Rheumatoid ArthritisNCT02257073
Cognitive-behavioral Treatment for Rheumatoid Arthritis
A study testing Cognitive-behavioral treatment and Waiting List in people with Rheumatoid Arthritis, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cognitive-behavioral treatment and Waiting List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jul 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed by rheumatology consultants with RA
Who cannot join
- severe psychological difficulties
- currently receiving mental health care
- any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease)
- previously attended an education programme
- had a Modified Health Assessment Questionnaire score >2 (score range 0-3), that is severe functional problems
- history of organic brain syndrome
Show all 11Show fewer
- presence of a psychotic disorder
- presence of other uncontrolled medical disorders
- presence of a major communication disorder, illiteracy
- presence of less than an 8th grade education (due to inability to complete questionnaires)
- presence of a therapeutic dosage of an antidepressant medication, or presence of another autoimmune disease/disabling condition
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Chengdu Military Area Command PLA
Chengdu, Sichuan, 610083
About this study
To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- Cognitive-behavioral treatment, Waiting List
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral treatmentBehavioural
Waiting ListBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Cognitive-behavioral treatment Receives: Behavioral: Cognitive-behavioral treatment |
| WLT | Sham comparator | Waiting in list Receives: Behavioral: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2018 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257073
- Sponsor's protocol ID
- CBRA20140102
- Other IDs
- BWS11J067
- Status last verified
- Mar 2017
- First submitted
- 2 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Treatment for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02257073
- Acronym / sponsor ID
- CBRA20140102
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 6 Oct 2014 (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.
To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive-behavioral treatmentCognitive-behavioral treatment |
| WLT | Sham comparator | Behavioral: Waiting ListWaiting in list |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed by rheumatology consultants with RA
Key exclusion criteria (11 listed)
- severe psychological difficulties
- currently receiving mental health care
- any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease)
- previously attended an education programme
- had a Modified Health Assessment Questionnaire score >2 (score range 0-3), that is severe functional problems
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 |
|---|---|---|
| Cognitive-behavioral treatment | Behavioural | CBT |
| Waiting List | Behavioural | WLT |
Primary outcome
Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks
Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral treatment and Waiting List in people with Rheumatoid Arthritis, run by Chengdu PLA General Hospital at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks (time frame: at 0 week, 12 weeks, 24 weeks, 48 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 4 Apr 2017.