End-stage Renal DiseaseNCT02565056
Feasibility RCT of ACT Self-help for Depression in Haemodialysis
A study testing Self help book + telephone support in people with End-stage Renal Disease and Depression, run by University of Lincoln at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, Depression
- What is being tested?
- Self help book + telephone support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Shipley Dialysis Unit, Ilkeston Community Hospital
Ilkeston, Derbyshire, DE7 8LN
Mike Cassidy Dialysis Unit, Kings Mill Hospital
Mansfield, Nottinghamshire, NG17 4JL
Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Acceptance and Commitment Therapy Self-help Intervention for Depression in Haemodialysis Patients: A Feasibility Randomised Controlled Trial
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.
Read the 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.
- Conditions
- End-stage Renal Disease, Depression
- Being tested
- Self help book + telephone support
- Keywords
- Acceptance and Commitment Therapy
- Medical subject headings
- Kidney Failure, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self help book + telephone supportOther
Self-help book based upon principles of Acceptance and Commitment Therapy
| Study group | Role | What they receive |
|---|---|---|
| Self-help | Active comparator | Self-help book completed over 6 weeks with up to 30 minutes of telephone support per week. Receives: Other: Self help book + telephone support |
| Treatment as usual | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
Validated self-report questionnaire assessing symptoms of depression
Measured: Baseline; 2 months; 4 months
Secondary outcomes (3)
Change in EQ-5D-5L at 2 and 4 months
Validated self-report questionnaire assessing health-related quality of life
Measured: Baseline; 2 months; 4 months
Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months
Validated self-report questionnaire assessing psychological flexibility
Measured: Baseline; 2 months; 4 months
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
Measured: Baseline; 2 months; 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Principal investigator, William Vogt, University of Lincoln
- Investigators
- William Vogt, MSc, BSc, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565056
- Sponsor's protocol ID
- 156756
- Status last verified
- May 2016
- First submitted
- 23 Sep 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy Self-help Intervention for Depression in Haemodialysis Patients: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02565056
- Acronym / sponsor ID
- 156756
- Conditions
- End-stage Renal Disease, Depression
- Keywords
- Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help | Active comparator | Other: Self help book + telephone supportSelf-help book completed over 6 weeks with up to 30 minutes of telephone support per week. |
| Treatment as usual | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self help book + telephone supportSelf-help book based upon principles of Acceptance and Commitment Therapy | Other | Self-help |
Primary outcome
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
3 secondary outcomes
Change in EQ-5D-5L at 2 and 4 months
Time frame: Baseline; 2 months; 4 months
Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months
Time frame: Baseline; 2 months; 4 months
Change in Valued Living Questionnaire (VLQ) at 2 and 4 months
Time frame: Baseline; 2 months; 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Vogt, MSc, BSc principal investigator
University of Lincoln
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self help book + telephone support in people with End-stage Renal Disease and Depression, run by University of Lincoln at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months (time frame: Baseline; 2 months; 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.