Feasibility RCT of ACT Self-help for Depression in Haemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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End-stage Renal Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-help

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

Group Type ACTIVE_COMPARATOR

Self help book + telephone support

Intervention Type OTHER

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

Treatment as usual

Treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self help book + telephone support

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No