Traumatic Brain InjuryLIFTNCT00878150
Life Improvement Following Traumatic Brain Injury
A study testing In-person Cognitive Behavioral Therapy and Telephone Cognitive Behavioral Therapy in people with Traumatic Brain Injury and Depression, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Depression
- What is being tested?
- In-person Cognitive Behavioral Therapy and Telephone Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized for TBI within the last 10 years, and at least one month post-injury
- sustained a complicated mild to severe TBI as indicated by Glasgow Coma Scale score of 3-12 or had documented intracranial abnormalities on CT scan or had post-traumatic amnesia (PTA) of at least 7 days
- meet screening criteria for major depression
- speak English fluently
- resides in any of the the 50 United States
Who cannot join
- does not have a telephone
- does not have a stable address
- history of bipolar disorder or schizophrenia, or current psychosis or suicidal intent
- current alcohol or substance dependence (within last month)
- evidence of significant cognitive impairment on neuropsychological testing
- started on an antidepressant medication within 6 weeks or planning to start on an antidepressant within the 16-week study
- currently in psychotherapy for depression or plan to start psychotherapy for depression within the 16-week study period
- refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Medicine
Seattle, Washington, 98195
About this study
Official title: Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury
The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).
Read the detailed description
Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute.
There are also multiple barriers to effective treatment of MDD in persons with TBI, including:
- under-diagnosis and under-treatment 20lack of access to care due to mobility, transportation and health care benefit limitations
- TBI neurocognitive impairments
- comorbid medical and psychiatric problems, including substance abuse
- stressors such as lack of social support and work instability
- inaccurate beliefs about depression and its treatment among TBI survivors.
The investigators are conducting a three arm trial of Cognitive Behavioral Therapy (CBT) to treat Major Depression Disorder (MDD) that emerges within the first 10 years after complicated mild to severe traumatic brain injury (TBI). The overall objective of the study is to develop a 12-session telephone-based and in-person CBT program for people with TBI (CBT-TBI), and to evaluate its feasibility, acceptability, and effectiveness.
The investigators project aims are to
- develop CBT for for Major Depression Disorder (MDD) in persons with TBI that can be delivered in-person or via the telephone
- conduct a trial of CBT-TBI delivered either in-person or via telephone versus care as usual
- refine the intervention and plan a definitive RCT of CBT-TBI if response rate is sufficient.
Participants are randomized to one of three groups: (1) 12 semi-weekly sessions of telephone-based CBT for depression provided by a study therapist, (2) 12 semi-weekly sessions of in-person CBT for depression provided by a study therapist, or (3) Usual Care (control). Randomization is stratified by injury severity to ensure equal proportions in each treatment group. Participants choose one of three randomization options that includes the groups to which he/she would like to be randomized:
- Option 1: Telephone counseling verses usual care
- Option 2: In-person counseling verses usual care
- Option 3: In-person counseling verses Telephone counseling verses usual care
Outcomes are assessed by a blinded research assistant at 8, 16, and 24 weeks after baseline.
- Conditions
- Traumatic Brain Injury, Depression
- Being tested
- In-person Cognitive Behavioral Therapy, Telephone Cognitive Behavioral Therapy
- Keywords
- traumatic brain injury, TBI, head injury, brain injury, depression, major depressive disorder, cognitive behavioral therapy, CBT, counseling
- Medical subject headings
- Brain Injuries, Traumatic, Depression, Craniocerebral Trauma, Brain Injuries, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person Cognitive Behavioral TherapyBehavioural
Also called In-person CBT, Counseling, CBT
12 sessions of CBT delivered in-person over 16 weeks
Telephone Cognitive Behavioral TherapyBehavioural
Also called Telephone CBT, CBT, Counseling
12 sessions of telephone-based CBT over 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Telephone-based CBT | Experimental | - 12 counseling sessions over 16 weeks over the telephone Receives: Behavioral: Telephone Cognitive Behavioral Therapy |
| In-person CBT | Experimental | - 12 counseling sessions over 16 weeks at either Harborview Medical Center or the University of Washington Medical Center in Seattle, WA Receives: Behavioral: In-person Cognitive Behavioral Therapy |
| 3: Usual care | No intervention | - No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
Measured: 16 weeks, 24 weeks
Symptom Checklist-20 (SCL-20)
Measured: 16 weeks, 24 weeks
Secondary outcomes (8)
Patient Health Questionnaire-9 (PHQ-9)
Measured: 16 weeks, 24 weeks
Head Injury Symptom Checklist
Measured: 16 weeks, 24 weeks
Structured Clinical Interview for DSM-IV (SCID)- Current MDD only
Measured: 16 weeks, 24 weeks
Automatic Thoughts Questionnaire
Measured: 16 weeks
Dysfunctional Attitudes Scale
Measured: 16 weeks
Environmental Reward Observation Scale (EROS)
Measured: 16 weeks
Medical Outcome Short Form- 36 (SF-36)
Measured: 16 weeks, 24 weeks
Sheehan Disability Scale
Measured: 16 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionDec 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), U.S. Department of Education
- Responsible party
- Principal investigator, Jesse Fann, University of Washington
- Investigators
- Jesse R Fann, MD, MPH, Principal investigator, University of Washington School of Medicine, Departments of Psychiatry & Behavioral Sciences and Rehabilitation MedicineCharles H. Bombardier, PhD, Principal investigator, University of Washington School of Medicine, Department of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878150
- Sponsor's protocol ID
- 40378 G
- Other IDs
- 1R21HD053736-01A1, H133G070016
- Acronym
- LIFT
- Status last verified
- Oct 2013
- First submitted
- 6 Apr 2009
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dyer JR, Williams R, Bombardier CH, Vannoy S, Fann JR. Evaluating the Psychometric Properties of 3 Depression Measures in a Sample of Persons With Traumatic Brain Injury and Major Depressive Disorder. J Head Trauma Rehabil. 2016 May-Jun;31(3):225-32. doi: 10.1097/HTR.0000000000000177.
PubMed 26291629Fann JR, Bombardier CH, Vannoy S, Dyer J, Ludman E, Dikmen S, Marshall K, Barber J, Temkin N. Telephone and in-person cognitive behavioral therapy for major depression after traumatic brain injury: a randomized controlled trial. J Neurotrauma. 2015 Jan 1;32(1):45-57. doi: 10.1089/neu.2014.3423.
PubMed 25072405
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00878150
- Acronym / sponsor ID
- LIFT / 40378 G
- Conditions
- Traumatic Brain Injury, Depression
- Keywords
- traumatic brain injury, TBI, head injury, brain injury, depression, major depressive disorder, cognitive behavioral therapy, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), U.S. Department of Education
- Study start
- Sep 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Apr 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 this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).
Detailed description
Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute.
There are also multiple barriers to effective treatment of MDD in persons with TBI, including:
- under-diagnosis and under-treatment 20lack of access to care due to mobility, transportation and health care benefit limitations
- TBI neurocognitive impairments
- comorbid medical and psychiatric problems, including substance abuse
- stressors such as lack of social support and work instability
- inaccurate beliefs about depression and its treatment among TBI survivors.
The investigators are conducting a three arm trial of Cognitive Behavioral Therapy (CBT) to treat Major Depression Disorder (MDD) that emerges within the first 10 years after complicated mild to severe traumatic brain injury (TBI). The overall objective of the study is to develop a 12-session telephone-based and in-person CBT program for people with TBI (CBT-TBI), and to evaluate its feasibility, acceptability, and effectiveness.
The investigators project aims are to
- develop CBT for for Major Depression Disorder (MDD) in persons with TBI that can be delivered in-person or via the telephone
- conduct a trial of CBT-TBI delivered either in-person or via telephone versus care as usual
- refine the intervention and plan a definitive RCT of CBT-TBI if response rate is sufficient.
Participants are randomized to one of three groups: (1) 12 semi-weekly sessions of telephone-based CBT for depression provided by a study therapist, (2) 12 semi-weekly sessions of in-person CBT for depression provided by a study therapist, or (3) Usual Care (control). Randomization is stratified by injury severity to ensure equal proportions in each treatment group. Participants choose one of three randomization options that includes the groups to which he/she would like to be randomized:
- Option 1: Telephone counseling verses usual care
- Option 2: In-person counseling verses usual care
- Option 3: In-person counseling verses Telephone counseling verses usual care
Outcomes are assessed by a blinded research assistant at 8, 16, and 24 weeks after baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telephone-based CBT | Experimental | Behavioral: Telephone Cognitive Behavioral Therapy- 12 counseling sessions over 16 weeks over the telephone |
| In-person CBT | Experimental | Behavioral: In-person Cognitive Behavioral Therapy- 12 counseling sessions over 16 weeks at either Harborview Medical Center or the University of Washington Medical Center in Seattle, WA |
| 3: Usual care | No intervention | –- No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hospitalized for TBI within the last 10 years, and at least one month post-injury
- sustained a complicated mild to severe TBI as indicated by Glasgow Coma Scale score of 3-12 or had documented intracranial abnormalities on CT scan or had post-traumatic amnesia (PTA) of at least 7 days
- meet screening criteria for major depression
- speak English fluently
- resides in any of the the 50 United States
Key exclusion criteria (8 listed)
- does not have a telephone
- does not have a stable address
- history of bipolar disorder or schizophrenia, or current psychosis or suicidal intent
- current alcohol or substance dependence (within last month)
- evidence of significant cognitive impairment on neuropsychological testing
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 |
|---|---|---|
| In-person Cognitive Behavioral TherapyAlso: In-person CBT, Counseling, CBT12 sessions of CBT delivered in-person over 16 weeks | Behavioural | In-person CBT |
| Telephone Cognitive Behavioral TherapyAlso: Telephone CBT, CBT, Counseling12 sessions of telephone-based CBT over 16 weeks | Behavioural | Telephone-based CBT |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 16 weeks, 24 weeks
Symptom Checklist-20 (SCL-20)
Time frame: 16 weeks, 24 weeks
8 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 16 weeks, 24 weeks
Head Injury Symptom Checklist
Time frame: 16 weeks, 24 weeks
Structured Clinical Interview for DSM-IV (SCID)- Current MDD only
Time frame: 16 weeks, 24 weeks
Automatic Thoughts Questionnaire
Time frame: 16 weeks
Dysfunctional Attitudes Scale
Time frame: 16 weeks
Environmental Reward Observation Scale (EROS)
Time frame: 16 weeks
Medical Outcome Short Form- 36 (SF-36)
Time frame: 16 weeks, 24 weeks
Sheehan Disability Scale
Time frame: 16 weeks, 24 weeks
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 18 Oct 2013.
- Derived from this study: PubMed 26291629Dyer JR, Williams R, Bombardier CH, Vannoy S, Fann JR. Evaluating the Psychometric Properties of 3 Depression Measures in a Sample of Persons With Traumatic Brain Injury and Major Depressive Disorder. J Head Trauma Rehabil. 2016 May-Jun;31(3):225-32. doi: 10.1097/HTR.0000000000000177.
- Derived from this study: PubMed 25072405Fann JR, Bombardier CH, Vannoy S, Dyer J, Ludman E, Dikmen S, Marshall K, Barber J, Temkin N. Telephone and in-person cognitive behavioral therapy for major depression after traumatic brain injury: a randomized controlled trial. J Neurotrauma. 2015 Jan 1;32(1):45-57. doi: 10.1089/neu.2014.3423.
- Related InfoLink provided by the sponsor.
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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.
Jesse R Fann, MD, MPH principal investigator
University of Washington School of Medicine, Departments of Psychiatry & Behavioral Sciences and Rehabilitation Medicine
Charles H. Bombardier, PhD principal investigator
University of Washington School of Medicine, Department of Rehabilitation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person Cognitive Behavioral Therapy and Telephone Cognitive Behavioral Therapy in people with Traumatic Brain Injury and Depression, run by University of Washington 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 5 inclusion and 8 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 18 Oct 2013. 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?
Hamilton Rating Scale for Depression (HAM-D) (time frame: 16 weeks, 24 weeks). 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 NCT00878150, which also lists 2 linked publications.
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 18 Oct 2013.