Kidney Failure, ChroniciDiDNCT02352870

Intervention for Improving Psychological Distress in Dialysis

A study testing Computerised Cognitive Behavioural Therapy and Telephone support in people with Kidney Failure, Chronic and Depression, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic, Depression, Anxiety
What is being tested?: Computerised Cognitive Behavioural Therapy and Telephone support
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2015to Jun 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

Aged 18 years or over and receive hospital haemodialysis three-times weekly
Presence of mild to moderately severe depressive symptoms (based on PHQ-9 scores of 5 to 19 in range; a self-report measure of depression) and/or presence of mild to moderate anxiety symptoms (based on GAD-7 scores of 5-14)
Speak English sufficiently well to engage with screening tools
Have a basic understanding of how to use the Internet and an email address
Have a minimum dialysis vintage of ≥3 months (electronic patient record)

Who cannot join

Hospitalised at the time of assessment or within 1 month prior to the assessment
Currently receiving active treatment for depression and/or anxiety. We consider active treatment to be any current psychological treatments (talking therapies) or receipt of a new anti-depressant and/or anti-anxiety medication. A medication is considered new if it is commenced three months prior to the completion of the depression and anxiety screening questionnaire
Severe mental health disorders, for example, psychosis, bi-polar disorder
Active suicidal thoughts-any participant that scores greater than one on the depression PHQ-9 item "Thoughts that you would be better off dead, or of hurting yourself" will be excluded from the study.
Evidence of addiction to alcohol or drugs

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Guy's and St Thomas NHS Trust
London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: Intervention for Improving Psychological Distress in Dialysis (iDiD) Feasibility Two Arm Randomised Controlled Trial: Online Cognitive Behavioural Therapy (CBT) Intervention With Therapist Support vs Online CBT Intervention Alone (no Therapist Support)

To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress

Conditions: Kidney Failure, Chronic, Depression, Anxiety
Being tested: Computerised Cognitive Behavioural Therapy, Telephone support
Keywords: Feasibility study, Randomised controlled trial, Cognitive behavioural therapy, Psychological distress, Cognitive illness representations, Common sense model
Medical subject headings: Kidney Failure, Chronic, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computerised Cognitive Behavioural TherapyBehavioural
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
Telephone supportBehavioural
Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.

Study groups in NCT02352870
Study group	Role	What they receive
Computerised CBT with therapist support	Experimental	Participants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website. Receives: Behavioral: Computerised Cognitive Behavioural Therapy; Behavioral: Telephone support
Computerised CBT without therapist support	Active comparator	Participants complete seven online cognitive behavioural therapy sessions weekly but do not receive any telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future Receives: Behavioral: Computerised Cognitive Behavioural Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
Record the number of patients approached for screening and their consent rate
Measured: Baseline recruitment/screening

Secondary outcomes (8)

Recruitment , randomisation, and retention rates
Descriptive statistics as per CONSORT flow diagram
Measured: Screening, baseline, and 12 weeks follow-up
Adherence to the online intervention + telephone support calls (therapist supported arm only)
Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only)
Measured: 12 weeks follow-up
PHQ-9 (A self-report 9 item measure of depression)
A self-report 9 item measure of depression
Measured: Change in depression from baseline to 12 weeks
GAD-7 (A self-report 7 item measure of anxiety)
A self-report 7 item measure of anxiety
Measured: Change in anxiety from baseline to 12 weeks
EQ-5D (A self-report measure of quality of life)
A self-report measure of quality of life
Measured: Baseline and 12 weeks follow-up
Brief Illness Perceptions Questionnaire
A self-report measure of beliefs about illness
Measured: Baseline and 12 weeks follow-up
Client Service Receipt Inventory (A self-report measure of health service utilisation)
A self-report measure of health service utilisation
Measured: Baseline and 12 weeks follow-up
Satisfaction with treatment (A 2 item measure generated for the purposes of present study)
A 2 item measure generated for the purposes of present study
Measured: Baseline and 12 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Jun 2016

First posted2 Feb 2015 (estimated)
Study startFeb 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
More trials run by King's College LondonThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02352870
Sponsor's protocol ID: PAHTMZA WPAH 68913
Other IDs: 14.LO.1934
Acronym: iDiD
Status last verified: Sep 2015
First submitted: 22 Jan 2015
Last updated: 10 Oct 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hudson JL, Moss-Morris R, Game D, Carroll A, Chilcot J. Improving Distress in Dialysis (iDiD): A tailored CBT self-management treatment for patients undergoing dialysis. J Ren Care. 2016 Dec;42(4):223-238. doi: 10.1111/jorc.12168. Epub 2016 Jul 26.
PubMed 27458126
Hudson JL, Moss-Morris R, Norton S, Picariello F, Game D, Carroll A, Spencer J, McCrone P, Hotopf M, Yardley L, Chilcot J. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial. J Psychosom Res. 2017 Nov;102:61-70. doi: 10.1016/j.jpsychores.2017.09.009. Epub 2017 Sep 21.
PubMed 28992899
Chilcot J, Hudson JL, Moss-Morris R, Carroll A, Game D, Simpson A, Hotopf M. Screening for psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS): Initial validation of structural validity in dialysis patients. Gen Hosp Psychiatry. 2018 Jan-Feb;50:15-19. doi: 10.1016/j.genhosppsych.2017.09.007. Epub 2017 Sep 28.
PubMed 28985589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intervention for Improving Psychological Distress in Dialysis (iDiD) Feasibility Two Arm Randomised Controlled Trial: Online Cognitive Behavioural Therapy (CBT) Intervention With Therapist Support vs Online CBT Intervention Alone (no Therapist Support)
ClinicalTrials.gov ID: NCT02352870
Acronym / sponsor ID: iDiD / PAHTMZA WPAH 68913
Conditions: Kidney Failure, Chronic, Depression, Anxiety
Keywords: Feasibility study, Randomised controlled trial, Cognitive behavioural therapy, Psychological distress, Cognitive illness representations, Common sense model
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: King's College LondonUniversity, hospital or other
Collaborators: National Health Service, United Kingdom, University of Southampton
Study start: Feb 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 2 Feb 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.

To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Computerised CBT with therapist support	Experimental	Behavioral: Computerised Cognitive Behavioural Therapy, Behavioral: Telephone supportParticipants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website.
Computerised CBT without therapist support	Active comparator	Behavioral: Computerised Cognitive Behavioural TherapyParticipants complete seven online cognitive behavioural therapy sessions weekly but do not receive any telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged 18 years or over and receive hospital haemodialysis three-times weekly
Presence of mild to moderately severe depressive symptoms (based on PHQ-9 scores of 5 to 19 in range; a self-report measure of depression) and/or presence of mild to moderate anxiety symptoms (based on GAD-7 scores of 5-14)
Speak English sufficiently well to engage with screening tools
Have a basic understanding of how to use the Internet and an email address
Have a minimum dialysis vintage of ≥3 months (electronic patient record)

Key exclusion criteria (5 listed)

Hospitalised at the time of assessment or within 1 month prior to the assessment
Currently receiving active treatment for depression and/or anxiety. We consider active treatment to be any current psychological treatments (talking therapies) or receipt of a new anti-depressant and/or anti-anxiety medication. A medication is considered new if it is commenced three months prior to the completion of the depression and anxiety screening questionnaire
Severe mental health disorders, for example, psychosis, bi-polar disorder
Active suicidal thoughts-any participant that scores greater than one on the depression PHQ-9 item "Thoughts that you would be better off dead, or of hurting yourself" will be excluded from the study.
Evidence of addiction to alcohol or drugs

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
Computerised Cognitive Behavioural TherapyOnline treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis	Behavioural	Computerised CBT with therapist support, Computerised CBT without therapist support
Telephone supportTelephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.	Behavioural	Computerised CBT with therapist support

Primary outcome

Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
Time frame: Baseline recruitment/screening
Record the number of patients approached for screening and their consent rate

8 secondary outcomes

Recruitment , randomisation, and retention rates
Time frame: Screening, baseline, and 12 weeks follow-up
Adherence to the online intervention + telephone support calls (therapist supported arm only)
Time frame: 12 weeks follow-up
PHQ-9 (A self-report 9 item measure of depression)
Time frame: Change in depression from baseline to 12 weeks
GAD-7 (A self-report 7 item measure of anxiety)
Time frame: Change in anxiety from baseline to 12 weeks
EQ-5D (A self-report measure of quality of life)
Time frame: Baseline and 12 weeks follow-up
Brief Illness Perceptions Questionnaire
Time frame: Baseline and 12 weeks follow-up
Client Service Receipt Inventory (A self-report measure of health service utilisation)
Time frame: Baseline and 12 weeks follow-up
Satisfaction with treatment (A 2 item measure generated for the purposes of present study)
Time frame: Baseline and 12 weeks follow-up

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 10 Oct 2017.
Background: PubMed 27458126Hudson JL, Moss-Morris R, Game D, Carroll A, Chilcot J. Improving Distress in Dialysis (iDiD): A tailored CBT self-management treatment for patients undergoing dialysis. J Ren Care. 2016 Dec;42(4):223-238. doi: 10.1111/jorc.12168. Epub 2016 Jul 26.
Derived from this study: PubMed 28992899Hudson JL, Moss-Morris R, Norton S, Picariello F, Game D, Carroll A, Spencer J, McCrone P, Hotopf M, Yardley L, Chilcot J. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial. J Psychosom Res. 2017 Nov;102:61-70. doi: 10.1016/j.jpsychores.2017.09.009. Epub 2017 Sep 21.
Derived from this study: PubMed 28985589Chilcot J, Hudson JL, Moss-Morris R, Carroll A, Game D, Simpson A, Hotopf M. Screening for psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS): Initial validation of structural validity in dialysis patients. Gen Hosp Psychiatry. 2018 Jan-Feb;50:15-19. doi: 10.1016/j.genhosppsych.2017.09.007. Epub 2017 Sep 28.

Related trials for Kidney Failure, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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.

Joseph Chilcot, PhD principal investigator

King's College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Computerised Cognitive Behavioural Therapy and Telephone support in people with Kidney Failure, Chronic and Depression, run by King's College London at 1 site 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 5 inclusion and 5 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 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) (time frame: Baseline recruitment/screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352870, which also lists 3 linked publications.

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 10 Oct 2017.