Feasibility RCT of ACT Self-help for Depression in Haemodialysis

University of Lincoln

Status: Completed

Conditions: Depression; End-stage Renal Disease

Treatments: Other: Self help book + telephone support

Study type: Interventional

Funder types: Other

Identifiers

NCT02565056

156756

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Self-help

Active Comparator group

Description:

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

Treatment:

Other: Self help book + telephone support

Treatment as usual

No Intervention group

Description:

Treatment as usual.