Brief Online Intervention for Chronic Pain | NCT01639196

Studies
Brief Online Intervention for Chronic Pain

NCT01639196

Sponsor

University of Maryland, College Park

Status

Completed

Last Update Posted

May 30, 2023Actual

Enrollment

93Actual

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Self-compassion writing
Self-efficacy writing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jul 10, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2023

Last Update Posted Date

May 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-compassion writing	Experimental		Other: Self-compassion writing
Self-efficacy writing	Active Comparator		Other: Self-efficacy writing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-compassion writing	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Self-Compassion Scale		Change from Baseline in Self-Compassion Scale at 4 weeks
Change from Baseline in Pain Self-Efficacy Scale		Change from Baseline in Pain Self-Efficacy Scale at 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Pain Severity	Pain severity is measured on a 10-point rating scale.	Change from Baseline in Pain Severity at 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Ann Hoffman, PhD	University of Maryland, College Park	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided