Trial Outcomes & Findings for Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention (NCT NCT01802554)

Results Overview

The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Change from Baseline CESD at 8-weeks

Results posted on

2016-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Information-Support (IS) Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided. Information Support (IS) : Supportive Psychotherapy and informational brochures	Pleasant Events Program (PEP) The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation. Pleasant Events Program (PEP) : Behavioral Activation Therapy
Overall Study STARTED	51	49
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pleasant Events Program (PEP) n=49 Participants The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.	Information Support (IS) n=51 Participants Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Age, Continuous	70.86 years STANDARD_DEVIATION 7.57 • n=5 Participants	71.33 years STANDARD_DEVIATION 9.08 • n=7 Participants	71.1 years STANDARD_DEVIATION 8.33 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline CESD at 8-weeks

The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.

Outcome measures

Outcome measures
Measure	Pleasant Events Program (PEP) n=49 Participants The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation. Pleasant Events Program (PEP): Behavioral Activation Therapy	Information-Support (IS) n=51 Participants Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided. Information Support (IS): Supportive Psychotherapy and informational brochures
Brief Center for Epidemiologic Studies Depression Scale (CESD)	-3.46 units on a scale Standard Error 0.75	-1.26 units on a scale Standard Error 0.74

PRIMARY outcome

Timeframe: Change from Baseline D-dimer at 8-weeks

D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease. Blood was collected by a research nurse in the caregivers' homes through a 22 gauge forearm catheter after a 20 minute rest. Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.

Outcome measures

Outcome measures
Measure	Pleasant Events Program (PEP) n=49 Participants The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation. Pleasant Events Program (PEP): Behavioral Activation Therapy	Information-Support (IS) n=51 Participants Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided. Information Support (IS): Supportive Psychotherapy and informational brochures
D-dimer	-92.22 ng/ml Standard Error 56.64	-61.0 ng/ml Standard Error 58.04

PRIMARY outcome

Timeframe: Change from Baseline IL-6 at 8-weeks

IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response. Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts. Higher concentrations of IL-6 raise CHD risk. Blood was collected by a research nurse in the caregivers' homes through a 22-gauge forearm catheter after a 20 min rest. Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.

Outcome measures

Outcome measures
Measure	Pleasant Events Program (PEP) n=49 Participants The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation. Pleasant Events Program (PEP): Behavioral Activation Therapy	Information-Support (IS) n=51 Participants Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided. Information Support (IS): Supportive Psychotherapy and informational brochures
Interleukin-6 (IL-6)	-0.58 pg/ml Standard Error 0.66	1.33 pg/ml Standard Error 0.65

SECONDARY outcome

Timeframe: Change from Baseline Positive Affect at 8-weeks

This scales contains ten items assessing Positive Affect. Items included are adjectives, such as "interested," "strong," and "inspired". Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Higher scores represent better outcomes.

Outcome measures

Outcome measures
Measure	Pleasant Events Program (PEP) n=49 Participants The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation. Pleasant Events Program (PEP): Behavioral Activation Therapy	Information-Support (IS) n=51 Participants Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided. Information Support (IS): Supportive Psychotherapy and informational brochures
Positive and Negative Affect Schedule	1.51 units on a scale Standard Error 0.82	0.23 units on a scale Standard Error 0.82

SECONDARY outcome

Timeframe: Change from Baseline Negative Affect at 8-weeks

This scales contains ten items assessing Negative Affect. Items included are adjectives, such as "distressed," "ashamed," and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Lower scores represent better outcomes.

Outcome measures

Outcome measures
Measure	Pleasant Events Program (PEP) n=49 Participants The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation. Pleasant Events Program (PEP): Behavioral Activation Therapy	Information-Support (IS) n=51 Participants Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided. Information Support (IS): Supportive Psychotherapy and informational brochures
Positive and Negative Affect Schedule	-3.43 units on a scale Standard Error 0.85	-0.61 units on a scale Standard Error 0.85

Adverse Events

Pleasant Events Program (PEP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Information-Support (IS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brent T Mausbach, PhD

University of California San Diego

Phone: 858-822-7529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place