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Completed

NCT Number: NCT02352870

Intervention for Improving Psychological Distress in Dialysis

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy's and St Thomas NHS Trust

London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Computerised Cognitive Behavioural Therapy

Behavioral

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

telephone support

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Recruitment , randomisation, and retention rates

    Time frame: Screening, baseline, and 12 weeks follow-up

    Descriptive statistics as per CONSORT flow diagram

  2. 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)

  3. 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

  4. 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

  5. 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

  6. Brief Illness Perceptions Questionnaire

    Time frame: Baseline and 12 weeks follow-up

    A self-report measure of beliefs about illness

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • National Health Service, United Kingdom
  • University of Southampton

Registry information

Official study 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)

Acronym: iDiD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2015
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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