Exercise-based Motivational Interviewing for Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00573612|
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : April 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Attention Control Counseling Behavioral: Motivational Interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Exercise-based Motivational Interviewing for Fibromyalgia|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Placebo Comparator: 1
Telephone Call for the Attention Control Group Each AC call will follow the same format as the MI call. During the AC call, study subjects will receive health information on important topics relevant to their illness. Specifically, there will be one topic during each phone call that includes the following: (a) overview of FMS, (b) pain, (c) fatigue (d) sleep, (e) stress, and (f) living well with FMS. The AC calls will be an avenue to transfer relevant health information from the RA to the study subject. The scheduled topics during each contact will give the call face validity (i.e., establish a credible pretense for the contact) while being neutral with respect to encouragement of exercise.
Behavioral: Attention Control Counseling
Subjects will receive educational-based telephone counseling regarding fibromyalgia.
Active Comparator: 2
Telephone-delivered Motivational Interviewing Participants will receive 6 telephone calls throughout the study. Harland et al reported that the most effective intervention for promoting exercise in the primary care setting was the most intensive treatment arm that included six MI sessions (208). Importantly, in our pilot study, participants who completed 5 to 6 phone calls achieved greater symptomatic benefits than participants who had ≤ 4 phone calls. The phone calls will be scheduled at week 3, 4, 6, 8, 10 and 12 of the study. Telephone sessions may run for 30 minutes on the average
Behavioral: Motivational Interviewing
Subjects will receive Motivational Interviewing telephone counseling.
- Measure the effects of exercise-based MI intervention improving exercise adherence. [ Time Frame: This is a five year study, each subject will participate in a 9-month study sequence ]
- To evaluate the effects of exercise-based MI intervention in pain severity and to determine between exercise-based MI intervention and the adherence. [ Time Frame: This is a five year study, each subject will participate in a 9-month study sequence ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573612
|United States, Indiana|
|National Institute of Fitness of Sports, IUPUI Campus|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Dennis C. Ang, MD||Indiana University|