Use of Massage Therapy to Reduce Anxiety and Improve Sleep in Patients Participating in an Inpatient Withdrawal Management (Detox) Program: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- State and Trait Anxiety (Spielberger State Trait Anxiety Inventory of Adults (Y1 and Y2))
研究概览
简要总结
In Canada, Addiction Prevention and Treatment Service's (APTS) offer programs specifically designed to help people withdrawal from psychoactive drugs. While participants of withdrawal management (Detox) programs generally reach their goals, the process is a difficult one often exacting an emotional and physical toll. Troublesome symptoms of withdrawal from psychoactive drugs may include anxiety and sleep disturbances. If untreated these symptoms can lead to discontinuation of withdrawal and /or affect the introduction of cognitive-behavioral and or motivational therapy components of Detox programs. In Detox the symptoms of withdraw are managed pharmacologically. Pharmacological tools for managing anxiety and sleep disturbances exist and while effective and safe, in many clinical settings, have limitations and liability in the addiction treatment setting. To address these concerns APTS has incorporated non-pharmacological anxiety management practices into its programs. Prominent among these is therapeutic massage (chair massage in the Swedish tradition). While therapeutic massage has been shown to reduce state and trait anxiety in a variety of clinical settings, no previous study has assessed its anxiolytic or sleep promoting efficacy in an addiction treatment setting. In keeping with ATPS's policy on evidence-based practice, evidence in support of this practice is now required.
Research Objectives: We propose to test the Hypothesis: Therapeutic Massage is an effective therapy for managing withdrawal-related anxiety and for improving sleep effectiveness in patients withdrawing from psychoactive drugs. Our specific objective is to perform a randomized controlled trial (RCT) to determine whether therapeutic massage is effective in comparison to relaxation control treatment in reducing the levels of state and trait anxiety associated with withdrawal and in promoting sleep efficiency.
Research Design: A RCT of the effects of therapeutic massage will be conducted on 80 patients (ages 18-65) attending an APTS Detox program. Patients will be assigned to 1 of 2 treatment groups (n=40/group) and will receive either: therapeutic massage or relaxation control treatment once a day for 3 consecutive days. Anxiety, state and trait, will be measured pre and post each treatment through a standardized tool and physiologic measures (heart rate & blood pre(state and trait) and sleep efficiency will be determined through actigraphy and daily sleep logs.
详细描述
BACKGROUND Alcohol and Other Drug (AOD) abuse has become a prominent health issue in Canada. According to a recent drug abuse survey, it can be estimated that approximately 2 million Canadians may meet the diagnostic criteria for being dependent upon or having abused AOD. At almost $40 billion/year, the costs of AOD abuse in Canada are substantial. Substance abuse represents a significant drain (both direct and indirect) on Canada's economy, with the largest single direct cost being associated with health care.
The impact on the citizens of Nova Scotia is equally dramatic, as illustrated by the 10,949 individuals who accessed Addiction Services in this province during the 2005 calendar year. 3,252 of these individuals (29.7%) accessed these services through the Addiction Prevention and Treatment Services (APTS), Capital Health. Capital Health exists within the largest integrated academic health district in the Maritimes and provides core health services to 395,000 residents, or 40% of the population of the Nova Scotia and tertiary and quaternary acute care services to residents of Atlantic Canada. Specialized adult health services are provided to a referral population of 550,000 from the rest of the province, as well as to residents of New Brunswick and Prince Edward Island. Of the 3,252 individuals who accessed APTS, Capital Health in 2005, 2020 were male (62.12%) and 1,232 were female (37.88%).
AOD abuse affects people from all walks of life and one prevention and treatment approach cannot be sufficient for all possible forms of abuse. The harms associated with AOD abuse have a significant and detrimental effect on the determinants of health which poses a considerable threat to the social, emotional, physical, and economic well being of Canadian families and communities. Determinants of health are factors impacting on living and working conditions conducive to health in its broadest sense, and include housing, education, genetics, income, employment, culture, physical environment, equity, gender and race. Canada's Drug Strategy (CDS), which was renewed in May 2003, is the federal government's response to addressing the problems associated with the harmful use of AOD, and comprises a series of evidence-based guidelines. Using a comprehensive four-pillar approach, CDS strives to assist individuals, families and communities impacted by substance abuse through education, prevention, harm reduction and enforcement initiatives.
APTS is committed to Canada's Drug Strategy and strives to help individuals, families, and communities of Nova Scotia deal with the harm associated with abuses of AOD. It accomplishes this through a comprehensive range of prevention, intervention and treatment services designed to promote, maintain, and improve health. Included among the services offered by APTS are programs designed to assist in: addiction recovery; withdrawal and management (Detox); tobacco cessation and prevention; substance abuse prevention and community education; women's services; methadone maintenance treatment; and community support groups for gamblers (http://www.cdha.nshealth.ca/programsandservices/addictionprevention/index.html).
The Withdrawal and Management (Detox) program was established at APTS in 1975 and provides care and treatment to approximately 800 individuals each year. This inpatient program consists of detoxification, assessment and education and employs a biopsychosocial approach to treat and empower individuals experiencing the physical/emotional stressors associated with AOD withdrawal. It operates through a supportive community atmosphere that nurtures the difficult process of change. The length of stay in the Detox program depends upon individual assessment, with an average stay of 5 days during which residents participate, under the guidance of nursing staff, in a series of recovery, support and relapse-prevention groups. It is delivered by a staff of 23 full time employees. Detox is available to all individuals residing within the Capital Health district with 15 in-patient beds dedicated to this program. The Detox program integrates a variety of evidence-based pharmacological and biopsychosocial approaches including, but not limited to, behavioral therapy (Wanberg & Milkman, 2002), structured relapse prevention and motivational interviewing (Burke et al., 2003). The participants of the Detox program generally reach their immediate goals, although the process of recovery itself is a difficult one, often exacting an emotional and physical toll. Among the many common and troublesome side effects of the withdrawal process are the development of acute anxiety, sleep disturbances (problems falling asleep or waking frequently) and slight depression (feeling down) which, if left unmanaged, may detrimentally influence the recovery process as well as the ability to engage in further addiction treatment programs.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals receiving inpatient treatment for withdrawal from psychoactive drugs and who were able to give informed consent and comply with study procedures were eligible to participate.
- •being at least 18 years of age;
- •self-reported primary presenting problem as one of the following: alcohol, cocaine, or opioids
排除标准
- •prior treatment or experience with massage therapy
- •prior history of anxiety or sleep disorder
- •history of coagulation or platelet disorders or be currently taking medications that may promote bleeding
- •contraindications to the treatment intervention as described in the standards of care of the College of Massage Therapists of Ontario (http://www.cmto.com/regulations/standard.htm).
结局指标
主要结局
State and Trait Anxiety (Spielberger State Trait Anxiety Inventory of Adults (Y1 and Y2))
时间窗: State and trait anxiety scores will be determined at baseline (at the time of recruitment into the study) and then immediately prior to and within 10 minutes following each intervention session (pre/post design)
次要结局
- Sleep Quality(On each intervention day subjects will wear an actigraph during normal sleep time. They will also be asked to complete a sleep log in the morning, upon waking for each post-intervention day)
- Heart Rate and Blood Pressure(Heart rate and blood pressure will be measured at baseline (at the time of recruitment into the study) and then immediately prior to and within 10 minutes following each intervention session (pre/post design))
