Development of a Recovery Oriented Treatment for Post Acute Suicidal Episode (PASE) Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in Recovery Assessment Scale
研究概览
简要总结
Mental health care for Veterans with suicidal symptoms is of paramount import to the VA. Unfortunately, VA suicide reports show suicide rates increasing, suggesting a need for enhancing current VA suicide mental health care efforts. While several psychotherapeutic treatments exist for acute suicidality, there are few treatments designed to help Veterans following an acute suicidal episode (Post-Acute Suicidal Episode; PASE), particularly after acute risk declines but when they still have ongoing mental health needs and, at times, long-term suicidal symptoms. Available suicide treatments are not designed to promote the recovery and rehabilitation of PASE Veterans. This is a significant gap in comprehensive suicide-focused mental health care. One avenue to close this gap lies through the development of a recovery-focused psychotherapy for PASE Veterans. Developing recovery-oriented care, "a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential" is a VA priority; however, available treatments for suicidal Veterans do not place a strong focus on recovery. Decades of research have shown the importance of increasing Veterans hopefulness about the future, developing a positive self-identity, promoting Veterans' sense of self-empowerment and improving relationships. Continuous Identity-Cognitive Therapy (CI-CT) is a promising new manualized suicide intervention focused on improving Veterans sense of their life story and personal future, with goals similar to recovery-oriented care.
The proposed study will assess and enhance the CI-CT treatment materials using Veteran feedback and acceptability and feasibility data. Then, with the guidance of scientific and Veteran consumer advisory boards, use these results to update the treatment. Findings will be used to make an updated adaptation of the treatment materials and to develop a research protocol for a pilot RCT of CI-CT for PASE Veterans. This study will develop and pilot test a well-specified, group-based intervention tailored to the unique needs of PASE Veterans. The results of the proposed study will provide data to 1) identify adaptations needed to optimize CI-CT for PASE Veterans: 2) identify possible benefits of CI-CT; 3) inform development of a pilot RCT of CI-CT for PASE Veterans.
详细描述
Research Design and Methods
Phase 1
CI-CT has not, to date, been used for the PASE Veteran population. To optimize CI-CT's effectiveness for a PASE population and continue to align it as closely as possible with a recovery orientation, a dynamic adaptation approach will be used to run multiple treatment development trials of the group therapy to continue to improve CI-CT prior to running a pilot RCT. In this first phase the treatment materials will be used to run 3 one-arm treatment development trials of CI-CT (each with an n of 4-6 Veterans) to test and improve the therapy protocol. One goal of these trials is to identify CI-CT features or materials that appear functional in theory but do not execute as expected in a clinical setting. Following each treatment development trial, the feedback of the members of the group about the treatment as well as the assessment materials will be used to assess acceptability and feasibility. Upon completion of the trials, through consultation with the SAB and CAB, these results will be used to update treatment materials, instruments used for assessment, and delivery form. The experience of running these treatment development trials will also be used to develop a CI-CT adherence measure which will then be tested during the pilot RCT.
Veteran Participants
To have a final sample of 15 Veterans, 19 Veterans will be recruited (estimating 20% attrition) with a recent (within 1 year) acute suicidal episode, for participation in treatment development trials of CI-CT. The 20% estimate attrition rate is based on the initial CI-CT pilot data. As suggested by the aforementioned Post-Acute focus, treatment will be limited to PASE Veterans after the first week following their suicidal episode and without current acute suicidality (see assessment strategy below). This clinical decision was based on; (1) Veteran feedback from the initial pilot of CI-CT asking for screening to be used to limit the group to those ready to work on recovery, (2) empirical evidence suggesting that the first week after a suicidal episode is a period of distinctly high suicide risk with men 175, and women 583, times more likely than matched controls to die by suicide (N > 20,000 suicide attempters). During this 'acute suicidality' period, treatments exist for Veterans that are more focused on their immediate safety needs while CI-CT focuses on the recovery of Veterans following this 'acute' period. Furthermore, participants will be screened for current acute suicidal symptoms using two validated measures of suicidal symptoms the Suicide Behavior Questionnaire - Revised (SBQ-R) and the Beck Suicide Intent Scale (BSI). Due to the historical nature of some of these measures' items, as have other studies, the SBQ-R item 4 will be used, focusing on self-perception of likelihood of future suicide, with scores above 3 (i.e. at least 'likely') considered current acute suicidality. For the BSI, a cut off score >21 (i.e. 1SD from the mean BSI score) will be used among suicide attempt survivors (Mean=16, SD=5.7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •suicide attempt, or creation of a suicide plan with intent or preparatory behavior, within the past year, as assessed using the Columbia Suicide Severity Rating Scale (CSSRS) - to provide this information, in addition to the standard lifetime/3 months categories in the CSSRS a 1 year category will be added
- •participation in mental health services at the JJPVA
- •sufficient clinical stability and readiness to participate in a group therapy as deemed by a mental health treatment provider
- •sufficient medical stability as deemed by a medical provider
- •Veteran of US Military
- •resides in NYC region
排除标准
- •active alcohol or opiate dependence requiring medically supervised withdrawal
- •imminent risk of suicidal or homicidal behavior
- •acute suicidal episode within past week
- •current acute suicidal symptoms (based on scores of the BSI and SBQ-R - see above)
- •inability to perform CI-CT treatment tasks based on their performance on a sample reading and writing task from the CI-CT manual (given during screening), operationalized as an ability to read the sample material, understand the instructions, and write a response connected with the material and in line with the writing instructions
- •unable to speak English
- •lack of capacity to consent
- •unable or unwilling to provide at least one contact for emergency purposes
- •unable to attend outpatient group treatment program
- •participation in another intervention RCT
- •insufficient interpersonal functioning to function appropriately within the group assessed through a consultation with the referrer and the Veterans' mental health provider about their interpersonal functioning and ability to tolerate group therapy, and a chart review searching for disruptive behavior in group therapy
研究组 & 干预措施
General Health Education Active Control Group
The control condition will receive General Health Education a structured manualized group health education intervention previously developed by VISN 2 MIRECC investigators as a control condition for group psychotherapy RCTs. It has 12 1.5-hour weekly group sessions focusing on health and wellness topics such as Sleep, Physical Activity, Impact of Stress, Relaxation Techniques, Substance Use, Nutrition, Managing Daily Activities, Medication Benefits and Side Effects. GHE was chosen for the AC because it aligns in many respects with CI-CT (e.g., group format, length of sessions, similar expectations) while diverging in specific topics and skills targeted allowing for control of common factors like attention without causing confounding due to overlap in concepts
干预措施: General Health Education (Behavioral)
CI-CT Group
The experimental group will receive CI-CT (Continuous Identity Cognitive Therapy). CI-CT is planned to be a weekly, 90-minute, 12-session group treatment and to be run by two clinicians using the final version manual and workbook. CI-CT was developed as a manualized treatment integrating components of CBT and Acceptance and Commitment Therapy (ACT) with self-continuity and future-self related interventions to help Veterans develop a better present-to-the-future life story as a framework for increasing hopefulness, a sense of life meaning, empowerment, and an ability to attain future self-goals. The CI-CT includes eight components: 1) constructing a CI narrative, 2) mindfulness training, 3) life values identification, 4) developing a self-growth perspective, 5) identifying possible future selves - timelines, 6) connecting with the desired future self, 7) CI as context for current problems, and 8) moving toward the future self.
干预措施: Continuous Identity Cognitive Therapy (CI-CT) (Behavioral)
CI-CT Treatment Development Group
The 3 treatment development groups will receive CI-CT (Continuous Identity Cognitive Therapy). CI-CT is planned to be a weekly, 90-minute, 12-session group treatment and to be run by two clinicians using the final version manual and workbook. CI-CT was developed as a manualized treatment integrating components of CBT and Acceptance and Commitment Therapy (ACT) with self-continuity and future-self related interventions to help Veterans develop a better present-to-the-future life story as a framework for increasing hopefulness, a sense of life meaning, empowerment, and an ability to attain future self-goals. The CI-CT includes eight components: 1) constructing a CI narrative, 2) mindfulness training, 3) life values identification, 4) developing a self-growth perspective, 5) identifying possible future selves - timelines, 6) connecting with the desired future self, 7) CI as context for current problems, and 8) moving toward the future self.
干预措施: Continuous Identity Cognitive Therapy (CI-CT) (Behavioral)
结局指标
主要结局
Change in Recovery Assessment Scale
时间窗: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention
The RAS is a 41-item self-report measure using a 5-point Likert scale with outcome scores ranging from 1-5 and increasing scores indicating better outcomes. Sample items include: 'I have a desire to succeed.' and 'I have goals in life that I want to reach.' Factor analysis identified five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by symptoms (Salzer \& Brusilovskiy, 2014). Narrative reviews of recovery measures have been highly favorable toward the RAS which has been described as the most acceptable and valid measure of personal recovery available (Salzer \& Brusilovskiy, 2014)
Change in Columbia Suicide Severity Rating Scale
时间窗: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention
a widely used semi-structured interview in VA clinical studies measuring suicide ideation and behavior has demonstrated sensitivity to change (Stanley \& Brown, 2008). The first subscale, (severity scale) is a 6-point ordinal scale, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). The second subscale, (intensity scale) is comprised of five items (i.e., frequency, duration, controllability, deterrents, reasons for ideation), rated on an ordinal scale (total scores ranging from 2 to 25). The behavior scale is a 5-point scale assessing interrupted, aborted, and actual suicide attempts; preparatory behavior for a suicide attempt; and non-suicidal self-injurious behavior.
次要结局
- Change in Satisfaction With Life Scale(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)
- Change in Beck Hopelessness Scale(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)
- Change in WHODAS 2.0(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)
- Change in Future Self Continuity Questionnaire(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)
- Change in WHOQOL-BREF(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)
- Change in Interpersonal Needs Questionnaire(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)
- Change in Lubben Social Network Scale-Revised(four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention)