Depression, End Stage Renal Disease
Conditions
Keywords
Comorbid Depression, Major Depressive Disorder, Dysthymia, Cognitive Behavioral therapy (CBT), Sertraline, Engagement Interview, End Stage Renal Disease (ESRD), Hemodialysis
Brief summary
Patients whose kidneys fail generally require dialysis treatments to sustain life. The ability of patients to make major adjustments in their lives for dialysis is hampered by depression that affects almost one-quarter of such individuals. There are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment, psychotherapy and anti-depressant drug therapy. To fill this important gap in the investigators knowledge, the investigators propose to undertake (1) a randomized controlled clinical trial of 200 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from among individuals receiving care in 50 dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants. In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined. The two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.
Detailed description
BACKGROUND Patients with end-stage renal disease undergoing maintenance hemodialysis (HD) have to adjust to complex treatment regimens, and experience frequent care transitions. This is compounded by a four-fold higher prevalence of comorbid depression than in the general population, which is strongly associated with poor patient-centered outcomes. Yet, depression is often not diagnosed when present, not treated when identified, and many HD patients are reluctant to accept treatment. This is likely a result of lack of high-quality evidence for the efficacy of different treatment options for comorbid depression in HD patients. OBJECTIVES Conduct an open-label, randomized controlled clinical trial among HD patients with comorbid depression to (1) compare the efficacy of an engagement interview with usual care in increasing acceptability of treatment (n=200); and (2) compare the efficacy of 12 weeks of cognitive behavioral therapy (CBT) or anti-depressant drug therapy (sertraline) for reducing the severity of depressive symptoms, and other meaningful outcomes (n=120). METHODS HD patients in up to 50 dialysis facilities in three different regions (Albuquerque, NM; Dallas, TX; Seattle, WA) will be pre-screened for the presence of clinically significant depressive symptoms. Patients with a confirmed diagnosis of major depression or dysthymia will be randomly assigned to an engagement interview or usual care to determine efficacy in increasing acceptability of treatment (n=200). Individuals who agree to treatment will be randomly assigned to individual CBT or drug therapy. CBT will be administered in a dialysis facility by a trained therapist. Sertraline will be titrated to the maximum tolerated dose using Measurement Based Care, a model of shared-decision-making. Patient-reported outcomes will be measured by a single assessor for all three sites, blinded to the treatment assignment. The primary efficacy measure will be a change in severity of depressive symptoms; secondary outcome measures will assess other important patient-reported outcomes such as somatic symptom burden, functioning, and adherence with dialysis treatment, diet, and medications. The longitudinal evolution of symptoms in patients who refuse to accept any treatment either within or outside the clinical trial will also be studied (n=40). PATIENT OUTCOMES (PROJECTED) This study will provide answers to three questions faced by HD patients with clinically significant depressive symptoms: (1) Given my preferences, what should I expect will happen to me?; (2) What are my options, and what are the potential benefits and harms of these options?; and (3) What can I do to improve the outcomes that are most important to me? Oversight of study will be provided by separate Patient Council and Stakeholder Council to align with PCORI's mission of generating high-integrity, evidence-based information from research guided by patients, caregivers, and broader health care community.
Interventions
BEHAVIORALEngagement 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.
BEHAVIORALCognitive 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. During the course of intervention, study subjects will 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).
DRUGAntidepressant 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, will be continued for the remaining 6 weeks.
Sponsors
University of Texas
University of New Mexico
Patient-Centered Outcomes Research Institute
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 years; 2. Undergoing thrice-weekly maintenance HD for ≥ 3 months; 3. Able to speak either English or Spanish; 4. BDI-II score ≥ 15; and 5. Meets diagnostic criteria for either current major depressive episode or dysthymia on the MINI.
Exclusion criteria
1. Active suicidal intent; 2. Ongoing psychotherapy or current treatment with certain anti-depressant drugs; 3. Evidence of cognitive impairment on Mini-Cog; 4. Present or past psychosis or bipolar disorder I or II on the MINI; 5. Alcohol or substance abuse diagnosed on the MINI or history of such abuse in the past three months; 6. Life expectancy \< 3 months, in the judgment of the site principal investigator; 7. Anticipated to receive living related donor kidney transplantation within 3 months; 8. Pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control; 9. Clinical and/or laboratory evidence of chronic liver disease; 10. History of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding; 11. Current use of class I anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and St. John's wort; and 12. Known hypersensitivity to sertraline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Initiated Depression Treatment | within four weeks of engagement interview or control visit | 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. |
| QIDS-C Score | Week 12 of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GAD-7 | Week 12 | Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety |
| Sheehan Disability Scale | Week 12 | range 0-30, higher scores indicate worse disability |
| SF-36 Energy/Vitality | Week 12 | Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality |
| Global Quality of Life Scale | Week 12 | range 0-10, higher scores indicate better quality of life |
| Satisfaction With Life Scale | Week 12 | range 1-35, higher scores indicate better satisfaction |
| Number of Participants Who Accepted Depression Treatment | within two weeks of engagement interview or control visit | 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. |
| PSQI | Week 12 | Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality |
| Exercise | Week 12 | Single item activity measure, range 1-6, higher indicates less activity |
| Percentage of Dialysis Treatment Sessions Skipped and/or Shortened | Over 12 Weeks | 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. |
| Percent Inter-dialytic Weight Gain | Week 12 | Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study |
| Serum Phosphorus Level | Week 12 | 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. |
| Perceived Social Support | Week 12 | Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support |
| BDI-II | Week 12 | Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression |
Countries
United States
Participant flow
Recruitment details
Participants screened at 3 sites in the United States.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| 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. | 92 |
| 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). | 60 |
| 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. | 60 |
| Obsevational Cohort Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study. | 20 |
| Total | 324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Comparative Efficacy Trial / Observation | Administrative Withdrawal | 0 | 0 | 1 | 0 | 0 |
| Comparative Efficacy Trial / Observation | Death | 0 | 0 | 2 | 0 | 0 |
| Comparative Efficacy Trial / Observation | Withdrawal by Subject | 0 | 0 | 2 | 2 | 2 |
| Screening Intervention | Death | 0 | 2 | 0 | 0 | 0 |
| Screening Intervention | Determined Ineligible | 5 | 6 | 0 | 0 | 0 |
| Screening Intervention | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Engagement Interview | Control Visit | Total | Cognitive Behavioral Therapy | Antidepressant Drug Therapy | Obsevational Cohort |
|---|---|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 14 | 53 years STANDARD_DEVIATION 12 | 52 years STANDARD_DEVIATION 13 | 50 years STANDARD_DEVIATION 13 | 53 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 13 |
| Dialysis Vintage | 32 months | 28 months | 31 months | 30 months | 32 months | 21 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 22 Participants | 49 Participants | 14 Participants | 20 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 69 Participants | 100 Participants | 46 Participants | 39 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 8 Participants | 15 Participants | 3 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 7 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 32 Participants | 53 Participants | 19 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | 6 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 12 Participants | 21 Participants | 7 Participants | 9 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 29 Participants | 60 Participants | 24 Participants | 28 Participants | 8 Participants |
| Sex: Female, Male Female | 42 Participants | 35 Participants | 59 Participants | 27 Participants | 25 Participants | 7 Participants |
| Sex: Female, Male Male | 50 Participants | 57 Participants | 107 Participants | 33 Participants | 35 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 60 | 0 / 60 |
| other Total, other adverse events | 4 / 60 | 12 / 60 |
| serious Total, serious adverse events | 11 / 60 | 14 / 60 |
Outcome results
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.
Time frame: within four weeks of engagement interview or control visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engagement Interview | Number of Participants Who Initiated Depression Treatment | 57 Participants |
| Control Visit | Number of Participants Who Initiated Depression Treatment | 54 Participants |
p-value: 0.77Likelihood Ratio Test
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.
Time frame: Week 12 of treatment
Population: QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | QIDS-C Score | 8.1 score on a scale |
| Control Visit | QIDS-C Score | 5.9 score on a scale |
| Observational Cohort | QIDS-C Score | 7.9 score on a scale |
Comparison: All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.p-value: 0.03595% CI: [-3.54, -0.13]Wald Test
Secondary
BDI-II
Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | BDI-II | 18.7 score on a scale |
| Control Visit | BDI-II | 14.1 score on a scale |
95% CI: [-7.4, -0.02]
Secondary
Exercise
Single item activity measure, range 1-6, higher indicates less activity
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Exercise | 3.5 score on a scale |
| Control Visit | Exercise | 3.2 score on a scale |
95% CI: [-0.5, 0.7]
Secondary
GAD-7
Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | GAD-7 | 7.5 score on a scale |
| Control Visit | GAD-7 | 6.5 score on a scale |
95% CI: [-3.1, 0.8]
Secondary
Global Quality of Life Scale
range 0-10, higher scores indicate better quality of life
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Global Quality of Life Scale | 5.6 score on a scale |
| Control Visit | Global Quality of Life Scale | 6.4 score on a scale |
95% CI: [-0.2, 1.4]
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.
Time frame: within two weeks of engagement interview or control visit
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Engagement Interview | Number of Participants Who Accepted Depression Treatment | 70 Participants |
| Control Visit | Number of Participants Who Accepted Depression Treatment | 70 Participants |
p-value: 0.96Likelihood Ratio Test
Secondary
Perceived Social Support
Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Perceived Social Support | 4.7 score on a scale |
| Control Visit | Perceived Social Support | 4.6 score on a scale |
95% CI: [-0.5, 0.5]
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.
Time frame: Over 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Percentage of Dialysis Treatment Sessions Skipped and/or Shortened | 22.2 percentage of sessions skipped/shortened |
| Control Visit | Percentage of Dialysis Treatment Sessions Skipped and/or Shortened | 17.3 percentage of sessions skipped/shortened |
95% CI: [0.55, 1.1]
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
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Percent Inter-dialytic Weight Gain | 2.6 percentage of body weight |
| Control Visit | Percent Inter-dialytic Weight Gain | 2.9 percentage of body weight |
95% CI: [-0.54, 0.34]
Secondary
PSQI
Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | PSQI | 9.5 score on a scale |
| Control Visit | PSQI | 6.8 score on a scale |
Secondary
Satisfaction With Life Scale
range 1-35, higher scores indicate better satisfaction
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Satisfaction With Life Scale | 16.8 score on a scale |
| Control Visit | Satisfaction With Life Scale | 20.1 score on a scale |
95% CI: [0.1, 5.1]
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Serum Phosphorus Level | 6.1 mg/dl |
| Control Visit | Serum Phosphorus Level | 6.3 mg/dl |
95% CI: [-0.25, 0.75]
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
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | SF-36 Energy/Vitality | 39.2 score on a scale |
| Control Visit | SF-36 Energy/Vitality | 53 score on a scale |
95% CI: [1.3, 19]
Secondary
Sheehan Disability Scale
range 0-30, higher scores indicate worse disability
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Engagement Interview | Sheehan Disability Scale | 15.2 score on a scale |
| Control Visit | Sheehan Disability Scale | 11.0 score on a scale |
95% CI: [-6.2, -0.1]