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Showing 1-7 of 7 trials
NCT07466979
The Physical Exercise on Women's Affective and Physical HeAlth (Exer-WAPA) project is a randomized controlled trial (RCT) designed to evaluate the effects of a supervised, group-based exercise program incorporating music-synchronized movement on the emotional and physical health of physically inactive, middle-aged women (35-60 years) experiencing psychological distress. The primary outcome will be emotional well-being, assessed at baseline and post-intervention using the Spanish version of the Positive and Negative Affect Schedule (PANAS). Secondary outcomes are grouped into five dimensions: (1) mental health, (2) physical health, (3) lifestyle, (4) gender-related outcomes, and (5) socioeconomic impact. Mental health outcomes include risk of poor mental health (GHQ-12), self-esteem (Rosenberg Self-Esteem Scale), global life satisfaction (Satisfaction with Life Scale, SWLS), anxiety symptoms (Beck Anxiety Inventory, BAI), depressive symptoms (Beck Depression Inventory-II, BDI-II), and general cognitive status (Montreal Cognitive Assessment, MoCA). Physical health outcomes include health-related body composition (bioimpedance) and anthropometric indicators, health-related physical fitness (cardiorespiratory fitness, muscular strength, flexibility, and agility), cardiometabolic risk (blood pressure), autonomic cardiovascular function (heart rate variability), static posture (OSPAT). Lifestyle outcomes include physical activity and sedentary behaviour (Axivity accelerometers and IPAQ), sleep quality (Axivity accelerometers and Pittsburgh Sleep Quality Index, PSQI), commuting behaviour, dietary habits (Mediterranean Diet Adherence Questionnaire, PREDIMED), health-related quality of life (SF-36), and tobacco and alcohol consumption (AUDIT-C). Gender-related outcomes include gender norms, caregiving responsibilities, reproductive health, social support (GVHR questionnaire), and menopause-related quality of life (MENQOL). The socioeconomic impact of the intervention will be evaluated through a cost-effectiveness analysis. A total of 100 participants will be recruited and randomly assigned to either an experimental group (GEx), receiving a 12-week supervised exercise intervention, or a waitlist control group (GC). The intervention follows World Health Organization (WHO) recommendations for physical activity (three sessions per week, 60 minutes per session; 180 minutes per week), with exercise intensity prescribed using heart rate reserve (50-85% HRR). Outcomes will be assessed at baseline, post-intervention, and three months after the intervention, following a 2 × 3 study design. In addition, adherence and compliance outcomes related to the exercise intervention will also be assessed, including attendance and punctuality at sessions, additional physical activity outside the training sessions, mood before and after each exercise session (Feeling Scale), perceived exhaustion prior to the start of each session (item 8 of the HPHEE Scale), adverse events, and subjective session effort (Borg Rating of Perceived Exertion, RPE 0-10). Additionally, immediately after the completion of the intervention, experimental group participants will complete an exercise enjoyment questionnaire. Furthermore, a focus group will be conducted with a subsample of participants from the experimental group to explore their experiences with the intervention program.
NCT07427524
The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults) aims to model the complex interrelations between child maltreatment, trauma exposure, food insecurity, and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale). Adopting a methodology structured around three complementary components, this study consists of: (1) a cross-sectional survey to identify key associations ; (2) a qualitative study based on semi-structured interviews exploring psychologists' subjective experiences, and (3) a longitudinal comparative interventional study involving two different support programs to assess and compare the impact of these interventions on participants' food insecurity and psychological well-being. Using a multi-phase design, MISAPSY seeks to move beyond linear risk-factor models by adopting a systemic and network-based approach to mental health and social vulnerability. The study integrates quantitative analyses, including network analyses, qualitative exploration of professional practices, and comparative longitudinal intervention to inform more holistic, equitable, and transferable models of care for vulnerable young adults.
NCT07208851
Therapists at the Grand Bahama Resilience Center (GBRC) will be trained to deliver Problem Management Plus (PM+), a WHO intervention. Then, those therapists will deliver PM+ (5 one-on-one skills-based sessions) to a total of 50 adult clients experiencing mild to moderate mental health difficulties (excluding anyone with cognitive difficulties or psychosis). Participants will complete (de-identified) self-report survey assessments before PM+, after PM+, 3 months later, and 6 months later. After receiving 5 sessions of PM+, participants will be randomized to either receive a one-time booster session of PM+ (to be co-created by the PI and the GBRC providers) three months later or to a control group which will receive a phone call reminding them that they will receive their third assessment soon.
NCT07060690
This study aims to evaluate the efficacy of a specially developed internet-based Cognitive Behavioural Therapy (CBT) programme with human interaction-referred to as the 3D programme-tailored specifically for women experiencing mild to moderate depressive symptoms. We hypothesise that participation in the intervention will lead to greater improvements in depression severity, compared to receiving only brief psychoeducational videos, when used as an add-on to treatment as usual (TAU) in this population. The 3D programme is a 10-week blended intervention that includes ten weekly online self-guided modules focused on depression and women's health, along with six individual video sessions with a health/clinical psychologist. The modules cover topics such as mood changes across the menstrual cycle, body image, stress, caregiving, and the impact of gender-based experiences on mental health. To explore how biological factors may influence how participants respond to treatment, the study will collect biological samples. These will be analysed to track hormone and metabolic changes, with the goal of identifying biological markers that might predict who benefits most from the intervention. Ultimately, the results of this study aim to improve access to effective and personalised mental health care for women by evaluating whether a structured and personalised online CBT programme can provide meaningful benefits.
NCT05589337
In recent years, the number of people with symptoms of depression or anxiety are on the rise. The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung functions.
NCT06401070
Depression is characterized by behavioral, cognitive and emotional changes. Depression can have a negative impact on decreasing quality of life because in many cases it occurs long-term. Chronic pain is often accompanied by various mental disorders, of which depression is the most common accompanying mental disorder. Chronic pain and depression themselves influence each other and are closely related, with globally around 30% to 45% of patients with chronic pain present with depression, and around 52% to 65% patients with depression suffer from chronic pain. There are various therapeutic options for treating depression that aim to shorten depressive episodes and relieve symptoms. Multimodal therapy is needed in treating depression with chronic pain because there are biopsychosocial aspects involved. Pharmacological therapy has long-term side effects and the risk of drug dependence. Apart from that, depression patients with chronic pain, often receive pharmacological therapy such as non-steroidal anti-inflammatory drugs (NSAIDs) and opioids where the side effects and risk of drug dependence are higher. Therefore, it is necessary to choose a therapeutic modality that is relatively safe and effective in treating depression in chronic pain. In various studies it has been proven that acupuncture is an efficient and safe therapy for chronic pain patients with depression. Auricular acupuncture using pr ess needles has minimal pain and can be applied longer on acupuncture points. This study aimed to assess the effectiveness of the auricular needle press on Patient with Depression Symptoms in Chronic Pain. This study was a double-blinded randomized clinical trial and was carried out on outpatients at Dr. Cipto Mangunkusumo National General Hospital Jakarta and Soerojo Hospital Magelang. There's also a collaborative study between the medical acupuncture department and the psychiatry department. This study includes 60 participants who will be randomly allocated into 2 groups, the press needle and sham press needle groups. The press needles will be placed at 6 auricular points bilaterally : MA-TF1 Shenmen, MA-IC7 Heart, and MA-IT1 Cingulate gyrus. The outcomes that will be assessed in this study are Patient Health Questionnaire-9 (PHQ-9) score and Heart Rate Variability (HRV).
NCT03989934
This study evaluates the effects of mindfulness on physiological stress mechanisms implicated in externalizing behaviors and symptoms of affective and traumatic stress among urban adolescents. Program effects on stress physiology will be evaluated using pre- and post-tests of heart rate variability (HRV) during a stress task. Emotional and behavioral outcomes will be measured using student and teacher ratings.