A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial

David Saxon, Kate Ashley, Lindsey Bishop-Edwards, Janice Connell, Phillippa Harrison, Sally Ohlsen, Gillian E Hardy, Stephen Kellett, Clara Mukuria, Toni Mank, Peter Bower, Mike Bradburn, John Brazier, Robert Elliott, Lynne Gabriel, Michael King, Stephen Pilling, Sue Shaw, Glenn Waller, Michael Barkham

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

BACKGROUND: NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.

METHODS: PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.

DISCUSSION: This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative.

TRIAL REGISTRATION: Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.

LanguageEnglish
Article number93
Number of pages14
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - 1 Mar 2017

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Cognitive Therapy
Counseling
Primary Health Care
Randomized Controlled Trials
Depression
Psychology
Cost-Benefit Analysis
Therapeutics
Non-Randomized Controlled Trials
Outcome Assessment (Health Care)
International Classification of Diseases
Registries
Anxiety
Quality of Life
Guidelines
Interviews

Keywords

  • depression
  • non-inferiority trial
  • cognitive behaviour therapy
  • counselling for depression
  • person-centred and experiential therapies
  • efficacy
  • cost-effectiveness

Cite this

Saxon, David ; Ashley, Kate ; Bishop-Edwards, Lindsey ; Connell, Janice ; Harrison, Phillippa ; Ohlsen, Sally ; Hardy, Gillian E ; Kellett, Stephen ; Mukuria, Clara ; Mank, Toni ; Bower, Peter ; Bradburn, Mike ; Brazier, John ; Elliott, Robert ; Gabriel, Lynne ; King, Michael ; Pilling, Stephen ; Shaw, Sue ; Waller, Glenn ; Barkham, Michael. / A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED) : Study protocol for a randomised controlled trial. In: Trials. 2017 ; Vol. 18, No. 1.
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abstract = "BACKGROUND: NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.METHODS: PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5{\%} significance level with 90{\%} power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.DISCUSSION: This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative.TRIAL REGISTRATION: Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.",
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Saxon, D, Ashley, K, Bishop-Edwards, L, Connell, J, Harrison, P, Ohlsen, S, Hardy, GE, Kellett, S, Mukuria, C, Mank, T, Bower, P, Bradburn, M, Brazier, J, Elliott, R, Gabriel, L, King, M, Pilling, S, Shaw, S, Waller, G & Barkham, M 2017, 'A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial' Trials, vol. 18, no. 1, 93. https://doi.org/10.1186/s13063-017-1834-6

A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED) : Study protocol for a randomised controlled trial. / Saxon, David; Ashley, Kate; Bishop-Edwards, Lindsey; Connell, Janice; Harrison, Phillippa; Ohlsen, Sally; Hardy, Gillian E; Kellett, Stephen; Mukuria, Clara; Mank, Toni; Bower, Peter; Bradburn, Mike; Brazier, John; Elliott, Robert; Gabriel, Lynne; King, Michael; Pilling, Stephen; Shaw, Sue; Waller, Glenn; Barkham, Michael.

In: Trials, Vol. 18, No. 1, 93, 01.03.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED)

T2 - Trials

AU - Saxon, David

AU - Ashley, Kate

AU - Bishop-Edwards, Lindsey

AU - Connell, Janice

AU - Harrison, Phillippa

AU - Ohlsen, Sally

AU - Hardy, Gillian E

AU - Kellett, Stephen

AU - Mukuria, Clara

AU - Mank, Toni

AU - Bower, Peter

AU - Bradburn, Mike

AU - Brazier, John

AU - Elliott, Robert

AU - Gabriel, Lynne

AU - King, Michael

AU - Pilling, Stephen

AU - Shaw, Sue

AU - Waller, Glenn

AU - Barkham, Michael

PY - 2017/3/1

Y1 - 2017/3/1

N2 - BACKGROUND: NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.METHODS: PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.DISCUSSION: This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative.TRIAL REGISTRATION: Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.

AB - BACKGROUND: NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.METHODS: PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.DISCUSSION: This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative.TRIAL REGISTRATION: Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.

KW - depression

KW - non-inferiority trial

KW - cognitive behaviour therapy

KW - counselling for depression

KW - person-centred and experiential therapies

KW - efficacy

KW - cost-effectiveness

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DO - 10.1186/s13063-017-1834-6

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JO - Trials

JF - Trials

SN - 1745-6215

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ER -