Chronic PainNCT01639196
Brief Online Intervention for Chronic Pain
A study testing Self-compassion writing and Self-efficacy writing in people with Chronic Pain, run by University of Maryland, College Park.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-compassion writing and Self-efficacy writing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic pain directly caused by a terminal condition (e.g., stage 4 cancer)
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Self-compassion writing, Self-efficacy writing
- Keywords
- Chronic pain, Psychological adjustment, Writing, Brief intervention, Online, Internet interventions
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion writingOther
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.
Self-efficacy writingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion writing | Experimental | Not described Receives: Other: Self-compassion writing |
| Self-efficacy writing | Active comparator | Not described Receives: Other: Self-efficacy writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Compassion Scale
Measured: Change from Baseline in Self-Compassion Scale at 4 weeks
Change from Baseline in Pain Self-Efficacy Scale
Measured: Change from Baseline in Pain Self-Efficacy Scale at 4 weeks
Secondary outcomes (1)
Change from Baseline in Pain Severity
Pain severity is measured on a 10-point rating scale.
Measured: Change from Baseline in Pain Severity at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Ann Hoffman, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639196
- Sponsor's protocol ID
- 338877-1
- Status last verified
- May 2023
- First submitted
- 10 Jul 2012
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expressive Writing Paradigm: A Study of Therapeutic Effectiveness for Chronic Pain
- ClinicalTrials.gov ID
- NCT01639196
- Acronym / sponsor ID
- 338877-1
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Psychological adjustment, Writing, Brief intervention, Online, Internet interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion writing | Experimental | Other: Self-compassion writing |
| Self-efficacy writing | Active comparator | Other: Self-efficacy writing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic pain directly caused by a terminal condition (e.g., stage 4 cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion writingParticipants 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. | Other | Self-compassion writing |
| Self-efficacy writingParticipants 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. | Other | Self-efficacy writing |
Primary outcome
Change from Baseline in Self-Compassion Scale
Time frame: 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
1 secondary outcome
Change from Baseline in Pain Severity
Time frame: Change from Baseline in Pain Severity at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ann Hoffman, PhD principal investigator
University of Maryland, College Park
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion writing and Self-efficacy writing in people with Chronic Pain, run by University of Maryland, College Park.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Self-Compassion Scale (time frame: Change from Baseline in Self-Compassion Scale at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.