Trial Outcomes & Findings for Cognitive Behavioral Therapy for Diabetic Neuropathic Pain (NCT NCT00829387)
NCT ID: NCT00829387
Last Updated: 2015-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
baseline to 12 weeks post-baseline [post-treatment]
Results posted on
2015-06-18
Participant Flow
Recruited June 2010 through March 2013 at VA Connecticut Healthcare System
Participant milestones
| Measure |
Behavioral
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Behavioral
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Disqualified by PI
|
1
|
0
|
Baseline Characteristics
Cognitive Behavioral Therapy for Diabetic Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Behavioral
n=23 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=24 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 7.58 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeks post-baseline [post-treatment]Population: Not everyone that completed baseline data completed 12 week post treatment assessments; making the number of participants analyzed different than reported for baseline data only.
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.
Outcome measures
| Measure |
Behavioral
n=20 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=21 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Intensity
|
-0.83 units on a scale
Interval -1.58 to -0.09
|
-0.45 units on a scale
Interval -1.23 to 0.33
|
PRIMARY outcome
Timeframe: baseline to 36 weeks post-baseline [follow-up]Population: Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.
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.
Outcome measures
| Measure |
Behavioral
n=17 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=14 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Intensity
|
-0.87 units on a scale
Interval -1.58 to -0.17
|
-0.89 units on a scale
Interval -1.65 to -0.12
|
SECONDARY outcome
Timeframe: baseline to 12 weeks post-baseline [post-treatment]Population: Not everyone that has baseline data completed 12-week post treatment data; making the number of participants analyzed different than reported for baseline data only.
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.
Outcome measures
| Measure |
Behavioral
n=20 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=21 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
The Interference Subscale of the Multidimensional Pain Inventory (MPI)
|
-0.03 units on a scale
Interval -0.58 to 0.52
|
0.31 units on a scale
Interval -0.28 to 0.91
|
SECONDARY outcome
Timeframe: baseline to 12 weeks post-baseline [post-treatment]Population: Not everyone that has baseline data completed 12-week post treatment; making the number of participants analyzed differant than reported for baseline data only.
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.
Outcome measures
| Measure |
Behavioral
n=20 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=21 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
|
-0.35 units on a scale
Interval -3.56 to 2.86
|
2 units on a scale
Interval -1.38 to 5.38
|
SECONDARY outcome
Timeframe: baseline to 36 weeks post-baseline [follow-up]Population: Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.
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.
Outcome measures
| Measure |
Behavioral
n=17 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=14 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
The Interference Subscale of the Multidimensional Pain Inventory (MPI)
|
0.06 units on a scale
Interval -0.48 to 0.61
|
0.99 units on a scale
Interval 0.35 to 1.62
|
SECONDARY outcome
Timeframe: baseline to 36 weeks post-baseline [follow-up]Population: Not everyone that has baseline data completed 36 week post treatment data; making the number of participants analyzed different than reported for baseline data only.
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
Outcome measures
| Measure |
Behavioral
n=17 Participants
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=14 Participants
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
|
.077 units on a scale
Interval -3.06 to 4.6
|
4.92 units on a scale
Interval 0.7 to 9.15
|
Adverse Events
Behavioral
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Educational
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral
n=23 participants at risk
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=24 participants at risk
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
General disorders
Hyperglycemia
|
4.3%
1/23 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/23 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Infections and infestations
Diabetic feet complications
|
0.00%
0/23 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 2 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Immune system disorders
Thymectomy
|
0.00%
0/23 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Cardiac disorders
Heart related issues
|
4.3%
1/23 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
8.3%
2/24 • Number of events 2 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
Other adverse events
| Measure |
Behavioral
n=23 participants at risk
Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.
CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist.
|
Educational
n=24 participants at risk
Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator
Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
|
|---|---|---|
|
Investigations
Biopsy
|
8.7%
2/23 • Number of events 2 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Infections and infestations
Infection
|
8.7%
2/23 • Number of events 2 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Surgical and medical procedures
Surgery or Procedure
|
4.3%
1/23 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
General disorders
ER due to pain
|
17.4%
4/23 • Number of events 6 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
0.00%
0/24 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
General disorders
Hypoglycemia
|
8.7%
2/23 • Number of events 2 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
0.00%
0/24 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/23 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
|
Psychiatric disorders
Suicidal Ideation (SI)
|
0.00%
0/23 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
4.2%
1/24 • Number of events 1 • AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Occurances of AEs were asking at weekly treatment sessions and confirmed in the electronic medical record for the previous week of the session. During 36 week follow up, the electronic medical record was reviewed from the last treatment session to the current date of the assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place