ISRCTN13363197进行中（未招募）未知
Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The study population are young people meeting BAR criteria. The inclusion criteria are:
- •1. 16-25 years old
- •2. Meet criteria for one of the following groups in the last 12 months (as assessed by the SCID-5):
- •2.1. Group I: Sub-threshold mania.
- •For at least 2 consecutive days but less than 7 days: period of abnormally and persistently elevated, expansive or irritable mood + at least 2 criteria from the list (>=3 for irritable mood):
- •2.1.1. Inflated self-esteem/grandiosity
- •2.1.2. Decreased need for sleep
- •2.1.3. More talkative than usual
- •2.1.4. Flight of ideas/racing thoughts
- •2.1.5. Distractibility
- •2.1.6. Increase goal-directed activity or psychomotor agitation
- •2.1.7. Excessive involvement in activities that have a high potential for painful consequences
- •2.2. Group II: Depression + Cyclothymic features:
- •Depression (for at least 1 week): depressed mood/loss of interest or please + two criteria from the list:
- •2.2.1. Significant weight loss
- •2.2.2. Insomnia or hypermania nearly every day
- •2.2.3. Psychomotor retardation/agitation
- •2.2.4. Fatigue/loss of energy
- •2.2.5. Feelings of worthlessness/excessive or inappropriate guilt
- •2.2.6. Diminished ability to think or concentrate
- •2.2.7. Recurrent thoughts of death/suicidal ideation
- •Cyclothymic features: numerous episodes with sub-threshold manic symptoms not meeting Group 1 criteria: subthreshold mania as defined in Group 1 for 4 hours within a 24-hour period and at least 4 cumulative lifetime days in the past 12 months.
- •2.3. Group III: Depression + genetic risk:
- •Depression (See Group 2)
- •Genetic risk: first degree relative with BD
- •3. Help seeking
- •4. Provision of written informed consent
排除标准
- •1. History of a treated/untreated manic episode or psychosis of 1-week duration or longer
- •2. Treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks (that evidences exclusion on point a or at the time of the assessment whereby at-risk status cannot be confirmed)
- •3. Organic brain disorder
- •4. Unable to complete assessments due to language barriers
- •5. Inpatient/acute psychiatric care needed
- •6. Primary substance abuse/dependency
研究者
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