NCT02686333

Brief Summary

This study examines the use of brief meditation interventions for patients with symptoms of anxiety and depression who are undergoing dialysis. Half of the participants will receive meditation interventions 3 times a week, while the other half will receive treatment as usual. This study will examine whether meditation is feasible and whether it has any effect on reducing symptoms of anxiety or depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3 depression

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

December 30, 2015

Last Update Submit

September 8, 2020

Conditions

DepressionAnxiety

Keywords

MeditationDialysis

Outcome Measures

Primary Outcomes (3)

  • Proportion of participants screened as eligible who enroll

    34 months

  • Proportion of participants who enrolled who completed the 8 week-trial

    34 months

  • Tolerability of Meditation Intervention on a 10-point Likert scale

    Tolerability of intervention on a 10-point Likert scale

    8 weeks

Secondary Outcomes (2)

  • Change in Patient Health Questionnaire (PHQ-9)

    Baseline and at 8 weeks

  • Change in General Anxiety Disorder-7 (GAD-7)

    Baseline and at 8 weeks

Study Arms (2)

Meditation Intervention Arm

EXPERIMENTAL

10-15 minute meditation practices (brief silent meditations, guided meditations, body scans, gentle arm movement exercises). Before each session, the interventionist will perform a brief check in, and may discuss the patient's experience with them for 1-2 minutes after the intervention. Patients will be encouraged to practice the techniques at home between sessions. Patients will also be offered literature on mental health promotion.

Other: Meditation

Control Group (No Meditation Exposure)

NO INTERVENTION

Patients randomized to the control group will be offered literature on mental health promotion and Treatment as Usual in the dialysis setting.

Interventions

MeditationOTHER

10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises).

Meditation Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients currently receiving maintenance hemodialysis
  • Patients with depression and/or anxiety as indicated by scores of ≥10 on the Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder-7 (GAD- 7)
  • Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test)

You may not qualify if:

  • Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
  • Acute psychotic symptoms
  • Acute Suicidal ideation/intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1A2, Canada

Location

Related Publications (1)

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PMID: 37651553DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Karl Looper, MD, FRCPC

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC, Chief of the Department of Psychiatry, Jewish General Hospital

Study Record Dates

First Submitted

December 30, 2015

First Posted

February 19, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Individual data will be coded and anonymized. Anonymized data will not be shared.

Locations

CA(1)