Intervention for Improving Psychological Distress in Dialysis

NCT02352870 | Completed

• 2 other identifiers: PAHTMZA WPAH 6891314.LO.1934
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Kidney Failure, Chronic; Depression; Anxiety

Keywords

Feasibility study; Randomised controlled trial; Cognitive behavioural therapy; Psychological distress; Cognitive illness representations; Common sense model

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline recruitment/screening

Secondary Outcomes (8)

• Recruitment , randomisation, and retention rates

  Screening, baseline, and 12 weeks follow-up

• Adherence to the online intervention + telephone support calls (therapist supported arm only)

  12 weeks follow-up

• PHQ-9 (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)

  Change in anxiety from baseline to 12 weeks

• EQ-5D (A self-report measure of quality of life)

  Baseline and 12 weeks follow-up

Study Arms (2)

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.

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

Behavioral: Computerised Cognitive Behavioural Therapy

Interventions

Computerised Cognitive Behavioural Therapy BEHAVIORAL

Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis

Computerised CBT with therapist support; Computerised CBT without therapist support

Telephone support BEHAVIORAL

Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.

Computerised CBT with therapist support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• National Health Service, United Kingdom: collaborator
• University of Southampton: collaborator

Study Sites (1)

Guy's and St Thomas NHS Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 27458126 BACKGROUND

• 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.

  PMID: 28992899 DERIVED

• 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.

  PMID: 28985589 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Joseph Chilcot, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 2, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 10, 2017

Record last verified: 2015-09

Locations

GB (1)