Clinical trial NCT02565056: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Depression
Keywords: Acceptance and Commitment Therapy
Lead sponsor: University of Lincoln
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
First posted: 2015-10-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
timeFrame: Baseline; 2 months; 4 months
Secondary outcomes:
measure: Change in EQ-5D-5L at 2 and 4 months
timeFrame: Baseline; 2 months; 4 months
measure: Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months
timeFrame: Baseline; 2 months; 4 months
measure: Change in Valued Living Questionnaire (VLQ) at 2 and 4 months
timeFrame: Baseline; 2 months; 4 months
Other outcomes:
Locations:
city: Ilkeston
country: United Kingdom
facility: Shipley Dialysis Unit, Ilkeston Community Hospital
state: Derbyshire
city: Mansfield
country: United Kingdom
facility: Mike Cassidy Dialysis Unit, Kings Mill Hospital
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital
state: Nottinghamshire
Study officials:
affiliation: University of Lincoln
name: William Vogt, MSc, BSc
role: PRINCIPAL_INVESTIGATOR
References: