Intervention for Improving Psychological Distress in Dialysis

Depression Clinical Trial

— iDiD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352870
• Other study ID #: PAHTMZA WPAH 68913
• Secondary ID: 14.LO.1934
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: October 9, 2017
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	National Health Service, United Kingdom, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment , randomisation, and retention rates	Descriptive statistics as per CONSORT flow diagram	Screening, baseline, and 12 weeks follow-up
Secondary	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)	12 weeks follow-up
Secondary	PHQ-9 (A self-report 9 item measure of depression)	A self-report 9 item measure of depression	Change in depression from baseline to 12 weeks
Secondary	GAD-7 (A self-report 7 item measure of anxiety)	A self-report 7 item measure of anxiety	Change in anxiety from baseline to 12 weeks
Secondary	EQ-5D (A self-report measure of quality of life)	A self-report measure of quality of life	Baseline and 12 weeks follow-up
Secondary	Brief Illness Perceptions Questionnaire	A self-report measure of beliefs about illness	Baseline and 12 weeks follow-up
Secondary	Client Service Receipt Inventory (A self-report measure of health service utilisation)	A self-report measure of health service utilisation	Baseline and 12 weeks follow-up
Secondary	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	Baseline and 12 weeks follow-up