Chronic Kidney DiseasesNCT06768983
Fatigue Reduction in Chronic Kidney Disease (CKD)
A study testing Cognitive Behavioral Therapy (CBT) in people with Chronic Kidney Diseases and Fatigue, run by NYU Langone Health at 1 site in United States.
Trial summary
In this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. This is a one-group design with qualitative and quantitative data collection integrated into the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Fatigue
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 16 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Interest in participating in a fatigue study
- Age ≥18 years old
- Estimated glomerular filtration rate (eGFR) 15-44 mL/min/1.73 m2
- Ability and willingness to provide informed consent
- Ability to speak English
- Ability to walk
- Ability to join remote study sessions via WebEx
Who cannot join
- Current involvement in an activity/exercise program
- High likelihood of a kidney transplant within 6 months (assessed via the medical record)
- Any safety concerns about increased walking (assessed via the medical record)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of Strategies to Reduce Fatigue for People With Chronic Kidney Disease (CKD)
In this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. This is a one-group design with qualitative and quantitative data collection integrated into the intervention.
- Conditions
- Chronic Kidney Diseases, Fatigue
- Being tested
- Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Renal Insufficiency, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
10 sessions of remotely delivered CBT; each session is about 45 minutes in length. The aim of the sessions is to cultivate skills that promote activity and reduce fatigue and its impact on daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Remotely Delivered Cognitive Behavioral Therapy (CBT) | Experimental | Patients with non-dialysis dependent kidney disease who have complaints of fatigue will be enrolled. Participants will receive remotely delivered CBT sessions, which will weekly with the goal of having 10 45-minute sessions over 12 weeks. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Adherence
Measure of feasibility; calculated as the percentage of planned sessions that were actually attended by participants.
Measured: Up to Week 12
Secondary outcomes (4)
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
The FACIT Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Fatigue Subscale comprises 13 items and measures symptoms of fatigue. Each item is rated on a scale from 0 (not at all) to 4 (very much); the total score is the sum of responses and ranges from from 0 to 52; lower scores indicate greater fatigue.
Measured: Baseline, Week 6
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
The FACIT Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Fatigue Subscale comprises 13 items and measures symptoms of fatigue. Each item is rated on a scale from 0 (not at all) to 4 (very much); the total score is the sum of responses and ranges from from 0 to 52; lower scores indicate greater fatigue.
Measured: Baseline, Week 12
Change in Dialysis Symptom Index (DSI) Score
The DSI is 30-item assessment of CKD-related unpleasant symptoms. Each item is rated on a scale from 0 (not at all) to 4 (very much). The total score is the sum of the responses, ranging from 0 to 120. A higher score indicates a greater symptom burden.
Measured: Baseline, Week 6
Change in Dialysis Symptom Index (DSI) Score
The DSI is 30-item assessment of CKD-related unpleasant symptoms. Each item is rated on a scale from 0 (not at all) to 4 (very much). The total score is the sum of the responses, ranging from 0 to 120. A higher score indicates a greater symptom burden.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start30 Jan 2025
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Cukor, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768983
- Sponsor's protocol ID
- 24-01055
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Daniel.Cukor@nyulangone.org. The protocol will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Strategies to Reduce Fatigue for People With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT06768983
- Acronym / sponsor ID
- 24-01055
- Conditions
- Chronic Kidney Diseases, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. This is a one-group design with qualitative and quantitative data collection integrated into the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remotely Delivered Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Patients with non-dialysis dependent kidney disease who have complaints of fatigue will be enrolled. Participants will receive remotely delivered CBT sessions, which will weekly with the goal of having 10 45-minute sessions over 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Interest in participating in a fatigue study
- Age ≥18 years old
- Estimated glomerular filtration rate (eGFR) 15-44 mL/min/1.73 m2
- Ability and willingness to provide informed consent
- Ability to speak English
Key exclusion criteria (3 listed)
- Current involvement in an activity/exercise program
- High likelihood of a kidney transplant within 6 months (assessed via the medical record)
- Any safety concerns about increased walking (assessed via the medical record)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)10 sessions of remotely delivered CBT; each session is about 45 minutes in length. The aim of the sessions is to cultivate skills that promote activity and reduce fatigue and its impact on daily activities. | Behavioural | Remotely Delivered Cognitive Behavioral Therapy (CBT) |
Primary outcome
Session Adherence
Time frame: Up to Week 12
Measure of feasibility; calculated as the percentage of planned sessions that were actually attended by participants.
4 secondary outcomes
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
Time frame: Baseline, Week 6
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
Time frame: Baseline, Week 12
Change in Dialysis Symptom Index (DSI) Score
Time frame: Baseline, Week 6
Change in Dialysis Symptom Index (DSI) Score
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Daniel.Cukor@nyulangone.org. The protocol will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cukor, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with Chronic Kidney Diseases and Fatigue, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Adherence (time frame: Up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.