Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression
NCT06467474 — Major Depressive Disorder (MDD
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder-mdd/NCT06467474/
Prediction of a Structured Clinical Assessment by Patient Reported Outcomes and Machine Learning Algorithms: A Comparative Study
Participants will be recruited to complete self reported surveys normally used as standards of care for screening and monitoring depression and anxiety symptom severity, provide a voice sample composed of an answer to open ended questions and then be assessed by a mental health professional using structured and clinically validated assessment tools for depression and anxiety. Their voice will be analyzed by machine learning models that predict the severity of depression and anxiety symptoms. The models' performance will be compared to the clinician assessments and how that correlation compares to a similar comparison between the clinician assessments with the self reported surveys. It is hypothesized that the performance of the machine learning models in assessing the severity of depression and anxiety symptoms is no worse than the self reported surveys when both are compared to clinician assessments. It is also hypothesized that presence or absence of the diagnoses of Major Depressive Disorder and Generalized Anxiety Disorder can be predicted better than chance by the analysis of the participant's voice sample using machine learning models.
NCT06464575 — Depression/Anxiety
Status: Enrolling by invitation
http://inclinicaltrials.com/depression-anxiety/NCT06464575/
Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression
Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression. Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied. The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.
NCT06464445 — Neuromodulation
Status: Not yet recruiting
http://inclinicaltrials.com/neuromodulation/NCT06464445/
Natural History of Depression, Bipolar Disorder and Suicide Risk
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation....
NCT06462196 — Major Depressive Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT06462196/
Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.
NCT06461260 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT06461260/
Adaptive Messaging to Support Depression Self-Management
This is a pilot randomized controlled trial of an adaptive 8-week text messaging intervention for depression self-management. Among 100 individuals with elevated depression symptoms, we will compare the effects of 8 weeks of the adaptive text messaging intervention (n=40) to 8 weeks of a non-adaptive text messaging intervention (n=40), and 8 weeks of a psychoeducation-only intervention (n=20). We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained. Both messaging arms will receive 8 weeks of daily text messaging. Messages will prompt learning and applying cognitive and behavioral self-management strategies. Whereas the non-adaptive messaging system will randomly select daily messaging styles (representing a variety of self-management strategies and message tones), the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement. Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm (if applicable). The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information. We will recruit participants through digital methods (e.g., advertising on social media platforms like Facebook and Instagram). Administration of study measures will occur at baseline, weeks 4 and 8, and 3-month and 6-month follow-up. The primary outcomes is depression symptom severity (PHQ-9). Secondary outcomes are: anxiety severity (GAD-7) and suicidality (DSI-SS). Using an Intention to Treat paradigm, we will test our hypothesis that: H1: Relative to the psychoeducation-only control, messaging interventions will reduce depression (H1a) and anxiety and suicidal ideation (H1b). H2: Relative to non-adaptive messaging, adaptive messaging will reduce depression (H1a) and anxiety and suicidality (H2b). H3: Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement.
NCT06458192 — Depression
Status: Not yet recruiting
http://inclinicaltrials.com/depression/NCT06458192/
Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia
This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.
NCT06457061 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT06457061/
The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
NCT06455293 — Depression
Status: Not yet recruiting
http://inclinicaltrials.com/depression/NCT06455293/
Temporal Interference Stimulation of Amygdala and dLPFC: A Randomized Controlled Trial for Adolescent Depression
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in adolescent depressive disorders.
NCT06452849 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT06452849/
A Single Case Experiment Design Investigating Wisdom Enhancement to Augment CBT Outcomes for Depression in Post-Stroke Populations
One-third of stroke survivors experience post-stroke depression, but there are currently no official guidelines for supporting them. Researchers aim to investigate whether the wisdom enhancement timeline technique can reduce depression in stroke survivors. The investigators also want to understand how this technique positively impacts mood, identity, self-esteem, and wisdom. The study will involve nine stroke survivors from the National Health Service (NHS) to gain insights into effective ways to support those with post-stroke depression.
NCT06451965 — Post-stroke Depression
Status: Active, not recruiting
http://inclinicaltrials.com/post-stroke-depression/NCT06451965/