- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01639196
Brief Online Intervention for Chronic Pain
May 25, 2023 updated by: University of Maryland, College Park
The Expressive Writing Paradigm: A Study of Therapeutic Effectiveness for Chronic Pain
The purpose of this study is to explore the effects of writing about chronic pain on mental and physical health.
The effectiveness of two different types of brief online writing interventions will be explored in individuals with chronic pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic pain is highly prevalent and costly, but often not treated effectively.
Psychological interventions are needed as part of chronic pain treatment since the pain affects many aspects of an individual's life.
In particular, brief psychological interventions that are easily accessible (i.e., online) could benefit many people with chronic pain.
Writing interventions have been used in recent years to understand difficult experiences.
Writing interventions have been found to help individuals explore distressing thoughts and feelings, such as those that are associated with pain.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed with chronic pain or a chronic pain condition or discussed pain management strategies (e.g., pain medication) with a doctor
- Experience pain on most days of the month for at least six months
- Able to read and write in English
Exclusion Criteria:
- Chronic pain directly caused by a terminal condition (e.g., stage 4 cancer)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-compassion writing
|
Participants are instructed to write about their chronic pain in a way that elicits self-compassion for 20 minutes once a week for three consecutive weeks.
|
|
Active Comparator: Self-efficacy writing
|
Participants are instructed to write about their chronic pain in a way that elicits self-efficacy for 20 minutes once a week for three consecutive weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Self-Compassion Scale
Time Frame: Change from Baseline in Self-Compassion Scale at 4 weeks
|
Change from Baseline in Self-Compassion Scale at 4 weeks
|
|
Change from Baseline in Pain Self-Efficacy Scale
Time Frame: Change from Baseline in Pain Self-Efficacy Scale at 4 weeks
|
Change from Baseline in Pain Self-Efficacy Scale at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Pain Severity
Time Frame: Change from Baseline in Pain Severity at 4 weeks
|
Pain severity is measured on a 10-point rating scale.
|
Change from Baseline in Pain Severity at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mary Ann Hoffman, PhD, University of Maryland, College Park
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
July 10, 2012
First Submitted That Met QC Criteria
July 10, 2012
First Posted (Estimated)
July 12, 2012
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 25, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 338877-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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