Recruiting

Pharmaco-Therapy & CBT

Sponsor:

University of Pittsburgh

Code:

NCT06978127

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Technology Assisted Stepped Collaborative Care

Usual Care Arm

Study Details

Brief summary:

The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Study ID

NCT06978127

Start date

Aug 28, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Eligibility Criteria:

1. age 18 years or older;
2. undergoing thrice-weekly maintenance hemodialysis (HD) for > 3 months;
3. English or Spanish speaking;
4. able to provide informed consent

Ineligibility Criteria:

1. active thought disorder, delusions or active suicidal ideation
2. active substance abuse
3. enrolled in hospice or life expectancy < 6 months (based on clinician's judgement)
4. too ill or cognitively impaired to participate based on renal provider's judgement
5. living kidney transplant scheduled in <3 months
6. undergoing active cancer treatment.
7. enrolled in another research study
8. plan to transition to home dialysis within 3 months
9. plan to move to another dialysis facility within 3 months

Study Design

Enrollment

424 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Technology Assisted Stepped Collaborative Care Group

Participants in the Technology Assisted Stepped Collaborative Care group will receive a stepped-approach for pharmaco and/or Cognitive Behavioral Therapy (CBT) and individualization of treatment to improve symptoms of fatigue, pain and/or depression, in a real-world setting.

active comparator: Usual Care Group

Participants in the Usual Care Group will continue with their usual care.

Interventions

Technology Assisted Stepped Collaborative Care

The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.

Usual Care Arm

Participants in the Usual Care Arm will continue with their usual care.

Primary outcome measure

  • TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) [ Time Frame: 6 months ]
  • TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome) [ Time Frame: 6 months ]
  • TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Manisha Jhamb, MD, MPH

412-647-7062jhambm@upmc.edu

Mark Unruh, MD, MS

(505) 272-0407MLUnruh@salud.unm.edu

Locations

UNM

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Mark Unruh, MD

(505) 272-0407MLUnruh@salud.unm.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Melissa Weimer, MS

412-802-6739mew97@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Chronic Kidney Disease
  • Hemodialysis
  • Pain
  • Depression
  • Fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-08-24.