Cognitive Behavioral Therapy for Diabetic Neuropathic Pain

• Sponsor: VA Connecticut Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00829387
• Collaborator: (none)
• Enrollment: 47
• Locations: 2
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 23.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathic Pain	Behavioral: CBT plus standard pharmaceutical care (CBT/SC); Behavioral: Diabetic Education plus standard pharmaceutical care (ED/SC)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioral Therapy for Diabetic Peripheral Neuropathic Pain
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.	Behavioral: CBT plus standard pharmaceutical care (CBT/SC); Ten sessions of individual treatment delivered by a doctoral level psychologist.; Other Names: cognitive behavioral therapy
Active Comparator: Educational Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator	Behavioral: 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.; Other Names: patient education

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale (NRS) Pain Intensity [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.

2. Numeric Rating Scale (NRS) Pain Intensity [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.

Secondary Outcome Measures

1. The Interference Subscale of the Multidimensional Pain Inventory (MPI) [baseline to 12 weeks post-baseline [post-treatment]]

   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.

2. Beck Depression Inventory (BDI) [baseline to 12 weeks post-baseline [post-treatment]]

   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.

3. The Interference Subscale of the Multidimensional Pain Inventory (MPI) [baseline to 36 weeks post-baseline [follow-up]]

   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.

4. Beck Depression Inventory (BDI) [baseline to 36 weeks post-baseline [follow-up]]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516
2	VA Connecticute Health Care System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• VA Connecticut Healthcare System

Investigators

• Principal Investigator: Robert D Kerns, PhD, VA Connecticut Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Connecticut Healthcare System
• ClinicalTrials.gov Identifier: NCT00829387
• Other Study ID Numbers: B6044R; RK0035
• First Posted: Jan 27, 2009
• Last Update Posted: Jun 18, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by VA Connecticut Healthcare System: Diabetes; Pain; Neuropathic Pain
• Additional relevant MeSH terms: Neuralgia; Diabetic Neuropathies

Study Results

Participant Flow

Recruitment Details	Recruited June 2010 through March 2013 at VA Connecticut Healthcare System

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	23	24
COMPLETED	20	21
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Behavioral	Educational	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	23	24	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (9.12)	60.8 (7.58)	62.3 (8.4)
Sex: Female, Male (Count of Participants)
Female	2 8.7%	1 4.2%	3 6.4%
Male	21 91.3%	23 95.8%	44 93.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 4.2%	1 2.1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 26.1%	6 25%	12 25.5%
White	16 69.6%	17 70.8%	33 70.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 4.3%	0 0%	1 2.1%

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Scale (NRS) Pain Intensity
Description	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.
Time Frame	baseline to 12 weeks post-baseline [post-treatment]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Measure Participants	20	21
Mean (95% Confidence Interval) [units on a scale]	-0.83	-0.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral, Educational
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -1.47 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	The Interference Subscale of the Multidimensional Pain Inventory (MPI)
Description	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.
Time Frame	baseline to 12 weeks post-baseline [post-treatment]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Measure Participants	20	21
Mean (95% Confidence Interval) [units on a scale]	-0.03	0.31

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral, Educational
	Comments	baseline to 36 weeks post-baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	Method	linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -1.15 to 0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Beck Depression Inventory (BDI)
Description	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.
Time Frame	baseline to 12 weeks post-baseline [post-treatment]

Outcome Measure Data

Analysis Population Description

Not everyone that has baseline data completed 12-week post treatment; making the number of participants analyzed differant than reported for baseline data only.

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Measure Participants	20	21
Mean (95% Confidence Interval) [units on a scale]	-0.35	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral, Educational
	Comments	baseline to 12 weeks post-baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.35
	Confidence Interval	(2-Sided) 95%; -7.02 to 2.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Numeric Rating Scale (NRS) Pain Intensity
Description	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.
Time Frame	baseline to 36 weeks post-baseline [follow-up]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Measure Participants	17	14
Mean (95% Confidence Interval) [units on a scale]	-0.87	-0.89

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral, Educational
	Comments	baseline to 12 weeks comparison
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.98
	Comments
	Method	linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -1.03 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	The Interference Subscale of the Multidimensional Pain Inventory (MPI)
Description	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.
Time Frame	baseline to 36 weeks post-baseline [follow-up]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Measure Participants	17	14
Mean (95% Confidence Interval) [units on a scale]	0.06	0.99

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral, Educational
	Comments	baseline to 36 weeks post-baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.92
	Confidence Interval	(2-Sided) 95%; -1.76 to -0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Beck Depression Inventory (BDI)
Description	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
Time Frame	baseline to 36 weeks post-baseline [follow-up]

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Behavioral	Educational
Arm/Group Description	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.	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.
Measure Participants	17	14
Mean (95% Confidence Interval) [units on a scale]	.077	4.92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral, Educational
	Comments	baseline to 36 weeks post-baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.16
	Confidence Interval	(2-Sided) 95%; -9.86 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	AEs were collected weekly during the 10 week treatment program and again at 36 weeks during follow up.
Adverse Event Reporting Description	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.
Arm/Group Title	Behavioral		Educational
Arm/Group Description	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.		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.
All Cause Mortality
	Behavioral		Educational
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Behavioral		Educational
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/23 (8.7%)		4/24 (16.7%)
Cardiac disorders
Heart related issues	1/23 (4.3%)	1	2/24 (8.3%)	2
General disorders
Hyperglycemia	1/23 (4.3%)	1	1/24 (4.2%)	1
Immune system disorders
Thymectomy	0/23 (0%)	0	1/24 (4.2%)	1
Infections and infestations
Diabetic feet complications	0/23 (0%)	0	1/24 (4.2%)	2
Injury, poisoning and procedural complications
Accident	0/23 (0%)	0	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	Behavioral		Educational
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/23 (39.1%)		5/24 (20.8%)
General disorders
ER due to pain	4/23 (17.4%)	6	0/24 (0%)	0
Hypoglycemia	2/23 (8.7%)	2	0/24 (0%)	0
Infections and infestations
Infection	2/23 (8.7%)	2	1/24 (4.2%)	1
Hepatitis C	0/23 (0%)	0	1/24 (4.2%)	1
Investigations
Biopsy	2/23 (8.7%)	2	1/24 (4.2%)	1
Psychiatric disorders
Suicidal Ideation (SI)	0/23 (0%)	0	1/24 (4.2%)	1
Surgical and medical procedures
Surgery or Procedure	1/23 (4.3%)	1	1/24 (4.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.