DepressionNCT00866632
Improving Psychological Wellness After Acquired Brain Injury
A study testing Cognitive Behavioural Therapy in people with Depression and Anxiety, run by Toronto Rehabilitation Institute at 2 sites in Canada.
Trial summary
The purpose of the study is to investigate the potential benefits of a psychological therapy, called cognitive behaviour therapy (CBT), for improving emotional well being after acquired brain injury and to demonstrate its efficacy in both under telephone (T-CBT) and face-to-face group (G-CBT) modes of delivery… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety, Brain Injury
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2008to Dec 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
- One standard deviation above the mean on the SCL-90-R, Global Severity Index (GSI)
- Moderate to severe brain injury, operationalized as a GCS of 12 or less in TBI participants and cognitive impairment of at least two standard deviations below expected levels in at least one cognitive domain in all participants
- on a stable dosage and being monitored by a physician(if on psychoactive medications)
- able to provide informed consent
Who cannot join
- Endorsement of significant suicidal ideation at the time of evaluation
- Engaged in another CBT or other psychotherapeutic intervention
- Communication disorder that would preclude participation in the intervention
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Peel Halton Acquired Brain Injury Service
Mississauga, Ontario, L4Z 3G1
Le-Anh Ngo, MSc., 905-949-4411 ext. 225, leanh@phabis.com
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
About this study
Official title: Improving Mood, Adjustment and Coping in People With Acquired Brain Injury: A Randomized Controlled Trial to Examine the Efficacy of a Cognitive Behaviour Therapy Protocol Adapted for Brain Injury and Remote Administration of Services.
The purpose of the study is to investigate the potential benefits of a psychological therapy, called cognitive behaviour therapy (CBT), for improving emotional well being after acquired brain injury and to demonstrate its efficacy in both under telephone (T-CBT) and face-to-face group (G-CBT) modes of delivery compared to an educational control group.
Read the detailed description
Each year, approximately 50,000 Canadians sustain an acquired brain injury (ABI) with 16,000 of those individuals living in Ontario. Individuals with ABI not only suffer significant cognitive and motor impairments, but they often experience debilitating emotional distress. Emotional distress uniquely contributes to poorer functional outcomes and decreased quality of life. Moreover, emotional distress confers risk for the subsequent development of serious mental illness such as depression, anxiety disorders, suicide and possibly psychotic illness. While a great deal of clinical resources are devoted to the cognitive and motor sequelae of ABI, the concomitant psychological and psychiatric sequelae of brain injury often receive relatively little attention in in-patient and day-hospital programs, and the expense and inaccessibility of therapeutic services are often prohibitive for consumers in the sub-acute and chronic stages of brain injury. Moreover, few psychological interventions are tailored to the specific cognitive needs and content issues of brain-injured consumers. We have taken a well-validated mode of psychological treatment used in face-to-face therapeutic settings - Cognitive Behaviour Therapy (CBT) - and adapted it for the needs of brain-injured clients. Thus far, the protocol has been adapted for content issues and cognitive impairments of people with ABI, it has been adapted for telehealth delivery, it has been through expert review, and its feasibility has been assessed. The aim of the proposed research is to demonstrate in a randomized control trial (RCT) the efficacy of the adapted protocol, both in a standard delivery modality (i.e., face to face and group) and in the telehealth delivery modality in comparison to an education control group. The treatment is focused on improving coping skills and decreasing psychological distress post-ABI. If proven effective, the intervention could be used cost-effectively by a range of therapists (e.g., Psychologists; Psychiatrists; Occupational Therapists and Social Workers) to improve coping, adjustment and quality of life for ABI consumers irrespective of geographical location, mobility restrictions or economic status.
- Conditions
- Depression, Anxiety, Brain Injury
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Depression, Anxiety, Brain Injury, Cognitive Therapy, Coping Skills
- Medical subject headings
- Depression, Anxiety Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Cognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session.
Cognitive Behavioural TherapyBehavioural
Cognitive behavioural therapy to be delivered in one-on-one via the telephone across 11 sessions, for 1 to 1.5 hours/session.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behavioural Therapy | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy |
| Telephone Cognitive Behavioural Therapy | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy |
| Group Education | No intervention | Not described |
| Telephone Education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater reduction in distress as determined by improved scores on the Global Severity Index of the Symptom Checklist 90-R.
Measured: 1 month and 6 months post treatment
Secondary outcomes (1)
Reduction in psychological distress and improvement in coping as determined by improved scores on the Depression Anxiety Stress Scale, Community Integration Scale, and the Satisfaction with Life questionnaire.
Measured: 1 month and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Peel Halton Acquired Brain Injury Services
- Investigators
- Robin E Green, Ph.D., C.Psych, Principal investigator, Toronto Rehabilitation InstituteCheryl Bradbury, Psy. D., C. Psych, Study chair, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866632
- Sponsor's protocol ID
- 2007-ABI-COP-538
- Status last verified
- Sep 2010
- First submitted
- 19 Mar 2009
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mood, Adjustment and Coping in People With Acquired Brain Injury: A Randomized Controlled Trial to Examine the Efficacy of a Cognitive Behaviour Therapy Protocol Adapted for Brain Injury and Remote Administration of Services.
- ClinicalTrials.gov ID
- NCT00866632
- Acronym / sponsor ID
- 2007-ABI-COP-538
- Conditions
- Depression, Anxiety, Brain Injury
- Keywords
- Depression, Anxiety, Brain Injury, Cognitive Therapy, Coping Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Peel Halton Acquired Brain Injury Services
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 20 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 investigate the potential benefits of a psychological therapy, called cognitive behaviour therapy (CBT), for improving emotional well being after acquired brain injury and to demonstrate its efficacy in both under telephone (T-CBT) and face-to-face group (G-CBT) modes of delivery compared to an educational control group.
Detailed description
Each year, approximately 50,000 Canadians sustain an acquired brain injury (ABI) with 16,000 of those individuals living in Ontario. Individuals with ABI not only suffer significant cognitive and motor impairments, but they often experience debilitating emotional distress. Emotional distress uniquely contributes to poorer functional outcomes and decreased quality of life. Moreover, emotional distress confers risk for the subsequent development of serious mental illness such as depression, anxiety disorders, suicide and possibly psychotic illness. While a great deal of clinical resources are devoted to the cognitive and motor sequelae of ABI, the concomitant psychological and psychiatric sequelae of brain injury often receive relatively little attention in in-patient and day-hospital programs, and the expense and inaccessibility of therapeutic services are often prohibitive for consumers in the sub-acute and chronic stages of brain injury. Moreover, few psychological interventions are tailored to the specific cognitive needs and content issues of brain-injured consumers. We have taken a well-validated mode of psychological treatment used in face-to-face therapeutic settings - Cognitive Behaviour Therapy (CBT) - and adapted it for the needs of brain-injured clients. Thus far, the protocol has been adapted for content issues and cognitive impairments of people with ABI, it has been adapted for telehealth delivery, it has been through expert review, and its feasibility has been assessed. The aim of the proposed research is to demonstrate in a randomized control trial (RCT) the efficacy of the adapted protocol, both in a standard delivery modality (i.e., face to face and group) and in the telehealth delivery modality in comparison to an education control group. The treatment is focused on improving coping skills and decreasing psychological distress post-ABI. If proven effective, the intervention could be used cost-effectively by a range of therapists (e.g., Psychologists; Psychiatrists; Occupational Therapists and Social Workers) to improve coping, adjustment and quality of life for ABI consumers irrespective of geographical location, mobility restrictions or economic status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural Therapy |
| Telephone Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural Therapy |
| Group Education | No intervention | – |
| Telephone Education | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One standard deviation above the mean on the SCL-90-R, Global Severity Index (GSI)
- Moderate to severe brain injury, operationalized as a GCS of 12 or less in TBI participants and cognitive impairment of at least two standard deviations below expected levels in at least one cognitive domain in all participants
- on a stable dosage and being monitored by a physician(if on psychoactive medications)
- able to provide informed consent
Key exclusion criteria (3 listed)
- Endorsement of significant suicidal ideation at the time of evaluation
- Engaged in another CBT or other psychotherapeutic intervention
- Communication disorder that would preclude participation in the intervention
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 Behavioural TherapyCognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session. | Behavioural | Group Cognitive Behavioural Therapy |
| Cognitive Behavioural TherapyCognitive behavioural therapy to be delivered in one-on-one via the telephone across 11 sessions, for 1 to 1.5 hours/session. | Behavioural | Telephone Cognitive Behavioural Therapy |
Primary outcome
Greater reduction in distress as determined by improved scores on the Global Severity Index of the Symptom Checklist 90-R.
Time frame: 1 month and 6 months post treatment
1 secondary outcome
Reduction in psychological distress and improvement in coping as determined by improved scores on the Depression Anxiety Stress Scale, Community Integration Scale, and the Satisfaction with Life questionnaire.
Time frame: 1 month and 6 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2010.
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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.
Robin E Green, Ph.D., C.Psych principal investigator
Toronto Rehabilitation Institute
Cheryl Bradbury, Psy. D., C. Psych study chair
Toronto Rehabilitation Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Depression and Anxiety, run by Toronto Rehabilitation Institute at 2 sites 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 4 inclusion and 3 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 10 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Jasmin Corbie, BA (416-597-3422 ext. 6207, Corbie.Jasmin@Torontorehab.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greater reduction in distress as determined by improved scores on the Global Severity Index of the Symptom Checklist 90-R. (time frame: 1 month and 6 months post treatment). 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 10 Sep 2010.