Back PainNCT00158275
Combined Interventions for Treating Depression and Chronic Back Pain
A study testing Cognitive behavioral therapy, Antidepressants and Problem solving therapy in people with Back Pain and Depression, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- Back Pain, Depression
- What is being tested?
- Cognitive behavioral therapy, Antidepressants and Problem solving therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Care for Depression and Chronic Back Pain
This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.
Read the detailed description
The relationship between depression and back pain is complex. Depression is the most common mental condition associated with chronic back pain. Despite this relationship, many patients with depression and back pain seek treatment only for one of the two conditions, which can worsen the untreated condition. An intervention that reduces the symptoms of both depression and back pain is needed. This study will determine the effectiveness of an integrated intervention in reducing both back pain and depression symptoms.
Participants will be randomly assigned to receive either an integrated intervention or standard of care for 6 months. Participants in the integrated intervention group 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; the time of tapering will depend on participant response to treatment and will be at the investigator's discretion. Depression and back pain symptoms will be assessed in all participants at study entry, at the end of treatment, and 6 months after the end of treatment. The study entry and study completion assessments will occur during study visits. The last assessment will be a telephone interview.
- Conditions
- Back Pain, Depression
- Being tested
- Cognitive behavioral therapy, Antidepressants, Problem solving therapy
- Keywords
- Cognitive behavioral therapy, Problem solving therapy, CBT
- Medical subject headings
- Back Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.
AntidepressantsDrug
Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.
Problem solving therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive behavioral therapy; Drug: Antidepressants; Behavioral: Problem solving therapy |
| Standard of Care | No intervention | Participants will receive care as usual from their health care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression patient health questionnaire
Measured: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Back pain limitations
Measured: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Roland disability score
Measured: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael R. VonKorff, ScD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158275
- Sponsor's protocol ID
- R34MH070642
- Other IDs
- R34MH070642, DSIR 83-ATAS
- Status last verified
- Oct 2017
- First submitted
- 7 Sep 2005
- Last updated
- 13 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care for Depression and Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00158275
- Acronym / sponsor ID
- R34MH070642
- Conditions
- Back Pain, Depression
- Keywords
- Cognitive behavioral therapy, Problem solving therapy, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.
Detailed description
The relationship between depression and back pain is complex. Depression is the most common mental condition associated with chronic back pain. Despite this relationship, many patients with depression and back pain seek treatment only for one of the two conditions, which can worsen the untreated condition. An intervention that reduces the symptoms of both depression and back pain is needed. This study will determine the effectiveness of an integrated intervention in reducing both back pain and depression symptoms.
Participants will be randomly assigned to receive either an integrated intervention or standard of care for 6 months. Participants in the integrated intervention group 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; the time of tapering will depend on participant response to treatment and will be at the investigator's discretion. Depression and back pain symptoms will be assessed in all participants at study entry, at the end of treatment, and 6 months after the end of treatment. The study entry and study completion assessments will occur during study visits. The last assessment will be a telephone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Intervention | Experimental | Behavioral: Cognitive behavioral therapy, Drug: Antidepressants, Behavioral: Problem solving therapyParticipants 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. |
| Standard of Care | No intervention | –Participants will receive care as usual from their health care provider. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyCognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts. | Behavioural | Integrated Intervention |
| AntidepressantsAntidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities. | Drug | Integrated Intervention |
| Problem solving therapyProblem 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. | Behavioural | Integrated Intervention |
Primary outcome
Depression patient health questionnaire
Time frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Back pain limitations
Time frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Roland disability score
Time frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R. VonKorff, ScD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy, Antidepressants and Problem solving therapy in people with Back Pain and Depression, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression patient health questionnaire (time frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.