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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: 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.