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Depression clinical trials

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NCT ID: NCT03535805 Enrolling by invitation - Anxiety Clinical Trials

Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances

MindMyMind RCT
Start date: September 7, 2017
Phase: N/A
Study type: Interventional

Background Impairing emotional and behavioural problems are common in children and adolescents and mark a three-fold increased risk of mental disorder in young adulthood. Evidence-based psychological interventions are recommended for indicated prevention and first-line treatment, but access to treatment is often limited. A new, modular cognitive and behavioural therapy program, Mind My Mind (MMM) comprising evidence-based interventions for children with emotional and behavioral problems was designed to be delivered by educational psychologists in the Danish municipalities. A feasibility RCT (ClinicalTrials.gov: NCT03448809), demonstrated that the study design was acceptable among children, parents, and therapists, and it provided data to estimate the sample size needed for the definitive RCT. We test the hypothesis that the parent-reported impact of mental health problems will be significantly lower for children in the MMM group as compared with children in the TAU group after the 18-week intervention period (primary hypothesis), and after follow-up at week 26 (first secondary hypothesis). Aim To investigate the effects and cost-effectiveness of MMM compared with TAU for children and adolescents with impairing anxiety, depressive symptoms and/or behavioral problems. Both beneficial and harmful effects are evaluated. Methods The study compares the new modular MMM with TAU for children aged 6-16 years with anxiety, depressive symptoms or behavioral problems impacting on their daily and social life. The trial is conducted in four Danish municipalities in the period from September 2017 to April 2019. Participants are children with indicated needs. The parents sign up the child for assessment in the Pedagogical Psychological Services in the Municipalities. The assessment includes web-based standardized questionnaires for child and parent: 1) the strengths and difficulties questionnaire (SDQ), 2) Spence Children's Anxiety Scale, 3) Mood and Feelings Questionnaire, and 4) family, social and school functioning. The questionnaires are supplemented with a clinical psychopathological interview by a trained psychologist. We exclude children with 1) low levels of problems and no indicated needs, or 2) high levels of problems and need of referral to the Child and Adolescent Psychiatry. 412 children will be included and randomized (1:1) to MMM versus TAU. The MMM program is supported by a central organization, who is responsible for the education and weekly supervision of the therapists, and the web-based data collection and feedback of data in real time to therapists and researchers. All outcomes are self-, parent- and teacher-reported scores on standardized questionnaires administered at baseline, week 18 and week 26. At entry, the child and the parents own description of the Top-problem is recorded and scored on a 10-point likert scale. The Top-problem and impact of problem is scored by parent and child every second week during the intervention period, and the progress is monitored by the therapists in the MMM group. Information on costs is gathered through administrative registers and questionnaires at baseline, week 18, and week 26. Primary objectives and outcome measures This primary outcome is measured with the parent-reported SDQ impact-scale (range 0-10). The minimum relevant difference in impact of mental health problems was set at 1.0 corresponding to a change from severe to moderate, or from moderate to little-or-no impact in one of five domains of child's life: distress, home-life, friendships, classroom learning and leisure activities. Secondary objectives and outcomes measures The key secondary hypotheses are that the children in the MMM group will show significantly lower levels of parent-reported anxiety, depressive symptoms, functional impairment, Top-problems and behavioural problems, and better school attendance and quality-of-life as compared with the children in the TAU group at week 18. All other outcomes are explored at week 18 and 26, including the primary and secondary measures of potential harm: 1) youths with severe and increased levels of self-reported suicidality, hopelessness and/or negative self-evaluation, and 2) youths with poor quality of life in relation to family, free time and friends. Statistical analyses All analyses will be intention-to-treat with two-sided significance tests. We will use mixed models with repeated measures for continuous outcomes and generalized linear mixed model for binary and non-normally distributed outcomes. For the key secondary outcomes, we will use the strategy of hierarchical testing allowing us to preserve the level of significance, α= 0.05, as long as the null hypotheses are rejected. The incremental cost-effectiveness ratio will be calculated to analyze cost-effectiveness. Perspectives The results will guide policy makers in deciding whether to implement modular CBT-programs like the MMM.

NCT ID: NCT03521388 Enrolling by invitation - Depressive Symptoms Clinical Trials

Internet-based Program for Prevention and Early Intervention of Adolescent Depression

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents. Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile. Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.

NCT ID: NCT03515564 Enrolling by invitation - Depression Clinical Trials

Alternative Therapies for High Stress and Trauma-Exposed Refugees

Start date: July 26, 2017
Phase: N/A
Study type: Interventional

Conflict in Syria and Iraq has created a humanitarian crisis that includes hundreds of thousands of refugees who have experienced trauma and suffer from a greater incidence of trauma-related disorders as compared to the general population. The need for intervention is clear: our research team has determined prevalence of probable PTSD, anxiety, and depression in adults at rates of 32.2%, 40.3% and 47.7%, respectively and children at rates of 6.3% for PTSD and 52.9% for anxiety. Barriers to treatment include cultural ideations surrounding psychiatric treatment, language barriers posed to psychotherapy, and high dropout associated exposure therapy—the standard treatment for PTSD. To overcome these challenges, the investigators developed a behavioral health program that addresses not only the psychological but also the somatic components of trauma-related disorders which are common but often less addressed by traditional treatment. This 12-week family-based program offers weekly, 90 minute sessions in Dance/Movement Therapy (DMT) or Art Therapy for children, mindful yoga for mothers, and High Intensity Interval Training (HIIT) for fathers as well as complimentary transportation to and from sessions. Self-report questionnaires and biological specimens (hair cortisol; saliva or blood inflammation markers) are collected at the beginning, middle, and end of the intervention phase, as well as 3, 6, and 12 months afterwards to measure acute and long-term effects of these treatments. By collecting psychological and biomarker data the investigators seek concrete scientific evidence supporting these non-pharmacological, cost effective, and accessible programs as reliable treatment options.

NCT ID: NCT03514355 Enrolling by invitation - Clinical trials for Rheumatoid Arthritis

MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms

PARIS-D
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

Despite their efficacy at controlling joint inflammation, current treatments of rheumatoid arthritis (RA) leave up to 40% of patients into non-remission. Non-remission is most frequently due to persistently negative self-reported global impact of RA, and not to remaining swollen joints or elevated levels of acute phase reactants. In a cohort of recent-onset RA patients diagnosed early and treated to remission (Sherbrooke Early Undifferentiated PolyArthritis (EUPA) cohort), treatment of active disease rapidly led to reduced depressive symptoms in most, but 20% still expressed elevated depressive symptoms (using the CES-D screening tool) after a mean of 7 months. Elevated CES-D scores at this early time strongly predicted never reaching remission over the following 4 years. Elevated CES-D scores were strongly correlated with increased levels of patient-related outcomes (PROs such as fatigue, pain, sleep quality, stiffness and functional limitation), but not with joint or systemic inflammation. In fact, 80% of patients expressing depressive symptoms had controlled joint disease at the same visit. The investigators propose that addressing depressive symptoms will improve RA patients' symptoms and quality of life. In clinical practice, the best indicator of depressive symptoms is the presence of a disconnect between the Patient's (Pt-VAS) and the Physician's (MD-VAS) evaluation of disease activity in patients without objective signs of inflammation. This pilot study will explore the feasibility and acceptability of testing MBSR in these patients. It will assess over 6 months the changes in depressive symptoms and PROs both in controls and MBSR-treated patients. If positive, the investigators plan to complete a multicenter 6-month Randomized Clinical trial (RCT) (with a 2 year follow up) to formally address the risks/benefits of group MBSR interventions in RA patients with controlled inflammatory disease but positive disconnect between Pt-VAS and MD-VAS.

NCT ID: NCT03497663 Enrolling by invitation - Schizophrenia Clinical Trials

VIA Family - Family Based Early Intervention Versus Treatment as Usual

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

This RCT aims to investigate the effect of an early family-based intervention (VIA Family) focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.The study is a randomized clinical trial including 100 children age 6-12 with familial high risk.The children and their parents will be assessed at baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family.

NCT ID: NCT03480841 Enrolling by invitation - Depression Clinical Trials

Using the LENA System in Early Intervention - b

Start date: April 2, 2018
Phase: N/A
Study type: Interventional

This project will determine whether an intervention to enhance communication between infants and toddlers with developmental disabilities and their depressed mothers can be integrated into federally-funded Early Intervention (EI) services. Participants will be mothers with depressive symptoms whose children are receiving EI services, along with their EI service providers. The investigators will conduct a small feasibility trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 10 mothers and one of their child's EI service providers. The LENA uses an infant or toddler garment with an integrated audiotape system that records adult speech centered on the child, child vocalizations, and reciprocal parent-child turn-taking conversations. The LENA software produces visual feedback that a mother can use to focus her language interactions with her child. They study will follow participants in the LENA with feedback intervention over 6 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours). The investigators will analyze data from measures on LENA communication data (adult word count, child vocalizations and conversational turn-taking), and measures of child language, maternal depressive symptoms, and child disability profiles.

NCT ID: NCT03464383 Enrolling by invitation - Depression Clinical Trials

Anxiety and Depression in Epilepsy: A Treatment Study

Start date: May 7, 2018
Phase: Phase 4
Study type: Interventional

As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this randomized trial aims to study treatment for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs. psychiatry referral (typical care). Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be randomized to the either the intervention group or the control group. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The control group will receive usual care, which is a referral order to psychiatry placed by their treating neurologist.

NCT ID: NCT03390218 Enrolling by invitation - Depression Clinical Trials

TAO Outpatient Trial for Anxiety and Depression

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This study will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.

NCT ID: NCT03376633 Enrolling by invitation - Depression Clinical Trials

The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is: 1. To conduct a randomized controlled trial to evaluate the impact of Working on Womanhood (WOW), a school-based, trauma-informed counseling and clinical mentoring program for young women in Chicago, on PTSD, anxiety, depression. In addition, this study will examine the effect of WOW on other, secondary outcomes such as school discipline, GPA, high school graduation, and criminal justice involvement, risky behaviors, and other social-emotional learning outcomes. 2. To evaluate the cost-effectiveness of the WOW program.

NCT ID: NCT03327259 Enrolling by invitation - Depressive Symptoms Clinical Trials

A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms

Start date: October 9, 2017
Phase: N/A
Study type: Interventional

There is literature to support both the need for and efficacy of brief interventions for depressive symptoms, particularly among college students.Brief behavioral activation interventions (BATD) have gained recognition as efficacious treatments for depression; yet a recent study evidenced a substantial (39%) non-response rate (Kuyken et al., 2017). In accordance with behavioral models of depression, the treatment involves increasing activity and positive experience, to break the negative reinforcement cycle maintaining depressed mood. Thus, strategies that may facilitate increasing activity may improve BATD outcomes. The objective of the current study is to examine whether briefly practicing a target activity during an activity planning session (modified single session of BATD) increases the likelihood of completing the activity during the upcoming week. We hypothesized that guided activity practice may improve self-efficacy within session and activity completion in the upcoming week. We further aim to explore whether activity completion mediates depressive symptom change.