| Primary | Number of Participants Who Initiated Depression Treatment | 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.
| | Posted | | Count of Participants | | Participants | | within four weeks of engagement interview or control visit | | | | ID | Title | Description |
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| OG000 | Engagement Interview | 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. | | OG001 | Control Visit | 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. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Likelihood Ratio Test | Likelihood ratio test obtained from logistic regression analysis adjusting for site | 0.77 | a priori threshold for significance is 0.05. | | | | | | | | | | | | | Superiority | | |
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| Primary | QIDS-C Score | 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. | QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 of treatment | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). The CBT will be administered while the patient is undergoing hemodialysis; however, alternative arrangements will be made upon individual patient's preferences. Cognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. | | OG001 | Antidepressant Drug Therapy | 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. Antidepressant Drug Therapy: The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be 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 will help establish 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 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, |
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| Secondary | Number of Participants Who Accepted Depression Treatment | 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.
| 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. | Posted | | Count of Participants | | Participants | | within two weeks of engagement interview or control visit | | | | ID | Title | Description |
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| OG000 | Engagement Interview | 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. |
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| Secondary | BDI-II | Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | GAD-7 | Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Sheehan Disability Scale | range 0-30, higher scores indicate worse disability | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | SF-36 Energy/Vitality | Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Global Quality of Life Scale | range 0-10, higher scores indicate better quality of life | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Satisfaction With Life Scale | range 1-35, higher scores indicate better satisfaction | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Perceived Social Support | Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | PSQI | Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Exercise | Single item activity measure, range 1-6, higher indicates less activity | 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. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Percentage of Dialysis Treatment Sessions Skipped and/or Shortened | Treatment 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. | | Posted | | Mean | 95% Confidence Interval | percentage of sessions skipped/shortened | | Over 12 Weeks | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Percent Inter-dialytic Weight Gain | Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study | 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. | Posted | | Mean | 95% Confidence Interval | percentage of body weight | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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| Secondary | Serum Phosphorus Level | 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. | 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. | Posted | | Mean | 95% Confidence Interval | mg/dl | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cognitive Behavioral Therapy | 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). | | OG001 | Antidepressant Drug Therapy | 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. |
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