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103 active trials for Depressive Symptoms

Cultural Adaptation of the TIM&SARA Prevention Program

Disparities between African-American and European-American youth regarding academic outcomes, mental health, and physical health exist. Depression, a very common mental health problem, plays a central role by impacting academic outcomes and cardiovascular health. Thus, a program that successfully reduces the likelihood for youths to develop depression should also reduce problems with academic outcomes and physical health and therefore reduce disparity in all three domains. Research demonstrates that European-American youth benefit more from programs preventing the development of depression than their African-American peers. Thus, the goals of this project are to (a) identify mechanisms that may result in differential program effectiveness across racial groups, and (b) adapt such a program (TIM&SARA) so youth from diverse racial backgrounds benefit similarly. Freshmen in an urban high-school will participate in TIM&SARA, fill out surveys and give biological data in saliva.

Start: August 2015

Stepped-Care Telehealth for Distress in Cancer Survivors

Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.

Start: July 2018

Southwest Hub for American Indian Youth Suicide Prevention Research

To use a SMART design to evaluate which of four sequences of New Hope (NH), Elders Resilience (ER) and Case Management (CM) have the greater effects on immediate and longer-term suicidal ideation (primary outcome) and resilience (secondary outcome) among American Indian (AI) adolescents ages 10-24 identified at risk for suicide. Hypotheses: i. New Hope vs. CM alone will significantly reduce participant suicidal ideation. ii. Elders Resilience vs. CM alone will significantly improve participant resilience. iii. New Hope followed by Elders Resilience will have the strongest effects on suicidal ideation and resilience. iv. CM alone will have the weakest effects of all combinations. Secondary Aims: To examine mediators and moderators of treatment effectiveness and sequencing in order to determine which types and sequence of interventions is best suited for which youth. To assess the acceptability, feasibility and capacity for sustainability of the Hub's key intervention components (Surveillance/Case Management, New Hope and Elders' Resilience) from the perspective of multiple stakeholders as they are implemented across different tribes.

Start: March 2019

Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion

The SARS-CoV-2 pandemic, and the associated government-imposed isolationary lockdowns, has led to a mental health crisis on a global scale. Empirical studies have reported a drastic increase in mental health problems, such as depression and anxiety, increased loneliness and feelings of disconnectedness from others, while resilience levels have been negatively affected, indicating an urgent need for intervention. The current study study is embedded in a larger study, the CovSocial study (www.covsocial) which focused in its first phase on evaluating the longitudinal changes in vulnerability, resilience and social cohesion during the SARS-CoV-2 pandemic. The present second phase of this CovSocial study will seek to investigate the efficacy of brief online mindfulness-based and socio-emotional interventions in reducing mental health problems, and enhancing psychological resilience, social competencies and social cohesion. After providing informed consent, participants will be assigned to one of three groups: 1) socio-emotional training group (with Affect Dyads as core exercise), 2) mindfulness-based mental training group (with attention-based mindfulness practices such as Breathing Meditation as core practice), or 3) Retest Control Group (waitlist control).All groups will first undergo a pre-intervention testing phase (pre-test) wherein they will provide a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and behavioral tasks), and biological parameters (saliva samples). During the 10-week intervention period, participants will undergo weekly assessments and daily Ecological Momentary Assessment pre and post the daily exercise practice, using self-report scales and questionnaires delivered through a webapp or mobile app. At the end of the intervention, participants will again undergo an assessment of psychometric measures and biological parameters, same as at pre-intervention time (post-test). In a second portion, the waitlist control group will undergo the socio-emotional intervention and will be tested at post-test II again. Results will reveal the effectiveness of brief online interventions in enhancing mental health and social cohesion outcomes. In addition to examining pre-post intervention-related changes, we will also use the data from the phase 1 of the project to evaluate the impact of trait markers of and the longitudinal changes in vulnerability, resilience and social cohesion on the intervention-related changes in markers of vulnerability, resilience and social cohesion. We will also evaluate the predictive impact of genetic markers of vulnerability, resilience and social cohesion (assessed in phase 1) on intervention-related changes in our variables of interest. The present study will serve as a pilot for future application of scalable, low-cost interventions at a broader level to reduce stress, improve mental health and build resilience in the face of global stressors.

Start: May 2021

Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness

Psychological and existential distress are a common cause of suffering among patients nearing the end of life, and a major reason for requesting medical aid in dying. Existing treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. There is a need to develop scalable, brief, and rapidly effective therapeutic approaches that can reduce psychological and existential distress in patients nearing the end of life. Repetitive Transcranial Magnetic Stimulation is an effective treatment for refractory depression, and new protocols and increasing availability of rTMS may make this therapy feasible and acceptable for patients who suffer from psychological or existential distress near the end of life. Among patients with advanced illness followed by a PC provider, the study objectives are to: Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. Test the feasibility and preliminary efficacy of rTMS for the treatment of psychological distress including: 1) ease of recruitment; 2) completion of follow-up; 3) effect size and variance estimates of treatment for primary and secondary outcomes; and 4) patient satisfaction with treatment. This study is a phase 2a dose-finding open-label clinical trial, followed by a phase 2b prospective, sham-control or sham-crossover study, depending on the therapeutic dose identified in phase 2a. The investigators will enroll eligible patients from an inpatient palliative care unit and administer rTMS according to established best practice international guidelines. Two screening tests will be conducted (one completed by patient and another by the treating physician) to ensure the patient has no contraindications to rTMS. In the open-label dose-finding study, investigators will determine the appropriate dose of treatment that leads to positive patient outcomes, assess characteristics associated with positive and rapid response to rTMS, and examine if this treatment is feasible and acceptable to patients by measuring rates of enrollment and completion of the treatment sessions. Based on results from this first phase, a phase 2b feasibility and preliminary efficacy randomized clinical trial will be conducted to measure the effect of rTMS by comparing patient symptoms before and after the rTMS intervention.

Start: November 2020

Collaborative Stepped-Care and Productive Ageing Program for Older People With Depressive Symptoms

The Jockey Club Holistic Support Project for Elderly Mental Wellness (JC JoyAge) has developed and implemented a collaborative stepped care model for older persons at-risk of or with depression in four districts in Hong Kong since 2015 (Clinical Trials Identifier: NCT03593889). Results from JC JoyAge show that the collaborative stepped-care model is effective in improving older persons' mental wellness, and the specialised training and engagement of Peer Supporters are effective in building capacity in the community. The proposed impact extension programme lasts for four years (from 2020 to 2023), and the overall goal is to expand the JC JoyAge model to all 18 districts in Hong Kong, to provide integrated and evidence-based mental health services to older adults with subclinical depressive symptoms, with the hope of model adoption in regular service upon project completion.

Start: March 2020

Youth Depression and Suicide Research Network

The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes must have the patient volume to be able to recruit up to 500 patients over the course of 14 months, and they will be required to work closely with Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).

Start: August 2020

Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses

This study investigates the underlying mechanisms of a novel emotion regulation intervention among recently bereaved spouses. More specifically, this study examines how thinking about an emotional stimulus in a more adaptive way can affect the relationship between psychological stress, psychophysiological biomarkers of adaptive cardiac response, and brain activity. The emotion regulation strategy targeted is reappraisal, specifically reappraisal-by-distancing (i.e., thinking about a negative situation in a more objective, impartial way) versus reappraisal-by-reinterpretation (i.e., thinking about a better outcome for a negative situation than what initially seemed apparent). The study seeks to determine if relatively brief, focused reappraisal training in bereaved spouses will result in reduction of self-reported negative affect, increases in respiratory sinus arrhythmia (RSA; a measure of heart rate variability reflecting adaptive cardiac vagal tone), and changes in neural activity over time. Reappraisal-by-distancing is expected to lead to greater changes in these variables relative to reappraisal-by-reinterpretation. Additionally, it is expected that across time decreases in self-reported negative affect, increases in RSA, and changes in neural activity will in turn lead to reductions in depressive symptoms and grief rumination. Finally, it is expected that distancing training will lead to reductions in depressive symptoms and grief rumination that are mediated by changes in the targeted neurobiological and behavioral mechanisms.

Start: June 2021

EMA Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms

Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein & Laraque, 2018). Two of the biggest challenges that clinicians and researchers face when dealing with youth depression are adherence and the establishment of a therapeutic alliance (TA; Nock & Ferriter, 2005). While several treatments are available to relief depressive symptomatology in youths, a significant number do not access them for a variety of reasons (DiMatteo, Lepper & Corgan, 2000). In the last decades, substantial research has been conducted on how youths and the general population perceive therapy, and different methods have been developed to assess clients and therapists in order to improve outcomes and other aspects of the psychotherapy process, such as feedback tools and real-time measurements like Ecological Momentary Assessment (EMA) (Shiffman, et al., 2008). With the aid of Information Communication Technologies (ICTs) and eMental Health strategies, feedback and assessment tools can be presented in a friendly manner, providing a novel way to possibly improving adherence rates and TA scores. This study aims to develop and test the effectiveness of an Ecological Momentary Assessment mobile application to improve initial adherence and TA in psychotherapy for youths with depression. The hypotheses for this trial are: Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve the TA. Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve initial adherence.

Start: November 2020

The Effects of the Be Mindful Intervention in Previously Depressed Individuals Experiencing Subclinical Symptoms

This study is designed to help individuals cope with their current depressive symptoms by providing them access to a 4-week online Mindfulness-Based Cognitive Therapy: Be Mindful. Research has shown that completion of the Be Mindful intervention can reduce depressive symptoms in a community sample, and this study aims to evaluate if it can also help reduce depressive symptoms in individuals with a confirmed history of depression. Participants will either receive the intervention at the start of the study or four months after the start of the study (i.e., at 3-month follow-up), which will allow research staff to assess if reductions in depression are due to the intervention or something else. Research staff will also evaluate if the reduction in depressive symptoms lasts over the three months following intervention, and will investigate possible reasons for the change in depression (i.e., why the intervention produces change).

Start: March 2021

Further Development and Initial Testing of RESTORE in Frontline Workers

There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the feasibility, initial safety, and efficacy of RESTORE for addressing mental health symptoms in first responders, health care workers (HCW), and Canadian Armed Forces members exposed to COVID-19-related traumatic or extreme stressors.

Start: March 2021

Reducing Depressive Symptoms Among Rural African Americans

Rural African Americans are disproportionately impacted by social stressors that place them at risk for experiencing elevated depressive symptoms. This project will test the effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use within rural African American churches. Further, this project will gather data on strategies necessary to promote the successful implementation of this intervention within rural African American churches.

Start: May 2016

TreadWill, an Automated Intervention for Depressive Symptoms

TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes: Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT); Mindfulness videos; Game-based Cognitive Bias Modification paradigms; An empathetic chatbot. This study's primary aim is to test the differential effectiveness of this full-featured version of TreadWill compared to a text-based CBT program.

Start: April 2021

Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

The purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.

Start: June 2021

Collaborative Stepped Care and Peer Support Programme for Older People At-Risk of or With Depression

To develop a viable and sustainable best practice model to promote elderly mental wellness and prevent elderly depression for Hong Kong, the Hong Kong Jockey Club Charities Trust has initiated a pilot holistic support project entitled "JC JoyAge: Holistic Support Project for Elderly Mental Wellness". Commenced in October 2016, this 3-year project will deliver six programmes: (1) social services staff training; (2) peer supporters certificate training; (3) outreach and engagement activities for at-risk older adults; (4) standardized prevention and early intervention service; (5) community education programmes; and (6) public awareness and public education activities in four pilot districts in Hong Kong, namely Kwun Tong, Sham Shui Po, Kwai Chung, and Tseung Kwan O. The project aims specifically to: Evaluate the effectiveness of a collaborative stepped care and peer support programme in engaging older people at-risk of or with depression; Evaluate the efficacy of the programme in reducing symptoms/risks and promoting wellbeing in older people at-risk of or with depression; Investigate the impact of the programme on care resources utilization in these older adults.

Start: October 2017

Hypertension and Diabetes Assessment in the Rohingya Refugee Population and in the Host Communities in Bangladesh

Due to a massive outbreak of violence against the Rohingya minority residing in the Rakhine State of Myanmar in late 2017, several hundred thousand Rohingya fled the country and sought a shelter in Bangladesh. Currently, in the refugee settlement areas east of the city of Cox's Bazar, close to 1 million Rohingya refugees live in refugee camps close to the municipalities of Ukhia and Shamlapur. According to previous examinations, there is a serious burden of non-communicable diseases in Bangladesh. But little is known about the health status and the epidemiology of non-communicable diseases in the Rohingya refugee population in Bangladesh. Most importantly, scientific evidence on non-communicable disease in humanitarian emergencies is rather limited. The aim of this study is to close this gap and to systematically assess the burden of hypertension and diabetes within the Rohingya refugee population in refugee camps in Bangladesh and in the host community in the Chittagong province. This assessment will help to design and to introduce community-based intervention strategies aiming to improve the population health status and reduce the disease burden.

Start: October 2021

The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients

The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.

Start: June 2019

Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)

This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.

Start: February 2021

Video Feedback to Improve Parental Sensitivity in Mother-infant Dyads With Depressive Symptoms

Title: "Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms: randomized controlled feasibility trial". Funding: ANID Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP ICS13_005 (MIDAP, www.midap.org). Principal Investigator: Marcia Olhaberry Huber, PhD, Academic, School of Psychology, Pontificia Universidad Católica de Chile, Associate Researcher, MIDAP. MIDAP Research Team: Javier Moran, PhD. Academic at the University of Valparaíso, María José León, PhD, Stefanella Costa, PhD. and Fanny Leyton, PhD. (c) University of Valparaíso. General Objective: To evaluate feasibility and acceptability of a brief Internet mentalization-based video feedback intervention to improve sensitivity in mothers with depressive symptoms. Key parameters for a future effectiveness study will be identified Design: Pilot randomized clinical trial; Participants: 60 mother-infant dyads (aged 4-12 months) attended in Public Health Centres.30 dyads will be assigned to the experimental group (EG) and will receive a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting. 30 dyads will be assigned to the control group (CG) and will receive only psycho-educational materials. The study includes 3 assessments (pre-intervention, post-intervention and follow-up) and four weekly intervention sessions. Data analysis: For quantitative data descriptive statistics and ANCOVA will be used, for qualitative data Grounded Theory.

Start: March 2021

Evaluation of an Acceptance and Commitment Therapy-Based Narrative Intervention for Individuals Taking Antidepressants

This study aims to compare the efficacy of LifeStories on depression symptomatology compared to antidepressant treatment alone, in addition to examining the effect of the intervention on health-related quality of life. Participants will be randomly assigned to either an online ACT-based narrative intervention (Lifestories) or the waitlist control condition (antidepressant treatment alone). It is hypothesized that participants who receive the LifeStories will result in decreased depression and increased quality of life, general functioning and decreased psychological inflexibility compared to the waitlist group.

Start: February 2021