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Psychological Distress clinical trials

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NCT ID: NCT06139718 Recruiting - Clinical trials for Psychological Distress

Examining the Efficacy of a Single Session Online Mental Health Program

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

There is a large body of evidence demonstrating that Acceptance and Commitment Therapy (ACT) can be delivered in a self-guided format to improve mental health among college students. However, previous research indicates there are challenges in engaging students in adhering to these time intensive, multi-session self-guided resources. Brief self-guided single session interventions could provide an accessible and acceptable intervention that is easier to adhere to, given their lower intensity and response effort for participation. This proposed study seeks to evaluate a single session online ACT Guide Lite intervention in a sample (n = 100) of Utah State University (USU) college students 18 years of age or older. A randomized controlled trial (RCT) design will be used in which students are randomized to receive ACT Guide Lite or to a waitlist condition in order to test the following predictions: (1) participants assigned to ACT Guide Lite will improve more on the primary therapeutic process of change, psychological flexibility, relative to those not receiving intervention, (2) participants assigned to ACT Guide Lite will improve more on distress, well-being, and interest in seeking help, relative to those not receiving intervention, (3) ACT Guide Lite will be acceptable to college students as indicated by recruitment rates, rates of completing ACT Guide Lite, and self-reported program satisfaction, and (4) areas for future program revisions will also be identified through participants' written feedback on their experiences using the program. USU students will be recruited to participate in the study through the SONA research platform in the Fall 2023 semester. All study procedures will be completed through the secure Qualtrics online research platform, in addition to email and phone contacts prompting relevant steps for the study. All analyses will be run with multilevel modeling with the full intent-to-treat sample to test time by condition interactions.

NCT ID: NCT06133114 Recruiting - Clinical trials for Psychological Distress

Psychopharmacological Treatment of Emotional Distress

Start date: March 13, 2024
Phase: Phase 4
Study type: Interventional

This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.

NCT ID: NCT06080607 Recruiting - Quality of Life Clinical Trials

PRO Survivorship Concerns ITA

PRO
Start date: January 18, 2022
Phase:
Study type: Observational [Patient Registry]

Breast cancer survivors typically experience fatigue, pain, insomnia, depression, anxiety, difficulty in concentrating, memory impairment, body image problems, vaginal dryness, interest in sex decreasing, hot flashes, gain weight, and infertility. All of these problems affect quality of life (QoL) mainly during the early survival and they become even more important to understand and address if long-term effects could be prevented. The use of PROs in care settings has demonstrated improvement in provider/patient communication, recognition of previously unrecognized issues, as well as patient satisfaction with care. In order to allow to patients the use of the PRO "survivorship concerns" in their mother tongue, it is imprtant to have validated translations with transcultural adaptation. The main goals of this multicentric study are the translation, adaptability and transcultural validation of the PRO questionnaire "survivorship concerns" to put in evidence rehabilitation needs in breast cancer patients in early stage.

NCT ID: NCT06073964 Completed - Clinical trials for Post-Traumatic Stress Disorder

GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda

GBV
Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The goal of this community-based interventional study was to determine the effectiveness of the 'Trauma Resilience & Understanding Self-help Therapy' (TRUST) in managing domestic violence & primary trauma among formerly Internally Displaced Persons (fIDPs) in northern Uganda. The main questions it aimed to answer were: - What was the level of utilization and short-term effects of the TRUST intervention on the experiences of domestic violence and high levels of primary trauma among fIDPs living in northern Uganda who would have been using TRUST within their communities after completing the training in the community-based TRUST utilization? - What were the clinical indications of the TRUST intervention and psychological operators among fIDPs living in northern Uganda who would have been using TRUST within their communities to manage their experiences of domestic violence and high levels of primary trauma? Participants found to have experienced domestic violence in the last one year and were having high levels of primary trauma were randomly assigned to the intervention group that was trained in the utilization of the TRUST within their communities and then followed up for 12 weeks (TRUST group). The investigators then compared the results obtained from the TRUST group with those attained from an age and gender cross-matched control group of fIDPs who were not trained in the utilization of the TRUST within their communities (Control group). This was done to see if the community-based utilization of the TRUST intervention changed the levels of primary trauma & experiences of domestic violence among its users (TRUST group) when compared to the non-users (Control group).

NCT ID: NCT06052904 Recruiting - Clinical trials for Psychological Distress

Music Breathing for Caregivers of Children Newly Diagnosed With Cancer

Start date: October 3, 2023
Phase: N/A
Study type: Interventional

This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.

NCT ID: NCT06026306 Recruiting - Depressive Symptoms Clinical Trials

A Scalable Psychological Intervention for Earthquake Survivors in Türkiye

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

This will be the first pilot randomized controlled trial (RCT) study that investigate the potential effectiveness of individual PM+ among earthquake survivors residing in container cities in Türkiye. The primary objective of this pilot study will be to test feasibility, acceptability, and potential effectiveness of individual PM+ for Turkish earthquake survivors, using RCT design which is considered the gold standard in research for evaluating effectiveness of interventions. Secondly, this study aims to test trial procedures in preparation for a future larger randomized controlled trial.

NCT ID: NCT06017414 Recruiting - Clinical trials for Psychological Distress

Systemic Psychotherapy-informed Self-help and Paraprofessional Training in a Naturalistic Setting

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

The main goal of this project is to address several gaps in the current literature in an exploratory way, by generating data via a synthesized research design. There are three fields of research this project seeks to have a meaningful impact on: the digital implementation of systemic psychotherapy-informed principles and approaches into unguided self-help growth paths, the training of paraprofessional mental health service providers with systemic psychotherapy-informed listener training, and the utilization of paraprofessional mental health service providers in the delivery of online guided systemic psychotherapy-informed self-help interventions. This impact will be derived from addressing the following research questions: - Are online self-help interventions based on systemic psychotherapy approaches and principles feasible? - Are online self-help interventions based on systemic psychotherapy approaches and principles efficacious (as compared to a waitlist), indicated by mental-health-related outcomes of participants? - Is training of paraprofessionals in guiding the use of self-help interventions based on systemic psychotherapy approaches and principles feasible? - Is this training of paraprofessionals based on systemic psychotherapy approaches and principles efficacious (as compared to a waitlist), indicated by mental-health-related outcomes of trainees?

NCT ID: NCT06014476 Completed - Clinical trials for Psychological Distress

Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness

Start date: August 1, 2021
Phase:
Study type: Observational

Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden predictors to caregivers.

NCT ID: NCT06002191 Recruiting - Suicidal Ideation Clinical Trials

Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents. The specific aims are to: Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, >35% underserved youth). H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates > 80% and imHere4U engagement > 70%. H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period. Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and >70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) > 6.

NCT ID: NCT05971160 Recruiting - Clinical trials for Psychological Distress

Creating Access to Resources and Economic Support

CARES
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are: 1. Do microgrants with or without peer mentoring improve mental health? 2. Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection? Researchers will compare mental health outcomes among three groups of participants: A. Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months. C. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.