Plain English Summary
Background and study aims
Acceptance and commitment therapy (ACT) is associated with clinically meaningful long-term improvements in function and quality of life among patients with chronic pain. However, much of the research to date on ACT for chronic pain has been done in the tertiary care setting (for example, specialist hospitals or clinics), and research is needed to determine whether ACT can be given to patients in a cost-effective way in a community setting (for example, at a patients home). To address these challenges, this study aims to test a newly developed therapist-assisted online ACT treatment for patients with chronic pain.
Who can participate?
Adults with chronic pain recruited from Guy’s and St. Thomas’ Pain Management Centre
What does the study involve?
Initially, ten patients are asked to test how easy it is to use the online ACT treatment. Participants are then randomly allocated into one of two groups. Those in group 1 are given access to the online ACT treatment in addition to medical treatment as usual. Those in group 2 are given just treatment as usual. The online ACT treatment is then compared with treatment as usual. All participants complete assessment questionnaires online before they are allocated into one of the two groups and then again at three months and nine months after the start of the study.
What are the possible benefits and risks of participating?
We expect that participation in this research will help improve treatment access and outcomes for people with chronic pain in the future. The study procedures are not expected to have a negative impact on participants’ safety and well-being. The risks associated with the study procedures are standard in studies evaluating psychological treatments. To maintain the security of participant data, we will use an encrypted online survey system to collect questionnaire responses.
Where is the study run from?
St Thomas’ Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2015 to April 2017
Who is funding the study?
International Association for the Study of Pain (USA)
Who is the main contact?
Dr Whitney Scott
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18687
Study information
Scientific title
Testing the feasibility of internet-administered acceptance and commitment therapy for patients with chronic pain: a randomized controlled trial
Acronym
Study hypothesis
The online ACT intervention will be feasible according the following criteria:
1. We expect to recruit and retain 35 participants per treatment arm to provide assessment data at the three month follow-up
2.Seventy percent of participants in the online ACT treatment will complete seventy percent of treatment sessions
3.The majority of participants will score in the upper end (i.e., 5 or more) on the self-report items assessing treatment acceptability
4. Less than 10% of data will be missing from participants’ assessment data
A secondary objective of the study is to provide a stable estimate of the variance for clinical outcome and theoretically-relevant treatment process measures.
Ethics approval
National Research Ethics Service Committee London (United Kingdom) - Central, 26/01/2015, ref: 14/L0/1936
Study design
Single-centre randomized-controlled feasibility trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Chronic non-malignant pain
Intervention
1. Online Acceptance and Commitment Therapy: The therapist-assisted online treatment program is based on principles of Acceptance and Commitment Therapy (ACT) for chronic pain. Patients will receive a standardized treatment package of two face-to-face sessions plus eight online sessions with the online component delivered over five weeks and the total treatment time including about eight weeks. This core package may be augmented with additional exercises by the therapist, depending on each patient’s progress. Online therapy sessions consist primarily of videoclips of therapists providing information and guiding patients through experiential exercises (e.g., meditation, values clarification, goal-setting) and metaphors. Following each session, patients will be asked to respond to several questions assessing their experiences in session, which will be sent by email to their therapist for feedback. Patients will have a face-to-face meeting with their therapist before and after the online treatment to establish the therapeutic relationship, set expectations, and review progress. Participants in this condition will also continue to receive medical treatment as usual.
2. Treatment as usual. All patients will receive usual medical care as deemed appropriate by their treating clinicians at the Guy’s and St. Thomas’ Pain Management Centre.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Recruitment and retention rates will be recorded by a researcher.
2. Treatment adherence: Adherence to the online treatment will be determined through a count of the number of sessions for which patients submit post-session email reflections to their therapists and attendance at the two face-to-face sessions. Therapists will record whether patients have submitted these responses and attended the face-to-face sessions (yes/no) following each scheduled session.
3. Treatment acceptability: Immediately following treatment, participants will respond to several questions asking them to rate how satisfied they were with the treatment they received on an 11 point Likert scale ranging from 0 (not at all) to 10 (completely). These items were created specifically for the purpose of the present study.
4. Completeness of data acquisition: Response rates on all questionnaires and the number of missing data points will be identified and recorded by a researcher following the final follow-up assessment.
Secondary outcome measures
The following clinical outcome and treatment process measures will be completed by all participants prior to randomization, and at 3 and 9 month follow-up intervals:
1.Daily Functioning: Brief Pain Inventory--Interference subscale (Cleeland et al., 1994).
2. Depressive Symptoms: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
3. Pain intensity: Current and average pain intensity and pain-related distress will be rated from 0 to 10.
4. Health Care utilization: Participants will report on their number of GP visits, specialist visits, accident and emergency visits, and days hospitalized over the preceding three-month period.
5. The single-item Patient Global Impression of Change rating will be used to examine patients’ self-reported overall impressions of change.
6. Treatment process: The short version of the Chronic Pain Acceptance Questionnaire (Fish et al., 2010), the Experiences Questionnaire (Fresco et al., 2007), and the short version of the Committed Action Questionnaire (McCracken et al., 2014) will be used to measure theoretically-relevant processes of psychological flexibility.
Overall trial start date
01/09/2014
Overall trial end date
30/04/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults aged 18 years and older
2. Outpatients at St. Thomas’ Pain Management Centre
3. Chronic pain non-malignant pain (at least 3 months duration), associated with significant distress and/or disability
4. Medical appropriateness for an online psychological treatment as determined by the referring clinician
5. Access to the Internet for the duration of the study
6. Ability to provide informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90 recruited, 70 retained
Participant exclusion criteria
1. History of ACT or traditional CBT for chronic pain
2. Currently receiving another form of psychological treatment
3. Presence of a serious, uncontrolled psychiatric disorder (e.g., schizophrenia, bipolar, etc.) or other impediments to treatment engagement (e.g., neuropsychological impairment)
4. Inability to complete study procedures in English
5. Inability to complete study procedures using a computer
Recruitment start date
10/04/2015
Recruitment end date
31/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy’s and St. Thomas’ Pain Management Centre
INPUT Pain Management Unit
Gassiot House
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Funders
Funder type
Government
Funder name
International Association for the Study of Pain
Alternative name(s)
IASP
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United States of America
Results and Publications
Publication and dissemination plan
Following completion of the trial, data concerning primary and secondary feasibility outcomes will be analysed and the results will be prepared for submission to a peer-reviewed journal and for presentation at scientific conferences.
IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Whitney Scott.
Intention to publish date
30/04/2018
Participant level data
Available on request
Results - basic reporting
Publication summary