NCT01639196

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable chronic-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

July 10, 2012

Last Update Submit

May 25, 2023

Conditions

Keywords

Chronic painPsychological adjustmentWritingBrief interventionOnlineInternet interventions

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Change from Baseline in Pain Severity

    Change from Baseline in Pain Severity at 4 weeks

Study Arms (2)

Self-compassion writing

EXPERIMENTAL
Other: Self-compassion writing

Self-efficacy writing

ACTIVE COMPARATOR
Other: Self-efficacy writing

Interventions

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-compassion 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.

Self-efficacy writing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic pain directly caused by a terminal condition (e.g., stage 4 cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Ann Hoffman, PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 12, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 30, 2023

Record last verified: 2023-05