- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01603797
Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients
October 2, 2012 updated by: Gerhard Andersson
Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients: a Randomized Controlled Trial
The aim of this study was to investigate if guided internet-delivered acceptance and commitment therapy (ACT)would help chronic pain patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study investigates internet-delivered ACT for persons with chronic pain.
The use of internet as a delivery format for interventions could be a way of overcome many barriers (financial obstacles, reluctance to seek treatment and paucity of clinicians trained in ACT) that hinder persons with chronic pain to seek or receive adequate help.
Persons were randomized to either treatment for 7 weeks or to a control group who were invited to participate in a moderated online discussion forum.
Follow up data was collected six months after the treatment.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- that participants had undergone medical investigation (within one year)
- had regular access to the internet
- had functional impairment caused by chronic pain
- had internet access
Exclusion Criteria:
- ongoing medical investigations or treatment that could interfere with participation in the study, such as planned surgery and suffering from acute physical or psychological conditions
- not fluent in the Swedish language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Internet delivered ACT
Internet delivered acceptance and commitment therapy (ACT), 7 weeks treatment
|
The treatment program consisted of seven sections and was based on ACT.The first part was about creative hopelessness and was followed in the next section by an introduction to willingness and to the process of acceptance of pain.
Information and assignments about committed action and values were also part of the treatment program.
Mindfulness exercises were a regular feature in the program.
The last part was about how to maintain learned strategies but also an evaluation of the program.
|
|
Active Comparator: Online discussion forum
Active wait-list condition.
Were offered to participate in a moderated online discussion forum.
After post-treatment assessment the control group were offered treatment.
|
The treatment program consisted of seven sections and was based on ACT.The first part was about creative hopelessness and was followed in the next section by an introduction to willingness and to the process of acceptance of pain.
Information and assignments about committed action and values were also part of the treatment program.
Mindfulness exercises were a regular feature in the program.
The last part was about how to maintain learned strategies but also an evaluation of the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic Pain Acceptance Questionnaire (CPAQ)
Time Frame: One week pre- and post-treatment
|
CPAQ consists of 20 items divided into two subscales: activity engagement and pain willingness.
Items are rated on a scale from 0 (never true) to 6 (always true).
Higher scores denote greater activity engagement and pain willingness.
Studies show acceptable reliability (α =.72-.92).
|
One week pre- and post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital and Anxiety Depression Scale (HADS)
Time Frame: One week pre- and post- treatment
|
HADS contains 14 items and evaluates severity of symptoms of depression and anxiety without contamination of scores of physical symptomatology.
|
One week pre- and post- treatment
|
|
The Coping Strategies Questionnaire (CSQ)
Time Frame: One week pre- and post- treatment
|
The CSQ contains 50 items divided into eight scales measuring different cognitive and behavioural coping strategies and has been widely used by chronic pain patients.
The coping strategies scales are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing and increased behavioral activities
|
One week pre- and post- treatment
|
|
Multidimensional Pain Inventory (MPI-S)
Time Frame: One week pre- and post- treatment
|
The Swedish version of MPI (MPI-S) consists of 34 items divided into 8 scales.
The first section addresses: Pain Severity, Interference, Life Control, Affective Distress and Support.
The second section addresses the patient's perception of how significant others respond to their displays of pain: Punishing Responses, Solicitous Responses and Distracting Responses.
|
One week pre- and post- treatment
|
|
The Pain and Impairment Relationship Scale (PAIRS)
Time Frame: One week pre- and post- treatment
|
PAIRS assess beliefs and attitudes associated with the experience of chronic pain and one's ability to function despite pain.
It consists of 15 personal statements that reflect thoughts, attitudes and opinions about pain.
|
One week pre- and post- treatment
|
|
Quality of Life Inventory (QOLI)
Time Frame: One week pre- and post- treatment
|
QOLI consists of 32 items for assessing life satisfaction.
The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood, and community.
|
One week pre- and post- treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gerhard Andersson, Professor, Linkoeping University
- Principal Investigator: Monica Buhrman, MSc, Uppsala University
- Study Chair: Timo Hursti, PhD, Uppsala University
- Study Chair: Torsten Gordh, Professor, Uppsala University
- Study Chair: Tomas Furmark, Professor, Uppsala University
- Study Chair: Astrid Skoglund, MSc, Uppsala University
- Study Chair: Josefin Husell, MSc, Uppsala University
- Study Chair: Kristina Bergström, MSc, Uppsala University
- Study Chair: Nina Bendelin, MSc, Linkoeping University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 19, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (Estimate)
May 22, 2012
Study Record Updates
Last Update Posted (Estimate)
October 3, 2012
Last Update Submitted That Met QC Criteria
October 2, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- smartaSIAMB_GA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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