Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder: A Randomized Open Controlled Trial Study
The hypothesis to be tested by this study is that an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with elevated inflammation biomarkers, namely C-reactive protein (CRP) and Interleukin 6 (IL-6) diagnosed with Major Depression Disorder (MDD), under treatment with antidepressant medication for a period of time less than or equal to 6 months. The main aim of this study is to understand if promoting the adherence to the MedDiet, as an adjuvant strategy in the treatment of MDD, is effective in decreasing symptoms of depression in MDD patients, with elevated levels of inflammation biomarkers. Other specific objectives of the study are 1. To assess the association between adherence to MedDiet and changes in inflammatory biomarkers; 2. To assess the association between changes in inflammatory biomarkers with symptoms of MDD; 3. To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD; 4. To characterize the association between adherence to MedDiet and changes in health-related quality of life 5. To evaluate the economic cost-effectiveness of dietary counselling, as an adjuvant treatment in MDD. The study will have a duration of 12 weeks, with a randomized parallel-group open controlled trial design, with two parallel groups with an allocation ratio of 1:1 - (a) intervention arm with six nutritional consultations with a registered nutritionist, promoting adherence to MedDiet, in addition to MDD Treatment-As-Usual (TAU) and (b) control group arm benefitting only from MDD TAU. A follow up assessment will be performed at 6- and 12-months. Having into consideration an attrition of 40 percentage at the end of the intervention, the minimum sample size estimated is 190 (95 per arm). The main outcome of the trial, changes in symptoms of depression, will be evaluated using the Beck Depression Inventory Second Edition (BDI-II).
NCT05745194 — Major Depressive Disorder - MDD
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder-mdd/NCT05745194/
Efficacy of Self-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress: A Pilot Randomized Controlled Trial
The objective of this pilot randomized controlled trial is to evaluate the efficacy and acceptability of self-help forest bathing on depression, anxiety, and stress in the Hong Kong adult population. Prior to all study procedures, eligible participants will be required to complete an online informed consent form (with telephone support). Around 80 eligible participants aged between 18 to 65 years old with at least a mild level of depression, anxiety, or stress symptoms will be randomly assigned to either the self-help forest bathing intervention group (FB group) or the waitlist control group (WL group) in a ratio of 1:1. Participants in the FB group will receive forest bathing guidance via an in-house smartphone app. The WL group will be asked to maintain their typical activity in week 1-7. This group will receive the guide upon trial completion in week 8. The outcomes of the interest will include generalized anxiety symptoms, depressive symptoms, insomnia symptoms, wellbeing, health-related quality of life, functional impairment at baseline (week 0), immediate (week 7), and 1-month post-intervention assessments (week 10). Treatment credibility and acceptability will be collected at baseline and immediately after the intervention.
NCT05743920 — Stress
Status: Not yet recruiting
http://inclinicaltrials.com/stress/NCT05743920/
Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.
NCT05738967 — Depression
Status: Active, not recruiting
http://inclinicaltrials.com/depression/NCT05738967/
Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes
This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in young adults with type 1 diabetes.
NCT05734313 — Diabetes
Status: Recruiting
http://inclinicaltrials.com/diabetes/NCT05734313/
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.
NCT05732311 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05732311/
Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
The goal of this clinical trial is to discover the effectiveness of group-based Acceptance and Commitment Therapy (ACT) in treating depression for acute stroke patients. The main question[s] it aims to answer are: - Group-based ACT (G-ACT) could significantly reduce the depressive symptoms in patients with acute stroke, - the interventional efficacy could be maintained at 3-month follow-up - similar benefits would be observed for quality of life (QOL), sleep quality, psychological flexibility, cognitive fusion, and confidence. The patients included to the control group received usual care support in hospital, and the patients included to the intervention group received G-ACT and usual care support. the G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.
NCT05727358 — Acute Stroke Patients With Depression
Status: Completed
http://inclinicaltrials.com/acute-stroke-patients-with-depression/NCT05727358/
Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.
The investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression. The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short. - CBT looks at the way people think and what they do, and how this affects their mood. - It involves making changes to thoughts and behaviours. - CBT can help people develop more helpful ways of coping with depression. - CBT is one of the most effective therapies for depression, this means it works well. There are four booklets that participants will work though weekly in their own time and at home. The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension. Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety. They will then be allocated at random to one of two groups. Group one will receive the self-help booklets, called the intervention group. Group two, or the wait list group, will receive the intervention at a later date if it is found to be helpful. Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else. Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part. Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month. Participants in group one will be contacted again to find out more about their experiences of the project.
NCT05726669 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05726669/
Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)
The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.
NCT05725239 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05725239/
Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer
This is a pilot double-blinded, randomized, placebo-controlled trial to determine if venlafaxine prevents depression in patients undergoing surgery for Head and Neck Cancer (HNC).
NCT05724849 — Depression
Status: Withdrawn
http://inclinicaltrials.com/depression/NCT05724849/
A Randomized Controlled Trial of the Effectiveness of Cognitive Behavior Therapy for Major Depression in Bangladesh
This was a randomized controlled clinical trial (RCT) carried out in three different hospitals in Dhaka city, Bangladesh.
NCT05724680 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT05724680/