Trial Outcomes & Findings for eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk (NCT NCT04437485)

Last Updated: 2023-11-02

Results Overview

Fasting blood samples were collected, and whole blood and plasma aliquots were frozen. Hemoglobin A1c will be measured by a standard method. A1c is the primary outcome because: (1) it is the gold standard measure of glycemia and a common surrogate endpoint, (2) it strongly predicts future diabetes, (3) interventions decreasing A1c improve clinical diabetes endpoints, and (4) diabetes prevention interventions targeting glycemic control result in lower rates of progression from prediabetes to type 2 diabetes. Higher hemoglobin A1c values indicate greater diabetes risk.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

6 months

Results posted on

2023-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	eIMPACT-DM Intervention eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) internet and telephonic CBT for depression and (2) select antidepressant medications in an algorithm optimized for diabetes risk reduction. A multidisciplinary team delivers established depression treatments consistent with patient preference. Good Days Ahead (GDA; MindStreet, Inc.) is an empirically supported internet CBT for depression that uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. GDA sessions occurred at a location with internet access selected by the patient or the PI's lab. Problem Solving Treatment in Primary Care (PST-PC) is an empirically supported CBT. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We delivered PST-PC by phone. Regarding medications, we first considered all FDA-approved antidepressants and excluded those with weight gain effects and those rarely used in primary care. We then made bupropion and fluoxetine our first-line and second-line antidepressants, given their association with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team made recommendations to the patient's PCP, who wrote prescriptions. Our team and the PCP collaboratively managed pharmacotherapy.	Active Control Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff). Active Control: (1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Overall Study STARTED	24	22
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Values are from observed dataset. 39 out of 46 participants had observed data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	eIMPACT-DM Intervention n=24 Participants eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) internet and telephonic CBT for depression and (2) select antidepressant medications in an algorithm optimized for diabetes risk reduction. A multidisciplinary team delivers established depression treatments consistent with patient preference. Good Days Ahead (GDA; MindStreet, Inc.) is an empirically supported internet CBT for depression that uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. GDA sessions occurred at a location with internet access selected by the patient or the PI's lab. Problem Solving Treatment in Primary Care (PST-PC) is an empirically supported CBT. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We delivered PST-PC by phone. Regarding medications, we first considered all FDA-approved antidepressants and excluded those with weight gain effects and those rarely used in primary care. We then made bupropion and fluoxetine our first-line and second-line antidepressants, given their association with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team made recommendations to the patient's PCP, who wrote prescriptions. Our team and the PCP collaboratively managed pharmacotherapy.	Active Control n=22 Participants Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff). Active Control: (1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.	Total n=46 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 11.8 • n=24 Participants	50.7 years STANDARD_DEVIATION 10.4 • n=22 Participants	49.6 years STANDARD_DEVIATION 11.1 • n=46 Participants
Sex: Female, Male Female	20 Participants n=24 Participants	16 Participants n=22 Participants	36 Participants n=46 Participants
Sex: Female, Male Male	4 Participants n=24 Participants	6 Participants n=22 Participants	10 Participants n=46 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=24 Participants	1 Participants n=22 Participants	4 Participants n=46 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=24 Participants	21 Participants n=22 Participants	42 Participants n=46 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=22 Participants	0 Participants n=46 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=24 Participants	0 Participants n=22 Participants	1 Participants n=46 Participants
Race (NIH/OMB) Asian	1 Participants n=24 Participants	1 Participants n=22 Participants	2 Participants n=46 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=22 Participants	0 Participants n=46 Participants
Race (NIH/OMB) Black or African American	16 Participants n=24 Participants	17 Participants n=22 Participants	33 Participants n=46 Participants
Race (NIH/OMB) White	4 Participants n=24 Participants	4 Participants n=22 Participants	8 Participants n=46 Participants
Race (NIH/OMB) More than one race	2 Participants n=24 Participants	0 Participants n=22 Participants	2 Participants n=46 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=22 Participants	0 Participants n=46 Participants
Region of Enrollment United States	24 participants n=24 Participants	22 participants n=22 Participants	46 participants n=46 Participants
Depressive Symptoms	1.82 Score on a scale STANDARD_DEVIATION 0.83 • n=24 Participants	1.73 Score on a scale STANDARD_DEVIATION 0.91 • n=22 Participants	1.78 Score on a scale STANDARD_DEVIATION 0.91 • n=46 Participants
Hemoglobin A1c	4.97 % (percentage of total hemoglobin) STANDARD_DEVIATION 0.44 • n=21 Participants • Values are from observed dataset. 39 out of 46 participants had observed data.	4.91 % (percentage of total hemoglobin) STANDARD_DEVIATION 0.32 • n=18 Participants • Values are from observed dataset. 39 out of 46 participants had observed data.	4.94 % (percentage of total hemoglobin) STANDARD_DEVIATION 0.38 • n=39 Participants • Values are from observed dataset. 39 out of 46 participants had observed data.
HOMA-IR score	2.99 HOMA-IR index STANDARD_DEVIATION 1.69 • n=21 Participants • Values are from observed dataset. 39 out of 46 participants had observed data.	2.10 HOMA-IR index STANDARD_DEVIATION 0.97 • n=18 Participants • Values are from observed dataset. 39 out of 46 participants had observed data.	2.58 HOMA-IR index STANDARD_DEVIATION 1.46 • n=39 Participants • Values are from observed dataset. 39 out of 46 participants had observed data.

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	eIMPACT-DM Intervention n=21 Participants eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) internet and telephonic CBT for depression and (2) select antidepressant medications in an algorithm optimized for diabetes risk reduction. A multidisciplinary team delivers established depression treatments consistent with patient preference. Good Days Ahead (GDA; MindStreet, Inc.) is an empirically supported internet CBT for depression that uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. GDA sessions occurred at a location with internet access selected by the patient or the PI's lab. Problem Solving Treatment in Primary Care (PST-PC) is an empirically supported CBT. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We delivered PST-PC by phone. Regarding medications, we first considered all FDA-approved antidepressants and excluded those with weight gain effects and those rarely used in primary care. We then made bupropion and fluoxetine our first-line and second-line antidepressants, given their association with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team made recommendations to the patient's PCP, who wrote prescriptions. Our team and the PCP collaboratively managed pharmacotherapy.	Active Control n=18 Participants Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff). Active Control: (1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Hemoglobin A1c at 6 Months	4.94 % (percentage of total hemoglobin) Standard Deviation 0.47	4.88 % (percentage of total hemoglobin) Standard Deviation 0.38

SECONDARY outcome

Timeframe: 6 months

Higher HOMA-IR scores indicate greater insulin resistance. Homeostatic Model of Assessment-Insulin Resistance (HOMA-IR) scores were derived from fasting glucose and insulin values measured by standard assays. HOMA-IR score is an established index of insulin resistance that correlates highly with the more invasive euglycemic clamp and is appropriate for assessing change. Higher HOMA-IR scores indicate greater insulin resistance.

Outcome measures

Outcome measures
Measure	eIMPACT-DM Intervention n=21 Participants eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) internet and telephonic CBT for depression and (2) select antidepressant medications in an algorithm optimized for diabetes risk reduction. A multidisciplinary team delivers established depression treatments consistent with patient preference. Good Days Ahead (GDA; MindStreet, Inc.) is an empirically supported internet CBT for depression that uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. GDA sessions occurred at a location with internet access selected by the patient or the PI's lab. Problem Solving Treatment in Primary Care (PST-PC) is an empirically supported CBT. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We delivered PST-PC by phone. Regarding medications, we first considered all FDA-approved antidepressants and excluded those with weight gain effects and those rarely used in primary care. We then made bupropion and fluoxetine our first-line and second-line antidepressants, given their association with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team made recommendations to the patient's PCP, who wrote prescriptions. Our team and the PCP collaboratively managed pharmacotherapy.	Active Control n=18 Participants Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff). Active Control: (1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Homeostatic Model of Assessment-Insulin Resistance (HOMA-IR) Score at 6 Months	3.48 HOMA-IR index Standard Deviation 2.16	2.38 HOMA-IR index Standard Deviation 0.93

SECONDARY outcome

Timeframe: 6 months

Population: Missing data was handled using within subject mean imputation when \< 25% of the data was missing.

Participants completed the reliable and valid Hopkins Symptom Checklist-20 (SCL-20) to assess depressive symptoms. Total scores (mean of items responses, range: 0-4) were computed, with higher scores indicating greater depressive symptoms.

Outcome measures

Outcome measures
Measure	eIMPACT-DM Intervention n=20 Participants eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) internet and telephonic CBT for depression and (2) select antidepressant medications in an algorithm optimized for diabetes risk reduction. A multidisciplinary team delivers established depression treatments consistent with patient preference. Good Days Ahead (GDA; MindStreet, Inc.) is an empirically supported internet CBT for depression that uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. GDA sessions occurred at a location with internet access selected by the patient or the PI's lab. Problem Solving Treatment in Primary Care (PST-PC) is an empirically supported CBT. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We delivered PST-PC by phone. Regarding medications, we first considered all FDA-approved antidepressants and excluded those with weight gain effects and those rarely used in primary care. We then made bupropion and fluoxetine our first-line and second-line antidepressants, given their association with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team made recommendations to the patient's PCP, who wrote prescriptions. Our team and the PCP collaboratively managed pharmacotherapy.	Active Control n=18 Participants Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff). Active Control: (1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Depressive Symptoms	1.11 Score on a scale Standard Deviation 0.73	1.58 Score on a scale Standard Deviation 0.89

Adverse Events

eIMPACT-DM Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Active Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	eIMPACT-DM Intervention n=24 participants at risk eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) internet and telephonic CBT for depression and (2) select antidepressant medications in an algorithm optimized for diabetes risk reduction. A multidisciplinary team delivers established depression treatments consistent with patient preference. Good Days Ahead (GDA; MindStreet, Inc.) is an empirically supported internet CBT for depression that uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. GDA sessions occurred at a location with internet access selected by the patient or the PI's lab. Problem Solving Treatment in Primary Care (PST-PC) is an empirically supported CBT. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We delivered PST-PC by phone. Regarding medications, we first considered all FDA-approved antidepressants and excluded those with weight gain effects and those rarely used in primary care. We then made bupropion and fluoxetine our first-line and second-line antidepressants, given their association with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team made recommendations to the patient's PCP, who wrote prescriptions. Our team and the PCP collaboratively managed pharmacotherapy.	Active Control n=22 participants at risk Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff). Active Control: (1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
Cardiac disorders Blood pressure above the call order levels	4.2% 1/24 • Number of events 1 • The adverse event monitoring period for each participant was 6 months, corresponding to the time from each participant's pre-treatment visit (i.e., randomization date) to the completion of their post-treatment visit.	13.6% 3/22 • Number of events 3 • The adverse event monitoring period for each participant was 6 months, corresponding to the time from each participant's pre-treatment visit (i.e., randomization date) to the completion of their post-treatment visit.

Additional Information

Jesse C. Stewart, PhD., Principal Investigator

Indiana University-Purdue University Indianapolis (IUPUI)

Phone: 317-274-6761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place