Cognitive Behavioral Therapy for Fatigue in Chronic Kidney Disease

Overseen By Daniel Cukor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Exercise program, Kidney transplant, Safety concerns

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cognitive behavioral therapy (CBT) to help manage fatigue in people with chronic kidney disease. The goal is to determine if CBT is useful and acceptable for reducing tiredness in this group. Participants will attend remote therapy sessions weekly for about three months. This trial may suit individuals with non-dialysis dependent kidney disease who feel very tired and can join online meetings. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for fatigue management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Cognitive Behavioral Therapy is safe for patients with chronic kidney disease?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. Various studies have used CBT for different conditions, including chronic kidney disease, without reporting major safety issues.

CBT, a type of talk therapy, helps people change negative thinking patterns. It does not involve medication, often resulting in fewer physical side effects. Participants typically experience few, if any, negative effects and find the therapy helpful and safe.

In summary, existing research considers CBT safe for individuals, including those with chronic kidney issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for fatigue in chronic kidney disease, which often rely on medications or lifestyle changes, cognitive behavioral therapy (CBT) offers a unique approach. Researchers are excited about CBT because it tackles fatigue through psychological strategies, equipping patients with tools to manage their symptoms actively. This treatment is delivered remotely, making it more accessible and convenient for patients who may struggle with frequent travel due to their condition. By focusing on cognitive and behavioral changes, CBT has the potential to provide long-lasting relief without the side effects associated with traditional medications.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for fatigue in chronic kidney disease?

Research shows that Cognitive Behavioral Therapy (CBT), which participants in this trial will receive remotely, can help reduce tiredness in people with chronic kidney disease. Studies have found that CBT significantly lowers the severity of this tiredness. For instance, a 2023 review of several studies found that CBT reduced tiredness by a noticeable amount. Other research suggests that CBT might also help ease tiredness in patients receiving treatments like hemodialysis. Overall, these findings suggest that CBT could be useful for managing tiredness in those with kidney problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel Cukor, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe Chronic Kidney Disease (CKD) who experience fatigue. Participants must be able to join remote sessions, speak English, and walk. Those already in exercise programs or expecting a kidney transplant within six months cannot join.

Inclusion Criteria

Ability to join remote study sessions via WebEx

My kidney function is low but not in the severe stage.

I am interested in joining a study about tiredness.

Exclusion Criteria

My medical records show no concerns about me walking more.

Current involvement in an activity/exercise program

High likelihood of a kidney transplant within 6 months (assessed via the medical record)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remotely delivered cognitive behavioral therapy sessions weekly, with the goal of 10 sessions over 12 weeks

12 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT)

Trial Overview

The study tests Cognitive Behavioral Therapy (CBT) as a treatment for fatigue in CKD patients. It's a small-scale pilot study designed to see if the therapy could work and be well-received before launching a larger trial.

How Is the Trial Designed?

Group I: Remotely Delivered Cognitive Behavioral Therapy (CBT) Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 173 patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD), fatigue was found to be a significant issue, with a mean fatigue score indicating substantial levels of fatigue across both groups.

Factors such as depressive symptoms, restless legs syndrome, excessive daytime sleepiness, and low serum albumin levels were identified as key contributors to fatigue, suggesting that addressing these issues could help improve the quality of life for patients with advanced CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and correlates of fatigue in chronic kidney disease and end-stage renal disease: are sleep disorders a key to understanding fatigue? Jhamb, M., Liang, K., Yabes, J., et al.[2022]

A cognitive-behavioral therapy intervention for renal fatigue showed potential to reduce fatigue in patients undergoing hemodialysis, but patient engagement was low, highlighting the need for better delivery methods.

The study identified that patients' understanding and acceptance of fatigue and the treatment model are crucial for engagement, suggesting that interventions should be tailored to address cognitive and treatment burdens while fostering collaboration with therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of a cognitive behavioural therapy (CBT) intervention for fatigue in patients receiving haemodialysis. Waite, F., Chilcot, J., Moss-Morris, R., et al.[2023]

This study is a feasibility randomized controlled trial involving 40 adult patients undergoing in-centre haemodialysis, aiming to assess the recruitment and acceptability of a cognitive-behavioral therapy (CBT) intervention for managing fatigue.

The trial will evaluate various self-reported outcomes related to fatigue, sleep quality, and mental health, with data collected at baseline and 3 months post-randomization to determine the potential benefits of the CBT intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioural therapy (CBT) for renal fatigue (BReF): a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients. Picariello, F., Moss-Morris, R., Macdougall, IC., et al.[2018]

Fatigue is a significant issue for individuals with chronic kidney disease (CKD), affecting 70% to 97% of patients and severely impacting their quality of life.

Most research on fatigue in CKD has concentrated on patients undergoing hemodialysis, leaving a gap in understanding fatigue in those on peritoneal dialysis and transplant patients, highlighting the need for more comprehensive studies in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue in Patients with Chronic Kidney Disease: Evidence and Measures. Joshwa, B., Campbell, ML.[2018]

A pilot study involving 10 adult patients with end-stage renal disease (ESRD) on hemodialysis showed that a technology-assisted cognitive-behavioral therapy (CBT) intervention was feasible and well-accepted, with high patient adherence and minimal disruption to treatment sessions.

While the study did not find statistically significant changes in depression, fatigue, or pain, there was a notable improvement in physical health as measured by the SF-36 score, and 67% of patients with elevated pain reported improvement after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-assisted cognitive-behavioral therapy intervention for end-stage renal disease. Jakubowski, KP., Jhamb, M., Yabes, J., et al.[2021]

Fatigue is a common and complex issue in patients with advanced kidney disease, affecting 42% to 89% of individuals, and is influenced by various factors including psychological conditions like depression and anxiety, as well as biological markers such as cytokines.

Nonpharmacological interventions, particularly physical exercise and cognitive-behavioral therapy, have shown promising results in alleviating fatigue, suggesting that treatment plans should incorporate a multifaceted approach to address the underlying causes of fatigue in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue in advanced kidney disease. Artom, M., Moss-Morris, R., Caskey, F., et al.[2022]

Social-psychological interventions can significantly reduce fatigue in end-stage kidney disease (ESKD) patients, with a moderate effect size observed in a meta-analysis of 16 randomized controlled trials involving 1536 participants.

Interventions that included stress-management and relaxation techniques were particularly effective, suggesting that tailored psychological support may be beneficial for managing fatigue in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the efficacy of social-psychological interventions for the management of fatigue in end-stage kidney disease (ESKD): a systematic review with meta-analysis. Picariello, F., Hudson, JL., Moss-Morris, R., et al.[2018]

The Personal Energy Planning (PEP) programme is a personalized, web-supported educational intervention designed to help individuals with end-stage renal disease (ESRD) manage fatigue, which is a significant issue affecting their quality of life.

A pilot randomized controlled trial (RCT) will assess the feasibility of the PEP programme, including participant eligibility and recruitment rates, and will evaluate its impact on fatigue and life participation over a 12-week follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a pilot randomised controlled trial of an educational programme for adults on chronic haemodialysis with fatigue (Fatigue-HD). Farragher, JF., Thomas, C., Ravani, P., et al.[2020]

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