DepressionNCT01055665
Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain
An observational study of Depression, run by Mayo Clinic.
Trial summary
The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- cognitive behavior therapy
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jun 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with chronic pain and depressive symptoms in a pain rehabilitation program.
Who may be able to join
- 18 and over with chronic pain and
- score of 27 or higher on CES-D scale
Who cannot join
- 17 or younger, no chronic pain,
- cognitively unable to participate in programming
About this study
The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.
Read the detailed description
Subjects will need to complete two questionnaires on admission and on discharge from the PRC program to measure self-efficacy and depression. The first is the Pain Self-Efficacy Scale (PSEQ) which is a measure of self-efficacy in persons with chronic pain. The second questionnaire is the Center for Epidemiologic Studies Depression Scale (CES-D) which is a measure of depressive symptoms in persons with chronic pain. Both scales will also be used for clinical information. Persons who score 27 or higher on the CES-D will be approached for potential consent to this evidence based project. Each patient in the PRC will participate in up to 6 CBT sessions but only persons who, upon admission, score 27 or greater on the CES-D will be studied for any changes in scores from admission to discharge.
- Conditions
- Depression
- Being tested
- cognitive behavior therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavior therapyOther
6 cognitive behavior therapy groups
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on a depression and self-efficacy scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Nash, Mayo Clinic
- Investigators
- Virginia R Nash, RN, MS, CNS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055665
- Sponsor's protocol ID
- 09-003969
- Status last verified
- May 2012
- First submitted
- 21 Jan 2010
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain
- ClinicalTrials.gov ID
- NCT01055665
- Acronym / sponsor ID
- 09-003969
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Jan 2010 (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.
The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.
Detailed description
Subjects will need to complete two questionnaires on admission and on discharge from the PRC program to measure self-efficacy and depression. The first is the Pain Self-Efficacy Scale (PSEQ) which is a measure of self-efficacy in persons with chronic pain. The second questionnaire is the Center for Epidemiologic Studies Depression Scale (CES-D) which is a measure of depressive symptoms in persons with chronic pain. Both scales will also be used for clinical information. Persons who score 27 or higher on the CES-D will be approached for potential consent to this evidence based project. Each patient in the PRC will participate in up to 6 CBT sessions but only persons who, upon admission, score 27 or greater on the CES-D will be studied for any changes in scores from admission to discharge.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with chronic pain and depressive symptoms in a pain rehabilitation program.
Key inclusion criteria (2 listed)
- 18 and over with chronic pain and
- score of 27 or higher on CES-D scale
Key exclusion criteria (2 listed)
- 17 or younger, no chronic pain,
- cognitively unable to participate in programming
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 behavior therapy6 cognitive behavior therapy groups | Other | – |
Primary outcome
Change on a depression and self-efficacy scale
Time frame: 3 weeks
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 3 May 2012.
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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.
Virginia R Nash, RN, MS, CNS principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Mayo Clinic.
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 2 inclusion and 2 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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Change on a depression and self-efficacy scale (time frame: 3 weeks). 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 3 May 2012.