NCT00371865

Brief Summary

The purpose of the study is to test a brief, group-administered psychosocial intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

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

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

April 10, 2015

Completed
Last Updated

April 10, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

August 31, 2006

Results QC Date

February 2, 2015

Last Update Submit

March 26, 2015

Conditions

Intractable Pain

Keywords

Behavior therapyChronic painCognitive therapyMeditationMindfulnessPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory

    This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.

    12 weeks (post treatment)

Secondary Outcomes (4)

  • West Haven-Yale Multidimensional Pain Inventory - Activity Subscales

    12 weeks (post treatment)

  • SF-12

    12 weeks (post treatment)

  • Beck Depression Inventory

    12 weeks (post treatment)

  • Pain Anxiety Symptom Scale - 20

    12 weeks (post treatment)

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

8 group-administered sessions of Cognitive-Behavioral Therapy

Behavioral: Cognitive-behavioral therapy

Acceptance-Based Therapy

EXPERIMENTAL

8 group-administered sessions of Acceptance-based therapy

Behavioral: Acceptance-based therapy

Interventions

Cognitive-behavioral therapyBEHAVIORAL

8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving

Also known as: CBT
Cognitive Behavioral Therapy
Acceptance-based therapyBEHAVIORAL

8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action

Also known as: ACT
Acceptance-Based Therapy

Eligibility Criteria

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

You may qualify if:

  • Age 18 years old or older;
  • Proficient in English;
  • Willing and able to provide written informed consent (proposed informed consent form attached as Appendix A);
  • Diagnosis of chronic benign pain as a secondary condition associated with a primary impairment due to a traumatic injury or congenital or acquired disorder as verified by a study physician after a medical diagnostic evaluation;
  • Average pain severity rated \> 4/10 with resulting functional limitations; and
  • Pain duration of at least 6 months.

You may not qualify if:

  • Participation in psychotherapy for pain the past 2 months;
  • Serious, unstable medical illness for which inpatient hospitalization is likely over the next 3 months; and
  • The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's CPRS medical record or diagnosed during a structured psychiatric interview: 1) schizophrenia; 2) other psychotic disorder; 3) bipolar disorder; 4) organic mental disorder; 5) borderline or antisocial personality disorder; or 6) alcohol or substance abuse or dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Publications (2)

  • Wetherell JL, Afari N, Rutledge T, Sorrell JT, Stoddard JA, Petkus AJ, Solomon BC, Lehman DH, Liu L, Lang AJ, Atkinson HJ. A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Pain. 2011 Sep;152(9):2098-2107. doi: 10.1016/j.pain.2011.05.016. Epub 2011 Jun 17.

    PMID: 21683527RESULT

  • Mostoufi SM, Afari N, Ahumada SM, Reis V, Wetherell JL. Health and distress predictors of heart rate variability in fibromyalgia and other forms of chronic pain. J Psychosom Res. 2012 Jan;72(1):39-44. doi: 10.1016/j.jpsychores.2011.05.007. Epub 2011 Jun 30.

    PMID: 22200521RESULT

MeSH Terms

Conditions

Pain, IntractableChronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Julie Wetherell, PI
Organization
VA San Diego Healthcare System
Julie.Wetherell@va.gov
858-552-8585

Study Officials

  • Julie L Wetherell, PhD

    VA San Diego Healthcare System, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2008

Study Completion

September 1, 2009

Last Updated

April 10, 2015

Results First Posted

April 10, 2015

Record last verified: 2015-03

Locations

US(1)