Clinical Research Directory

An Online Tailored Cognitive Therapy-Based Intervention for Depression in Multiple Sclerosis: ACTION-MS Online

Individuals with MS experience significantly high levels of depression which are higher than in any other chronic illness or neurological disorder. Depression can occur at any point in the course of the disease. Cognitive behavioural therapy (CBT) has been found to be effective in treating depression in people with MS. However, many individuals with MS who would benefit from CBT for depression do not participate in face-to-face treatment due to lack of clinician referral, accessibility, modality preference, cost, and mobility and travel issues due to health reasons. Given the acceptability and preference for telehealth treatment options, digital-based psychological interventions can be another appealing treatment option as these programs have the ability to deliver interactive CBT treatments for depression to individuals with MS at a time and location convenient to the individual. The current trial proposes to test the acceptability, effectiveness, satisfaction and cost-effectiveness of an 8-week online depression intervention targeting individuals with multiple sclerosis and compare this intervention with an 8-week online health and wellbeing in MS informational intervention.

Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation

This study examines online programs for parents navigating divorce or separation. Researchers will study whether a self-guided mindfulness app called Healing Hearts, followed by a self-guided online parenting program called the electronic New Beginnings Program, is feasible and acceptable to parents and shows promising effects on parent and child wellbeing. Ninety-six parents who live in the United States, have a child aged 6 to 18 with a former partner, and report mild to moderate psychological distress will be randomly assigned to one of three groups: Healing Hearts followed by the parenting program, the parenting program alone, or a set of online educational resources. Participants complete online assessments before assignment, about seven weeks later, and about seven weeks after the second assessment. The study measures parent wellbeing, parenting, parent reports of child behavior, program use, and participant experiences. All participation takes place remotely.

Remote Group Cognitive Behavioral Skills Training for Mexican University Students With Anxiety or Depression

The aim is to assess the effectiveness of remote group cognitive behavioral skills training for reducing symptoms of depression and anxiety among university students in Mexico. The investigators will conduct a two-arm randomised control trial comparing a 10-session online group CBT intervention to a mood monitoring web-based application as an active control group.

IPV Prevention Among FDP

Forcibly displaced women and their male partners experience compounding social and structural vulnerabilities to intimate partner violence (IPV) and mental health challenges, yet rigorous studies or examples of evidence-based interventions that seek to prevent and reduce IPV and mental health problems among forcibly displaced populations (FDPs) who seek asylum and rebuild their lives in the United States (US) are scarce. Guided by the the Assessment, Decision, Adaptation, Production, Topical experts-integration, Training, and Testing (ADAPT-ITT) framework, Cascade Implementation Framework, and NIMH experimental therapeutics approach, we propose to address this gap in research and practice by (1) adapting the Economic and Social Empowerment (EA$E) curriculum for US-based FD Congolese couples, (2) using a hybrid type 2 pilot study design to explore preliminary effects of EA$E-US on IPV, mental health outcomes and intermediary outcomes, and (3) examining implementation processes and outcomes

CanCOG®: Pilot Trial of Cognitive Rehabilitation for Cancer Survivors

Cancer-related cognitive impairment (CRCI) affects a large proportion of non-central nervous system cancer survivors and can negatively impact cognitive functioning and daily life. Cognitive rehabilitation has shown promising results in addressing these difficulties. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and preliminary efficacy of the CanCOG®- Cognitive Rehabilitation in Cancer program in Portuguese adult cancer survivors with CRCI. Adult non-central nervous system cancer survivors (n=60) will be randomly assigned to receive either the CanCOG® intervention or treatment as usual. CanCOG® is a structured cognitive rehabilitation program designed to help cancer survivors manage cognitive difficulties through cognitive training exercises, psychoeducation, and compensatory strategy training. The program consists of six weekly sessions of 1 hour and 30 minutes each, delivered over six consecutive weeks. Sessions are administered in person in small groups (3-9 participants) and are led by a trained professional. The main focus of the study is to assess feasibility outcomes, including recruitment, retention, adherence to the intervention, and completion of study assessments, as well as acceptability and participant satisfaction. The study will also explore preliminary effects of the intervention on cognitive functioning (both perceived and objective), symptoms of anxiety and depression, and quality of life. Participants will complete assessments at baseline (2 weeks after the intervention), 2 weeks after the intervention, and at 3- and 6-month follow-ups. Some participants (10-15) will also take part in interviews to provide feedback on their experience with the program.

Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City

The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment. Participants are recruited from community-based substance use treatment facilities and recovery services. Participants must be adults who have or are currently using opioids and/or stimulants.

The Effect of Loving-Kindness Meditation on Mood and Anxiety Symptoms, Interpersonal Relationships, and Emotions: An Initial Randomized Controlled Trial With a Non-Clinical Sample of Undergraduate Women

The goal of this clinical trial was to examine the effects of Loving-Kindness Meditation (LKM) on anhedonic depressivity, interpersonal relationships (other inclusive self-concept, willingness to sacrifice, interaction quality) and emotions (positive affect, negative affect). The second aim was to conduct exploratory analyses investigating potential mediators that help explain changes in anhedonic depressivity over the course of short-term targeted LKM. Participants were randomly assigned to receive one week of \~5-minute daily audio recordings of Loving-Kindness Meditation or a visualization meditation, both of which were focused on a same-gender close friend. Participants completed baseline and follow-up questionnaires measuring psychological, social, and emotional variables; participants also completed daily questionnaires.