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临床试验/NCT03997344
NCT03997344已完成不适用

Veterans Nature Therapy: A Pilot Randomized Trial of Hiking for Veterans With PTSD

University of Washington2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年5月10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
26
试验地点
2
主要终点
Retention

研究概览

简要总结

This pilot study evaluates the feasibility of conducting a study to evaluate the impact of nature exposure/hiking in groups on symptoms of posttraumatic stress disorder in Veterans. Participants will be randomized to one of two groups: 1) nature hikes and 2) urban hikes.

详细描述

Objectives and hypothesis: Posttraumatic stress disorder (PTSD) is a tragically common problem among US Military Veterans. Current treatment options for PTSD are not uniformly effective and dropout rates are high. Treatment approaches that are evidence-based, effective, and acceptable to Veterans are needed. Nature therapy is a promising, low-cost intervention, yet there are few rigorous studies that have evaluated it as a therapeutic intervention in Veterans with PTSD.

The specific aims of this study are to lay the ground work for a full-scale study by assessing the feasibility and acceptability of: i) recruitment, screening, and data collection methods; and ii) the nature hiking and urban hiking control group interventions. The investigators hypothesize that the interventions will be feasible and the recruitment, screening, and data collection methods will be acceptable.

Key eligibility criteria for this two-arm pilot randomized controlled trial include being a Veterans with PTSD, physical fitness/ability sufficient to walk for at least 2 hours, and willingness to complete assessments. Eligible individuals will be randomized to one of two groups: 1) nature hiking group, 2) urban hiking group. The investigators will enroll up to 60 individuals, to randomize up to 15 participants per group. Note that the number enrolled and randomized are not expected to be the same since he investigators anticipate some individuals who enroll will be determined not to be eligible based on responses to the baseline questionnaire. Individuals randomized to groups 1 or 2 will be invited to participate in six hikes of 2-4 hours in duration, over approximately 12 weeks. Individuals will be asked to complete questionnaires at baseline and weekly for 12 weeks, and then again at 24 weeks. The primary outcomes for this study relate to feasibility and acceptability. The investigators will collect information on time to recruit the sample, retention and survey completion at each time point, and attendance at hikes. A secondary aim is to ascertain changes in PTSD symptoms (which will serve as the primary outcome of the full-scale trial), secondary outcomes (e.g., quality of life) and mediators of the intervention, including factors such as depression, perceived stress, affect, loneliness, anxiety, social connectedness, rumination, and nature connection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • U.S. Military Veteran;
  • Active PTSD symptoms based on the PCL-5;
  • No diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders (based on self-report);
  • Low risk of suicide (based on responses to the MINI Suicidal module);
  • No inpatient admission in last 3 months (based on self-report);
  • No current alcohol disorder/dependence (based on having a score<16 on the 10-item self-administered AUDIT questionnaire);
  • No evidence of drug-related problems (based on having a score <3 on the DAST-10)
  • Capable of safely participating in hikes as evidenced by no "yes's" on the Physical Activity Readiness Questionnaire (or approval of their primary care physician) and individual assertion that they can walk at least 2 hours at an easy to moderate effort with breaks;
  • Willing to be randomized to one of two groups and complete all study procedures;
  • Able to provide written informed consent to participate.

排除标准

  • Schizophrenia, bipolar disorder or other psychotic disorder

结局指标

主要结局

Retention

时间窗: 12-week follow-up

Percentage of participants that complete assessments

Recruitment

时间窗: Baseline

Time to recruit the sample

次要结局

  • Quality of life/well-being: Satisfaction with Life Scale(Baseline and 6-, 12-, 24-week follow-ups)
  • Perceived stress(Baseline and 6-, 12-, 24-week follow-ups)
  • Rumination(Baseline and 6-, 12-, 24-week follow-ups)
  • Social connectedness(Baseline and 6-, 12-, 24-week follow-ups)
  • Depression(Baseline and 6-, 12-, 24-week follow-ups)
  • PTSD symptoms(Baseline and 6-, 12-, 24-week follow-ups)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Bratman

Assistant Professor: College of the Environment

University of Washington

研究点 (2)

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