NCT00158275

Brief Summary

This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

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

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

September 7, 2005

Last Update Submit

October 11, 2017

Conditions

Back PainDepression

Keywords

Cognitive behavioral therapyProblem solving therapyCBT

Outcome Measures

Primary Outcomes (3)

  • Depression patient health questionnaire

    Measured at study entry, at the end of treatment, and 6 months after the end of treatment

  • Back pain limitations

    Measured at study entry, at the end of treatment, and 6 months after the end of treatment

  • Roland disability score

    Measured at study entry, at the end of treatment, and 6 months after the end of treatment

Study Arms (2)

Integrated Intervention

EXPERIMENTAL

Participants will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration.

Behavioral: Cognitive behavioral therapyDrug: AntidepressantsBehavioral: Problem solving therapy

Standard of Care

NO INTERVENTION

Participants will receive care as usual from their health care provider.

Interventions

Cognitive behavioral therapyBEHAVIORAL

Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.

Integrated Intervention
AntidepressantsDRUG

Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.

Integrated Intervention
Problem solving therapyBEHAVIORAL

Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.

Integrated Intervention

Eligibility Criteria

Age25 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Roland back pain score of 7 or greater
  • Diagnosis of major depression
  • Plan to stay enrolled in Group Health Cooperative for the duration of the study and 1 year after the study

You may not qualify if:

  • Prior surgery
  • Cauda equina syndrome (compression and paralysis of nerve roots)
  • Schizophrenia or bipolar disorder treatment within 2 years prior to study entry
  • Current or prior psychiatric or psychological care for back pain or depression
  • At high risk for suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Back PainDepression

Interventions

Cognitive Behavioral TherapyAntidepressive Agents

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPsychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Michael R. VonKorff, ScD

    Kaiser Permanente

    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

September 7, 2005

First Posted

September 12, 2005

Study Start

October 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)