Condition category
Signs and Symptoms
Date applied
14/06/2016
Date assigned
11/01/2017
Last edited
11/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The progress of modern medicine has substantially increased life expectancy and improved changes of survival from previously fatal diseases. This has led to a rise in multimorbididy (MM), where a person is suffering from two or more long term diseases in which neither condition is considered primary. For example, a person may be suffering from asthma (a breathing condition) and diabetes (inability to control blood sugar). This can greatly affect quality of life as well as being distressing for the patient involved. Acceptance and Commitment Therapy (ACT) is a type of taking therapy which uses that uses acceptance and mindfulness (a way of observing experiences in the present moment, without judgment) strategies, together with commitment and behaviour change strategies, to help a person to deal with difficult situations they may face. The aim of this study is to determine whether an online Acceptance and Commitment Therapy (ACT) programme is effective among people living with multimorbidity in Ireland.

Who can participate?
Adults who live in the Republic of Ireland who have two or more long-term medical conditions.

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives access to the online therapy immediately and the other group will be part of a waiting list group that will receive access to the therapy at the end of the study. The online therapeutic intervention consists of eight sessions that are designed to run over eight weeks. Each session should last approximately 30-40 minutes. It will be delivered online and will progress at the convenience of participants. The program consists of information, mindfulness exercises, homework assignments and learning relevant metaphors. Throughout the trial, participants receive a weekly email to remind them to complete their therapy. On three occasions, after session one, three and seven, participants receive a phone call from the researchers, should they have any questions, and to motivate them. These phone calls are structured and are not considered part of the treatment regimen. At the start of the study and again after eight weeks and three months, participants in both groups complete a number of questionnaires designed to measure their quality of life and physical and mental wellbeing.

What are the possible benefits and risks of participating?
Participants benefit from having access to a free online psychological ACT programme, receiving useful information on multimorbidity and long-term conditions, and a greater understanding of the individual’s role and training in tailored mindfulness techniques. There are no notable risks involved with participating in this study.

Where is the study run from?
Centre for Pain Research, National University of Ireland Galway (Ireland)

When is the study starting and how long is it expected to run for?
June 2015 to August 2017

Who is funding the study?
Health Research Board (Ireland)

Who is the main contact?
Dr Brian Slattery
brian.slattery@nuigalway.ie

Trial website

Contact information

Type

Public

Primary contact

Dr Brian Slattery

ORCID ID

Contact details

Centre for Pain Research
National University of Ireland Galway
Galway
H91 EV56
Ireland
+353 91 495832
brian.slattery@nuigalway.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Brian McGuire RLA/2013

Study information

Scientific title

Comparing the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control on health related quality of life among adults with multimorbidity

Acronym

Study hypothesis

People in the ACT treatment group will report significant improvements in health-related quality of life, physical functioning, emotional functioning and rating of overall improvement, and reductions in symptom reporting relative to a wait-list control group.

Ethics approval

Research Ethics Committee of the National University of Ireland, Galway, 16/01/2016, ref: 'NUI Galway Research Ethics Committee 16/JAN/01'

Study design

Single-blind randomised wait-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Multimorbidity

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 questions they have about the trial at this time. The waitlist control group will be offered the opportunity to use the online ACT intervention following the 3-month follow-up assessment.

Participants in both the intervention and wait-list control groups will complete follow up questionnaires (identical to those administered at pre and post intervention) in order to assess any lasting effects of the intervention.

Intervention type

Other

Phase

Drug names

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 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

Overall trial start date

15/06/2015

Overall trial end date

10/08/2017

Reason abandoned

Eligibility

Participant 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 the study
7. Provision of informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

Not fulfilling the inclusion criteria.

Recruitment start date

01/09/2016

Recruitment end date

10/05/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

Centre for Pain Research
National University of Ireland Galway
Galway
H91 EV56
Ireland

Sponsor information

Organisation

Health Research Board

Sponsor details

Grattan House
67-72 Lower Mount Street
Dublin
D02 H638
Ireland

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

Results and Publications

Publication and dissemination plan

The findings of the trial will be submitted for publication in peer-reviewed journals and will be disseminated through conference presentations.

Intention to publish date

10/08/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes