Cerebral PalsyNCT06269926
Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy
A study testing Cognitive Behavioral Therapy for Chronic Pain in people with Cerebral Palsy and Pain, Chronic, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to understand if cognitive behavioral therapy can feasibly be provided to groups of adults with cerebral palsy and chronic pain via virtual group therapy sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy, Pain, Chronic
- What is being tested?
- Cognitive Behavioral Therapy for Chronic Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age
- Has a diagnosis of cerebral palsy
- Able to send and receive information effectively with familiar communication partners
- Able, during the consent process, to answer questions about the study to indicate that they understand and consent to participation
- Has pain that at least moderately interferes with some aspect(s) of their daily activities
- Able and willing to participate in all assessment and group sessions regardless of randomization outcome
Show all 11Show fewer
- Appears on a screening assessment to have enough cognitive ability to recognize their thoughts, feelings, and behaviors to be able to benefit from CBT-CP
- Exclusion Criteria: (if met then participant will not eligible to participate)
- Previously received Cognitive Behavioral Therapy (CBT) for chronic pain
- Endorses that most of their pain is attributable to a recent event (e.g. trauma, surgery that occurred in the past 3 months)
- Unable to attend weekly CBT-CP sessions from a location in the state of Maryland
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
The purpose of this study is to understand if cognitive behavioral therapy can feasibly be provided to groups of adults with cerebral palsy and chronic pain via virtual group therapy sessions.
Read the detailed description
Many adults with cerebral palsy have chronic pain that interferes with daily activities, but evidence regarding pain treatments for adults with cerebral palsy is limited. In other chronic pain patient populations, behavioral therapies such as cognitive behavioral therapy for chronic pain (CBT-CP) are a key component of evidence-based pain management. This study will assess challenges, implementation barriers, and preliminary efficacy of CBT-CP administered in a virtual group setting for adults with CP to design larger trials to definitively estimate treatment efficacy.
This study will invite 40 adult participants with CP and chronic pain that impacts their life to participate in a trial of CBT-CP. CBT-CP involves weekly group-therapy sessions for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). Participants will complete surveys every 3 months over a period of 12 months (a total of five surveys before and after CBT-CP). Participants will also continue to receive their usual medical care throughout.
All enrolled participants will receive the CBT intervention. Participants will be randomly assigned to receive CBT either upon enrollment (group 1; CBT_now) or after a three month delay (group 2; CBT_later).
This study will be conducted at the Kennedy Krieger Institute in Baltimore, Maryland, USA. Group CBT-CP will be conducted virtually via Zoom. 40 individuals with cerebral palsy who meet all inclusion/exclusion criteria will be recruited in two waves (one in early 2025 and one in early 2026). Participants must be at least 18 years old, able to make informed medical decision for themselves, and must endorse the ability and willingness to participate in all assessment and group sessions regardless of randomization outcome. Participants must also either live in Maryland, or be able to travel to Maryland on a weekly basis for the group therapy sessions.
- Conditions
- Cerebral Palsy, Pain, Chronic
- Being tested
- Cognitive Behavioral Therapy for Chronic Pain
- Keywords
- cerebral palsy, chronic pain, cognitive behavioral therapy, group therapy
- Medical subject headings
- Cerebral Palsy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Chronic PainBehavioural
CBT-CP consists of skill-based therapy sessions completed weekly for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). It will be completed in Maryland in an online real-time audio/video virtual group therapy format.
| Study group | Role | What they receive |
|---|---|---|
| CBT_later | Experimental | The CBT_later group will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a 12-week group therapy course) beginning approximately 3 months after enrollment. Receives: Behavioral: Cognitive Behavioral Therapy for Chronic Pain |
| CBT_now | Experimental | The CBT_now group will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a 12-week group therapy course) beginning shortly after enrollment. Receives: Behavioral: Cognitive Behavioral Therapy for Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection achieved (feasibility assessment)
We will examine the rate of survey completion for each survey (0 = survey incomplete, 1 = survey complete). Higher scores indicate a better outcome (greater feasibility of recruiting adults with CP and chronic pain and retaining their engagement to complete this clinical trial over a period of 12 months).
Measured: Five assessments (at enrollment and at 3, 6, 9, and 12 months post-enrollment)
Secondary outcomes (7)
Therapy attendance
Therapists will track frequency of group therapy attendance (present/absent) for each participant throughout the 12 week intervention. We will assess the rate of treatment adherence by looking at the number of sessions attended by each participant over the course of the intervention, as well as at a cohort level
Measured: Weekly x 12 weeks during therapy administration
Patient Global Impressions of Change
These questions ask about how participants feel now, compared to before the intervention. Responses are recorded on a 7-point scale ranging 1 being "very much worse" to 7 being "very much improved"; higher scores represent better outcomes.
Measured: Four assessments (at 3, 6, 9, and 12 months post-enrollment)
Change in Pain Catastrophizing Scale score
The Pain Catastrophizing Scale assesses specific patterns of pain-related thoughts. Responses are recorded on a 5-point scale, with 1 being "Not at all" and 5 being "All the time". Higher scores represent worse outcomes.
Measured: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Change in Pain Self-Efficacy-4 Score
This 4-item questionnaire assesses an individual's confidence in their ability to complete various activities despite the presence of pain. Responses are recorded on a 7-point scale, with 1 being "Not at all confident" and 7 being "Completely confident". Higher scores represent better outcomes.
Measured: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Changes in Brief Pain Inventory Pain Interference Subtest scores
This survey asks how much pain is interfering with various activities. Responses are recorded on a 10-point scale, with 1 being "Does not interfere" and 7 being "Completely interferes". Higher scores represent worse outcomes. We will examine 1) improvement in the activity that saw the greatest pain-related impairment at baseline and 2) average improvement across all activities listed.
Measured: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a T-score
These questions ask about pain levels over the previous 7 days. Responses are recorded on a 5-point scale, with 1 being "had no pain" and 5 being "very severe"; higher scores represent worse outcomes.
Measured: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Changes in Patient Health Questionnaire-4 (PHQ-4)
This 4-item questionnaire asks about symptoms of anxiety and depression in the last 14 days. Responses are recorded 4-point scale, with 0 being "not at all" and 4 being "nearly every day"; higher scores represent worse outcomes. We will examine changes in anxiety symptom scores and in depression symptom scores.
Measured: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start27 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Crossover
- Model description
- The investigators will randomize 40 adults with cerebral palsy and pain-related impairment in daily activities into two study arms: Group 1 (CBT\_now) will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a once weekly, 12-week group therapy course) shortly after enrollment. Group 2 (CBT\_later) will receive CBT-CP after a three month delay. To maintain reasonable therapy cohort sizes (n=10 per cohort), each group (n=20 participants) will consist of two separate therapy cohorts (n=10 each). Participants will be evaluated at the beginning of the study, and then once every 3 months during the 12-month duration of the study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Eric Chin, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Eric Chin, M.D, Principal investigator, Kennedy Krieger Institute, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269926
- Sponsor's protocol ID
- IRB00446666
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06269926
- Acronym / sponsor ID
- IRB00446666
- Conditions
- Cerebral Palsy, Pain, Chronic
- Keywords
- cerebral palsy, chronic pain, cognitive behavioral therapy, group therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Feb 2024 (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 purpose of this study is to understand if cognitive behavioral therapy can feasibly be provided to groups of adults with cerebral palsy and chronic pain via virtual group therapy sessions.
Detailed description
Many adults with cerebral palsy have chronic pain that interferes with daily activities, but evidence regarding pain treatments for adults with cerebral palsy is limited. In other chronic pain patient populations, behavioral therapies such as cognitive behavioral therapy for chronic pain (CBT-CP) are a key component of evidence-based pain management. This study will assess challenges, implementation barriers, and preliminary efficacy of CBT-CP administered in a virtual group setting for adults with CP to design larger trials to definitively estimate treatment efficacy.
This study will invite 40 adult participants with CP and chronic pain that impacts their life to participate in a trial of CBT-CP. CBT-CP involves weekly group-therapy sessions for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). Participants will complete surveys every 3 months over a period of 12 months (a total of five surveys before and after CBT-CP). Participants will also continue to receive their usual medical care throughout.
All enrolled participants will receive the CBT intervention. Participants will be randomly assigned to receive CBT either upon enrollment (group 1; CBT_now) or after a three month delay (group 2; CBT_later).
This study will be conducted at the Kennedy Krieger Institute in Baltimore, Maryland, USA. Group CBT-CP will be conducted virtually via Zoom. 40 individuals with cerebral palsy who meet all inclusion/exclusion criteria will be recruited in two waves (one in early 2025 and one in early 2026). Participants must be at least 18 years old, able to make informed medical decision for themselves, and must endorse the ability and willingness to participate in all assessment and group sessions regardless of randomization outcome. Participants must also either live in Maryland, or be able to travel to Maryland on a weekly basis for the group therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The investigators will randomize 40 adults with cerebral palsy and pain-related impairment in daily activities into two study arms: Group 1 (CBT_now) will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a once weekly, 12-week group therapy course) shortly after enrollment. Group 2 (CBT_later) will receive CBT-CP after a three month delay. To maintain reasonable therapy cohort sizes (n=10 per cohort), each group (n=20 participants) will consist of two separate therapy cohorts (n=10 each). Participants will be evaluated at the beginning of the study, and then once every 3 months during the 12-month duration of the study.
| Arm | Type | Receives |
|---|---|---|
| CBT_later | Experimental | Behavioral: Cognitive Behavioral Therapy for Chronic PainThe CBT_later group will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a 12-week group therapy course) beginning approximately 3 months after enrollment. |
| CBT_now | Experimental | Behavioral: Cognitive Behavioral Therapy for Chronic PainThe CBT_now group will receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a 12-week group therapy course) beginning shortly after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years of age
- Has a diagnosis of cerebral palsy
- Able to send and receive information effectively with familiar communication partners
- Able, during the consent process, to answer questions about the study to indicate that they understand and consent to participation
- Has pain that at least moderately interferes with some aspect(s) of their daily activities
Key exclusion criteria (0 listed)
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 Therapy for Chronic PainCBT-CP consists of skill-based therapy sessions completed weekly for 12 weeks. Participants are oriented to CBT and set individualized goals (sessions #1-3) before focusing on cognitive and behavior skill building including physical activity, pacing, relaxation training, and cognitive restructuring (#4-10) then focusing on maintenance and discharge planning (#11-12). It will be completed in Maryland in an online real-time audio/video virtual group therapy format. | Behavioural | CBT_later, CBT_now |
Primary outcome
Data collection achieved (feasibility assessment)
Time frame: Five assessments (at enrollment and at 3, 6, 9, and 12 months post-enrollment)
We will examine the rate of survey completion for each survey (0 = survey incomplete, 1 = survey complete). Higher scores indicate a better outcome (greater feasibility of recruiting adults with CP and chronic pain and retaining their engagement to complete this clinical trial over a period of 12 months).
7 secondary outcomes
Therapy attendance
Time frame: Weekly x 12 weeks during therapy administration
Patient Global Impressions of Change
Time frame: Four assessments (at 3, 6, 9, and 12 months post-enrollment)
Change in Pain Catastrophizing Scale score
Time frame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Change in Pain Self-Efficacy-4 Score
Time frame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Changes in Brief Pain Inventory Pain Interference Subtest scores
Time frame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a T-score
Time frame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Changes in Patient Health Questionnaire-4 (PHQ-4)
Time frame: Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Eric Chin, M.D principal investigator
Kennedy Krieger Institute, Johns Hopkins University
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 Therapy for Chronic Pain in people with Cerebral Palsy and Pain, Chronic, run by Hugo W. Moser Research Institute at Kennedy Krieger, 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 11 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Data collection achieved (feasibility assessment) (time frame: Five assessments (at enrollment and at 3, 6, 9, and 12 months post-enrollment)). 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 27 Apr 2026.