Low Back PainPhase 2WWNCT01337843
Online Cognitive Behavioral Therapy (CBT) Workbook
A Phase 2 study testing Wellness Workbook and Pain Management Print Materials in people with Low Back Pain, run by Talaria, Inc at 1 site in United States.
Trial summary
This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Wellness Workbook and Pain Management Print Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2013
- Phase
- Phase 2
- 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
- currently experiencing chronic non-cancer pain in the lower back
Who cannot join
- has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer)
- does not have regular Internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain
This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability and pain severity.
Read the detailed description
This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). The Wellness Workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (CBT) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the Wellness Workbook or alternative self-help materials for 10 weeks. Participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.
- Conditions
- Low Back Pain
- Being tested
- Wellness Workbook, Pain Management Print Materials
- Keywords
- Chronic low back pain, cognitive behavioral pain management, coping, mindfulness, physical activity, Back Pain Lower Back Chronic
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness WorkbookOther
A web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase physical activity and manage stress. This is a 10 week intervention. Participants use one chapter of the workbook each week. Each chapter takes approximately 1.5 hours to complete.
Pain Management Print MaterialsOther
Print materials comparable to the content within Wellness Workbook
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control Group participants will receive a well-regarded book for back pain patients. Receives: Other: Pain Management Print Materials |
| Wellnes Workbook | Experimental | Participants will receive the Wellness Workbook, a web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase their physical activity and manage stress with relaxation and mindfulness training Receives: Other: Wellness Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower pain related disability and interference scores.
As compared to the control group participants, CLBP patients who use the WW intervention will report lower pain-related disability and lower pain interference scores.
Measured: Baseline, 10 weeks, 18 weeks
Secondary outcomes (1)
Fewer pain-related disabling beliefs and attitudes.
As compared to the control group participants, CLBP patients who use the WW will report fewer pain-related disabling beliefs and attitudes, have better self-efficacy for managing pain and negative affect and will score higher on mindfulness/present moment awareness. They will also have higher physical activity scores and lower depression scores.
Measured: Baseline, 10 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talaria, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Susan Stoner, Ph.D., Principal investigator, Talaria, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337843
- Sponsor's protocol ID
- AR052569
- Other IDs
- 5R44AR052569-03
- Acronym
- WW
- Status last verified
- May 2014
- First submitted
- 15 Apr 2011
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01337843
- Acronym / sponsor ID
- WW / AR052569
- Conditions
- Low Back Pain
- Keywords
- Chronic low back pain, cognitive behavioral pain management, coping, mindfulness, physical activity, Back Pain Lower Back Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Talaria, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Apr 2011 (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.
This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability and pain severity.
Detailed description
This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). The Wellness Workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (CBT) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the Wellness Workbook or alternative self-help materials for 10 weeks. Participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Pain Management Print MaterialsControl Group participants will receive a well-regarded book for back pain patients. |
| Wellnes Workbook | Experimental | Other: Wellness WorkbookParticipants will receive the Wellness Workbook, a web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase their physical activity and manage stress with relaxation and mindfulness training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- currently experiencing chronic non-cancer pain in the lower back
Key exclusion criteria (2 listed)
- has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer)
- does not have regular Internet access
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 |
|---|---|---|
| Wellness WorkbookA web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase physical activity and manage stress. This is a 10 week intervention. Participants use one chapter of the workbook each week. Each chapter takes approximately 1.5 hours to complete. | Other | Wellnes Workbook |
| Pain Management Print MaterialsPrint materials comparable to the content within Wellness Workbook | Other | Control Group |
Primary outcome
Lower pain related disability and interference scores.
Time frame: Baseline, 10 weeks, 18 weeks
As compared to the control group participants, CLBP patients who use the WW intervention will report lower pain-related disability and lower pain interference scores.
1 secondary outcome
Fewer pain-related disabling beliefs and attitudes.
Time frame: Baseline, 10 weeks, 18 weeks
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 7 May 2014.
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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.
Susan Stoner, Ph.D. principal investigator
Talaria, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wellness Workbook and Pain Management Print Materials in people with Low Back Pain, run by Talaria, Inc at 1 site in United States.
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 1 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lower pain related disability and interference scores. (time frame: Baseline, 10 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2014.