Intervention for Improving Psychological Distress in Dialysis (iDiD)

King's College London

Status: Completed

Conditions: Depression; Anxiety; Kidney Failure, Chronic

Treatments: Behavioral: Computerised Cognitive Behavioural Therapy; Behavioral: Telephone support

Study type: Interventional

Funder types: Other

Identifiers

NCT02352870

14.LO.1934 (Other Identifier)

PAHTMZA WPAH 68913

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Computerised CBT with therapist support

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone support

Behavioral: Computerised Cognitive Behavioural Therapy

Computerised CBT without therapist support

Active Comparator group

Description:

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

Treatment:

Behavioral: Computerised Cognitive Behavioural Therapy