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Feasibility RCT of ACT Self-help for Depression in Haemodialysis

Primary Purpose

End-stage Renal Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self help book + telephone support
Sponsored by
University of Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring Acceptance and Commitment Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • undergoing haemodialysis treatment at one of three identified units
  • receiving haemodialysis treatment for more than 6 months
  • moderate depression (as indicated by the PHQ-9)

Exclusion Criteria:

  • receiving concurrent psychological treatment
  • lacking mental capacity to consent due to cognitive impairment
  • inadequate reading ability (indicated by inability to complete PHQ-9 screening measure)
  • visual or hearing impairment that would prevent completion of the self-help book or engagement in telephone calls

Sites / Locations

  • Shipley Dialysis Unit, Ilkeston Community Hospital
  • Mike Cassidy Dialysis Unit, Kings Mill Hospital
  • Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Self-help

Treatment as usual

Arm Description

Self-help book completed over 6 weeks with up to 30 minutes of telephone support per week.

Treatment as usual.

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
Validated self-report questionnaire assessing symptoms of depression

Secondary Outcome Measures

Change in EQ-5D-5L at 2 and 4 months
Validated self-report questionnaire assessing health-related quality of life
Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months
Validated self-report questionnaire assessing psychological flexibility
Change in Valued Living Questionnaire (VLQ) at 2 and 4 months
Validated self-report questionnaire assessing the extent to which individuals live consistently with their identified values

Full Information

First Posted
September 23, 2015
Last Updated
May 10, 2016
Sponsor
University of Lincoln
Collaborators
Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02565056
Brief Title
Feasibility RCT of ACT Self-help for Depression in Haemodialysis
Official Title
Acceptance and Commitment Therapy Self-help Intervention for Depression in Haemodialysis Patients: A Feasibility Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lincoln
Collaborators
Nottingham University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the feasibility of conducting a trial to evaluate a self-help treatment for depression in people with end-stage renal disease.
Detailed Description
Chronic Kidney Disease (CKD) is a long-term condition in which the function of the kidneys - to filter out waste products from the blood - slowly declines. When renal function becomes sufficiently low it is described as End Stage Renal Disease (ESRD) and renal replacement therapy (RRT) is likely to be needed to prolong life. The most common type of RRT is haemodialysis, in which the patient's blood is filtered through a machine. It is estimated that depression is experienced by 20-40% of people with ESRD. Depression not only affects the quality of life of individuals with ESRD but is also associated with higher rates of hospitalisation and poorer physical health outcomes. Acceptance and Commitment Therapy (ACT) has been found to be an effective treatment for depression and has been used successfully as a self-help treatment. However, no study has examined the effectiveness of an ACT self-help treatment for depression in ESRD. This study aims to assess the feasibility of conducting such a study and will look at suitability of recruitment, assessment methods and the acceptability of the self-help treatment, as well as helping to calculate the number of people needed for a definitive study. Haemodialysis patients receiving dialysis through an NHS renal service will be invited to participate. To participate they will be consenting, over 18 years of age and experiencing depressive symptoms at a clinical level. Those eligible will be randomly assigned into one of two conditions; a control condition receiving treatment as usual (TAU), and an intervention condition receiving TAU alongside an ACT self-help manual with weekly telephone support. The manual will be completed over six weeks. Both groups will be asked to complete questionnaires prior to intervention and 2 and 4 months post-intervention. Participants from each condition will be asked to participate in interviews to explore their experiences of taking part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Depression
Keywords
Acceptance and Commitment Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-help
Arm Type
Active Comparator
Arm Description
Self-help book completed over 6 weeks with up to 30 minutes of telephone support per week.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual.
Intervention Type
Other
Intervention Name(s)
Self help book + telephone support
Intervention Description
Self-help book based upon principles of Acceptance and Commitment Therapy
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
Description
Validated self-report questionnaire assessing symptoms of depression
Time Frame
Baseline; 2 months; 4 months
Secondary Outcome Measure Information:
Title
Change in EQ-5D-5L at 2 and 4 months
Description
Validated self-report questionnaire assessing health-related quality of life
Time Frame
Baseline; 2 months; 4 months
Title
Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months
Description
Validated self-report questionnaire assessing psychological flexibility
Time Frame
Baseline; 2 months; 4 months
Title
Change in Valued Living Questionnaire (VLQ) at 2 and 4 months
Description
Validated self-report questionnaire assessing the extent to which individuals live consistently with their identified values
Time Frame
Baseline; 2 months; 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: undergoing haemodialysis treatment at one of three identified units receiving haemodialysis treatment for more than 6 months moderate depression (as indicated by the PHQ-9) Exclusion Criteria: receiving concurrent psychological treatment lacking mental capacity to consent due to cognitive impairment inadequate reading ability (indicated by inability to complete PHQ-9 screening measure) visual or hearing impairment that would prevent completion of the self-help book or engagement in telephone calls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Vogt, MSc, BSc
Organizational Affiliation
University of Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shipley Dialysis Unit, Ilkeston Community Hospital
City
Ilkeston
State/Province
Derbyshire
ZIP/Postal Code
DE7 8LN
Country
United Kingdom
Facility Name
Mike Cassidy Dialysis Unit, Kings Mill Hospital
City
Mansfield
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

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Feasibility RCT of ACT Self-help for Depression in Haemodialysis

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