Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial

Sara Hayes; Michael Hogan; Haulie Dowd; Edel Doherty; Siobhan O'Higgins; Saoirse Nic Gabhainn; Padraig MacNeela; Andrew W Murphy; Thomas Kropmans; Ciaran O'Neill; John Newell; Brian E McGuire

doi:10.1136/bmjopen-2014-005092

Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial

Sara Hayes
, Michael Hogan
, Haulie Dowd
, Edel Doherty
, Siobhan O'Higgins
, Saoirse Nic Gabhainn
, Padraig MacNeela
, Andrew W Murphy
, Thomas Kropmans
, Ciaran O'Neill
, John Newell
, Brian E McGuire

Research output: Contribution to journal › Article › peer-review

Abstract

INTRODUCTION: Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain.

METHODS AND ANALYSIS: Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial.

ETHICS AND DISSEMINATION: The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ISRCTN18166896.

Original language	English
Article number	e005092
Pages (from-to)	e005092
Journal	BMJ Open
Volume	4
Issue number	7
DOIs	https://doi.org/10.1136/bmjopen-2014-005092 https://doi.org/10.1136/bmjopen-2014-005092
Publication status	Published - 2014

Keywords

Acceptance and Commitment Therapy/economics
Adult
Chronic Pain/therapy
Cost-Benefit Analysis
Humans
Internet
Research Design
Single-Blind Method
Treatment Outcome
Waiting Lists

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Hayes, S., Hogan, M., Dowd, H., Doherty, E., O'Higgins, S., Nic Gabhainn, S., MacNeela, P., Murphy, A. W., Kropmans, T., O'Neill, C., Newell, J., & McGuire, B. E. (2014). Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial. BMJ Open, 4(7), e005092. Article e005092. https://doi.org/10.1136/bmjopen-2014-005092, https://doi.org/10.1136/bmjopen-2014-005092

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title = "Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial",

abstract = "INTRODUCTION: Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain.METHODS AND ANALYSIS: Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial.ETHICS AND DISSEMINATION: The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN18166896.",

keywords = "Acceptance and Commitment Therapy/economics, Adult, Chronic Pain/therapy, Cost-Benefit Analysis, Humans, Internet, Research Design, Single-Blind Method, Treatment Outcome, Waiting Lists",

author = "Sara Hayes and Michael Hogan and Haulie Dowd and Edel Doherty and Siobhan O'Higgins and \{Nic Gabhainn\}, Saoirse and Padraig MacNeela and Murphy, \{Andrew W\} and Thomas Kropmans and Ciaran O'Neill and John Newell and McGuire, \{Brian E\}",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",

year = "2014",

doi = "10.1136/bmjopen-2014-005092",

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Hayes, S, Hogan, M, Dowd, H, Doherty, E, O'Higgins, S, Nic Gabhainn, S, MacNeela, P, Murphy, AW, Kropmans, T, O'Neill, C, Newell, J & McGuire, BE 2014, 'Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial', BMJ Open, vol. 4, no. 7, e005092, pp. e005092. https://doi.org/10.1136/bmjopen-2014-005092, https://doi.org/10.1136/bmjopen-2014-005092

Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial. / Hayes, Sara; Hogan, Michael; Dowd, Haulie et al.
In: BMJ Open, Vol. 4, No. 7, e005092, 2014, p. e005092.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain

T2 - Study protocol for a randomised controlled trial

AU - Hayes, Sara

AU - Hogan, Michael

AU - Dowd, Haulie

AU - Doherty, Edel

AU - O'Higgins, Siobhan

AU - Nic Gabhainn, Saoirse

AU - MacNeela, Padraig

AU - Murphy, Andrew W

AU - Kropmans, Thomas

AU - O'Neill, Ciaran

AU - Newell, John

AU - McGuire, Brian E

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2014

Y1 - 2014

N2 - INTRODUCTION: Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain.METHODS AND ANALYSIS: Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial.ETHICS AND DISSEMINATION: The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN18166896.

AB - INTRODUCTION: Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain.METHODS AND ANALYSIS: Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial.ETHICS AND DISSEMINATION: The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN18166896.

KW - Acceptance and Commitment Therapy/economics

KW - Adult

KW - Chronic Pain/therapy

KW - Cost-Benefit Analysis

KW - Humans

KW - Internet

KW - Research Design

KW - Single-Blind Method

KW - Treatment Outcome

KW - Waiting Lists

UR - https://www.scopus.com/pages/publications/84903602810

U2 - 10.1136/bmjopen-2014-005092

DO - 10.1136/bmjopen-2014-005092

M3 - Article

C2 - 24993763

AN - SCOPUS:84903602810

VL - 4

SP - e005092

JO - BMJ Open

JF - BMJ Open

IS - 7

M1 - e005092

ER -

Hayes S, Hogan M, Dowd H, Doherty E, O'Higgins S, Nic Gabhainn S et al. Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial. BMJ Open. 2014;4(7):e005092. e005092. doi: 10.1136/bmjopen-2014-005092, 10.1136/bmjopen-2014-005092

Comparing the clinical-effectiveness and cost-effectiveness of an internetdelivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: Study protocol for a randomised controlled trial

Abstract

Keywords

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