpose of this study is to investigate the effects of a type of non-invasive transcranial alternating current stimulation (tACS) on patients diagnosed with systemic lupus erythematosus (SLE) who are experiencing depression. Targeting depression in patients with SLE may provide benefit to these patients, as there is a clear relationship between chronic pain and depression. The investigators propose that a tACS stimulation montage that was previously used in depression could be beneficial to patients with SLE, resulting in reduced depression symptoms, thus resulting in reduced chronic pain and cognitive difficulties.
Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)
Mental DisorderDepressive Disorder3 moreA growing number of trials have demonstrated treatment effectiveness for mental illness by non-specialist providers, such as primary care providers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against people with mental illness. Therefore, interventions are needed to address attitudes among non- specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE), is an intervention for non-specialists in which social contact with persons with mental illness is added to training and supervision programs. A cluster randomized control trial will address primary objectives including changes in stigma (Social Distance Scale) and improved quality of mental health services, operationalized as accuracy of identifying patients with mental illness in primary care. The control condition is existing mental health training and supervision for non-specialists delivered through the Nepal Ministry of Health's adaptation of the World Health Organization mental health Gap Action Programme. The intervention condition will incorporate social contact with people with mental illness into existing training and supervision. Participants in the cluster randomized control trial will be the direct beneficiaries of training and supervision (primary care providers) and indirect beneficiaries (their patients). Primary care workers' outcomes include stigma (Social Distance Scale), knowledge (mental health Gap Action Programme knowledge scale), implicit attitudes (Implicit Association Test), clinical self-efficacy (mental health Gap Action Programme knowledge scale), and clinical competence (Enhancing Assessment of Common Therapeutic factors) to be assessed pre-training, post-training, and at 3- and 6-month follow-up. Accuracy of diagnoses will be determined through the Structured Clinical Interview for the Diagnostic and Statistical Manual version 5, which will be assessed at 3 months after patient enrollment. Patient outcomes include functioning, quality of life, psychiatric symptoms, medication side effects, barriers to care, and cost of care assessed at enrollment and 3 and 6 months. This study will inform decisions regarding inclusion of persons living with mental illness in training primary care providers.
Affective Touching on Poststroke Depression
Post-stroke DepressionThis mixed-method study includes a randomised controlled trial and an exploratory qualitative study, and aims to examine the effects of caregiver-delivered affective touch on depressive symptoms, state of attachment security, self-esteem, and perceived family harmony among stroke survivors, and to explore the mediating effect of attachment security and how an intervention may affect depressive symptoms from stroke survivor's perspective. A total of 184 survivor-caregiver dyads will be recruited from various non-governmental organisations. The dyads will be randomly allocated to intervention (IG) and control (CG) groups, stratified by the survivor's attachment style. IG caregivers will be taught to deliver a 15-minute affective touch intervention to stroke survivors. To address the attention effect, CG caregivers will be asked to sit with the survivors during a 15-minute fine motor coordination exercise. Both activities, affective touching and fine motor exercise, will be performed for 12 weeks (3 times/week), and the outcomes mentioned earlier will be measured at baseline, 12 and 36 weeks after study entry.
Neuroimaging Sleep and Mood in Depression
Major DepressionThis study will investigate how sleep and mood are related in patients with depression and in healthy controls. It will use MRI-based measures of brain function to determine how neural systems are modulated by sleep and sleep deprivation, and its links to mood in depression.
Is Brain Insulin Resistance a Feature of the Biology of Depression in Adolescents
Major Depressive DisorderDepressionThis study will examine if brain insulin resistance is a feature of depression in humans using magnetic resonance imaging (MRI) measures sensitive to brain insulin action. This study will examine adolescents, as depression onset commonly occurs during this age, and the impacts of cumulative medication exposure and other lifestyle-related confounds are also lower in this age group, improving our ability to understand the underlying biology.
Transcranial Pulse Stimulation for Depression
Major DepressionTranscranial pulse stimulation (TPS) is a newly developed brain stimulation therapy from Austria & Germany with highly promising applicability in neuropsychiatric disorders. Major depressive disorder (MDD) is the world's leading cause of disability. Novel treatment approaches are urgently needed given that a significant fraction of patients does not sufficiently respond to standard antidepressant treatments. Our open-label pilot study using TPS in MDD indicates preliminary efficacy. However, experimental control is necessary to infer reliable scientific evidence for the efficacy of TPS. Here, we propose a randomized, double-blind, sham-controlled clinical trial to probe the utility of TPS as a modern antidepressant treatment.
The Pill Project - Oral Contraceptive and Serotonergic Brain Signaling
Major Depressive DisorderSexual Behavior5 moreLarge register based work has shown that starting on oral contraceptives (OCs) is associated with an increased risk of developing depressive episodes. It is not known why this is, but changes in the serotonergic brain system might play a role. Intriguingly, in cross-sectional work, the investigators have demonstrated a lower level of the serotonin 4 receptor globally in the brain of healthy women using oral contraceptives compared to non-users. The order of magnitude of this difference is comparable to what has been observed in depressed individuals relative to healthy controls. In this study, the investigators will apply a longitudinal design to determine if starting on oral contraceptives induces a reduction in the serotonin 4 receptor in healthy women and whether such changes are related to potential changes in measures of cognition as well as mood/affect and sexual desire. The study is a single-blind randomized placebo-controlled trial with a 3-month intervention paradigm of either Femicept (2nd generation combined oral contraceptive) or placebo. The investigators will include participants until 20 women have completed the study in each arm. Participants will go through an investigational program, including PET and MR brain scans and neuropsychological testing, before starting on the treatment and again during the third pill cycle. To capture changes in mood/ and sexual desire, the participants will complete daily questionnaires during the baseline menstrual cycle and during third pill cycle. A linear latent variable model will be used to evaluate if OC use induces changes in the serotonin 4 receptor level and such changes will be correlated to changes in secondary outcomes (i.e., cognitive and psychometric measures).
Prucalopride and Cognition in Recovered Depression
Depression in RemissionThe current study has two aims: To test the effect of 5-HT4 receptor agonism on cognition (including memory, attention and cognitive control) in individuals with previous history of depression. To explore if prucalopride has an effect on emotional processing biases consistent with its effects on serotonin.