跳至主要内容
临床试验/NCT01441258
NCT01441258已完成不适用

Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression

Maurizio Fava, MD1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Beck Scale for Suicidal Ideation (SSI)

研究概览

简要总结

Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT) skills-groups and therapist consultation to treatment as usual successfully reduced symptoms of depression. The present study will expand upon these findings. Second, DBT is not known for reducing suicidal ideation (SI), a major risk factor for suicide . The present study will tailor the aforementioned skills-groups to specifically target suicidal thoughts and behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study will extend this DBT-based approach to a novel population. Fourth, the present study is the first DBT intervention to employ state-of-the-art multi-method measurement (including objective assessment) of suicidal thoughts and behaviors.

The investigators hypothesize that participants in the DBT skills (DBT-S) group will show improvements in level of suicidality as measured by decreased scores on the Beck Scale for Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU) group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants will be at least 18 years of age.
  • •Participants will meet criteria for Major Depressive Disorder (MDD) on the Structured Clinical Interviews for Axis I DSM-IV Disorders
  • •Participants must report current suicidal ideation on the Self-Injurious Thoughts and Behaviors Interview
  • •Participants must have an outpatient psychiatric provider who they see "regularly" (i.e., at least every other week for therapy, case management, or medication management).
  • •English language proficiency.

排除标准

  • •DSM-IV diagnosis of bipolar disorder, schizophrenia, psychotic disorder NOS, or personality disorders.
  • •Active current substance dependence.
  • •Severe or unstable medical conditions that would prohibit regular group attendance or participation.
  • •Other group therapy.
  • •Significant dementia or cognitive impairment that would interfere with the learning of DBT skills.

研究组 & 干预措施

Dialectical Behavior Therapy Skills (DBT-S) Groups

Experimental

Patients in the Dialectical Behavior Therapy Skills (DBT-S) group will receive the newly adapted 18-week group-skills training protocol, one-and-a-half hours in length, with weekly homework assignments to facilitate skill generalization.

干预措施: Dialectical Behavior Therapy Skills (DBT-S) Groups (Behavioral)

Wait List-Treatment as Usual

Placebo Comparator

Participants assigned to the wait-list condition will be given the opportunity to participate in a DBT skills group after their 18-week wait period has ended.

干预措施: Wait List-Treatment as Usual (Behavioral)

Wait List-Treatment as Usual

Placebo Comparator

Participants assigned to the wait-list condition will be given the opportunity to participate in a DBT skills group after their 18-week wait period has ended.

干预措施: No intervention-treatment as usual (Behavioral)

结局指标

主要结局

Beck Scale for Suicidal Ideation (SSI)

时间窗: Participants will be assessed using the SSI monthly throughout the duration of their study participation for up to 15 months (see description for details)

If randomized to the intervention, they will be assessed monthly for 18 weeks, then at 3 and 6-month follow-up visits. If they are randomized to the Wait list-Treatment as Usual (WL-TAU) group and then cross over into the intervention group, they will be assessed for a total of 36 weeks, not including the 3 and 6-month follow-up assessments.

次要结局

未报告次要终点

研究者

发起方
Maurizio Fava, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maurizio Fava, MD

Executive Vice Chair, Department of Psychiatry

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验