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Low Mood clinical trials

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NCT ID: NCT06188962 Recruiting - Depression Clinical Trials

Evaluating Knowledge Insight Tools (KIT) for Reducing Anxiety and Low Mood in UK Secondary School Students

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Background and Study Aims: Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. The aim of this trial is to test a new form of school-based psychological therapy called Knowledge Insight Tools (KIT). KIT is based on Cognitive Behavioural Therapy, which is known to be helpful for young people experiencing difficulties with anxiety and low mood. The investigators want to see whether offering KIT to secondary school students can reduce their anxiety and/or low mood, compared to a period of time when they did not receive any support. Who can participate? Children and young people aged 11-18 can participate if they are attending a secondary school in England or Scotland, are experiencing problems with low mood and/or anxiety that are disrupting their everyday lives and are not mainly the result of external factors, and are actively seeking support. Children and young people cannot participate if they pose a significant risk to themselves and/or others, if their primary difficulties are not related to anxiety and/or low mood, if they have significant special educational needs or learning difficulties, and are younger than 16 years and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services. What does the study involve? The study starts with a waiting period, where each young person will not receive any support for 3-8 weeks, except for a weekly check-in with a trained professional. This is meant to provide a stable measurement of young people's mental health before KIT is introduced. The length of the waiting period for each young person is chosen at random by a computer program. This helps mix up the influence of things other than KIT that could impact young people's mental health, such as differences in the natural (and sometimes healing) passage of time. Young people will then be offered 10 sessions of KIT, where they will learn about the ways in which unhelpful thoughts and behaviours can inadvertently make them feel low or anxious. They will also be asked to practice ways of testing their unhelpful thoughts and changing their behaviours outside of sessions, and the investigators will review how this affects their mood and well-being over the course of treatment. What are the possible benefits and risks of participating? The main benefit of participating is that young people will be contributing to science, which will help young people struggling with anxiety and mood problems in future be offered forms of school-based psychological therapy that have been rigorously tested. The main risk is that young people might wait longer to start KIT than had they not participated in the study. Young people will still receive KIT if they refuse to participate or withdraw their participation, which they can do at any time. Where is the study run from? The study is run from secondary schools in the UK and is being conducted by the Evidence-Based Practice Unit (a research group and collaboration between University College London and the Anna Freud) and researchers and school-based practitioners from Place2Be. When is the study starting and how long is it expected to run for? The study started on 01/08/2022 with the recruitment of the first student. The study is expected to run until September 2024. There are plans to extend the study until September 2025 if another wave of recruitment is needed. Who is funding the study? The study is funded by Place2Be and Anna Freud, both UK-based charities. Who is the main contact? The main contact and principle investigator for the trial is Professor Jessica Deighton (j.deighton@ucl.ac.uk).

NCT ID: NCT06058364 Recruiting - Low Mood Clinical Trials

Effect of a Nutritional Supplement on Mental Wellness in Adults

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Trillions of microbes reside in human gut and constitute "gut microbiota". Composition of these microbes and substances produced by them play an important role in human health and wellness. The goal of this study is to determine if a unique orally consumed triglyceride supplement will impart mood benefits. Investigators hypothesize that a part of the fatty acids will be released in upper gastrointestinal (GI) tract and can be absorbed and reach different organs via systemic circulation (blood), including to the brain, and provide health benefits. Rest of the portion would reach the colon and may modulate gut microbiota and provide health benefits via the gut-brain axis (a bi-directional communication between emotional and cognitive centers and the gastrointestinal system). These health benefits could include alleviation of stress, occasional anxiousness and low mood. Participants with self-reported low mood will be randomized to two groups - one group will receive triglyceride supplement in softgel form and another group will receive a placebo (softgel with no active substance). Investigators will evaluate the effect of consumption of triglyceride supplement compared to Placebo on occasional low mood, occasional anxiousness, stress, sleep and general health by measuring changes from baseline.

NCT ID: NCT06025838 Not yet recruiting - Clinical trials for Major Depressive Disorder

Positive Feedback vs. No-Feedback Games for Behavioral Change

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

We aim to investigate here whether we can develop a reinforcement learning game which provides game-based feedback to encourage positive actions (behaviors) both inside and outside of the game. Does providing positive reward when participants make decisions which are associated with value-based actions (like those in BA) result in different game decisions? We propose that it will increase positive actions in the game. And, secondly, how does it affect short-term behavior (in one week)? We propose that it will increase pro-health activities and may reduce depressive symptoms.

NCT ID: NCT05963581 Recruiting - Depression Clinical Trials

Oxford Social Movement Activation Study

SOMA
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

For adolescents and young people particularly, there is need for better and more readily available treatments for depression and low mood. Comparatively less work has been done to characterize and treat depression specifically in young people. Previous literature indicates that often the unaddressed or under-addressed mental health difficulties in youth perseverate into adulthood and contribute to a host of individual and communal difficulties throughout the lifespan. Specifically, if depression goes unaddressed in young adulthood, the likelihood of a chronic course and multiple relapses or recurrences is much higher. In the present research, we seek to investigate the potential efficacy of a novel intervention for young people with low mood. Depression disrupts social functioning, and social connectedness is especially important during adolescence for healthy development. Within a growing body of literature, social dance has been linked to social and mental health benefits along the dimensions of those disrupted in depression. We hypothesize that social dance might preferentially and efficiently target the goals of addressing loneliness, closeness, and enjoyment in young people compared to other approaches to the treatment of low mood and depression in a way that could lead to mood improvements. Specifically, we are interested in the impact of a social movement-based activity, salsa dancing, on young peoples' mood and social and emotional processing. Social and emotional processing (SEP) tasks, such as emotional facial recognition and memory for emotional words, have been demonstrated to correspond with early changes that can be predictive of mood changes and treatment efficacy downstream. Including SEP tasks in this research will help to elucidate the potential mechanisms underlying mood improvements, should social dance correspond to improved mood in participants. The present research seeks to: 1. Aim 1: Investigate the effect of a social dance intervention on low mood. This will be assessed by administering psychological questionnaires to participants before, during, and after the study course of social dance sessions. In particular, we hypothesize that participants will experience reductions in low mood (assessed via the PHQ-9) following the social movement intervention as compared to a waitlist control. 2. Aim 2: Characterize any early social and emotional processing changes that correspond to social dance versus a waitlist control. This will be assessed via social and emotional processing task performance before, during, and following the social movement sessions. We anticipate that improvements in social and emotional functioning as demonstrated via one or several of these tasks will assist in elucidating the possible mechanisms responsible for mood improvement from social movement. 3. Aim 3: Characterize any social interaction difference from pre to post intervention that correspond to the social dance versus waitlist condition. This will be assessed via a version of the trust game before and following the social movement sessions and waitlist control. We anticipate seeing more disrupted trust behavior prior to the intervention or control conditions and less disrupted trust behavior following salsa dancing classes, but not the waitlist control. In this randomized controlled trial, participants in the experimental group will complete six to eight sessions of social movement (salsa dance) classes within an eight-week period, and complete psychological questionnaires and tasks before, during, and after these eight weeks. Their scores will be compared with those of a control group that will participate in an active waitlist condition. If the present study suggests that social movement benefits young people with low mood, it could form the basis for investigating a potential new cost-effective, non-invasive, accessible intervention that could be made available to young people.

NCT ID: NCT05627154 Recruiting - Depression Clinical Trials

Combined Antidepressant and Behavioural Intervention

CABIN
Start date: May 28, 2021
Phase: N/A
Study type: Interventional

A body of evidence from both animal and human research suggests that antidepressant drugs may induce early changes in emotional processing that interact with environmental factors to produce a later change in mood. This experimental medicine study will examine the effect of citalopram on emotional cognition under different environmental conditions (as manipulated by the presence or absence of behavioural activation training). Participants will be administered either citalopram or placebo over the course of two weeks. Citalopram will be taken either alone or in combination with behavioural activation training.

NCT ID: NCT05518019 Completed - Anxiety Clinical Trials

An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.

NCT ID: NCT05386745 Completed - Low Mood Clinical Trials

Feasibility Study of an Online Physical Activity Intervention for Youth With Depression

Start date: February 22, 2022
Phase: N/A
Study type: Interventional

Physical activity (PA) has recently been established as both a primary intervention for mild to moderate, and a secondary therapy for moderate to severe Major Depressive Disorder (MDD; Fortier et al., 2020). Those with mental health disorders do not on average achieve recommended levels of PA (Hallgren et al., 2016), and exercise prescription is extremely lacking in clinical care (Stanton, Reaburn, & Happell, 2015; Stanton et al., 2018). Theory-based behavioural interventions have proven to be an effective tool for improving physical activity levels in clinical populations (Glowacki, et al., 2017; Stanton et al., 2015). More research is needed to understand PA intervention effectiveness for MDD patients (Glowacki et al., 2017), support integration of such behavioural treatments with primary care (Lederman et al., 2017), and address growing concerns regarding mental health during the global pandemic and beyond (Boyce, 2021). This community-based study examines the feasibility of a co-designed, 10-week, asynchronous, web-based beta platform PA intervention for patients with experience of low mood and/or mild to moderate depression, and will provide important parameters for a future randomized-controlled trial (RCT). Primary outcome measures will focus on acceptability and feasibility, including recruitment and retention rates. Secondary measures will include physical activity and depression symptom severity. Behavioural predictors of PA are to be evaluated as tertiary outcomes. Questionnaires will include an adapted participant experience measure, Godin Leisure-Time Exercise Questionnaire, and the Patient Health Questionnaire-9. This study features a controlled baseline, post-intervention evaluative design with an embedded quantitative process evaluation with a waitlist control. Participants will be young adults with experience of low mood and/or mild to moderate depression, 19-30 years of age, with access to a device with internet, English speaking, living within British Columbia, CAN., and falling below the minimum Canadian recommendations for PA. Study recruitment will primarily be facilitated by multiple youth mental health primary and community care clinics. This study will contribute to understanding of acceptable, efficacious, behaviour-based and mobile health intervention approaches for young adults with depression. It will also provide young people with a platform to share invaluable feedback to direct innovations in their own alternative care and mental health treatment. If outcome benchmarks set based on previous literature are met or exceeded for each of recruitment, retention, and acceptability, and depressive symptoms trend downwards for intervention participants, then a future randomized controlled trial exploring principally mental health outcomes will be recommended.

NCT ID: NCT05373121 Completed - Depression Clinical Trials

Is Signposting to Online Peer Support Helpful in Decreasing Loneliness in Parents of Children With Long-term Conditions and Disabilities?

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

The present study aims to evaluate whether signposting to online peer support will be associated with a significant decrease in self-reported loneliness for parents of children with long-term conditions and disabilities. Parents of children with long-term conditions and disabilities will be randomised to either the treatment condition, being signposted to online peer support, or to the waitlist condition. Whether signposting to online peer support has an impact on social capital and anxiety and depression will also be investigated.

NCT ID: NCT05061381 Active, not recruiting - Anxiety Clinical Trials

Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children

Start date: October 11, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to assess the effectiveness of a school-based multi-component universal programme for the reduction of internalising problems (i.e. anxiety and low mood) in primary school pupils.

NCT ID: NCT04959916 Active, not recruiting - Anxiety Clinical Trials

Group-based Metacognitive Therapy for Burns and Plastics Patients

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Serious burns and other traumatic or disfiguring injuries represent a significant public health burden. Survivors often need intense medical or surgical treatment, including plastic surgery. As well as devastating physical injuries, up to 45% of people develop significant mental health difficulties following a traumatic injury. These difficulties include depression, anxiety and post-traumatic stress disorder (PTSD). Cognitive Behavioural Therapy (CBT) is the most widely offered treatment within the National Health Service (NHS) and the most common treatment provided for burns and plastics patients. However, CBT is limited in efficacy, time-consuming, and focuses on treating the most distressing problem first. One way to overcome these limitations is to evaluate a group therapy that can treat multiple mental health problems at once. One such treatment is called Metacognitive Therapy (MCT; Wells 2009). MCT targets metacognitive beliefs (beliefs people hold about their thinking) rather than the content of patients' thoughts (i.e. reality testing), which is advantageous over cognitive therapies as often following a burns or plastics injury patients experience realistic negative thoughts (e.g. thoughts about disfigurement). MCT has been shown to be more effective at treating anxiety and depression in mental health settings than CBT, however, more research is needed to evaluate MCT in physical health settings. The aim of this study is to examine the acceptability and feasibility of group-MCT within the Department of Burns, Plastics and Reconstructive Surgery at Wythenshawe Hospital. We aim to recruit 20 patients to receive six weekly sessions of group-MCT. Sessions will last approximately 90 minutes. Indicators of feasibility and acceptability will be described including rates of referrals, recruitment, and dropout. Data on symptom outcomes (as measured by the PHQ-9 and GAD-7) at pre and post treatment will be assessed and benchmarked against usual treatment delivered. The data will be used to inform a future large-scale trial on the effectiveness of MCT.