Trial · NCT02358343
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | BDI-II | Week 12 | Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression |
| Secondary | GAD-7 | Week 12 | Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety |
| Secondary | Sheehan Disability Scale | Week 12 | range 0-30, higher scores indicate worse disability |
| Secondary | 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 |
| Secondary | Global Quality of Life Scale | Week 12 | range 0-10, higher scores indicate better quality of life |
| Secondary | Satisfaction With Life Scale | Week 12 | range 1-35, higher scores indicate better satisfaction |
| Secondary | Perceived Social Support | Week 12 | Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support |
| Secondary | PSQI | Week 12 | Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality |
| Secondary | Exercise | Week 12 | Single item activity measure, range 1-6, higher indicates less activity |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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