Spinal Cord InjuriesCBTNCT00861393
Cognitive Behavioural Therapy (CBT) For Improving Emotional Well Being in Spinal Cord Injuries (SCI)
A study testing CBT and Waitlist CBT in people with Spinal Cord Injuries, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
The purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- CBT and Waitlist CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Jan 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between ages 18-65
- diagnosed with spinal cord injury
- currently endorsing significant distress as measured
- able to provide informed consent
- if taking psychoactive meds, on a stable dosage
- are not currently enrolled in any other psychological treatment program
- speak basic english with no diagnosis of communication disorder
Who cannot join
- they endorse current suicidal ideation
- have a Neurodegenerative disorder such as Multiple Sclerosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute (Lyndhurst Center)
Toronto, Ontario, M4G 3V9
About this study
Official title: The Impact of a Brief Cognitive Behavior Therapy Intervention Aimed at Improving Emotional Well-Being and Quality of Life for Individuals With Spinal Cord Injuries
The purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances.
Read the detailed description
The goal of the current proposed research project is to investigate the potential efficacy of a group cognitive behavioural therapy (CBT) intervention aimed at improving emotional well-being, specifically mood, adjustment and quality of life (QOL), after Spinal Cord Injury(SCI). The intervention will be adapted to meet the unique needs of patients suffering from an SCI. The study objectives are:
(1) to evaluate the impact of a brief CBT intervention aimed at decreasing emotional distress and improving quality of life; (2) to evaluate the sustainability of CBT therapeutic gains over time; (3) to conduct sub group analyses in order to better determine why some patients may improve post CBT, while others may not.
- Conditions
- Spinal Cord Injuries
- Being tested
- CBT, Waitlist CBT
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
12 Session CBT group
Waitlist CBTBehavioural
Participants in the waitlist will receive CBT when first group has completed CBT and been tested.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Other | Not described Receives: Behavioral: CBT |
| Waitlist | Other | Not described Receives: Behavioral: Waitlist CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom checklist -90-R (SCL-90-R) Depression Anxiety Stress Scales (DASS-21) Personality Assessment Inventory (PAI) PAI measure a broad range of psychological symptoms and personality characteristics.
Measured: one year
Secondary outcomes (1)
The Ways of Coping Scale- Revised (WOC-R) Community Integration Questionnaire (CIQ) Satisfaction with Life Scale (SWLS) Life satisfaction Checklist (LiSat-11) Stage of change Scales (SOC)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861393
- Sponsor's protocol ID
- CBT-08-06
- Acronym
- CBT
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2009
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Brief Cognitive Behavior Therapy Intervention Aimed at Improving Emotional Well-Being and Quality of Life for Individuals With Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT00861393
- Acronym / sponsor ID
- CBT / CBT-08-06
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 13 Mar 2009 (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.
The purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances.
Detailed description
The goal of the current proposed research project is to investigate the potential efficacy of a group cognitive behavioural therapy (CBT) intervention aimed at improving emotional well-being, specifically mood, adjustment and quality of life (QOL), after Spinal Cord Injury(SCI). The intervention will be adapted to meet the unique needs of patients suffering from an SCI. The study objectives are:
(1) to evaluate the impact of a brief CBT intervention aimed at decreasing emotional distress and improving quality of life; (2) to evaluate the sustainability of CBT therapeutic gains over time; (3) to conduct sub group analyses in order to better determine why some patients may improve post CBT, while others may not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Other | Behavioral: CBT |
| Waitlist | Other | Behavioral: Waitlist CBT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- between ages 18-65
- diagnosed with spinal cord injury
- currently endorsing significant distress as measured
- able to provide informed consent
- if taking psychoactive meds, on a stable dosage
Key exclusion criteria (2 listed)
- they endorse current suicidal ideation
- have a Neurodegenerative disorder such as Multiple Sclerosis
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 |
|---|---|---|
| CBT12 Session CBT group | Behavioural | CBT |
| Waitlist CBTParticipants in the waitlist will receive CBT when first group has completed CBT and been tested. | Behavioural | Waitlist |
Primary outcome
Symptom checklist -90-R (SCL-90-R) Depression Anxiety Stress Scales (DASS-21) Personality Assessment Inventory (PAI) PAI measure a broad range of psychological symptoms and personality characteristics.
Time frame: one year
1 secondary outcome
The Ways of Coping Scale- Revised (WOC-R) Community Integration Questionnaire (CIQ) Satisfaction with Life Scale (SWLS) Life satisfaction Checklist (LiSat-11) Stage of change Scales (SOC)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2009.
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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 CBT and Waitlist CBT in people with Spinal Cord Injuries, run by Toronto Rehabilitation Institute at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Mar 2009. 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 Canada. 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?
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?
Symptom checklist -90-R (SCL-90-R) Depression Anxiety Stress Scales (DASS-21) Personality Assessment Inventory (PAI) PAI measure a broad range of psychological symptoms and personality characteristics. (time frame: one year). 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 13 Mar 2009.