NCT01986257已完成不适用
Emotion Regulation Group Therapy (ERGT) for Women Engaging in Non-suicidal Self-Injury (NSSI) - an Effectiveness Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)
研究概览
简要总结
The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •NSSI a minimum of three times in the last six months
- •Meets at least three criteria for Borderline Personality Disorder according to DSM-IV-TR
- •Contact with an other individual therapist, psychiatrist, "case manager" or equal
排除标准
- •Insertion/withdrawal of psychopharmacological substances within two months prior to the treatment
- •Other acute primary axis I diagnosis (e.g. anorexia nervosa) that demand treatment in first hand
- •Bipolar disorder I or primary psychosis
- •Current substance dependence (the last month)
- •Current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse)
- •Insufficient Swedish language skills
- •Cocurrent treatment with Mentalization based therapy (MBT) or Dialectical behavioral therapy (DBT)
研究组 & 干预措施
Emotion Regulation Group Therapy (ERGT).
Experimental
干预措施: Emotion Regulation Group Therapy (ERGT). (Behavioral)
结局指标
主要结局
Frequency of non-suicidal self-injury as measured by Deliberate Self-Harm Inventory (DSHI)
时间窗: Baseline (from inclusion to treatment start), (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.
Change from Baseline in deliberate self-harm after 14 weeks and at 6- and 12 months after treatment has ended.
次要结局
- Diary questionnaire (DQ)(Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.)
- Borderline Symptom List Behavior supplement (BSL-supplement)(Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks), and six and twelve months follow-up.)
- Difficulties in Emotion Regulation Scale (DERS)(Baseline (from inclusion to treatment start), pre-treatment (7 days prior to treatment start), weekly (once a week following treatment start), post-treatment (14 weeks) and six and twelve months follow-up.)
- The Borderline Evaluation of Severity over Time (BEST).(Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.)
- The Depression Anxiety Stress Scales (DASS)(Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.)
- Inventory of Interpersonal Problems - Borderline Personality Disorder (IIP-BPD)(Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.)
- Euroqol-5D (EQ-5D)(Baseline, post-treatment (14 weeks) and six and twelve months follow-up.)
- Sheehan Disability Scale (SDS)(Pre-treatment (7 days prior to treatment start), post-treatment (14 weeks) and six and twelve months follow-up.)
- Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)(Baseline, post-treatment (14 weeks) and six and twelve months follow-up.)
研究者
Clara Hellner Gumpert
Ph.D.
Karolinska Institutet
研究点 (2)
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