Chronic PainNCT01603797

Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients

A study testing Guided internet-delivered acceptance and commitment therapy in people with Chronic Pain, run by Gerhard Andersson.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study was to investigate if guided internet-delivered acceptance and commitment therapy (ACT)would help chronic pain patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Guided internet-delivered acceptance and commitment therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: No sites listed yet
Study dates: Feb 2010to Dec 2010
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Conditions: Chronic Pain
Being tested: Guided internet-delivered acceptance and commitment therapy
Keywords: internetdelivered CBT, chronic pain, acceptance and commitment therapy, mindfulness, guided self help
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guided internet-delivered acceptance and commitment therapyBehavioural
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.

Study groups in NCT01603797
Study group	Role	What they receive
Internet delivered ACT	Experimental	Internet delivered acceptance and commitment therapy (ACT), 7 weeks treatment Receives: Behavioral: Guided internet-delivered acceptance and commitment therapy
Online discussion forum	Active comparator	Active wait-list condition. Were offered to participate in a moderated online discussion forum. After post-treatment assessment the control group were offered treatment. Receives: Behavioral: Guided internet-delivered acceptance and commitment therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Chronic Pain Acceptance Questionnaire (CPAQ)
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).
Measured: One week pre- and post-treatment

Secondary outcomes (5)

Hospital and Anxiety Depression Scale (HADS)
HADS contains 14 items and evaluates severity of symptoms of depression and anxiety without contamination of scores of physical symptomatology.
Measured: One week pre- and post- treatment
The Coping Strategies Questionnaire (CSQ)
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
Measured: One week pre- and post- treatment
Multidimensional Pain Inventory (MPI-S)
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.
Measured: One week pre- and post- treatment
The Pain and Impairment Relationship Scale (PAIRS)
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.
Measured: One week pre- and post- treatment
Quality of Life Inventory (QOLI)
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.
Measured: One week pre- and post- treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Dec 2010

First posted22 May 2012 (estimated)
Study startFeb 2010
Primary completionMay 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01603797
Sponsor's protocol ID: smartaSIAMB_GA
Status last verified: Oct 2012
First submitted: 19 May 2012
Last updated: 3 Oct 2012
Results posted: No
Data monitoring committee: No

Publications

Bendelin N, Bjorkdahl P, Risell M, Nelson KZ, Gerdle B, Andersson G, Buhrman M. Patients' experiences of internet-based Acceptance and commitment therapy for chronic pain: a qualitative study. BMC Musculoskelet Disord. 2020 Apr 6;21(1):212. doi: 10.1186/s12891-020-03198-1.
PubMed 32252707

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Recruiting
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Pain, Chronic
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01603797
Acronym / sponsor ID: smartaSIAMB_GA
Conditions: Chronic Pain
Keywords: internetdelivered CBT, chronic pain, acceptance and commitment therapy, mindfulness, guided self help
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Gerhard AnderssonOther government
Study start: Feb 2010
Primary completion: May 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 22 May 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study was to investigate if guided internet-delivered acceptance and commitment therapy (ACT)would help chronic pain patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Internet delivered ACT	Experimental	Behavioral: Guided internet-delivered acceptance and commitment therapyInternet delivered acceptance and commitment therapy (ACT), 7 weeks treatment
Online discussion forum	Active comparator	Behavioral: Guided internet-delivered acceptance and commitment therapyActive wait-list condition. Were offered to participate in a moderated online discussion forum. After post-treatment assessment the control group were offered treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guided internet-delivered acceptance and commitment therapyThe 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.	Behavioural	Internet delivered ACT, Online discussion forum

Primary outcome

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).

5 secondary outcomes

Hospital and Anxiety Depression Scale (HADS)
Time frame: One week pre- and post- treatment
The Coping Strategies Questionnaire (CSQ)
Time frame: One week pre- and post- treatment
Multidimensional Pain Inventory (MPI-S)
Time frame: One week pre- and post- treatment
The Pain and Impairment Relationship Scale (PAIRS)
Time frame: One week pre- and post- treatment
Quality of Life Inventory (QOLI)
Time frame: One week pre- and post- treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
Derived from this study: PubMed 32252707Bendelin N, Bjorkdahl P, Risell M, Nelson KZ, Gerdle B, Andersson G, Buhrman M. Patients' experiences of internet-based Acceptance and commitment therapy for chronic pain: a qualitative study. BMC Musculoskelet Disord. 2020 Apr 6;21(1):212. doi: 10.1186/s12891-020-03198-1.

Related trials for Chronic Pain

Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Recruiting
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Pain, Chronic
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gerhard Andersson, Professor study director

Linkoeping University

Monica Buhrman, MSc principal investigator

Uppsala University

Timo Hursti, PhD study chair

Uppsala University

Questions about this trial

What is this clinical trial studying?

A study testing Guided internet-delivered acceptance and commitment therapy in people with Chronic Pain, run by Gerhard Andersson.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic Pain Acceptance Questionnaire (CPAQ) (time frame: One week pre- and post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.