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Depression, Anxiety clinical trials

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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: NCT04085861 Completed - Mental Health Clinical Trials

Mental Health in Dancers; an Intervention Study

MeHeDa
Start date: September 5, 2019
Phase: N/A
Study type: Interventional

International studies reveal high prevalence of eating disorders (ED) and mental health issues amongst professional dancers, and the Norwegian National Ballet's house previously (2005) reported a lifetime prevalence of ED by 50% amongst female ballet dancers. Mental health issues and ED have been acknowledged for several years in most sports; still the same do not apply to dance sports. The objective of this study is to improve the knowledge on prevalence of mental health issues in professional dancers and the corresponding awareness of such among dance teachers. Additional objectives are to evaluate the effect of an intervention aimed to improve knowledge on nutrition, recovery strategies and mental health literacy among professional dancers and their teachers.

NCT ID: NCT04082871 Completed - Depression, Anxiety Clinical Trials

Medication Review in Women With Depression and Anxiety

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

This study sought to assess the impact of the MMR service on identifying and resolving TRPs, improving adherence, depression and anxiety scores in females diagnosed with depression and anxiety in Jordan

NCT ID: NCT04065126 Completed - Physical Activity Clinical Trials

Physical Activity Intervention for Trauma Afflicted Refugees

Start date: August 28, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effects of a 10-session physical activity intervention for trauma afflicted refugees. Half of participants will receive this 10-session physical activity intervention and half of the participants will be allocated to the control group.

NCT ID: NCT04060940 Completed - Clinical trials for Generalized Anxiety Disorder

Emotion Regulation Therapy for Clinical Worry and Rumination

ERT
Start date: November 6, 2015
Phase: N/A
Study type: Interventional

The present project aims to broaden our understanding of neural mechanisms which may underlie change in symptoms occurring over the course of Emotion Regulation Therapy. Specifically, we aim to examine neural changes as a result of either an 8-session or 16-session version of the treatment.

NCT ID: NCT04052451 Completed - Depression, Anxiety Clinical Trials

The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

Start date: May 16, 2019
Phase: Phase 1
Study type: Interventional

This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

NCT ID: NCT03994809 Completed - Pain Clinical Trials

International Study of Biofield Therapy

Start date: January 1, 2008
Phase:
Study type: Observational

Participants from 14 different countries received a single session of biofield therapy (Okada Purifying Therapy) lasting 30 minutes or longer from the volunteer practitioners. Before and after the therapy, they reported the severity of physical pain, anxiety/depression, dizziness/palpitation, and overall symptoms. The team compared the effectiveness/safety of biofield therapy between countries and analyzed the factors associated with the outcomes.

NCT ID: NCT03980873 Completed - Alcohol Abuse Clinical Trials

Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach

Start date: September 20, 2020
Phase: N/A
Study type: Interventional

Background: LGB people experience a large number of anxiety and mood disorders, and risk behaviors than heterosexual (Marshall et al., 2011). The evidence points to the importance played by the stress of minorities in the development of such problems (Bränstrom, Hatzenbuehler, Pachankis and Link, 2016). Objective: The present study aims to adapt and analyze the efficacy of the ESTEEM program designed for this population (Burton, Wang and Pachankis, in press) in: 1) the reduction of psychopathological symptoms, abusive alcohol consumption and risky sexual behavior, 2 ) the decrease in the level of stress, anxiety for rejection, internalized homophobia and level of concealment, and finally, 3) the improvement of assertiveness levels. The effect of the variables social support, emotional regulation strategies and rumination will be analyzed. Method: A quasi-experimental design will be used, where the LGB people (n = 63, 18<) will be assigned to the experimental group (immediate treatment), or to the control group (three-month waitlist). At baseline, 3-month, 6-month and 12-month assessments, participants completed self-reports of mental health and minority stress. Results: It is expected that after treatment, LGB people mental health will be improved, as well as, minority stress will be reduced.

NCT ID: NCT03925259 Completed - Depression, Anxiety Clinical Trials

Dismantling the Efficacy of Self-As-Context During Acceptance and Commitment Therapy

Start date: January 1, 2012
Phase: N/A
Study type: Interventional

The six processes within the psychological flexibility model of acceptance and commitment therapy (ACT) are seen as being equally theoretically and clinically important. The utility of self-as-context component however has never been isolated in a dismantling study. The present study therefore sought to conduct a pilot two-arm dismantling component study of ACT, quarantining the self-as-context component from one of the arms. Patients with a long-term health condition (LTC) and concurrent mental health condition were randomised into one of two study arms; (1) Full-ACT or (2) ACT minus self-as-context (ACT-SAC). Participants in each arm were compared with regards to their ability to engage in psychological flexibility and decentering. Clinical outcomes were compared at end of treatment and also at 6-weeks follow-up.

NCT ID: NCT03912753 Completed - Clinical trials for Human Immunodeficiency Virus

Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings

Start date: May 20, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to provide help and support for mental health and human immunodeficiency virus (HIV) risk reduction among Romanian gay and bisexual men. GBM will participate in this study using mobile device (phones, tablets, or laptops) and will complete several confidential surveys and 8 confidential one-hour sessions, either with a trained counselor via chat or by reading about health information. This study also involves testing for HIV, syphilis, chlamydia, and gonorrhea.