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Psychological Distress clinical trials

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NCT ID: NCT06397105 Not yet recruiting - PTSD Clinical Trials

Boosting Refugee Integration Through Psychological Intervention - a Pilot RCT

BRIGHT
Start date: May 13, 2024
Phase: N/A
Study type: Interventional

Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities. The objective of this pilot RCT is to assess the feasibility and acceptability of an adapted version of PM+ for refugees and asylum-seekers. This will inform the design of a definitive RCT and implementation study.

NCT ID: NCT06395311 Not yet recruiting - Quality of Life Clinical Trials

Psychological Distress in Patients With COPD

Start date: May 13, 2024
Phase:
Study type: Observational

Chronic obstructive pulmonary disease (COPD) can significantly impact a person's quality of life, not only physically but also mentally. This cross-sectional study aims to assess the psychological well-being of COPD patients by utilising specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. By understanding the psychological impact of COPD, this research hopes to emphasize the importance of medical education and mental health support in COPD management strategies.

NCT ID: NCT06389565 Not yet recruiting - Depression Clinical Trials

Pilot Randomized Clinical Trial of Change My Story

Start date: January 1, 2025
Phase: N/A
Study type: Interventional

Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.

NCT ID: NCT06388044 Not yet recruiting - Infertility Clinical Trials

ACT for Infertility: Case Series

Start date: April 2024
Phase: N/A
Study type: Interventional

In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT.

NCT ID: NCT06350383 Not yet recruiting - Clinical trials for Psychological Distress

Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic.

NCT ID: NCT06331767 Not yet recruiting - HIV Clinical Trials

Development of a Multilevel HIV Prevention Intervention for the Emergency Department

mSYNC
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits.

NCT ID: NCT06231927 Not yet recruiting - Depression Clinical Trials

Feasibility of SOLAR Group Program Among MHPSS Workers After the Earthquake

Start date: February 2024
Phase: N/A
Study type: Interventional

The goal of this intervention program is to provide the feasibility of a culturally adapted version of the SOLAR program among mental health and psychosocial support (MHPSS) workers who provide psychological or psychosocial support to the survivors of the earthquakes on February 6, 2023, in Türkiye. The main questions it aims to answer are: 1. Will the SOLAR Group Program reduce psychological distress at the post-test and follow-up compared to the pre-test? 2. Will the SOLAR Group Program reduce secondary traumatic stress at the post-test and follow-up compared to the pre-test? 3. Will the SOLAR Group Program reduce anxiety and depressive symptoms at the post-test and follow-up compared to pre-test? Participants will be asked to sign a consent form. Upon accepting it, they will fill out: - a demographic form, - the Kessler Psychological Distress Scale (K10), - Assessment of Suicidal Thoughts for the screening. Before the SOLAR intervention program, participants will be asked to complete: - the Secondary Traumatic Stress Scale (STSS), - Generalized Anxiety Disorder-7 (GAD-7), - the Patient Health Questionnaire (PHQ-9) if they approve participation in these surveys. After collecting their pre-test scores, they will receive the SOLAR intervention program. During the program, they will be asked to participate in each session, lasting 5 weeks. After the program, they will be asked to participate process evaluation interview.

NCT ID: NCT06172907 Not yet recruiting - Cancer Clinical Trials

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

YAD
Start date: February 14, 2024
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

NCT ID: NCT05952245 Not yet recruiting - Stroke Clinical Trials

Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The proposed trial aims to assess the effectiveness of Cognitive-behavioural therapy for insomnia (CBT-I) based ecological momentary intervention (EMI) for reducing insomnia symptoms among stroke caregivers.

NCT ID: NCT05927987 Not yet recruiting - Anxiety Disorders Clinical Trials

Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT

PROSPER
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question[s] it aims to answer are: - To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons? - To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms? Researchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.