Mindfulness and HEP in Dialysis Patients With Depression and Anxiety

NCT03406845 | Completed

• 1 other identifier: MM-CODIM-MBM-17-169
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot clinical trial examines the acceptability of meditation techniques versus health promotion in people receiving dialysis who have anxiety or depression. 50% of people who undergo dialysis experience anxiety or depression, but these conditions go undetected and untreated. Meditation and help promotion is helpful for anxiety and depression, but no one has compared the effects of meditation versus health promotion in people on dialysis specifically. Our aim is to evaluate whether meditation is more effective than health promotion. Nephrology doctors and nurses from collaborating hospitals in Montreal (MUHC) will help the recruit participants. The study will last 8 weeks, including a 6-month follow-up to measure depression and anxiety symptoms. Assessment will include pre-post evaluations about their depression and anxiety symptoms, overall health, sleep (Acti-watch), heart rate variability and blood draws (for inflammatory markers). A qualitative interview assessing participant experience will take place at program end. Participants will be randomly assigned. The participants will practice meditation or health promotion exercises with a trained interventionist in 20-minute sessions 3 times a week, during their dialysis sessions. Participants in the meditation group will learn mindfulness meditation exercises, whereas participants in the health promotion group will learn about healthy diet, music, exercise and positive health-enhancing life changes. Many people find meditation and health promotion enjoyable and relaxing. In the unlikely event people may have intense, but not dangerous reactions to meditation, the interventionists are trained to manage their reaction and direct them to appropriate care. Their hemodialysis treatment will not be affected by this study. It is hoped to improve mental health care for people on dialysis suffering from depression and anxiety. If this study shows that people in the meditation group greatly benefited than those participating in health promotion, investigators will create a bigger study to confirm whether it is truly effective for anxiety and depression in dialysis patients. Meditation may become a widely used treatment for people on dialysis with anxiety and depression, and investigators would train nephrology staff to make this treatment as accessible as possible.

Conditions

Renal Disease; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Depression scores measured by the Patient Health Questionnaire (PHQ-9)

  Represents a self-reported 9-item depression scale and it is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder with responses to questions ranging from 0 ("not at all") to 3 ("nearly every day") for each item. Low scores are equivalent to less symptoms of depression (scale range is 0 to 27, 9 items). Summed scores ≥10 are considered clinically significant. Our primary endpoint is change in PHQ-9 scores between baseline and 8-weeks. Our primary analysis will be in the subgroup of patients randomized into the study with a baseline PHQ-9 score ≥10. Our secondary analysis for this primary outcome will be with all patients randomized into the study (PHQ-9 or GAD-7 ≥6).

  Baseline, 8 weeks and 6 months

Secondary Outcomes (1)

• Anxiety scores measured by the General Anxiety Questionnaire (GAD-7)

  Baseline, 8 weeks and 6 months

Other Outcomes (9)

• Perceived Stress Scale (PSS)

  Baseline and 8 weeks

• Perceived Improvement Questionnaire (PIQ)

  At program end (8 weeks)

• Athens Insomnia Scale (AIS)

  Baseline and 8 weeks

Study Arms (2)

Chair-side mindfulness intervention

EXPERIMENTAL

Consists of individually conducted meditative practices, lasting 20 minutes/session, 3 times per week for 8 weeks. The interventions will be conducted during their dialysis sessions. The mindfulness meditation sessions include well-described meditations such as the body scan (being aware of bodily sensation), gentle arm movements, guided and silent breath meditations.

Behavioral: Chair-side mindfulness intervention

Health Enhancement Plan (HEP)

ACTIVE COMPARATOR

Has been previously designed and used for the purpose of being a manualized active control in meditation-based intervention trials, controlling for several non-specific factors found in a mindfulness meditation group. Participants will learn about health promotion, healthy diet, music, exercise as well as implementing positive health-enhancing life changes both in-session and during at-home practice with the support of a group facilitator, but do not learn mindfulness techniques.

Behavioral: Chair-side mindfulness intervention

Interventions

Chair-side mindfulness intervention BEHAVIORAL

Tailored mindfulness intervention to chair-side type, based from Mindfulness Based Cognitive Therapy (MBCT). Health promotion based on the Health Enhancement Program (HEP).

Also known as: HEP active control

Chair-side mindfulness intervention; Health Enhancement Plan (HEP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18yrs.\>
• Currently receiving maintenance hemodialysis, with depression (Patient Health Questionnaire (PHQ-9) score ≥6) and/or anxiety (General Anxiety Disorder-7 (GAD- 7) score ≥6).
• Normal cognition or Mild Cognitive Impairment will be addressed on a normal screening result on the 3-minute Mini-Cog Test (53).
• Patients should have sufficient hearing to follow verbal instructions, be able to sit for 20-25 minutes without discomfort
• Have adequate understanding of English and/or French

You may not qualify if:

• Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test (53))
• Acute psychotic symptoms,
• Acute suicidal ideation/intent
• Patients currently receiving active psychotherapy

Sponsors & Collaborators

• Lady Davis Institute: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• University of Toronto: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (2)

Lady David Institute

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Related Publications (2)

• Thomas Z, Novak M, Platas SGT, Gautier M, Holgin AP, Fox R, Segal M, Looper KJ, Lipman M, Selchen S, Mucsi I, Herrmann N, Rej S. Brief Mindfulness Meditation for Depression and Anxiety Symptoms in Patients Undergoing Hemodialysis: A Pilot Feasibility Study. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2008-2015. doi: 10.2215/CJN.03900417. Epub 2017 Oct 12.

  PMID: 29025788 RESULT

• Rigas C, Park H, Nassim M, Su CL, Greenway K, Lipman M, McVeigh C, Novak M, Trinh E, Alam A, Suri RS, Mucsi I, Torres-Platas SG, Noble H, Sekhon H, Rej S, Lifshitz M. Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial. Can J Kidney Health Dis. 2022 Mar 4;9:20543581221074562. doi: 10.1177/20543581221074562. eCollection 2022.

  PMID: 35273807 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Diseases; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Soham Rej, MD/MSc

  Psychiatrist and researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As described above.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatris and researcher

Model Details: RCT

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: January 23, 2018
• Study Start: May 10, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

CA (2)