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NCT ID: NCT04113967 Completed - Mood Disorders Clinical Trials

Efficacy of a Biodanza Program in People With Alzheimer's Disease.

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

This study aims to know the efficacy of a biodanza program in adults diagnosed with Alzheimer's, and it is a randomized controlled trial where the control group, which maintains its usual treatment, will form a waiting list to perform any of the treatments outside the follow-up period. There will also be a group that will carry out intervention with biodanza. For the selection of the sample, there will be the participation of different Alzheimer associations and geriatric centers in the province of Almeria. The inclusion criteria will be between 60 and 75 years old, with a primary diagnosis of Alzheimer's disease, and who have never participated in any biodanza session or have knowledge about it. Those whose diagnosis is different from Alzheimer's disease or who suffers from a physical or psychological illness that prevents the execution of the sessions and all who do not participate in at least 75% (9 sessions) of the sessions will be excluded from the study. The biodanza program will consist of 12 sessions, one per week, during three months. The control group will continue with its usual treatment and activities, without suffering any alteration. A measurement of the groups (control group and biodanza group) will be carried out before the start and after the end of the sessions. The questionnaires and scales administered to the participants include demographical and clinical variables, physical state variables, cognitive variables, and emotional and behavioral variables. Finally, statistical analyzes will be performed using SPSS version 23. In the case of quantitative variables, they will be expressed as mean and standard deviation and, when the variables are of qualitative type, they will be represented by frequency and percentages.

NCT ID: NCT04110548 Completed - Emotion Regulation Clinical Trials

Emotion and Craving Regulation Among Individuals With Internet Gaming Disorders

Start date: September 26, 2019
Phase: N/A
Study type: Interventional

To investigate the potential deficits in emotion and craving regulation capacities of drug-naïve young adults with Internet gaming disorder as compared with healthy controls.

NCT ID: NCT04103606 Completed - Eating Disorders Clinical Trials

A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students

Start date: January 30, 2019
Phase: N/A
Study type: Interventional

Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs). Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "GGBI: Positive Body Image" in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).

NCT ID: NCT04098952 Completed - Clinical trials for Temporomandibular Disorders

Effects of Electric Massage on the Cervical Region in Subjects Diagnosed With Temporomandibular Disorders

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

To know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders.

NCT ID: NCT04091633 Completed - ADHD Clinical Trials

School Health Implementation Network: Eastern Mediterranean

SHINE
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

Background An estimated 10-20% of children globally are affected by a mental health problem. Child mental health has been identified as a priority issue by the World Health Organization's Eastern Mediterranean Regional Office (WHO EMRO). Following consultations with international and regional experts and stakeholders, WHO EMRO developed an evidence-based School Mental Health Program (SMHP), endorsed by WHO EMRO member countries, including Pakistan. The federal and provincial health departments in Pakistan made recommendations for a phased implementation of the SMHP in a pilot district. In the formative phase of this program, a number of implementation challenges were identified by the stakeholders. Broadly, these included the need to operationalize and adapt the existing components of the intervention to the local context and to develop sustainable mechanisms for delivery of quality training and supervision. Informed by the results of a formative phase investigations, the SHINE scale-up research team adapted the SMHP (henceforth called Conventional SMHP or cSMHP) to address these implementation challenges. The enhanced version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to cSMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's wellbeing, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings. Objectives The primary objective of the study is to evaluate the effectiveness of eSMHP in reducing socio-emotional difficulties in school-going children, aged 8-13, compared to cSMHP in Gujar Khan, a rural sub-district of Rawalpindi, Pakistan. The secondary objectives are to compare the cost-effectiveness, acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability of scaled-up implementation of eSMHP and cSMHP. It is hypothesized that eSMHP will prove to be both more effective and more scalable than cSMHP. Study population The research is embedded within the phased district level implementation of the cSMHP in Rawalpindi, Pakistan. The study population will consist of children of both genders, aged 8-13 (n=960) with socio-emotional difficulties, studying in rural public schools of sub-district Gujar Khan in Rawalpindi. Design The proposed study design is a cluster randomized controlled trial (cRCT), embedded within the conventional implementation of the SMHP. Following relevant ethics committees and regulatory approvals, 80 eligible schools, stratified by gender, will be randomized into intervention and control arms with a 1:1 allocation ratio. Following informed consent from the parent/ primary caregiver, children will be screened for socio-emotional difficulties using Strengths and Difficulties Questionnaire (SDQ). 960 children scoring > 12 on the teacher-rated SDQ total difficulty scores and > 14 on the parent-rated SDQ total difficulty scores will be recruited and equally randomized into intervention and control arms (480 in each arm). Teachers in the intervention arm will receive training in eSMHP, whereas teachers in the active control will be trained in cSMHP. Trained teachers will deliver the program to children in their respective arms. Outcome measures Primary Outcome: The primary outcome is reduction in socio-emotional total difficulties scores, measured with the parent-rated SDQ, 9 months after commencing intervention delivery. Secondary Outcomes: Implementation data on acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability outcomes will be collected from children, parents/primary caregivers, head teachers and teachers. In addition, data will be collected on self-reported Psychological Outcome Profiles (PSYCHLOPS)-KIDS to measure progress on psycho-social problems and wellbeing; annual academic performance; classroom absenteeism, stigmatizing experiences and parent-teacher interaction. Data on teachers' sense of efficacy and subjective well-being, and on the schools' psychosocial environment profile will be collected. All secondary outcome data will be collected at baseline and 9 months after commencing intervention delivery. Outcomes will be analyzed on an intention to treat basis. The role of various factors as potential mediators and moderators eSMHP effectiveness will be explored. Cost-effectiveness evaluation of SMHP shall be evaluated in terms of costs associated with implementation of eSMHP compared with cSMHP.

NCT ID: NCT04091477 Completed - Eating Disorder Clinical Trials

Impact of Neuropsychological Alteration of Patients With Eating Disorders

NeuropsyTCA
Start date: October 1, 2019
Phase:
Study type: Observational

Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).

NCT ID: NCT04091321 Completed - Anesthesia Clinical Trials

Association Between Chronic Headache and Back Pain With Childbirth

Start date: September 13, 2019
Phase:
Study type: Observational

This study uses a single questionnaire to evaluate two separate primary outcomes: 1. To identify association between chronic headache in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them 2. To identify association between chronic back pain in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them

NCT ID: NCT04091139 Completed - Anxiety Disorders Clinical Trials

Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong

Start date: September 24, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. Ehrenreich and colleagues developed UP for adolescents (UP-A). The current study aims at evaluating efficacy of UP-A for the treatment of emotional disorders in Chinese adolescents in Hong Kong. The current study would recruit 27 Chinese-speaking patients, age 13 to 18, with a primary diagnosis of any Diagnostic and Statistical Manual (Fifth edition) anxiety disorders and/or depressive disorder. They would be randomized into one of the two treatment arms, namely UP-A treatment condition (UP-A), and treatment-as-usual (TAU) condition. Following randomization, participants in the UP-A condition would attend individual treatment based on UP-A, which last for 10 to 12 weeks. Participants in the TAU condition would be provided with usual clinical psychological service (i.e. treatment as usual) in the first 12 weeks before they start attending the same individual treatment program. Primary outcomes would be patient's self-rated measures on clinical symptoms, and secondary outcomes would be their clinical diagnoses, parent-rated and other self-rated measures. It is hypothesized that, comparing to those in TAU, participants in the UP-A condition would show improvements in depressive symptoms, anxiety symptoms and functional impairment at the end of treatment. When the outcomes of all participants are combined, it is hypothesized that participants will show demonstrate improvement in depressive symptoms, anxiety symptoms, and functional impairment after completing the UP-A and at the 3-month follow-up.

NCT ID: NCT04086654 Completed - Clinical trials for Post Traumatic Stress Disorder (PTSD)

Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The aim of the project is to evaluate the psychometric properties (e.g. validity, reliability) of the International Trauma Interview (ITI) - German version. The ITI is a structured clinical interview that corresponds to the ICD-11 criteria for diagnosing both posttraumatic stress disorder (PTSD) and complex posttraumatic stress disorder (CPTSD). Eligible participants from psychiatric inpatient and outpatient facilities in Switzerland who have provided informed will complete various self-report measures about trauma-related mental health complaints. In addition, the ITI will be conducted by a trained clinician. Lastly, information from the medical chart will be further used for scientific purpose. The overall assessment will take approximately 1-2 hours to complete.

NCT ID: NCT04081519 Completed - Depression Clinical Trials

Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder

Start date: August 2, 2016
Phase: N/A
Study type: Interventional

This study aims to investigate the effects of individualized repetitive transcranial magnetic stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major depressive disorder (MDD). Specifically, patients will be randomized to one of three groups and will receive 15 days of rTMS over three weeks. Each day they will receive one active session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets in the LPC will be individualized for each patient based on their resting-state functional connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will be acquired before and after the treatment course.