Diabetic Peripheral Neuropathic PainNCT00829387
Cognitive Behavioral Therapy for Diabetic Neuropathic Pain
A study testing CBT plus standard pharmaceutical care (CBT/SC) and Diabetic Education plus standard pharmaceutical care (ED/SC) in people with Diabetic Peripheral Neuropathic Pain, run by VA Connecticut Healthcare System at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with diabetic peripheral neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- CBT plus standard pharmaceutical care (CBT/SC) and Diabetic Education plus standard pharmaceutical care (ED/SC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Dec 2013
- 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
- Established diagnosis of type 2 diabetes mellitus according to American Diabetes Association criteria
- History of daily lower extremity pain or discomfort (burning, tingling or other paresthesias) for a period of at least 3 months immediately prior to enrollment,
- Presence of neuropathy, as determined by evaluation at the VACHS Neuromuscular Disease and Neuropathy Clinic at the time of the baseline examination
- Judgment of the study endocrinologist (EH) that the patient is not experiencing a paradoxical precipitation of neuropathy following institution of good control which can be expected to resolve spontaneously
- Confirmation of the study neurologists that pain is not attributable to other medical conditions that could mimic DPNP (e.g., HIV, Hepatitis C, cryoglobulinemia, pernicious anemia, untreated hypothyroidism)
- Documentation of treatment of neuropathic pain with the maximum dose of one of the medications identified as a first line or second line treatment in either VA guidelines28 or other published consensus recommendations27 with maximum dose defined as either the maximum allowable dose or the maximum tolerated dose for the recommended duration of an adequate trial, unless otherwise contraindicated or patient refusal)
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- Continued use of a guideline endorsed medication for neuropathic pain (unless otherwise contraindicated or patient refusal)
- Continued refractory pain despite pharmacological intervention as described above (as determined by a pain intensity score at least 4 on a 0-10 numeric rating scale)
- No medical condition that could impair the subject's ability to participate (e.g., unstable angina, severe COPD, limb amputation, intermittent claudication)
- No psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair subjects' ability to participate as defined by their responses to the SCID and BDI (e.g., presence of major Depressive Disorder and BDI score 30 or greater or presence of suicidal intent; presence of these conditions will require immediate medical/psychiatric attention to assure safety and institution of appropriate treatment)
- Absence of dementia defined by a score of 24 or greater on the Folstein Mini-Mental Status Exam (MMSE)
- Urine toxicology screen confirming the absence of illegal substances or non-prescribed opioids
- Provision of participant consent to consult their primary care physician and review their medical records to ensure that eligibility criteria are met,
- Availability of a touch-tone telephone in the participant's residence to facilitate the provision of IVR data
- English fluency sufficient to participate meaningfully in treatment. Prospective participants' medical and pharmacy records will be reviewed to determine whether they meet the 4th and 5th criteria listed above.
Who cannot join
- No history of Type 2 diabetes mellitus
- Any life threatening illnesses or acute physical disease
- Any current psychiatric condition (psychosis, substance abuse/dependence)
- Any current suicidal thoughts or ideations
- The presence of profound cognitive impairment rendering successful participation in CBT or ED impossible
- prior or current psychological treatment for chronic pain
- The presence of physical disabilities resulting in an inability to attend treatment sessions and/or inability to participate in telephone interventions (e.g., severe dysarthria)
- No access to touch tone telephone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
VA Connecticute Health Care System
West Haven, Connecticut, 06516
About this study
Official title: Cognitive Behavioral Therapy for Diabetic Peripheral Neuropathic Pain
The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with diabetic peripheral neuropathic pain.
Read the detailed description
Research Design: A randomized controlled design will be employed in which CBT plus standard pharmaceutical care (CBT/SC) is compared to an educational intervention plus standard pharmaceutical care (ED/SC) treatment condition. A target sample size of approximately 215 participants will be recruited. Participants will be randomized in equal numbers to the two conditions.
Methodology: Study participants will be evaluated pre-treatment (baseline), 12 weeks post-baseline (post-treatment) and at 36 weeks post-baseline (follow-up). Baseline assessment will include a physical examination to confirm the diagnosis of diabetic neuropathy. The primary outcome measure will be pain intensity. Secondary outcome measures will be pain quality, pain-related disability, and physical and emotional functioning. Measures of treatment feasibility will also be examined. CBT and ED will be provided in 10 weekly, individual treatment sessions of 60 minutes. The effectiveness of the randomization process will be tested by examining potential between condition differences on important demographic and pain-relevant descriptive variables, as well as on the dependent measures. Analyses of covariance will be employed to determine whether statistically significant differences in the two treatment conditions are observed at the 12- and 36-week intervals controlling for pretreatment/baseline scores on these same measures and other covariates identified previously.
Hypotheses Treatment outcome hypotheses
- Persons with DPNP receiving cognitive behavioral therapy with standard pharmaceutical care (CBT/SC), relative to those receiving diabetic education with standard pharmaceutical care (ED/SC), will demonstrate, immediately following treatment improvements on several measures of the experience of persistent pain, including pain intensity, pain quality, pain-related disability, sleep quality, physical functioning, and emotional functioning, and they will have fewer added pain medication doses and concomitant pain treatments.
- Persons with DPNP receiving CBT/SC, relative to those receiving ED/SC, will demonstrate maintenance of these benefits at a 36-week post-baseline follow-up period.
Treatment satisfaction and feasibility hypotheses
- Persons with DPNP receiving CBT/SC, relative to those receiving ED/SC, will demonstrate, immediately following treatment higher ratings of treatment credibility and treatment satisfaction, and higher rates of treatment session attendance and lower rates of treatment dropout.
Exploratory secondary analyses of predictors of treatment participation and outcome
- Increased readiness to adopt a self-management approach will be positively associated with higher ratings of treatment credibility and treatment satisfaction, higher rates of treatment session attendance and lower rates of treatment dropout, and for participants in the CBT condition only, higher rates of adherence to therapist recommendations for pain coping skill practice and other intersession goals.
- Increased readiness to adopt a self-management approach over the course of treatment will be associated with improved outcomes following treatment.
- Increased readiness to adopt a self-management approach at treatment termination will significantly predict maintenance of treatment benefits on follow-up.
- Persons with medical and psychiatric comorbidities will demonstrate, relative to those without these comorbidities, less improved outcomes, lower rates of treatment session attendance and higher rates of treatment dropout, and for the CBT condition only, lower rates of adherence to therapist recommendations for pain coping skill practice and other intersession goals.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- CBT plus standard pharmaceutical care (CBT/SC), Diabetic Education plus standard pharmaceutical care (ED/SC)
- Keywords
- Diabetes, Pain, Neuropathic Pain
- Medical subject headings
- Diabetes Mellitus, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT plus standard pharmaceutical care (CBT/SC)Behavioural
Also called cognitive behavioral therapy
Ten sessions of individual treatment delivered by a doctoral level psychologist.
Diabetic Education plus standard pharmaceutical care (ED/SC)Behavioural
Also called patient education
Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist. Receives: Behavioral: CBT plus standard pharmaceutical care (CBT/SC) |
| Educational | Active comparator | Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator Receives: Behavioral: Diabetic Education plus standard pharmaceutical care (ED/SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Pain Intensity
Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms
Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported.
Measured: baseline to 12 weeks post-baseline [post-treatment]
Numeric Rating Scale (NRS) Pain Intensity
Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms
Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity.
Measured: baseline to 36 weeks post-baseline [follow-up]
Secondary outcomes (4)
The Interference Subscale of the Multidimensional Pain Inventory (MPI)
Secondary outcome is the estimated mean change in pain interference from baseline to 12 weeks post-baseline comparing CBT to Education.
Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning.
Measured: baseline to 12 weeks post-baseline [post-treatment]
Beck Depression Inventory (BDI)
Estimated mean change in depressive symptoms from baseline to 12 weeks post-baseline combaring CBT and ED.
0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed.
Measured: baseline to 12 weeks post-baseline [post-treatment]
The Interference Subscale of the Multidimensional Pain Inventory (MPI)
Secondary outcome is the estimated mean change in pain interference from baseline to 36 weeks post-baseline comparing CBT to Education.
Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning.
Measured: baseline to 36 weeks post-baseline [follow-up]
Beck Depression Inventory (BDI)
Estimated mean change in depressive symptoms from baseline to 36 weeks post-baseline comparing CBT to Education.
0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed
Measured: baseline to 36 weeks post-baseline [follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert D Kerns, PhD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829387
- Sponsor's protocol ID
- B6044R
- Other IDs
- RK0035
- Status last verified
- Jun 2015
- First submitted
- 24 Jan 2009
- Last updated
- 18 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00829387
- Acronym / sponsor ID
- B6044R
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Keywords
- Diabetes, Pain, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 18 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with diabetic peripheral neuropathic pain.
Detailed description
Research Design: A randomized controlled design will be employed in which CBT plus standard pharmaceutical care (CBT/SC) is compared to an educational intervention plus standard pharmaceutical care (ED/SC) treatment condition. A target sample size of approximately 215 participants will be recruited. Participants will be randomized in equal numbers to the two conditions.
Methodology: Study participants will be evaluated pre-treatment (baseline), 12 weeks post-baseline (post-treatment) and at 36 weeks post-baseline (follow-up). Baseline assessment will include a physical examination to confirm the diagnosis of diabetic neuropathy. The primary outcome measure will be pain intensity. Secondary outcome measures will be pain quality, pain-related disability, and physical and emotional functioning. Measures of treatment feasibility will also be examined. CBT and ED will be provided in 10 weekly, individual treatment sessions of 60 minutes. The effectiveness of the randomization process will be tested by examining potential between condition differences on important demographic and pain-relevant descriptive variables, as well as on the dependent measures. Analyses of covariance will be employed to determine whether statistically significant differences in the two treatment conditions are observed at the 12- and 36-week intervals controlling for pretreatment/baseline scores on these same measures and other covariates identified previously.
Hypotheses Treatment outcome hypotheses
- Persons with DPNP receiving cognitive behavioral therapy with standard pharmaceutical care (CBT/SC), relative to those receiving diabetic education with standard pharmaceutical care (ED/SC), will demonstrate, immediately following treatment improvements on several measures of the experience of persistent pain, including pain intensity, pain quality, pain-related disability, sleep quality, physical functioning, and emotional functioning, and they will have fewer added pain medication doses and concomitant pain treatments.
- Persons with DPNP receiving CBT/SC, relative to those receiving ED/SC, will demonstrate maintenance of these benefits at a 36-week post-baseline follow-up period.
Treatment satisfaction and feasibility hypotheses
- Persons with DPNP receiving CBT/SC, relative to those receiving ED/SC, will demonstrate, immediately following treatment higher ratings of treatment credibility and treatment satisfaction, and higher rates of treatment session attendance and lower rates of treatment dropout.
Exploratory secondary analyses of predictors of treatment participation and outcome
- Increased readiness to adopt a self-management approach will be positively associated with higher ratings of treatment credibility and treatment satisfaction, higher rates of treatment session attendance and lower rates of treatment dropout, and for participants in the CBT condition only, higher rates of adherence to therapist recommendations for pain coping skill practice and other intersession goals.
- Increased readiness to adopt a self-management approach over the course of treatment will be associated with improved outcomes following treatment.
- Increased readiness to adopt a self-management approach at treatment termination will significantly predict maintenance of treatment benefits on follow-up.
- Persons with medical and psychiatric comorbidities will demonstrate, relative to those without these comorbidities, less improved outcomes, lower rates of treatment session attendance and higher rates of treatment dropout, and for the CBT condition only, lower rates of adherence to therapist recommendations for pain coping skill practice and other intersession goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: CBT plus standard pharmaceutical care (CBT/SC)Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist. |
| Educational | Active comparator | Behavioral: Diabetic Education plus standard pharmaceutical care (ED/SC)Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Established diagnosis of type 2 diabetes mellitus according to American Diabetes Association criteria
- History of daily lower extremity pain or discomfort (burning, tingling or other paresthesias) for a period of at least 3 months immediately prior to enrollment,
- Presence of neuropathy, as determined by evaluation at the VACHS Neuromuscular Disease and Neuropathy Clinic at the time of the baseline examination
- Judgment of the study endocrinologist (EH) that the patient is not experiencing a paradoxical precipitation of neuropathy following institution of good control which can be expected to resolve spontaneously
- Confirmation of the study neurologists that pain is not attributable to other medical conditions that could mimic DPNP (e.g., HIV, Hepatitis C, cryoglobulinemia, pernicious anemia, untreated hypothyroidism)
Key exclusion criteria (8 listed)
- No history of Type 2 diabetes mellitus
- Any life threatening illnesses or acute physical disease
- Any current psychiatric condition (psychosis, substance abuse/dependence)
- Any current suicidal thoughts or ideations
- The presence of profound cognitive impairment rendering successful participation in CBT or ED impossible
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 |
|---|---|---|
| CBT plus standard pharmaceutical care (CBT/SC)Also: cognitive behavioral therapyTen sessions of individual treatment delivered by a doctoral level psychologist. | Behavioural | Behavioral |
| Diabetic Education plus standard pharmaceutical care (ED/SC)Also: patient educationTen individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator. | Behavioural | Educational |
Primary outcome
Numeric Rating Scale (NRS) Pain Intensity
Time frame: baseline to 12 weeks post-baseline [post-treatment]
Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported.
Numeric Rating Scale (NRS) Pain Intensity
Time frame: baseline to 36 weeks post-baseline [follow-up]
Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity.
4 secondary outcomes
The Interference Subscale of the Multidimensional Pain Inventory (MPI)
Time frame: baseline to 12 weeks post-baseline [post-treatment]
Beck Depression Inventory (BDI)
Time frame: baseline to 12 weeks post-baseline [post-treatment]
The Interference Subscale of the Multidimensional Pain Inventory (MPI)
Time frame: baseline to 36 weeks post-baseline [follow-up]
Beck Depression Inventory (BDI)
Time frame: baseline to 36 weeks post-baseline [follow-up]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
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SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
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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.
Robert D Kerns, PhD principal investigator
VA Connecticut Healthcare System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT plus standard pharmaceutical care (CBT/SC) and Diabetic Education plus standard pharmaceutical care (ED/SC) in people with Diabetic Peripheral Neuropathic Pain, run by VA Connecticut Healthcare System at 2 sites 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 15 inclusion and 8 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 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 18 Jun 2015). 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?
Numeric Rating Scale (NRS) Pain Intensity (time frame: baseline to 12 weeks post-baseline [post-treatment]). The study lists 2 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 18 Jun 2015; AzTrials last refreshed its copy on 5 Nov 2026.