Persistent Post-surgical PainNCT03351309
Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
A study testing Telephone-based Cognitive Behavioral Therapy (CBT) in people with Persistent Post-surgical Pain and Veterans, run by Iowa City Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The study team propose to investigate the feasibility and pilot a Telephone Cognitive Behavioral Therapy intervention for those identified to be at risk for chronic pain following surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Persistent Post-surgical Pain, Veterans
- What is being tested?
- Telephone-based Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2017to 1 Aug 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) >18 years of age, 2) scheduled for hernia repair, breast surgery, amputation, thoracotomy, cholecystectomy, cardiac surgery, splenectomy, orthopedic, urological or vascular surgery, 3) Rural dwelling
Who cannot join
- 1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Trial locations and contacts
1 site in 1 country.
About this study
The study team propose to investigate the feasibility and pilot a Telephone Cognitive Behavioral Therapy intervention for those identified to be at risk for chronic pain following surgery.
- Conditions
- Persistent Post-surgical Pain, Veterans
- Being tested
- Telephone-based Cognitive Behavioral Therapy (CBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based Cognitive Behavioral Therapy (CBT)Behavioural
Four session telephone CBT protocol.
| Study group | Role | What they receive |
|---|---|---|
| Telephone-based cognitive behavioral therapy | Experimental | Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management. Receives: Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT) |
| Treatment as Usual | No intervention | Treatment as Usual (TAU) - Routine perioperative management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
Measured: 3 months post-surgery
Secondary outcomes (8)
Qualitative analysis of feasibility data
Qualitative interviews with a subset of TCBT participants, until data saturation is reached.
Measured: Between 1-2 weeks post-TCBT
Pain severity - continuous
Brief Pain Inventory
Measured: 3 months post-surgery
Pain-related functioning
Pain Disability Index
Measured: 3 months post-surgery
Opioid and other analgesic use
Self-report medication use
Measured: 3 months post-surgery
Depression
Patient Health Questionnaire
Measured: 3 months post-surgery
Anxiety
Generalized Anxiety Disorder Scale
- Generalized Anxiety Disorder 7-item (GAD-7) scale measures endorsement/symptoms of generalized anxiety.
- The scores for each individual question range from 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). A total score can range from 0-21.
- A score of 5 is a cut-off for mild anxiety, 10 is a cut-off for moderate anxiety, and 15 is a cut-off for severe anxiety. Higher values represent worse outcomes.
- To compute a total score, all items with endorsements of 1 or greater are added together for a composite score of 0-21.
Measured: 3 months post-surgery
Health-related quality of life: SF-36
SF-36
- 36-Item Short Form Survey Instrument (SF-36) measures eight constructs related to quality of life:
- Physical functioning
- Role limitations due to physical health
- Role limitations due to emotional problems
- Energy/fatigue
- Emotional well-being
- Social functioning
- Pain
- General health
- Each item is recoded to reflect score ranges from 0 to 100 where 0 is the least favorable and 100 is the most favorable. Each item corresponds to a specific construct. Items associated with each construct are averaged to retrieve a construct score. Scores are then converted into z-scores.
- Higher z-scores reflect a more favorable health status.
Measured: 3 months post-surgery
Patient satisfaction with outcomes
Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT)
- Overall, how satisfied are you with the TCBT? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
- How satisfied are you with the TCBT for reducing your pain or helping you cope with your pain? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
- How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start25 Nov 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Post-surgical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa City Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Katherine Hadlandsmyth, Iowa City Veterans Affairs Medical Center
- Investigators
- Katherine Hadlandsmyth, Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351309
- Sponsor's protocol ID
- 201708823
- Status last verified
- Aug 2021
- First submitted
- 2 Nov 2017
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03351309
- Acronym / sponsor ID
- 201708823
- Conditions
- Persistent Post-surgical Pain, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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 study team propose to investigate the feasibility and pilot a Telephone Cognitive Behavioral Therapy intervention for those identified to be at risk for chronic pain following surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-based cognitive behavioral therapy | Experimental | Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management. |
| Treatment as Usual | No intervention | –Treatment as Usual (TAU) - Routine perioperative management. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) >18 years of age, 2) scheduled for hernia repair, breast surgery, amputation, thoracotomy, cholecystectomy, cardiac surgery, splenectomy, orthopedic, urological or vascular surgery, 3) Rural dwelling
Key exclusion criteria (1 listed)
- 1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
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 |
|---|---|---|
| Telephone-based Cognitive Behavioral Therapy (CBT)Four session telephone CBT protocol. | Behavioural | Telephone-based cognitive behavioral therapy |
Primary outcome
Pain Severity
Time frame: 3 months post-surgery
Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
8 secondary outcomes
Qualitative analysis of feasibility data
Time frame: Between 1-2 weeks post-TCBT
Pain severity - continuous
Time frame: 3 months post-surgery
Pain-related functioning
Time frame: 3 months post-surgery
Opioid and other analgesic use
Time frame: 3 months post-surgery
Depression
Time frame: 3 months post-surgery
Anxiety
Time frame: 3 months post-surgery
Health-related quality of life: SF-36
Time frame: 3 months post-surgery
Patient satisfaction with outcomes
Time frame: 3 months post-surgery
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 24 Aug 2021.
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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.
Katherine Hadlandsmyth, Ph.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-based Cognitive Behavioral Therapy (CBT) in people with Persistent Post-surgical Pain and Veterans, run by Iowa City Veterans Affairs 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 1 inclusion and 1 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 24 Aug 2021. 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.
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?
Pain Severity (time frame: 3 months post-surgery). 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 24 Aug 2021.