NCT01498510

Brief Summary

The purpose of this study is to develop and evaluate an innovative, web-based self-management intervention for opioid-treated chronic pain patients who display aberrant drug-related behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

December 21, 2011

Last Update Submit

May 23, 2017

Conditions

Chronic Pain

Keywords

chronic paincognitive behavior therapyweb-based intervention

Outcome Measures

Primary Outcomes (3)

  • pain severity, as measured by the Multidimensional Pain Inventory (MPI)

    6 months

  • pain interference, as measured by the Multidimensional Pain Inventory (MPI)

    6 months

  • aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)

    6 months

Secondary Outcomes (2)

  • pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)

    6 months

  • Emergency Department visits for pain

    6 months

Other Outcomes (6)

  • General Activities, Social Activities, Activities Away from Home, Household Chores

    6 months

  • psychiatric distress, assessed via the SCL-10R

    6 months

  • positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)

    6 months

  • +3 more other outcomes

Study Arms (2)

treatment-as-usual (TAU)

NO INTERVENTION

The standard medical treatment provided to chronic pain patients at the study site pain specialty practice

TAU plus web-based intervention

EXPERIMENTAL

An interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that teaches chronic pain patients with aberrant behavior self-management skills to reduce pain severity and medication misuse and improve functioning

Behavioral: Web-based CBT for chronic pain

Interventions

Web-based CBT for chronic painBEHAVIORAL

An interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that is designed to train chronic pain patients in self-management skills to reduce pain and aberrant behavior and improve functioning

Also known as: cognitive behavior therapy (CBT), web-based intervention
TAU plus web-based intervention

Eligibility Criteria

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

You may qualify if:

  • moderate-to-severe pain for at least 3 months (score of 5 or greater on Brief Pain Inventory)
  • patient at pain treatment program study site
  • prescribed opioid analgesics
  • aberrant drug-related behavior within the past 30 days (endorsing 4 or more items on the Current Opioid Misuse Measure)

You may not qualify if:

  • primary headache or cancer pain
  • scheduled for major surgery within the next 6 months
  • described by physician as likely to die within the next year
  • plans to move out of the area within the next 3 months
  • insufficient ability to provide informed consent or insufficient English to participate in consent process, assessments or computer intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andrew Rosenblum, Ph.D.

    National Development and Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR

  • Lisa A. Marsch, Ph.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

February 1, 2012

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

US(1)