CatastrophizationCT_TKANCT01772329

Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects

A study testing Cognitive Therapy and Routine Care in people with Catastrophization, run by Rush University Medical Center at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Catastrophization
What is being tested?: Cognitive Therapy and Routine Care
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Oct 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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

undergoing standard primary TKR; THR or Shoulder Surgery
18- 85 yrs of age;
Surgical joint is the primary source of patient's pain;
Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
Patient has been diagnosed with osteoarthritis.

Who cannot join

Currently using antidepressant medication or undergoing cognitive therapy;
chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;
history of opioid abuse;
inability to understand and communicate with the investigators to complete the study related questionnaires
patient is planning to undergo another elective joint procedure during the 6-mo period of participation;
any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects

The investigators propose a randomized controlled trial to evaluate the effects of treatment intended to reduce pain catastrophizing among patients reporting high pain catastrophizing prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor of PPP following total knee replacement is highly innovative and have potentially high impact for public health. Cognitive therapy is a well-tolerated modality among chronic pain patients with few if any side effects. Cognitive therapy (CT) represents an inexpensive method that could greatly reduce suffering and costly post-surgical pain management for high risk TKR patients.

Read the detailed description

Aim 1 is to determine which CT protocol is most effective in reducing Pain Catastrophizing Scale (PCS) and Coping Strategies Questionnaire Catastrophizing Subscale (CSQ-CAT) scores in high-risk TKR candidates. CT will consist of four-to-eight weekly 1-hr individual cognitive therapy sessions prior to surgery.

Aim 2 is to compare the most efficient treatment from Aim 1 with a control group to evaluate pain relief at 3 months.

Conditions: Catastrophization
Being tested: Cognitive Therapy, Routine Care

What participants receive

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

Cognitive TherapyOther
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
Routine CareOther
Routine Care. No Cognitive Therapy Intervention

Study groups in NCT01772329
Study group	Role	What they receive
4 weekly CT sessions - in person	Experimental	4 weekly CT sessions; all will be 1-hr individual cognitive therapy sessions with the psychology staff (under the supervision of John Burns, PhD). Receives: Other: Cognitive Therapy
8 weekly CT sessions	Experimental	8 weekly CT sessions; 1st and 8th will be 1-hr individual cognitive therapy session with the psychology staff (under the supervision of John Burns, PhD). The intermediate CT sessions will be by telephone call or video/"Skype". Our group will purchase and setup a web camera and headphone/microphone for the subjects in the CT groups that use "Skype". The 1-hr CT protocol was adapted from Dr. Beverly E. Thorn's CT manual (Cognitive Therapy for Chronic Pain: A Step-by-Step Guide; Thorn, 2004; with the Client and Therapy Workbooks. Receives: Other: Cognitive Therapy
4 weekly CT sessions - Tele-video	Experimental	4 weekly CT sessions; 1st and 4th will be 1-hr individual cognitive therapy session with the psychology staff. The intermediate CT sessions will be by telephone call or video/"Skype". Receives: Other: Cognitive Therapy
Routine care	Placebo comparator	Routine care; no CT sessions Receives: Other: Routine Care

What is being measured

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

(Aim 1) Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.
Measured: 4 or 8 weeks after start of treatment
(Aim 2) Proportion of patients with pain relief
Proportion of patients w a 3 month decrease in WOMAC pain subscale <= 4. (WOMAC Osteoarthritis Index)
Measured: 3 month

Secondary outcomes (2)

Patient Health Questionnaire (PHQ-8)
Patient Health Questionnaire (PHQ-8): The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders
Measured: 4 and 8 weeks after start of treatment
Generalized anxiety disorder (GAD-7)
Generalized anxiety disorder (GAD-7): The seven-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire.
Measured: 4 and 8 weeks after start of treatment

Timeline

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

Jan 2013Oct 2020

First posted21 Jan 2013 (estimated)
Study startJan 2013
Primary completionAug 2020
Study completionOct 2020

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 CatastrophizationStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2
Masking: Single blind
Who is masked: Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01772329
Sponsor's protocol ID: 12031901
Acronym: CT_TKA
Status last verified: Jun 2022
First submitted: 17 Jan 2013
Last updated: 28 Jun 2022
Results posted: No
Data monitoring committee: No
Individual data sharing: No: No plan to share data as of yet but may be willing to.

Publications

Buvanendran A, Sremac AC, Merriman PA, Della Valle CJ, Burns JW, McCarthy RJ. Preoperative cognitive-behavioral therapy for reducing pain catastrophizing and improving pain outcomes after total knee replacement: a randomized clinical trial. Reg Anesth Pain Med. 2021 Apr;46(4):313-321. doi: 10.1136/rapm-2020-102258. Epub 2021 Jan 15.
PubMed 33452201

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?

See locations

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All Catastrophization trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects
ClinicalTrials.gov ID: NCT01772329
Acronym / sponsor ID: CT_TKA / 12031901
Conditions: Catastrophization
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Collaborators: Pfizer
Study start: Jan 2013 (actual)
Primary completion: Aug 2020 (actual)
Study completion: Oct 2020 (actual)
First posted: 21 Jan 2013 (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.

Detailed description

Aim 2 is to compare the most efficient treatment from Aim 1 with a control group to evaluate pain relief at 3 months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4
Model description: n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2

Arm	Type	Receives
4 weekly CT sessions - in person	Experimental	Other: Cognitive Therapy4 weekly CT sessions; all will be 1-hr individual cognitive therapy sessions with the psychology staff (under the supervision of John Burns, PhD).
8 weekly CT sessions	Experimental	Other: Cognitive Therapy8 weekly CT sessions; 1st and 8th will be 1-hr individual cognitive therapy session with the psychology staff (under the supervision of John Burns, PhD). The intermediate CT sessions will be by telephone call or video/"Skype". Our group will purchase and setup a web camera and headphone/microphone for the subjects in the CT groups that use "Skype". The 1-hr CT protocol was adapted from Dr. Beverly E. Thorn's CT manual (Cognitive Therapy for Chronic Pain: A Step-by-Step Guide; Thorn, 2004; with the Client and Therapy Workbooks.
4 weekly CT sessions - Tele-video	Experimental	Other: Cognitive Therapy4 weekly CT sessions; 1st and 4th will be 1-hr individual cognitive therapy session with the psychology staff. The intermediate CT sessions will be by telephone call or video/"Skype".
Routine care	Placebo comparator	Other: Routine CareRoutine care; no CT sessions

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

undergoing standard primary TKR; THR or Shoulder Surgery
18- 85 yrs of age;
Surgical joint is the primary source of patient's pain;
Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.

Key exclusion criteria (6 listed)

Currently using antidepressant medication or undergoing cognitive therapy;
chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;
history of opioid abuse;
inability to understand and communicate with the investigators to complete the study related questionnaires
patient is planning to undergo another elective joint procedure during the 6-mo period of participation;

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 TherapyCT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.	Other	4 weekly CT sessions - Tele-video, 4 weekly CT sessions - in person, 8 weekly CT sessions
Routine CareRoutine Care. No Cognitive Therapy Intervention	Other	Routine care

Primary outcome

(Aim 1) Pain Catastrophizing Scale (PCS)
Time frame: 4 or 8 weeks after start of treatment
Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.
(Aim 2) Proportion of patients with pain relief
Time frame: 3 month
Proportion of patients w a 3 month decrease in WOMAC pain subscale <= 4. (WOMAC Osteoarthritis Index)

2 secondary outcomes

Patient Health Questionnaire (PHQ-8)
Time frame: 4 and 8 weeks after start of treatment
Generalized anxiety disorder (GAD-7)
Time frame: 4 and 8 weeks after start of 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 28 Jun 2022.
Derived from this study: PubMed 33452201Buvanendran A, Sremac AC, Merriman PA, Della Valle CJ, Burns JW, McCarthy RJ. Preoperative cognitive-behavioral therapy for reducing pain catastrophizing and improving pain outcomes after total knee replacement: a randomized clinical trial. Reg Anesth Pain Med. 2021 Apr;46(4):313-321. doi: 10.1136/rapm-2020-102258. Epub 2021 Jan 15.
Individual participant dataSharing planned: No. No plan to share data as of yet but may be willing to.

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Not yet recruiting
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Frozen Shoulder, Adhesive Capsulitis
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Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
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Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
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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.

Asokumar Buvanendran, MD principal investigator

Rush UMC

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 Therapy and Routine Care in people with Catastrophization, run by Rush University Medical Center 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 6 inclusion and 6 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 28 Jun 2022. 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. 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?

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?

(Aim 1) Pain Catastrophizing Scale (PCS) (time frame: 4 or 8 weeks after start of treatment). The study lists 2 primary outcomes in all. 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 NCT01772329, 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 28 Jun 2022.