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Completed

NCT Number: NCT02565056

Feasibility RCT of ACT Self-help for Depression in Haemodialysis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shipley Dialysis Unit, Ilkeston Community Hospital, Ilkeston, Derbyshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self help book + telephone support

Other

Self-help book based upon principles of Acceptance and Commitment Therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Lincoln

Other

Collaborators

  • Nottingham University Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2015
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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