CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 69 enrolled
Drug / intervention
Operant Learning +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01674335
NCT01674335N/ACompleted

Operant Learning Versus Energy Conservation Activity Pacing Interventions in a Sample of Fibromyalgia Patients: A Randomized Controlled Trial

In Brief

A clinical study evaluating Operant Learning and Energy Conservation for Fibromyalgia and Chronic Pain. Completed, enrolled 69 participants across 1 site.

Detailed Summary

Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people with pain try to continue their daily activities at the same level as they were able to manage before they had pain. This way of coping causes increases in their pain; they become discouraged and give up on their activities. AP treatments involve helping them regulate their activity level so that they can achieve important life goals. Although AP is widely used, its effectiveness is still unproven. There are two key approaches: The operant learning (OL) approach uses quotas related to time or goals the person sets. The energy conservation (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We will examine the effects of these treatments on pain, fatigue, quality of life, physical functioning and mental well-being. We will also investigate whether other factors influence treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care London. OL and EC treatment manuals will be developed by experts in the field and both interventions will be given by two occupational therapists over a 3 month period as "stand-alone" interventions (10 sessions of 120 min). All sessions will be recorded in order to assess intervention fidelity. This study will be the first to base AP interventions on a clearly delineated theoretical framework. It will clarify whether AP strategies benefit individuals with FMS and whether either of these two approaches is more effective. Our results will help to direct clinical resources and funding toward the most beneficial interventions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2012
Enrollment StartSep 1, 2012
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.8 years ago

Interventions

Operant Learningbehavioral

The present therapist manual focuses on the operant learning approach, which emphasizes the use of positively reinforced activity quotas that are time and/or goal contingent, rather than pain-contingent, using a gradually increased "activity-rest" cycling approach (Fordyce, 1976). This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.

Energy Conservationbehavioral

The present therapist manual focuses on the energy conservation approach, which emphasizes management of participant energy expenditure, and seeks to achieve a balance between accomplishing important day-to-day activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004). This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.