Therapeutic Massage to Manage Withdrawal Related Anxiety

This study has been completed.
Sponsor:
Collaborator:
Holistic Health Research Foundation of Canada
Information provided by:
Dalhousie University
ClinicalTrials.gov Identifier:
NCT00992979
First received: October 1, 2009
Last updated: October 8, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Substance Withdrawal Syndrome
Drug Withdrawal Symptoms
Anxiety
Procedure: Therapeutic Massage
Procedure: Relaxation Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dalhousie University:

Primary Outcome Measures:
  • State and Trait Anxiety (Spielberger State Trait Anxiety Inventory of Adults (Y1 and Y2)) [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Rate and Blood Pressure [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Sleep Quality [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Massage Procedure: Therapeutic Massage
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.
Other Name: Massage
Active Comparator: Relaxation Control
Relaxation Control Session
Procedure: Relaxation Control
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 Name: Relaxation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992979

Locations
Canada, Nova Scotia
Addiction Prevention and Treatment Services; Capital District
Halifax, Nova Scotia, Canada, B2Y 3Z6
Sponsors and Collaborators
Dalhousie University
Holistic Health Research Foundation of Canada
Investigators
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
  More Information

No publications provided

Responsible Party: Robert William Gilbert, School of Health Sciences, Dalhousie University
ClinicalTrials.gov Identifier: NCT00992979     History of Changes
Other Study ID Numbers: DAL09-01, HHRFC #2007-06
Study First Received: October 1, 2009
Last Updated: October 8, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Dalhousie University:
Addiction
Anxiety
Withdrawal
Psychoactive Drugs
Therapeutic Massage

Additional relevant MeSH terms:
Anxiety Disorders
Substance Withdrawal Syndrome
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 16, 2014