Trial Outcomes & Findings for A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND} (NCT NCT02358343)
NCT ID: NCT02358343
Last Updated: 2019-07-23
Results Overview
The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition. This will be defined as one of the following: * Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia. * Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
184 participants
Primary outcome timeframe
within four weeks of engagement interview or control visit
Results posted on
2019-07-23
Participant Flow
Participants screened at 3 sites in the United States.
Participant milestones
| Measure |
Engagement Interview
An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home.
|
Control Visit
A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT is administered while the patient is undergoing hemodialysis unless alternative arrangements preferred by participant. During the course of intervention, study subjects undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).
|
Antidepressant Drug Therapy
Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This protocol establishes the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.
|
Observational Cohort
Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C.
|
|---|---|---|---|---|---|
|
Screening Intervention
STARTED
|
92
|
92
|
0
|
0
|
0
|
|
Screening Intervention
COMPLETED
|
86
|
84
|
0
|
0
|
0
|
|
Screening Intervention
NOT COMPLETED
|
6
|
8
|
0
|
0
|
0
|
|
Comparative Efficacy Trial / Observation
STARTED
|
0
|
0
|
60
|
60
|
20
|
|
Comparative Efficacy Trial / Observation
COMPLETED
|
0
|
0
|
55
|
58
|
18
|
|
Comparative Efficacy Trial / Observation
NOT COMPLETED
|
0
|
0
|
5
|
2
|
2
|
Reasons for withdrawal
| Measure |
Engagement Interview
An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home.
|
Control Visit
A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT is administered while the patient is undergoing hemodialysis unless alternative arrangements preferred by participant. During the course of intervention, study subjects undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).
|
Antidepressant Drug Therapy
Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This protocol establishes the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.
|
Observational Cohort
Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C.
|
|---|---|---|---|---|---|
|
Screening Intervention
Death
|
0
|
2
|
0
|
0
|
0
|
|
Screening Intervention
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Screening Intervention
Determined Ineligible
|
5
|
6
|
0
|
0
|
0
|
|
Comparative Efficacy Trial / Observation
Death
|
0
|
0
|
2
|
0
|
0
|
|
Comparative Efficacy Trial / Observation
Withdrawal by Subject
|
0
|
0
|
2
|
2
|
2
|
|
Comparative Efficacy Trial / Observation
Administrative Withdrawal
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Screening Intervention Period
Baseline characteristics by cohort
| Measure |
Engagement Interview
n=92 Participants
An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home.
|
Control Visit
n=92 Participants
A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Cognitive Behavioral Therapy
n=60 Participants
Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2).
|
Antidepressant Drug Therapy
n=60 Participants
Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects.
|
Obsevational Cohort
n=20 Participants
Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 14 • n=92 Participants • Screening Intervention Period
|
53 years
STANDARD_DEVIATION 12 • n=92 Participants • Screening Intervention Period
|
50 years
STANDARD_DEVIATION 13 • n=60 Participants • Comparative Efficacy Trial / Observation Period
|
53 years
STANDARD_DEVIATION 12 • n=60 Participants • Comparative Efficacy Trial / Observation Period
|
53 years
STANDARD_DEVIATION 13 • n=20 Participants • Comparative Efficacy Trial / Observation Period
|
52 years
STANDARD_DEVIATION 13 • n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Sex: Female, Male
Female
|
42 Participants
n=92 Participants • Screening Intervention Period
|
35 Participants
n=92 Participants • Screening Intervention Period
|
27 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
25 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
7 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
59 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Sex: Female, Male
Male
|
50 Participants
n=92 Participants • Screening Intervention Period
|
57 Participants
n=92 Participants • Screening Intervention Period
|
33 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
35 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
13 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
81 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=92 Participants • Screening Intervention Period
|
22 Participants
n=92 Participants • Screening Intervention Period
|
14 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
20 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
5 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
39 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=92 Participants • Screening Intervention Period
|
69 Participants
n=92 Participants • Screening Intervention Period
|
46 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
39 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
15 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
100 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=92 Participants • Screening Intervention Period
|
1 Participants
n=92 Participants • Screening Intervention Period
|
0 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
1 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
0 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
1 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=92 Participants • Screening Intervention Period
|
8 Participants
n=92 Participants • Screening Intervention Period
|
3 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
6 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
1 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
10 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=92 Participants • Screening Intervention Period
|
5 Participants
n=92 Participants • Screening Intervention Period
|
1 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
2 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
3 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
6 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=92 Participants • Screening Intervention Period
|
3 Participants
n=92 Participants • Screening Intervention Period
|
4 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
0 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
0 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
4 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=92 Participants • Screening Intervention Period
|
32 Participants
n=92 Participants • Screening Intervention Period
|
19 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
15 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
6 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
40 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
White
|
48 Participants
n=92 Participants • Screening Intervention Period
|
29 Participants
n=92 Participants • Screening Intervention Period
|
24 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
28 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
8 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
60 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=92 Participants • Screening Intervention Period
|
3 Participants
n=92 Participants • Screening Intervention Period
|
2 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
0 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
2 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
4 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=92 Participants • Screening Intervention Period
|
12 Participants
n=92 Participants • Screening Intervention Period
|
7 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
9 Participants
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
0 Participants
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
16 Participants
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
|
Dialysis Vintage
|
32 months
n=92 Participants • Screening Intervention Period
|
28 months
n=92 Participants • Screening Intervention Period
|
30 months
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
32 months
n=60 Participants • Comparative Efficacy Trial / Observation Period
|
21 months
n=20 Participants • Comparative Efficacy Trial / Observation Period
|
31 months
n=140 Participants • Comparative Efficacy Trial / Observation Period
|
PRIMARY outcome
Timeframe: within four weeks of engagement interview or control visitThe primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition. This will be defined as one of the following: * Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia. * Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia.
Outcome measures
| Measure |
Engagement Interview
n=86 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=84 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Number of Participants Who Initiated Depression Treatment
|
57 Participants
|
54 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 12 of treatmentPopulation: QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome.
The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups.
Outcome measures
| Measure |
Engagement Interview
n=55 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=58 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
n=18 Participants
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
QIDS-C Score
|
8.1 score on a scale
Interval 6.7 to 9.4
|
5.9 score on a scale
Interval 4.8 to 7.1
|
7.9 score on a scale
Interval 6.1 to 9.8
|
SECONDARY outcome
Timeframe: within two weeks of engagement interview or control visitPopulation: Screening Intervention Period. Two participants who died both consented to treatment within the clinical trial and therefore were counted as non-missing for accepting treatment outcome by definition even though they did not complete the study.
The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment. This will be measured by the patient's intent and will be defined as one of the following: * Signing the informed consent to be randomly assigned to individual CBT or drug therapy * Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community. * Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia.
Outcome measures
| Measure |
Engagement Interview
n=86 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=86 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Number of Participants Who Accepted Depression Treatment
|
70 Participants
|
70 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 5 participants in the CBT arm and 2 participants in the drug arm.
Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression
Outcome measures
| Measure |
Engagement Interview
n=48 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=51 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
BDI-II
|
18.7 score on a scale
Interval 15.2 to 22.2
|
14.1 score on a scale
Interval 11.2 to 17.0
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 4 participants in the drug arm.
Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety
Outcome measures
| Measure |
Engagement Interview
n=50 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=49 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
GAD-7
|
7.5 score on a scale
Interval 5.9 to 9.2
|
6.5 score on a scale
Interval 4.9 to 8.1
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 1 participant in the drug arm.
range 0-30, higher scores indicate worse disability
Outcome measures
| Measure |
Engagement Interview
n=50 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=52 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Sheehan Disability Scale
|
15.2 score on a scale
Interval 12.8 to 17.6
|
11.0 score on a scale
Interval 8.7 to 13.3
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the CBT arm and 4 participants in the drug arm.
Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality
Outcome measures
| Measure |
Engagement Interview
n=51 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=49 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
SF-36 Energy/Vitality
|
39.2 score on a scale
Interval 33.4 to 44.9
|
53 score on a scale
Interval 45.7 to 60.3
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks.
range 0-10, higher scores indicate better quality of life
Outcome measures
| Measure |
Engagement Interview
n=53 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=53 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Global Quality of Life Scale
|
5.6 score on a scale
Interval 5.0 to 6.2
|
6.4 score on a scale
Interval 5.8 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm.
range 1-35, higher scores indicate better satisfaction
Outcome measures
| Measure |
Engagement Interview
n=53 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=52 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Satisfaction With Life Scale
|
16.8 score on a scale
Interval 14.9 to 18.6
|
20.1 score on a scale
Interval 17.9 to 22.3
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the drug arm.
Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support
Outcome measures
| Measure |
Engagement Interview
n=53 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=51 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Perceived Social Support
|
4.7 score on a scale
Interval 4.3 to 5.1
|
4.6 score on a scale
Interval 4.2 to 5.1
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 11 participants in the CBT arm and 13 participants in the drug arm.
Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality
Outcome measures
| Measure |
Engagement Interview
n=42 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=40 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
PSQI
|
9.5 score on a scale
Interval 8.1 to 10.8
|
6.8 score on a scale
Interval 5.5 to 8.1
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm.
Single item activity measure, range 1-6, higher indicates less activity
Outcome measures
| Measure |
Engagement Interview
n=53 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=52 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Exercise
|
3.5 score on a scale
Interval 3.1 to 4.0
|
3.2 score on a scale
Interval 2.8 to 3.7
|
—
|
SECONDARY outcome
Timeframe: Over 12 WeeksTreatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment.
Outcome measures
| Measure |
Engagement Interview
n=55 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=58 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Percentage of Dialysis Treatment Sessions Skipped and/or Shortened
|
22.2 percentage of sessions skipped/shortened
Interval 16.4 to 28.0
|
17.3 percentage of sessions skipped/shortened
Interval 13.0 to 21.6
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: In addition to participants withdrawn / died, 11 participants were missing average weight gain at week 12: 3 in CBT arm and 8 in Drug arm.
Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study
Outcome measures
| Measure |
Engagement Interview
n=52 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=50 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Percent Inter-dialytic Weight Gain
|
2.6 percentage of body weight
Interval 2.3 to 3.0
|
2.9 percentage of body weight
Interval 2.5 to 3.4
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: In addition to participants withdrawn / died, 8 participants were missing serum phosphorus level at week 12: 3 in CBT arm and 5 in Drug arm.
Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study.
Outcome measures
| Measure |
Engagement Interview
n=52 Participants
Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.
Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
Control Visit
n=53 Participants
Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial.
|
Observational Cohort
Participants not accepting treatment but consented to be followed.
|
|---|---|---|---|
|
Serum Phosphorus Level
|
6.1 mg/dl
Interval 5.6 to 6.6
|
6.3 mg/dl
Interval 5.9 to 6.8
|
—
|
Adverse Events
Cognitive Behavioral Therapy
Serious events: 11 serious events
Other events: 4 other events
Deaths: 2 deaths
Antidepressant Drug Therapy
Serious events: 14 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Behavioral Therapy
n=60 participants at risk
The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2).
|
Antidepressant Drug Therapy
n=60 participants at risk
The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Cardiac disorders
Afib
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Cardiac disorders
Syncope
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Cardiac disorders
Volume overload
|
3.3%
2/60 • Number of events 2 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
3.3%
2/60 • Number of events 2 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Cardiac disorders
Cardiovascular event
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Infections and infestations
Catheter infection
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Infections and infestations
Healthcare-associated pneumonia
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 2 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Musculoskeletal and connective tissue disorders
Leg fracture
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Musculoskeletal and connective tissue disorders
Leg amputation
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Nervous system disorders
Vertigo, facial palsy (shingles)
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Nervous system disorders
Convulsions
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
3.3%
2/60 • Number of events 2 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Surgical and medical procedures
Kidney transplant
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Surgical and medical procedures
Arteriovenous grafts vascular access surgery
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Vascular disorders
Leg ischemia
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Vascular disorders
Arteriovenous graft malfunction
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Vascular disorders
Renal artery aneurysm
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Blood and lymphatic system disorders
Unknown System Organ Class
|
1.7%
1/60 • Number of events 1 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
Other adverse events
| Measure |
Cognitive Behavioral Therapy
n=60 participants at risk
The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2).
|
Antidepressant Drug Therapy
n=60 participants at risk
The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.
|
|---|---|---|
|
Cardiac disorders
Dizziness
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
8.3%
5/60 • Number of events 5 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
4/60 • Number of events 4 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
10.0%
6/60 • Number of events 7 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
|
General disorders
Fatigue
|
0.00%
0/60 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
8.3%
5/60 • Number of events 6 • Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).
Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.
|
Additional Information
Tessa Rue, Biostatistician
Center for Biomedical Statistics, University of Washington
Phone: 206-543-4246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place