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Self-Injurious Behavior clinical trials

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NCT ID: NCT04404309 Recruiting - Depression Clinical Trials

Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)

OASIS-D
Start date: August 1, 2020
Phase:
Study type: Observational

This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75 years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a moderate or severe unipolar depressive episode and suicidal tendencies who agree to participate in a prospective study (cohort 2); and moderate or severe unipolar depressive episodes validated by research interviews and and suicidal tendencies that persist for at least 48 hours after admission who are followed up for 6 months (cohort 3).

NCT ID: NCT04318899 Recruiting - Clinical trials for Borderline Personality Disorder

Predictors of Clinical Course and Treatment Response in DBT Programmes

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

The project is a collaboration between The National Centre for Suicide Research and Prevention (NSSF) and clinical units with Dialectical Behaviour Therapy (DBT) programmes. A methodological and technological platform has been established that enables clinicians to deliver high quality treatments over extended periods of time, to evaluate their own performance and productivity and to report it in a uniform and systematic way that will enable comparison across clinical settings and programmes. The collected data constitute the basis for conducting the clinical study with the overall aim to study predictors of the clinical course and treatment response in patients admitted to DBT programmes in Norway.

NCT ID: NCT04242914 Recruiting - Clinical trials for Non Suicidal Self Injury

The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

Start date: February 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Non-suicidal self-injuries (NSSI) is a deliberate harm a person causes directly to their body, resulting in structural or functional damage, without suicidal ideation. This behavior is related to unbearable internal stress, thoughts, or mental pain, which NSSI assists in dismantling. To date, there is no generally approved therapy that assists in lowering NSSI. Ketamine is a sedative drug, presently at the focus of psychopharmacologic research, which was found to improve depression, when taken orally, and lower suicidal ideation, when given intravenously. Our aim is to assess the efficiency of intravenous ketamine in decreasing NSSI symptomology in women with a history of childhood sexual abuse presenting with such behavior. Participants will be recruited among hospitalized patients from the Tel-Aviv Medical Central psychiatric ward, who will present with either NSSI urges or behavior. The study design is a randomized control, double blind trial. Each patient will be assessed before, during, and after the trial by physical examination, blood tests and questionnaires. The patients will be randomized into research group (treated by ketamine and midazolam intravenously) or control group (treated intravenously via midazolam only). Our hypothesis is that treatment by intravenous ketamine will lower NSSI symptomology, and enable optimal treatment while being hospitalized.

NCT ID: NCT04191122 Recruiting - Depression Clinical Trials

Community Outpatient Psychotherapy Engagement Service for Self-harm

COPESS
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Background: Self-harm (SH) is any act of intentional self-injury or self-poisoning, with or without the intention to die. People who SH are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who SH and may be an underlying driver of self-harm behaviour. Treating depression in people who SH has the potential to reduce the risk of further SH and suicide. Self-harm is often repeated, and risk of repetition is highest immediately after an act of self-harm. Readily accessible brief talking therapies show promise in helping people who SH, but further evaluation of these approaches is needed. The Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) is a brief talking therapy intervention for depression and self-harm. This intervention was shown to be feasible and acceptable in hospital emergency department settings, but accessibility was limited; thus, the investigators wish to develop and test a community-based version of this intervention. The COPESS project moves this therapy into a community setting, thereby increasing the number of people who can be helped, especially those in hard-to-reach groups and from disadvantaged areas. Aim: To assess the feasibility of conducting a trial of the COPESS intervention in a community setting, for people with depression who self-harm, in relation to participant recruitment and retention. Therapy, acceptability and safety of the intervention will also be assessed. Methods: Using a Single Blind Randomised Control Trial (RCT) design, the investigators will recruit a sample of n=60 participants with a history of SH within the last six months, who are also currently depressed. Recruitment will take place via GP practices for patients who: 1) seek consultation for self-harm; 2) have consulted for self-harm in the previous 6 months (determined by GPs' search of their own data-systems); or 3) self-refer via their GP. Following baseline assessment participants will be randomly allocated to either receive COPESS plus Treatment as Usual [TAU; n = 30)] or TAU alone (n=30). Follow-up assessments will take place at one, two and three months. Recruitment rates, attrition and data completeness will be monitored. Qualitative interviews with participants and stakeholders will further investigate feasibility.

NCT ID: NCT04045600 Recruiting - Aggression Clinical Trials

Refinements of Functional Communication Training

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

Although treatments for problem behavior, like functional communication training (FCT), can be highly effective in the clinic, changes in the way the FCT is implemented (e.g., when transferring treatment to the home, when teachers implement treatment with poor fidelity) can result in treatment relapse. The goal of this study is to evaluate whether using treatment signals and gradually introducing materials from natural contexts can help mitigate treatment relapse during context changes and poor treatment-integrity scenarios.

NCT ID: NCT00694668 Recruiting - Clinical trials for Self-Injurious Behavior

The (Cost-) Effectiveness of Mindfulness-training and Cognitive Behavioural Therapy in Adolescents and Young Adults With Deliberate Self Harm

DSH
Start date: May 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Background: In recent years, there has been a marked rise in the frequency of young people engaging in Deliberate Self-Harm (DSH). DSH refers to all kinds of self-harming behaviour, with and without suicidal intent. Early identification and treatment of persons who engaged in DSH is important because every episode of DSH increases the risk of future episodes and, eventually, suicide. A number of comprehensive treatment programs have been developed and proven to be effective in reducing DSH in adults. Especially the modification of inadequate emotion regulation strategies seems to be essential in the prevention of future episodes of DSH. The first short-term results of a Dutch time-limited and structured individual cognitive-behavioral treatment (CBT) for DSH in adolescents and young adults also showed positive effects on repetition of DSH and associated problems. Objective: To study the effects and costs of the total individual CBT package and one of the components of the total CBT treatment package (i.e. mindfulness training) in a group format compared to Treatment-as-Usual (TAU) on the short and long term. Design: Multi-center randomized controlled clinical trial with repeated measurements at baseline (M0),and posttreatment (M6)), 12 (M12) and 18 months (M18) after baseline. Procedure: Young persons aged 15-35 who recently have engaged in DSH and have been referred to the Leiden University Medical Centre, the mental health centre Rivierduinen or the University Medical Centre St. Radboud following an act of DSH will be invited to participate. Persons reporting severe psychiatric disorders requiring intensive inpatient treatment or serious cognitive impairments will be excluded. Interventions: Participants are randomly allocated to CBT, Mindfulness-Based Cognitive Therapy(MBCT) or Treatment-as-Usual (TAU). The CBT treatment consists of up to 12 weekly sessions of individual treatment mainly consisting of emotion regulations skills, cognitive restructuring, and behavioural skills training. The MBCT training consists of 8 2-hour sessions in a group format within a three months time frame. Outcome measures: The same outcome measures to assess the clinical effects of treatment as in the previous study will be used (repetition of DSH, depression (BDI-II), anxiety (SCL-90), self-concept(RSC-Q), and suicide cognitions (SCS)) allowing a historical comparison of treatment effectiveness across both randomized clinical trials. In addition at all assessments health-related quality of life, use of medical resources and loss of productivity will be assessed (EuroQol, VAS and TTO). In addition,problems in emotion regulation (an important risk mechanism for repetition of DSH) will be assessed before and after treatment. Economic evaluation: Differences in societal costs (intervention, other (health) care and productivity)will be compared to differences in the frequency of DSH and quality adjusted life years (EuroQol, VAS and TTO). Data-analysis/power: Based on our previous study at least a medium effect of treatment on repetition of DSH may be expected. Assuming a medium effect of one of the treatments compared to TAU (delta =.75) and an attrition rate of about 20 %, at least 42 patients per study arm are needed to detect a minimal clinical relevant difference in repetition of DSH with a power of 80% and alpha set at .05.

NCT ID: NCT00491478 Recruiting - Mental Retardation Clinical Trials

Repetitive Behavior Disorders in People With Severe Mental Retardation

Start date: September 1992
Phase: Phase 3
Study type: Interventional

Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual’s daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. The trial will evaluate the effectiveness of two medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic, in treating repetitive behavior disorders in people with mental retardation.

NCT ID: NCT00169884 Recruiting - Clinical trials for Self-Injurious Behavior

The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients

Start date: March 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether the proposed cognitive-behavioural intervention is effective for DSH patients in the age group 15-35 years. In addition, we will examine which elements derived from the theoretical model can explain the efficacy of the intervention.