Feasibility RCT of ACT Self-help for Depression in Haemodialysis

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565056
• Other study ID #: 156756
• Status: Completed
• Phase: N/A
• First received: September 23, 2015
• Last updated: May 10, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Lincoln
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• End-stage Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• Self help book + telephone support
Self-help book based upon principles of Acceptance and Commitment Therapy

Locations

Country	Name	City	State
United Kingdom	Shipley Dialysis Unit, Ilkeston Community Hospital	Ilkeston	Derbyshire
United Kingdom	Mike Cassidy Dialysis Unit, Kings Mill Hospital	Mansfield	Nottinghamshire
United Kingdom	Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Lincoln	Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months	Validated self-report questionnaire assessing symptoms of depression	Baseline; 2 months; 4 months	No
Secondary	Change in EQ-5D-5L at 2 and 4 months	Validated self-report questionnaire assessing health-related quality of life	Baseline; 2 months; 4 months	No
Secondary	Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months	Validated self-report questionnaire assessing psychological flexibility	Baseline; 2 months; 4 months	No
Secondary	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	Baseline; 2 months; 4 months	No