Mindfulness-Based Cognitive Therapy (MBCT) vs. Health Enhancement Program (HEP) Active Control for the Treatment of Late-Life Depression: An RCT
Study Design & Recruitment: Phase III randomized controlled trial (RCT) with 200 patients. Participants with a diagnosis of late-life depression (LLD), excluding dementia and other psychiatric comorbidities, will be recruited at three health networks. LLD patients had no earlier depressive episodes before the age of 65. Interventions: Mindfulness-based Cognitive Therapy (MBCT) or Health Enhancement Program (HEP) for 8-weeks, in addition to TAU. MBCT and HEP will have the same group sizes, meeting frequency, and amount of home practice. HEP is a recognized active control where participants learn about diet and exercise, but not meditation.
NCT05366088 — Cognitive Decline
Status: Not yet recruiting
http://inclinicaltrials.com/cognitive-decline/NCT05366088/
A Multicenter Clinical Study to Evaluate the Efficacy and Safety of Shuganjieyu Capsule Combined With Fluoxetine in the Treatment of Depression
This study mainly evaluates the efficacy and safety of Shuganjieyu capsule combined with Fluoxetine as well as the Fluoxetine monotherapy for the treatment of depression in the basic study, and also explores the efficacy for the extended study period as well as the efficacy and safety for the full trial period (basic study period and extended study period).
NCT05361330 — Outpatients / Inpatients With Depression
Status: Not yet recruiting
http://inclinicaltrials.com/outpatients-inpatients-with-depression/NCT05361330/
A Randomized Placebo-controlled Trial for Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness
This is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.
NCT05357313 — Bipolar Depression
Status: Recruiting
http://inclinicaltrials.com/bipolar-depression/NCT05357313/
Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction
Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.
NCT05356611 — Mild Cognitive Impairment
Status: Recruiting
http://inclinicaltrials.com/mild-cognitive-impairment/NCT05356611/
The Effect of the Online Postpartum Follow-up on Depression and Postpartum Adaptation: A Randomized Controlled Study
Objective: To determine the effect of online postpartum follow-up on depression and postpartum adaptation. Design: A parallel-randomized-controlled study Setting: During 2021 in Turkey Participants: 52 women in the postpartum period Measurements: Data were collected through the Personal Information Form, the Follow-up Form, the Edinburgh Postpartum Depression Scale (EPDS), and the Postpartum Self-Assessment Scale (PSAS). The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk. The women in the control group received the routine follow-up and care provided by the hospital.
NCT05356026 — Postpartum Depression
Status: Completed
http://inclinicaltrials.com/postpartum-depression/NCT05356026/
Type 1 Diabetes and Depression: Role of Brain Glutamate
The goal of this study is to examine the effect of chronic and acute hyperglycemia in type 1 diabetes mellitus (T1DM) on brain glutamate levels using magnetic resonance spectroscopy (MRS), and associations of brain glutamate with symptoms of depression.
NCT05355285 — Major Depressive Disorder
Status: Completed
http://inclinicaltrials.com/major-depressive-disorder/NCT05355285/
Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention
Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention.
NCT05355142 — Treatment Resistant Depression
Status: Recruiting
http://inclinicaltrials.com/treatment-resistant-depression/NCT05355142/
Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement
Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective interventions. Participation in mindfulness interventions has been demonstrated to reduce anxiety and depressive symptoms among teenagers. Parents' participation in mindfulness interventions has also been shown to reduce their children's mental health symptoms. However, there is no available evidence regarding potential additional benefits for adolescents' mental health of having both the adolescent and their parent or caregiver learn and practice mindfulness simultaneously. This pilot intervention study aims to explore potential additive effects of parent/caregiver participation in a digitally-based, kindness-focused, coached mindfulness intervention program for adolescents that lasts 9 weeks. Participating parent/caregiver-child pairs (n = 30) will include one teenager between 12 and 17 years old with a current diagnosis of an anxiety or depressive disorder and one parent/caregiver. All adolescent participants will take part in the mindfulness intervention. Half of the parents/caregivers will be randomized to also take part in the mindfulness program. Outcomes will be compared between families in which only the teen participates in the mindfulness program and families in which the teen and parent/caregiver participate in the intervention. Adolescents and parents/caregivers will take part in evaluations before, in the middle of, and after the end of the mindfulness program, meaning that participation in the study will take a total of approximately 12 weeks. Pre, mid, and post evaluations will include online questionnaires. Pre and post evaluations will also include clinical interviews via phone or video conference. Evaluations will include measures of mental health diagnoses and symptoms, mood, interpersonal and family functioning, mindfulness, and perceptions of/satisfaction with the program. Participating adolescents and parents/caregivers will also fill out weekly brief questionnaires of anxiety and depressive symptoms. The primary outcome of interest is adolescent mental health, including anxiety and depressive symptoms.
NCT05353751 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05353751/
Virtual Mindfulness Training for Adults With History of Depression
Mindfulness Based Cognitive Therapy (MBCT) has shown to be an effective method of preventing relapse of an episode Major Depressive Disorder (MDD). MBCT is a group program that integrates mindfulness skills training with cognitive-behavioral strategies. However, the cost of MBCT is not affordable to many families. The aim of this study is to explore the feasibility and efficacy of an MBCT intervention designed to be delivered at low cost through a virtual delivery format. This study will recruit 240 participants who are in remission from depression and randomize them to an MBCT intervention group or treatment as usual (TAU) for the wait list control group. The wait list control group will complete the intervention after the MBCT intervention group. Assessment administered at pre-intervention (baseline), post-intervention for experimental group, and post-intervention for the wait list control group and follow-up for experimental group. The primary outcome is to test the efficacy of this community-based delivery in reducing depression severity and psychiatric distress in the relapse of an episode of MDD. The secondary outcomes include perceived stress, post-traumatic stress symptoms, adherence to treatment plans not given as part of this study, frequency of relapse of MDD, mindfulness skills, and quality of life. This study will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBCT intervention adherence. Finally, the study will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.
NCT05347719 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05347719/
Post-Acute COVID-19, Inflammation, and Depression
Single site, double blind, placebo-controlled, longitudinal study of depression in Subjects with COVID- 19 long haulers syndrome using a 1:1 ratio randomization for a single IV infusion of 6 million cells/kg allogeneic marrow stromal cells (MSCs).
NCT05346120 — Post COVID -19 Depression
Status: Withdrawn
http://inclinicaltrials.com/post-covid-19-depression/NCT05346120/