Trial · NCT02358343
A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
NCT02358343, Phase 3, Completed, University of Washington; results first posted 2019-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}. Trials, record NCT02358343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02358343
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
- NCT number
- NCT02358343
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 184 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Depression, End Stage Renal Disease
- Interventions
- Engagement Interview, Cognitive Behavioral Therapy, Antidepressant Drug Therapy
- First posted
- 2015-02-06
- Last updated
- 2019-07-23
- Results first posted
- 2019-07-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Initiated Depression Treatment | within four weeks of engagement interview or control visit | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | QIDS-C Score | Week 12 of treatment | QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome. | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Accepted Depression Treatment | within two weeks of engagement interview or control visit | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | BDI-II | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | GAD-7 | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Sheehan Disability Scale | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | SF-36 Energy/Vitality | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Global Quality of Life Scale | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Satisfaction With Life Scale | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Perceived Social Support | Week 12 | 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. | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Initiated Depression Treatment | Engagement Interview | 57 | Participants | ||
| Number of Participants Who Initiated Depression Treatment | Control Visit | 54 | Participants | ||
| QIDS-C Score | Cognitive Behavioral Therapy | 8.1 | 95% Confidence Interval 6.7 to 9.4 | score on a scale | |
| QIDS-C Score | Antidepressant Drug Therapy | 5.9 | 95% Confidence Interval 4.8 to 7.1 | score on a scale | |
| QIDS-C Score | Observational Cohort | 7.9 | 95% Confidence Interval 6.1 to 9.8 | score on a scale | |
| Number of Participants Who Accepted Depression Treatment | Engagement Interview | 70 | Participants | ||
| Number of Participants Who Accepted Depression Treatment | Control Visit | 70 | Participants | ||
| BDI-II | Cognitive Behavioral Therapy | 18.7 | 95% Confidence Interval 15.2 to 22.2 | score on a scale | |
| BDI-II | Antidepressant Drug Therapy | 14.1 | 95% Confidence Interval 11.2 to 17.0 | score on a scale | |
| GAD-7 | Cognitive Behavioral Therapy | 7.5 | 95% Confidence Interval 5.9 to 9.2 | score on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Intervention | STARTED | Engagement Interview | 92 | |
| Screening Intervention | STARTED | Control Visit | 92 | |
| Screening Intervention | STARTED | Cognitive Behavioral Therapy | 0 | |
| Screening Intervention | STARTED | Antidepressant Drug Therapy | 0 | |
| Screening Intervention | STARTED | Observational Cohort | 0 | |
| Screening Intervention | COMPLETED | Engagement Interview | 86 | |
| Screening Intervention | COMPLETED | Control Visit | 84 | |
| Screening Intervention | COMPLETED | Cognitive Behavioral Therapy | 0 | |
| Screening Intervention | COMPLETED | Antidepressant Drug Therapy | 0 | |
| Screening Intervention | COMPLETED | Observational Cohort | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Cardiac disorders | Cognitive Behavioral Therapy | 0 | 60 | 0 |
| other | Dizziness | Cardiac disorders | Antidepressant Drug Therapy | 5 | 60 | 5 |
| other | Vomiting | Gastrointestinal disorders | Cognitive Behavioral Therapy | 4 | 60 | 4 |
| other | Vomiting | Gastrointestinal disorders | Antidepressant Drug Therapy | 6 | 60 | 7 |
| other | Fatigue | General disorders | Cognitive Behavioral Therapy | 0 | 60 | 0 |
| other | Fatigue | General disorders | Antidepressant Drug Therapy | 5 | 60 | 6 |
| serious | Hypertension | Cardiac disorders | Cognitive Behavioral Therapy | 1 | 60 | 1 |
| serious | Hypertension | Cardiac disorders | Antidepressant Drug Therapy | 0 | 60 | 0 |
| serious | Afib | Cardiac disorders | Cognitive Behavioral Therapy | 1 | 60 | 1 |
| serious | Afib | Cardiac disorders | Antidepressant Drug Therapy | 0 | 60 | 0 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cognitive Behavioral Therapy | 2 | 60 |
| Total, all-cause mortality | Antidepressant Drug Therapy | 0 | 60 |
| Total, other adverse events | Cognitive Behavioral Therapy | 4 | 60 |
| Total, other adverse events | Antidepressant Drug Therapy | 12 | 60 |
| Total, serious adverse events | Cognitive Behavioral Therapy | 11 | 60 |
| Total, serious adverse events | Antidepressant Drug Therapy | 14 | 60 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Engagement Interview vs Control Visit: Number of Participants Who Accepted Depression Treatment | Trial comparisons |
| Cognitive Behavioral Therapy vs Antidepressant Drug Therapy: deaths from any cause | Trial comparisons |
| Engagement Interview vs Control Visit: Number of Participants Who Initiated Depression Treatment | Trial comparisons |
| Cognitive Behavioral Therapy vs Antidepressant Drug Therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02358343
GET https://conductscience.org/api/trials/v1/NCT02358343/results?page=2