Therapeutic Massage to Manage Withdrawal Related Anxiety
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
2 other identifiers
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedOctober 9, 2009
January 1, 2009
7 months
October 1, 2009
October 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
State and Trait Anxiety (Spielberger State Trait Anxiety Inventory of Adults (Y1 and Y2))
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)
Secondary Outcomes (2)
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)
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
Study Arms (2)
Therapeutic Massage
EXPERIMENTALRelaxation Control
ACTIVE COMPARATORRelaxation Control Session
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Addiction Prevention and Treatment Services; Capital District
Halifax, Nova Scotia, B2Y 3Z6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert W Gilbert, PhD
Dalhousie University
- STUDY DIRECTOR
Shaun Black, MSc
Capital District Health Authority, Addiction Prevention and Treatment Services
- STUDY DIRECTOR
Kathleen Jacques, PhD, RMT
Canadian College of Massage and Hydrotherapy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 9, 2009
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
October 9, 2009
Record last verified: 2009-01