Clinical Research Directory

Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia

The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to 1. reduce caregivers' Expressed Emotion (EE), 2. reduce caregivers' depressive symptoms, 3. reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and 4. improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD). Researchers will compare COPE to a control group (standard therapy) to examine how effective the COPE programme is. Participants will take part in: Pretest prior to COPE implementation Post-test after COPE completion Follow up test in 3 months after COPE completion

Future School of Comprehensive Well-Being

Good physical, mental and social health, particularly in childhood and early adolescence, are powerful predictors of positive life trajectories. Contrary to this, problems in these domains expose individuals to negative developmental trajectories. Schools are ideal settings to address these issues due to their incisiveness and long-term impact. However, school-based well-being interventions are not designed to be ingrained in basic pedagogical processes of school, this is, learning, teaching and studying. In this study the effects of a school-based pedagogically ingrained comprehensive well-being trial will be studied, involving curriculum embedded socio-pedagogical activities, designed to cultivate simultaneously learning and their mental, social and physical well-being. In the Future School of Comprehensive Well-Being (SchoolWell) Comprehensive wellbeing pedagogy intervention for primary and lower secondary school students: rationale and study protocol for the SchoolWell cluster randomized controlled trial -study the investigators use a cluster randomized hybrid type 1 effectiveness-implementation design. SchoolWell involves 10 Finnish speaking Teacher Training Schools including both primary and secondary schools. Randomization occurs at the school level. The intervention is a multicomponent implementation strategy that has been co-designed by SchoolWell research team and case schools' teachers. All 5th and 8th graders (aged 11-12 years and 14-15 years), from the control and intervention schools are eligible for the study. Total of 1440 students (560 5th and 880 8th graders) will be recruited for the study (n=717 students from intervention schools and n=723 students from control schools). Data is collected from Grade 5 and 8 students representing schools randomized to experimental (n=5) and control condition (n=5). The control group in Year 1 remains on the waitlist until the start of Year 2, when the second cohort of the experiment (low support condition) for these schools begins. The purpose of the low support condition is to examine whether intervention effects can be achieved with less support than in the high support condition, where researchers are more actively involved. Schools allocated to the intervention group deliver weekly SchoolWell activities over the full school year as part of the regular curriculum. The activities include socio-pedagogical activities, these are modes of teaching, learning and studying, promoting student mental, social and physical well-being as well as learning aligned with regular curriculum goals. Intervention schools have access to six implementation support strategies in addition to the training received as usual delivery to build knowledge and skills. Implementation and effectiveness outcomes are assessed using weekly online surveys, interviews at baseline T0 (8/2024), T1 (11/2024), T2 (4/2025) and at 19-month follow-up (T3; 4/2026) and four dialogues with teachers. Semi-structured interviews with teachers and support staff will be used to examine which implementation strategies worked for whom and under what conditions. The primary outcome is study engagement. Secondary outcomes include measures on learning, mental, social and physical well-being. Economic and process evaluations will also be conducted to determine cost-effectiveness, program acceptability, implementation, adaptability, and sustainability in schools. SchoolWell draws on the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Implementation Studies (StaRI) in evaluating the SchoolWell intervention. Also, the Consolidated Framework for Implementation Research (CFIR) is used to guide support strategies. The CFIR provides constructs that have been associated with effective implementation (intervention, outer settings, inner settings, individuals, implementation process). Subsequently, the Proctor's framework is followed to evaluate the implementation process. The framework stands for acceptability (treatment is agreeable or satisfactory), adoption (intention to employ an innovation or evidence-based practice), appropriateness (fit of the innovation to address a particular issue or problem), cost (cost impact of an implementation effort), feasibility (extent to which a new treatment can be successfully carried out in given setting), fidelity (extent how intervention is delivered as intended), penetration (number of providers who deliver treatment), and sustainability (extent to which a newly implemented treatment is maintained). Hypotheses are: H1. SchoolWell 1 intervention will have a positive effect on student-level outcomes (8- and 19-month post-tests). H2. The multidisciplinary intervention enhances both learning and mental, physical, and social well-being.

Music Breathing in Enhancing Resilience Among Elders at Risk of Mental Health Problems

The goal of this pilot randomised controlled trial is to examine the effects of a mindfulness-based music breathing intervention in enhancing resilience (primary outcome), and in reducing anxiety, depressive symptoms, loneliness, and improving health-related quality of life (secondary outcomes) among community-dwelling older adults at risk of mental health problems. It is hypothesised that compared with the control group, participants in the intervention group will report enhanced resilience, reduced anxiety, depressive symptoms, and loneliness, and improved health-related quality of life immediately post-intervention.

Online Therapist-guided Receptive Music Therapy in Adults With Psoriasis

This single-center, three-arm randomized controlled trial evaluated a four-week online therapist-guided receptive music therapy program as an adjunct to treatment as usual in adults with moderate-to-severe psoriasis and clinically relevant psychological or quality-of-life burden. Seventy-five participants were randomized in a 1:1:1 ratio to treatment as usual, treatment as usual plus an audio-based active relaxation control, or treatment as usual plus therapist-guided receptive music therapy. The principal comparison was between the music therapy and active control groups. Dermatology-specific quality of life, perceived psychological stress, anxiety, and depressive symptoms were assessed at baseline, at the end of the four-week intervention, and at three and six months after the intervention. Dermatological severity, treatment adherence, intervention adherence, and other prespecified or documented exploratory measures were also assessed. Alcohol, drugs and nicotine-use information, as well as the Revised Illness Perception Questionnaire 9, are reserved for a distinct secondary exploratory analysis and are not part of the primary efficacy evaluation.

Effect of an ACT-based Intervention to Reduce Anxiety in Medical Students

Objective: To evaluate the association between ACT-process with negative psychological variables in a cross-sectional design, and to evaluate the effect of an ACT-based intervention to diminish anxiety in a sample of medical students. Methods: An ACT-based intervention was designed to diminish anxiety in medical students and implemented in 4 in-person sessions, the pre-test and post-test measurements were performed one week before and one week after the first and last sessions respectively. The control group received a mental health psychoeducational intervention of 90 minutes. The students were intentionally assigned to each study group based on schedule availability. The cross-sectional study was performed with the pre-test measurements in the students of both groups.\<

Nebulized Ketamine for the Treatment of Major Depressive Disorder

This is a double-blind active placebo controlled clinical trial for individuals with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.

Digital Cognitive Behavioral Therapy for Chinese Adolescents With Depressive Symptoms（CADS-D )

CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms.

Musical Training to Enhance Resilience of Underprivileged School-aged Children

This is a multi-centre randomised controlled trial aims to examine the effects of a group-based gamified instrumental musical training in enhancing resilience (primary outcome), reducing psychological distress (depressive symptoms and anxiety), enhancing self-esteem, and improving HRQoL (secondary outcomes) among underprivileged school-aged children at risk of mental health problems (depression and anxiety) during a 12-month follow-up.

Breathing Exercises on Depression in Postmenopausal Women

Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women