Feasibility RCT of ACT Self-help for Depression in Haemodialysis

May 10, 2016 updated by: William Vogt, University of Lincoln

Acceptance and Commitment Therapy Self-help Intervention for Depression in Haemodialysis Patients: A Feasibility Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Derbyshire
      • Ilkeston, Derbyshire, United Kingdom, DE7 8LN
        • Shipley Dialysis Unit, Ilkeston Community Hospital
    • Nottinghamshire
      • Mansfield, Nottinghamshire, United Kingdom, NG17 4JL
        • Mike Cassidy Dialysis Unit, Kings Mill Hospital
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-help
Self-help book completed over 6 weeks with up to 30 minutes of telephone support per week.
Other: Self help book + telephone support
Self-help book based upon principles of Acceptance and Commitment Therapy
No Intervention: Treatment as usual
Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
Time Frame: Baseline; 2 months; 4 months
Validated self-report questionnaire assessing symptoms of depression
Baseline; 2 months; 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lincoln

Collaborators

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: William Vogt, MSc, BSc, University of Lincoln

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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