Authors
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Slattery, Brian -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2017
INTERVENTION: When a participant agrees to take part in the trial they will be randomly assigned to the intervention or waiting list control group using random permuted blocks to ensure groups are balanced. The randomisation process will be performed by a web‐based password secured and encrypted data management system designed specifically for the randomisation of participants into clinical trials. Experimental Group: Participants receive the Acceptance and Commitment Therapy (ACT). This consists of eight sessions over an eight week period and will be hosted on the NUI Galway, Centre for Pain Research Website. The programme will be delivered via an interactive online platform, and it will consist of information, homework assignments, relevant metaphors and mindfulness exercises. The focus of this treatment protocol is on increasing psychological flexibility by developing acceptance, present‐focused awareness and engagement in values‐based action. Over the course of the trial, those participants in the experimental group will be prompted to complete each session weekly by a reminder sent to their email via the online ACT platform. As in the Hayes et al. protocol, participants will be contacted by phone three times (i.e., after session one, three, and seven) to motivate participants to continue and to provide them with some contact time with the researchers should they have any questions. The phone calls are structured and are required to maintain participant numbers and avoid participant attrition; the phone calls are not part of the treatment regimen. Adherence to the intervention will be remotely monitored. If a participant wishes to discontinue their involvement they will be withdrawn from the intervention and this will be reported as attrition. Control Group: Participants in the waitlist control group will be contacted by the study coordinator to explain that they have been allocated to the waiting list control group. The participants will be given the chance to ask any que CONDITION: Multimorbidity ; Signs and Symptoms ; Multimorbidity PRIMARY OUTCOME: Current primary outcome measures as of 15/02/2018:; Health related quality of life will be measured using the EQ‐5D and pain interference will be measured using the Brief Pain Inventory. Both measures will be administered at baseline, post‐intervention (week 8) and three months post‐intervention.; ; Previous primary outcome measures:; Health related quality of life will be measured using the SF‐36 and will be administered at baseline, post‐intervention (week 8) and three months post‐intervention. SECONDARY OUTCOME: Current secondary outcome measures as of 15/02/2018:; 1. Global improvement with treatment is measured using the Patient Global Impression of Change Scale at baseline, post‐intervention (week 8) and three months post‐intervention.; 2. Psychological inflexibility and experiential avoidance is measured using The Acceptance and Action Questionnaire II at baseline, post‐intervention (week 8) and three months post‐intervention.; 3. Patient illness perceptions in the presence of multimorbidity is measured using The Multimorbidity Illness Perceptions Scale at baseline, post‐intervention (week 8) and three months post‐intervention.; 4. Depression is measured using the Patient Health Questionnaire at baseline, post‐intervention (week 8) and three months post‐intervention.; 5. Anxiety is measured using the Generalized Anxiety Disorder 7‐item (GAD‐7) scale at baseline, post‐intervention (week 8) and three months post‐intervention.; 6. Health Care Use is measured using the Client Services Receipt Inventory a baseline, post‐intervention (week 8) and three months post‐intervention.; ; Previous secondary outcome measures:; 1. Global improvement with treatment is measured using the Patient Global Impression of Change Scale at baseline, post‐intervention (week 8) and three months post‐intervention; 2. Psychological inflexibility and experiential avoidance is measured using The Acceptance and Action Questionnaire II at baseline, post‐intervention (week 8) and three months post‐intervention; 3. Patient illness perceptions in the presence of multimorbidity is measured using The Multimorbidity Illness Perceptions Scale at baseline, post‐intervention (week 8) and three months post‐intervention; 4. Depression is measured using the Patient Health Questionnaire at baseline, post‐intervention (week 8) and three months post‐intervention; 5. Anxiety is measured using the Generalized Anxiety Disorder 7‐item (GAD‐7) scale at baseline, post‐intervention (week 8) and three months post‐intervention; 7. Pain and the impact of pain on daily life is measured using the Brief Pain Inventory ‐ Short form at baseline, post‐intervention (week 8) and three months post‐intervention; 8. Health Care Use is measured using the Client Services Receipt Inventory a baseline, post‐intervention (week 8) and three months post‐intervention INCLUSION CRITERIA: Current inclusion criteria as of 15/02/2018: 1. Aged 18 years or over 2. Presence of chronic pain and at least one other chronic conditions reported by the patient as having been diagnosed by a doctor 3. Resident of the Republic of Ireland 4. Access to a computer and the internet 5. Not currently undergoing any form of psychological treatment 6. Sufficiently competent in the English language (as determined by the participant) to complete the various elements of the study 7. Provision of informed consent Previous INCLUSION CRITERIA: 1. Aged 18 years or over 2. Presence of two or more chronic conditions reported by the patient as having been diagnosed by a doctor 3. Resident of the Republic of Ireland 4. Access to a computer and the internet 5. Not currently undergoing any form of psychological treatment 6. Sufficiently competent in the English language (as determined by the participant) to complete the various elements of
Epistemonikos ID: 636a452f92833f05599a3a39f000018f2a72dd43
First added on: Aug 23, 2024