PainCAMMPSNCT01757301
Comprehensive vs. Assisted Management of Mood and Pain Symptoms
A study testing Assisted Symptom Management (ASM) and Comprehensive Symptom Management (CSM) in people with Pain and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Pain is the most common presenting symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. All three conditions are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Depression, Anxiety
- What is being tested?
- Assisted Symptom Management (ASM) and Comprehensive Symptom Management (CSM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2014to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Individuals must be patients of the Richard L. Roudebush VAMC in Indianapolis, Indiana Individuals will be eligible if they have pain plus comorbid anxiety and/or depression.
- Pain must:
- be musculoskeletal, either localized (in the arms, legs, back, or neck) or widespread (fibromyalgia)
- have persisted 3 months or longer despite a trial of at least one analgesic medication
- at least moderate in severity, defined as a Brief Pain Inventory average severity score of 5 or greater
- Depression must be of at least moderate severity, defined as a PHQ-8 score of 10 or greater with either depressed mood and/or anhedonia being endorsed, OR
- Anxiety must be of at least moderate severity, defined as a GAD-7 score of 10 or greater, OR
- A composite mood score (anxiety and depression) of sufficient severity, defined as a GAD-7 + PHQ-8 score of 12 or greater.
Who cannot join
- Individuals will be excluded if they:
- do not speak English
- have moderately severe cognitive impairment as defined by a validated 6-item cognitive screener
- have schizophrenia, bipolar disorder or other psychosis
- have other severe mental illness and/or high risk of suicide
- are pregnant
- have an anticipated life expectancy of less than 12 months. Patients who are on antidepressants but still meet the PHQ-9 and/or GAD-7 entry criterion for clinical depression and/or anxiety may still be eligible if they have been on an adequate dose of the antidepressant for an adequate duration of time (i.e., 12 weeks).
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial
Pain is the most common presenting symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. All three conditions are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are frequently comorbid with one another and have reciprocal negative effects on treatment response and additive effects on adverse health outcomes. The PAD triad is especially burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and other anxiety disorders. The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of Veterans suffering from with pain plus comorbid anxiety and/or depression.
Read the detailed description
The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of Veterans suffering from with pain plus comorbid anxiety and/or depression.
This is a single-site study enrolling Veterans. Patients followed in primary care clinics at the Roudebush VAMC will be eligible if they have clinically significant levels of pain plus comorbid anxiety and/or depression. A total of 300 eligible patients who provide informed consent will be randomized to one of two treatment arms. One group (n=150) will receive assisted symptom management (ASM) consisting of automated symptom monitoring by interactive voice recording or Internet and prompted pain self-management guided by symptom levels. The second group (n=150) will receive comprehensive symptom management (CSM) which combines ASM with optimized medication management delivered by a nurse-physician specialist team and facilitated mental health care. This team will partner with both VA primary care physicians and psychologists embedded in primary care to monitor and adjust treatments using evidence-based analgesic and antidepressant algorithms, reinforced self-management, and care coordination. The investigators postulate that although both interventions are likely to be beneficial, CSM will be superior to ASM.
In short, this trial compares: 1) usual care plus assisted symptom management (ASM) vs. 2) usual care plus ASM plus optimized medication and care management and facilitated mental health care (CSM). Outcomes will be assessed at baseline, 1, 3, 6, and 12 months. The primary outcome is a composite pain-anxiety-depression severity score. Secondary outcomes include individual pain, anxiety, and depression scores; functional status and health-related quality of life; treatment satisfaction; and perceived barriers and facilitators of the CSM and ASM interventions. The rationale for ASM is preliminary evidence of its effectiveness and its lower use of resources. The rationale for CSM is that the addition of optimized medication management, facilitated mental health care, and coordination with both primary care physicians/Patient Aligned Care Teams (PACTs) and psychologists for the PAD symptoms should substantially enhance the benefits of ASM.
- Conditions
- Pain, Depression, Anxiety, Musculoskeletal, Fibromyalgia
- Being tested
- Assisted Symptom Management (ASM), Comprehensive Symptom Management (CSM)
- Keywords
- Pain, Depression, Anxiety, Musculoskeletal, Fibromyalgia
- Medical subject headings
- Pain, Depression, Anxiety Disorders, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Symptom Management (ASM)Other
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
Comprehensive Symptom Management (CSM)Other
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
| Study group | Role | What they receive |
|---|---|---|
| Assisted Symptom Management (ASM) | Active comparator | There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Receives: Other: Assisted Symptom Management (ASM) |
| Comprehensive Symptom Management (CSM) | Experimental | This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only). Receives: Other: Comprehensive Symptom Management (CSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Z-score of Pain-anxiety-depression Severity
The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
Measured: 12 months
Secondary outcomes (4)
Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)
The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Measured: 12 months
Patient Health Questionnaire 9-item Depression Scale (PHQ-9)
The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes.
Measured: 12 months
Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)
The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes.
Measured: 12 months
Brief Pain Inventory (BPI)
The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study start2 Jan 2014
- Primary completion31 Jul 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kurt Kroenke, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757301
- Sponsor's protocol ID
- IIR 12-095
- Acronym
- CAMMPS
- Status last verified
- Mar 2019
- First submitted
- 20 Dec 2012
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Toussaint A, Kroenke K, Baye F, Lourens S. Comparing the Patient Health Questionnaire - 15 and the Somatic Symptom Scale - 8 as measures of somatic symptom burden. J Psychosom Res. 2017 Oct;101:44-50. doi: 10.1016/j.jpsychores.2017.08.002. Epub 2017 Aug 2.
PubMed 28867423Kroenke K, Evans E, Weitlauf S, McCalley S, Porter B, Williams T, Baye F, Lourens SG, Matthias MS, Bair MJ. Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial: Study design and sample characteristics. Contemp Clin Trials. 2018 Jan;64:179-187. doi: 10.1016/j.cct.2017.10.006. Epub 2017 Oct 12.
PubMed 29031492
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial
- ClinicalTrials.gov ID
- NCT01757301
- Acronym / sponsor ID
- CAMMPS / IIR 12-095
- Conditions
- Pain, Depression, Anxiety, Musculoskeletal, Fibromyalgia
- Keywords
- Pain, Depression, Anxiety, Musculoskeletal, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jan 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Posted 13 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is the most common presenting symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. All three conditions are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are frequently comorbid with one another and have reciprocal negative effects on treatment response and additive effects on adverse health outcomes. The PAD triad is especially burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and other anxiety disorders. The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of Veterans suffering from with pain plus comorbid anxiety and/or depression.
Detailed description
The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of Veterans suffering from with pain plus comorbid anxiety and/or depression.
This is a single-site study enrolling Veterans. Patients followed in primary care clinics at the Roudebush VAMC will be eligible if they have clinically significant levels of pain plus comorbid anxiety and/or depression. A total of 300 eligible patients who provide informed consent will be randomized to one of two treatment arms. One group (n=150) will receive assisted symptom management (ASM) consisting of automated symptom monitoring by interactive voice recording or Internet and prompted pain self-management guided by symptom levels. The second group (n=150) will receive comprehensive symptom management (CSM) which combines ASM with optimized medication management delivered by a nurse-physician specialist team and facilitated mental health care. This team will partner with both VA primary care physicians and psychologists embedded in primary care to monitor and adjust treatments using evidence-based analgesic and antidepressant algorithms, reinforced self-management, and care coordination. The investigators postulate that although both interventions are likely to be beneficial, CSM will be superior to ASM.
In short, this trial compares: 1) usual care plus assisted symptom management (ASM) vs. 2) usual care plus ASM plus optimized medication and care management and facilitated mental health care (CSM). Outcomes will be assessed at baseline, 1, 3, 6, and 12 months. The primary outcome is a composite pain-anxiety-depression severity score. Secondary outcomes include individual pain, anxiety, and depression scores; functional status and health-related quality of life; treatment satisfaction; and perceived barriers and facilitators of the CSM and ASM interventions. The rationale for ASM is preliminary evidence of its effectiveness and its lower use of resources. The rationale for CSM is that the addition of optimized medication management, facilitated mental health care, and coordination with both primary care physicians/Patient Aligned Care Teams (PACTs) and psychologists for the PAD symptoms should substantially enhance the benefits of ASM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted Symptom Management (ASM) | Active comparator | Other: Assisted Symptom Management (ASM)There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. |
| Comprehensive Symptom Management (CSM) | Experimental | Other: Comprehensive Symptom Management (CSM)This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals must be patients of the Richard L. Roudebush VAMC in Indianapolis, Indiana Individuals will be eligible if they have pain plus comorbid anxiety and/or depression.
- Pain must:
- Depression must be of at least moderate severity, defined as a PHQ-8 score of 10 or greater with either depressed mood and/or anhedonia being endorsed, OR
- Anxiety must be of at least moderate severity, defined as a GAD-7 score of 10 or greater, OR
- A composite mood score (anxiety and depression) of sufficient severity, defined as a GAD-7 + PHQ-8 score of 12 or greater.
Key exclusion criteria (7 listed)
- do not speak English
- have moderately severe cognitive impairment as defined by a validated 6-item cognitive screener
- have schizophrenia, bipolar disorder or other psychosis
- have other severe mental illness and/or high risk of suicide
- are pregnant
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 |
|---|---|---|
| Assisted Symptom Management (ASM)There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. | Other | Assisted Symptom Management (ASM) |
| Comprehensive Symptom Management (CSM)This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only). | Other | Comprehensive Symptom Management (CSM) |
Primary outcome
Composite Z-score of Pain-anxiety-depression Severity
Time frame: 12 months
The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
4 secondary outcomes
Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)
Time frame: 12 months
Patient Health Questionnaire 9-item Depression Scale (PHQ-9)
Time frame: 12 months
Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)
Time frame: 12 months
Brief Pain Inventory (BPI)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28867423Toussaint A, Kroenke K, Baye F, Lourens S. Comparing the Patient Health Questionnaire - 15 and the Somatic Symptom Scale - 8 as measures of somatic symptom burden. J Psychosom Res. 2017 Oct;101:44-50. doi: 10.1016/j.jpsychores.2017.08.002. Epub 2017 Aug 2.
- Background: PubMed 29031492Kroenke K, Evans E, Weitlauf S, McCalley S, Porter B, Williams T, Baye F, Lourens SG, Matthias MS, Bair MJ. Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial: Study design and sample characteristics. Contemp Clin Trials. 2018 Jan;64:179-187. doi: 10.1016/j.cct.2017.10.006. Epub 2017 Oct 12.
- Individual participant dataSharing planned: Undecided
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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.
Kurt Kroenke, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted Symptom Management (ASM) and Comprehensive Symptom Management (CSM) in people with Pain and Depression, run by VA Office of Research and Development 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 8 inclusion and 7 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 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Z-score of Pain-anxiety-depression Severity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01757301, which also lists 2 linked publications.
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 Mar 2019.