Intervention for Improving Psychological Distress in Dialysis (iDiD)

October 9, 2017 updated by: King's College London

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18 years or over and receive hospital haemodialysis three-times weekly
  2. 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)
  3. Speak English sufficiently well to engage with screening tools
  4. Have a basic understanding of how to use the Internet and an email address
  5. Have a minimum dialysis vintage of ≥3 months (electronic patient record)

Exclusion Criteria:

  1. Hospitalised at the time of assessment or within 1 month prior to the assessment
  2. 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
  3. Severe mental health disorders, for example, psychosis, bi-polar disorder
  4. 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.
  5. Evidence of addiction to alcohol or drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerised CBT with therapist support

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

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
Behavioral: Computerised Cognitive Behavioural Therapy
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline recruitment/screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment , randomisation, and retention rates
Time Frame: Screening, baseline, and 12 weeks follow-up
Descriptive statistics as per CONSORT flow diagram
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
Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only)
12 weeks follow-up
PHQ-9 (A self-report 9 item measure of depression)
Time Frame: Change in depression from baseline to 12 weeks
A self-report 9 item measure of depression
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
A self-report 7 item measure of anxiety
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
A self-report measure of quality of life
Baseline and 12 weeks follow-up
Brief Illness Perceptions Questionnaire
Time Frame: Baseline and 12 weeks follow-up
A self-report measure of beliefs about illness
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
A self-report measure of health service utilisation
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
A 2 item measure generated for the purposes of present study
Baseline and 12 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

University of Southampton
National Health Service, United Kingdom

Investigators

  • Principal Investigator: Joseph Chilcot, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAHTMZA WPAH 68913
  • 14.LO.1934 (Other Identifier: NHS research ethics committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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