跳至主要内容
临床试验/NCT02803125
NCT02803125已完成不适用

Improving Psychosocial Functioning in Older Veterans With PTSD

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Quality of Life Inventory (QOLI)

研究概览

简要总结

The purpose of this project is to develop an intervention to improve psychosocial functioning and quality of life for older Veterans with partial or full PTSD.

详细描述

This project will develop, implement, and evaluate a group protocol geared toward restoring older Veterans to better, fuller functioning. This project will determine the feasibility and acceptability of such an intervention. The intervention developed will then be compared to a support group control condition. Primary outcomes are psychosocial functioning and quality of life, with PTSD and depressive symptoms as secondary outcomes. A complementary objective is to improve attitudes toward mental health treatment and to increase readiness for change and engagement in evidence-based psychotherapies, as appropriate. Results from this study will provide feasibility data for future development and testing of the intervention protocol.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Focus groups:
  • Veterans need to be at least 60 years old to be eligible to participate in the focus groups.
  • Potential participants will be assessed with the Primary Care Posttraumatic Stress Disorder Screener (PC-PTSD-5) prior to being invited to participate.
  • Inclusion criteria include endorsement of a military-related criterion A event and a score of 3 or higher on the PC-PTSD-
  • Veterans need to be at least 60 years old to be eligible to participate in the study.
  • Potential participants will be assessed for PTSD symptoms.
  • Inclusion criteria include endorsement of a military-related criterion A event and several PTSD symptoms.
  • Comparison:
  • Veterans need to be at least 60 years old to be eligible to participate in the study.
  • For both intervention and support groups, participants (who will be assessed for PTSD), must endorse a military-related criterion A event and several PTSD symptoms.

排除标准

  • Focus groups:
  • Veterans who are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder.
  • Potential participants will also be excluded if they do not agree to be audio recorded.
  • Veterans who are in current treatment for PTSD, are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder.
  • Veterans will be asked not to join therapy groups or other interventions for the duration of their participation in the study.
  • Potential participants will also be excluded if they do not agree to be audio recorded.
  • Comparison:
  • Veterans who are in current treatment for PTSD, are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder.
  • Veterans will be asked not to join therapy groups or other interventions for the duration of their participation in the study.
  • Potential participants will also be excluded if they do not agree to be audio recorded.
  • In addition, Veterans who participated in the pilot phase of the study will be excluded from participating in the comparison condition phase.

结局指标

主要结局

Quality of Life Inventory (QOLI)

时间窗: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)

The QOLI is a 32 item self-report measure that assesses life satisfaction across 16 life domains (e.g., health, work, recreation). For each domain, the respondent rates how important the domain is on a 0-2 scale and how satisfied he or she is in this area of life on a 7-point scale. Satisfaction scores on the measure are weighted based on the respondent's rating of the importance of the life domain in order to achieve a total score with higher scores indicating higher quality of life. The measure was validated across a number of samples, including psychiatric inpatient and outpatient VA samples. Test-retest reliability was excellent over a one-month interval (r = .91) as was the internal consistency of the measure (alphas ranged from .86-.89). The measure also demonstrated convergent and discriminant validity with other measures of life satisfaction. T scores were used with range 0 - 100, Mean (of reference population) =50, Standard deviation = 10

Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales

时间窗: Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline)

The IPF is an 80-item self-report measure designed to assess functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Respondents have the option to skip sections that do not apply to them. The IPF has excellent internal consistency reliability (overall alpha = .93) and the scale correlates with other self-report measures of quality of life and functional impairment, such as the QOLI (r = .59). Reporting on romantic relationships (range = 0-66), family (range = 0-42), and friends/socializing (range = 0-48) functioning subscales here. Higher scores indicate more impairment.

Veterans Rand 12-item (VR-12) Health Survey

时间窗: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)

The VR-12 is a 12-item scale that assesses the effects of physical and mental health on well-being, and is often used to assess quality of life. Item scores are used to compute two broad component scores: the physical component score (PCS) and the mental component score (MCS). The component scores are standardized T-Scores and the population standard for this measure was recently updated. Higher scores indicate better functioning. T scores were used with range 0 - 100, Mean (of reference population) = 50, Standard deviation = 10

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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