Therapeutic Massage to Manage Withdrawal Related Anxiety
Condition: Substance Withdrawal Syndrome; Drug Withdrawal Symptoms; Anxiety
MeSH terms: Substance Withdrawal Syndrome; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.

      The need for management of the withdrawal symptoms are quite compelling; lack of sleep
      exacerbates anxiety and anxiety negatively impacts patient comfort and engagement in working
      memory tasks (Eysenck, 1985), social interaction (Strahan & Conger, 1998), and prospective
      memory tasks (Harris & Cumming, 2003). Cumulatively, these negative impacts are of concern in
      regard to the behavioral therapy attributes of the Detox program. Behavioral therapy is based
      on the assertion that undesirable behaviors can be replaced by teaching patients new, more
      desirable ones. It focuses on the patient's responsibility for change and is dependent upon
      the maintenance of patient comfort and the development of effective, therapeutic
      relationships (Wanberg & Milkman, 2002). Unchecked anxiety can, and often does, affect the
      development of these effective relationships. Therefore, the participant may not receive the
      full benefit of the Detox treatment, potentially leading to decreased overall effectiveness
      and an increased risk of relapse.

      Effective pharmacotherapy's are available for the treatment of anxiety and promotion and
      maintenance of sleep. Unfortunately, pharmacological therapies are often deemed
      inappropriate, insufficient or cost-prohibitive in these patient populations. In addressing
      these concerns, APTS uses a holistic approach to the management of anxiety. While biofeedback
      techniques and hypnotherapy may be valuable adjuncts for the treatment of anxiety, financial
      constraints have limited their use at APTS. APTS has chosen to incorporate therapeutic
      massage and auricular acupuncture into its behavioral therapies, practices that both clinical
      staff, practitioners and clients report to play an integral role in the success of their
      addiction recovery program.

      Chair massage employing Swedish techniques, currently offered to clients at APTS, consists of
      continuous systematic strokes including kneading and stretching to loosen and rehabilitate
      the soft tissues of the body (muscles, tendons and fascia) and to provide general relaxation.
      The manual techniques include, for example, effleurage (smooth gliding movements intended to
      evoke the relaxation response), soothing petrissage (lifting, squeezing, wringing, or
      kneading of soft tissues to increase circulation and to reduce muscle spasm), repetitive
      stroking (a soothing technique used to decrease sympathetic nervous system firing and to
      decrease pain perception), rocking (rhythmical side to side motion of a limb or trunk),
      squeezing (compression of a muscle) and mild joint mobilization (slight distraction and
      stretch of joint capsules and surrounding tissue). Swedish massage is an inexpensive
      treatment modality with a low-side effect profile (Ernst, 2003). This treatment has been
      studied in the management of alcohol withdrawal (Reader et al. 2005), and a recent meta
      analysis of 37 therapeutic massage studies identified significant reductions in anxiety,
      blood pressure and heart rate post massage (Moyer et al., 2004). Clinical opinion suggests
      that the most profound benefits accrue to those most in need, e.g. individuals experiencing
      physical or emotional stressors (Rattray & Ludwig, 2000).

      RATIONALE For the vast majority of clinical disciplines, the delivery of therapy is defined
      by a series of highly structured treatment regimes. In contrast, the delivery of care for the
      treatment of addiction is far less structured. This reflects the fact that unlike most other
      clinical conditions, the manifestations of addiction are highly variable, both at the level
      of patients and communities. As such, the service delivery framework provided by individual
      addiction treatment centers possess varying degrees of distinctness, with each centre granted
      the freedom to apply combinations of biopsychosocial approaches that they believe best suits
      their specific patient population. Health Canada now recommends the application of
      evidence-based decision making principles in all areas of research and clinical practice. The
      implementation of evidence-based principles has lead clinicians and researchers alike to
      identify a variety of challenges in addiction treatment programs in Canada. Included among
      these is an absence of defined behavioral outcomes or evidence of efficacy for many of the
      programs offered. Even more surprising is the realization that some long entrenched therapies
      have never been empirically verified for their general efficacy or the subpopulations which
      they might best serve (e.g. alcohol, drugs, gambling and/or combinations there in). Given the
      impact that addiction has on the social and economic fabric of Nova Scotia, many in the
      addiction treatment field are now asking the question "How effective is our particular
      addiction treatment program and can it be improved?" Today therapeutic massage is used in
      addiction treatment programs across North America and Europe and was first initiated as an
      outreach program to APTS by the Canadian College of Massage and Hydrotherapy in 2005. Among
      experienced clinical professionals, the belief is strong that therapeutic massage plays an
      important role in managing the level of anxiety in their patients. However, no peer-reviewed
      scientific study has ever been performed to test the efficacy of therapeutic chair massage in
      reducing acute anxiety and improving sleep quality in patients participating in an addiction
      recovery setting. This is of importance in light of the fact that Health Canada now
      recommends the use evidence-based decision making principles in all areas of research and
      clinical practice.

      STATEMENT OF RESEARCH QUESTION One area in need of attention at APTS is our use of
      complementary and alternative therapies like therapeutic chair massage and auricular
      acupuncture. While numerous studies have illustrated the effectiveness of therapeutic massage
      in reducing anxiety (Moyer et al., 2004), no experimental study has been designed to test its
      anxiolytic or sleep enhancement effects in an addiction treatment setting. Today we are
      challenged with the task of substantiating the efficacy of this apparently important
      component of our addiction treatment program.

      The objective of this application is test the HYPOTHESIS: Therapeutic massage (chair massage
      utilizing Swedish techniques) is an effective therapy for the management of acute
      recovery-related anxiety and for promoting sleep onset and improved sleep efficiency in
      patients attending the Detox program at APTS.

      Our Specific Objective is:

      a) To perform a randomized controlled trial to determine whether therapeutic massage is
      effective, compared with relaxation control treatment, in reducing the level of state and
      trait recovery-related anxiety and in promoting sleep onset and improved sleep efficiency.
    

Intervention name(s): Therapeutic Massage; Relaxation Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Massage therapists with at least 5 years experience will perform the massages. On each of three consecutive days, participants (while fully clothed and in a seated position) will receive a 20-minute back, shoulder, neck and head massage. Subjects will be treated with conventional light pressure Swedish massage techniques which consisted of continuous systematic strokes including kneading and stretching to loosen and rehabilitate the soft tissues of the body and to provide general relaxation. The manual techniques include: effleurage , soothing petrissage , repetitive stroking, rocking , squeezing and mild joint mobilization. As is standard practice in massage therapy delivery, room lights will be dimmed and soft, soothing music played to enhance relaxation during therapy.; On each of three consecutive evenings, subjects in this group will participate in a 20 minute relaxation session. This session will be delivered in the same location and with the same lighting and music as with the therapeutic massage group. Each participant will be asked to choose a comfortable position in a chair and a massage therapist will sit quietly in the room approximately 4 feet behind the participant.
Other intervention name(s): Massage; Relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Addiction; Anxiety; Withdrawal; Psychoactive Drugs; Therapeutic Massage