Clinical Research Directory

A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experienced a Perinatal Death

The goal of this feasibility randomised control trial is to determine if a trial to evaluate perinatal bereavement counselling for parents who have experienced a perinatal death is feasible. The main question it aims to answer is: • Is a trial to evaluate access to perinatal bereavement counselling feasible? Researchers will compare the intervention group (parents who have received counselling) to the control group (parents who have not received counselling) to see if there are differences in measurements of parents' grief and psychological symptoms. * Participants allocated to the intervention and control group will receive usual bereavement care from the perinatal bereavement team at the hospital * Parents allocated to the intervention group will receive counselling * Parents will complete validated psychometric questionnaires about their levels of perinatal grief, psychological distress, depression, and quality of life * Parents in the intervention group will be asked a series of open-ended written questions about their experience of participating in the trial * Healthcare professionals who have been involved with delivery of the intervention/referrals will be interviewed about their experience of the trial.

Evaluation of Grief Therapy Approaches for Bereaved Parents

The purpose of this study is to compare three types of support programs for parents who have lost a child. The study will see how these support programs affect participants' grief and depression symptoms. The three support programs are called Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care.

Walk With Me (WWM) for Perinatal Grief

The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes. The main questions it aims to answer are: • Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation. Participants will: * Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * Receive check-ins with a Peer Guide (in the Peer Guide condition only)

Improving Mental Health for Care Partners of Persons With AD/ADRD

The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia

Cardiovascular Effects of Grieving

Self-affirmation (SA) theory proposes that people are motivated to maintain a positive self-image of being worthy, stable, and capable. Self-affirmation (SA) manipulations have been shown to effectively increase self-worth as well as reduce cardiovascular reactivity while enhancing cardiovascular recovery in response to stress. While SA is discussed as a way to alleviate grief, its effect on cardiovascular reactivity (CVR) and recovery to grief recall has yet to be studied within laboratory settings. This study proposes an experimental design to examine how an in-lab manipulation promoting self-affirmation can improve patients' cardiovascular responses during and after a grief recall procedure. The investigators hypothesized that grief severity (a continuous variable) interacts with condition (a categorical variable with two levels, i.e., SA intervention vs. control) to predict CV reactivity and recovery as outcomes. Primary Objective 1: To investigate effects of self-affirmation intervention on cardiovascular responses among grieving participants during and after grief recall. Secondary Objective 1: To investigate the relationship of grief severity with psychological stress.

Individualized Grief Support With Swanson Model

This study aims to examine the effects of individualized grief support for women experiencing pregnancy loss. The research, which will be conducted at Süleyman Demirel University, is a mixed-method design and includes both phenomenological qualitative analysis and randomized controlled quantitative trials. The sample will include 48 women; those with severe depression will be excluded. Quantitative data will be analyzed using SPSS, and qualitative data will be analyzed using content analysis.

Rise & Renew: Supporting Well-Being in Black Women After the Loss of a Loved One

This study is testing a new grief support program called Rise \& Renew (Remembering, Expressing, Navigating, Embracing, Witnessing) designed for Black women ages 40 and older who have experienced the loss of a close loved one, such as a spouse or significant other, parent, or child (including pregnancies). The program includes a weekend wellness retreat followed by 10 weeks of online group support. Participants will be randomly assigned to start weekly virtual sessions right away or after a 10-week delay. The study will help the investigators learn whether the program is helpful, easy to take part in, and meaningful for those who attend. The investigators believe that a culturally tailored program that focuses on healing, wellness, and community will improve emotional health, spiritual well-being, and resilience during the grief process.

Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants

The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

ACT for Individuals With MNCD and Their Care Partners

This project aims to implement and evaluate a dyadic intervention (i.e., acceptance commitment therapy) for persons with AD/ADRD and their care partners. We hypothesize the intervention will be feasible, acceptable, and show preliminary efficacy of the dyadic interveniotns.

A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.

Islamically Integrated Chair-Work for Bereaved Muslims

This study aims to develop and to evaluate the efficacy of an Islamically integrated chair-work intervention designed to assist Muslims experiencing prolonged grief in resolving unfinished business tension. Employing a randomized, non-concurrent, multiple baseline design, the study comprises five phases: (1) baseline assessment, (2) empathic attunement, (3) Traditional Islamically Integrated Psychotherapy (TIIP) chair-work intervention, (4) cognitive consolidation \& spiritually behavioral activation, and (5) follow-up. By integrating insights from early Islamic scholars like Al-Kindi, Abu Bekir er-Razi, and Ibn Sina, alongside psychological counseling and cultural elements, this intervention aims to fill a crucial gap in existing literature. Grief, a normal emotional reaction after the loss of a loved one, is typically resolved over time without professional intervention. However, a small yet significant number of individuals experience prolonged grief disorder (PGD), a persistent and impairing form of grief lasting over 6 months. Unfinished business, indicating unresolved relational issues with the deceased, is a key risk factor for severe PGD. Higher levels of unfinished business are associated with increased psychological problems and unhealthy expressions of grief. Within the framework of Traditional Islamically Integrated Psychotherapy (TIIP), unfinished business is viewed as an emotionally charged problem. Processing this emotional burden during TIIP sessions aims to facilitate resolution, replacing maladaptive emotions with adaptive ones, fulfilling emotional needs, and establishing new meanings for unresolved conflicts. Sense-making of one's loss is crucial for a healthier grieving process, making meaning-oriented techniques more effective in grief therapy. Moreover, research indicates that the expression of grief is influenced by spirituality, religious beliefs, and practices. Yet, there is a lack of faith-based intervention programs tailored for grieving Muslims. This study seeks to address this gap by providing closure and therapeutic methods that cater to the nuanced emotional struggles of bereaved Muslims, offering a faith-based approach previously unavailable in the literature.

Accelerated Resolution Therapy for Early Maladaptive Grief

The purpose study is to test the effects of accelerated resolution therapy (ART) on pre-loss grief and prolonged grief disorder among older adult family caregivers (FCGs). Additionally, to better understand predictors of response to ART, and cognitive processes that occur among grieving individuals following ART.

Support for Bereaved Cancer Caregivers

Friend and family caregivers of recently deceased cancer patients experience acute bereavement following the death. Post death bereavement is an intense period of mourning that includes an unfolding of the grief process and is characterized by strong emotions and demands on cognitive resources to those who have put aside their own needs to support the dying patient with cancer. This research will test the feasibility and acceptability of a nature-based healing meditation (NBHM) intervention to support cancer caregivers' during the bereavement process.

Adolescent Suicide Loss Survivors Grief Intervention Group

This study will provide evidence-based recommendations for designing interventions tailored to adolescents dealing with suicide loss. By exploring how these young people experience and make meaning of their grief, the study will contribute to the development of best practices for mental health professionals and educators working with suicide loss survivors. This study will provide evidence-based recommendations for designing interventions tailored to adolescents dealing with suicide loss. By exploring how these young people experience and make meaning of their grief, the study will contribute to the development of best practices for mental health professionals and educators working with suicide loss survivors. This study will enhance scientific understanding by examining how adolescents experience grief after suicide loss and identifying which components of bereavement interventions are most effective for this age group. It will improve societal welfare by informing the development of targeted, evidence-based support programs that address the unique mental health needs of bereaved adolescents. Long-term, the findings may reduce the risk of complicated grief and suicidality, support emotional resilience, and guide best practices in schools, clinics, and community settings for supporting youth after traumatic loss.

The Aarhus Bereavement Study

Psychological distress is a natural reaction following the death of a loved one. Nevertheless, research has shown that for a significant minority of bereaved individuals the grieving process is disturbed. These individuals experience an intense grief reaction that persists across time characterized by longing for the deceased or persistent preoccupation with the deceased. It has been suggested that this intense, persistent grief reaction meets criteria to be considered a distinct mental disorder. Prolonged grief disorder (PGD) has been proposed to capture this condition and will be included in the forthcoming ICD-11. The proposed project aims to prepare healthcare services to use the diagnosis of prolonged grief disorder (PGD) by determining the frequency of PDG in a population sample of bereaved spouses and their adult children. It will also identify early predictors of PGD and trajectories of natural and prolonged grief as well as investigate the specificity of PGD in relation to other common loss-related reactions. Thus, the project will provide a prognostic tool to identify individuals with high versus low risk of developing PGD.

Families Left Behind

The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.

Prevention of Psychological Health Problems Via Integrated Operational Support

Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.

Telehealth to Reduce Mental Health in Family Caregivers

The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia when provided over telehealth.

Nature-Focused Mindfulness and Spiritual Well-being Among Adults with Moderate Prolonged Grief Symptoms

The goal of this randomized controlled trial is to evaluate whether a nature-focused mindfulness intervention can enhance spiritual well-being and reduce grief symptoms among adults with moderate prolonged grief symptoms. The main questions it aims to answer are: Does a nature-focused mindfulness intervention improve spiritual well-being compared to an active control condition (noticing nature) and a waitlist control condition? Does a nature-focused mindfulness intervention reduce grief severity and improve mental well-being, nature connectedness, selflessness, ability to adapt, personal recovery, and elevation compared to control conditions? How do spiritual well-being, ability to adapt, nature connectedness, selflessness, grief reactions, and positive/negative affect change during the intervention period? Researchers will compare a nature-focused mindfulness intervention to both a noticing-nature active control group and a waitlist control group to isolate mindfulness-specific effects from possible general nature exposure benefits. Participants will: Complete baseline, post-intervention, and follow-up assessments (at one and three months) Engage in either 10 sessions of nature-focused mindfulness practice or noticing nature activities over a two-week period (intervention and active control groups) Provide daily diary responses about their experiences throughout the 14-day intervention period