Traumatic Brain InjuryNCT00211835
Treatment of Post-TBI Depression
A study testing Cognitive behavioral therapy and Supportive psychotherapy in people with Traumatic Brain Injury and Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of changes in mood (primarily depression and anxiety), participation in activities and life satisfaction. 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?
- Cognitive behavioral therapy and Supportive psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being at least 18years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury)
- Being at least 6 months post injury
- Being English-speaking
- Having residential telephone service
- Living within 1.5 hours of New York City
Show all 12Show fewer
- Having at least a sixth-grade reading level
- Meeting DSM-IV criteria for a current depressive mood disorder
- Not being in psychotherapy and being willing to abstain from seeking psychotherapy during the course of participation
- Being willing to complete questionnaires and interviews about mood, thinking skills, community participation and life satisfaction
- Agreeing to participate, verified by completion of informed consent and HIPAA documents.
- Individuals who meet criteria and are currently using prescribed mood medications will be included in the study if dosage has been stable for sixty days.
Who cannot join
- Pre-existing neurological disorder, including brain injury from an etiology other than trauma
- History of mental retardation
- Lack of capacity to sign informed consent
- Taking antidepressant medications for less than six months
- Having any changes in antidepressant medications in the last six months
- History of current or past psychosis or mania
- Current substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
About this study
Official title: Treatment of Post-TBI Depression - A Randomized Clinical Trial
Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.
Read the detailed description
Goals Demonstrate the efficacy of cognitive behavioral therapy (CBT), both immediately after treatment and in the long term, in alleviating post-TBI depression.
Examine the relationship between improved mood, participation, and life satisfaction.
Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment.
Maximize potential application to clinical practice by:
Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity, and Creating and disseminating a manual detailing CBT treatment. This study is a randomized clinical trial that compares two treatment conditions: CBT and supportive psychotherapy (SPT). CBT has been shown to be effective in diverse studies. In this study, CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges. All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping. Both CBT and SPT will involve 16 sessions of individual treatment. The initial session will be 90 minutes, with remaining sessions 50 minutes. In both treatments, participants will be seen for three months, with sessions twice weekly for the first month and once a week subsequently. The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participant's randomly assigned treatment condition. Evaluation instruments will be administered at baseline and at three points of follow-up: one week, six months, and one year after treatment. A detailed manual describing treatment methods will be developed based on the intervention.
- Conditions
- Traumatic Brain Injury, Depression
- Being tested
- Cognitive behavioral therapy, Supportive psychotherapy
- Keywords
- TBI, traumatic brain injury, depression, cognitive behavioral therapy, supportive psychotherapy, psychotherapy
- Medical subject headings
- Brain Injuries, Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
Supportive psychotherapyBehavioural
A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant. Receives: Behavioral: Cognitive behavioral therapy |
| Treatment Arm 2 | Experimental | A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness. Receives: Behavioral: Supportive psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of depression (DSM-IV diagnosis no longer met)
Measured: baseline
Remission of depression (DSM-IV diagnosis no longer met)
Measured: one week after treatment completion
Remission of depression (DSM-IV diagnosis no longer met)
Measured: six months after treatment completion
Remission of depression (DSM-IV diagnosis no longer met)
Measured: one year after treatment completion
Secondary outcomes (8)
Increased participation (Participation Objective, Participation Subjective)
Measured: baseline
Improved quality of life (Life-3).
Measured: baseline
Increased participation (Participation Objective, Participation Subjective)
Measured: one week after treatment completion
Increased participation (Participation Objective, Participation Subjective)
Measured: six months after treatment completion
Increased participation (Participation Objective, Participation Subjective)
Measured: one year after treatment completion
Improved quality of life (Life-3).
Measured: one week after treatment completion
Improved quality of life (Life-3).
Measured: six months after treatment completion
Improved quality of life (Life-3).
Measured: one year after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Icahn School of Medicine at Mount SinaiThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Wayne Gordon, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211835
- Sponsor's protocol ID
- GCO 04-0782
- Other IDs
- H133B040033
- Status last verified
- Sep 2013
- First submitted
- 13 Sep 2005
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ashman T, Cantor JB, Tsaousides T, Spielman L, Gordon W. Comparison of cognitive behavioral therapy and supportive psychotherapy for the treatment of depression following traumatic brain injury: a randomized controlled trial. J Head Trauma Rehabil. 2014 Nov-Dec;29(6):467-78. doi: 10.1097/HTR.0000000000000098.
PubMed 25370439
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-TBI Depression - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00211835
- Acronym / sponsor ID
- GCO 04-0782
- Conditions
- Traumatic Brain Injury, Depression
- Keywords
- TBI, traumatic brain injury, depression, cognitive behavioral therapy, supportive psychotherapy, psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Nov 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Sep 2005 (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.
Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.
Detailed description
Goals Demonstrate the efficacy of cognitive behavioral therapy (CBT), both immediately after treatment and in the long term, in alleviating post-TBI depression.
Examine the relationship between improved mood, participation, and life satisfaction.
Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment.
Maximize potential application to clinical practice by:
Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity, and Creating and disseminating a manual detailing CBT treatment. This study is a randomized clinical trial that compares two treatment conditions: CBT and supportive psychotherapy (SPT). CBT has been shown to be effective in diverse studies. In this study, CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges. All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping. Both CBT and SPT will involve 16 sessions of individual treatment. The initial session will be 90 minutes, with remaining sessions 50 minutes. In both treatments, participants will be seen for three months, with sessions twice weekly for the first month and once a week subsequently. The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participant's randomly assigned treatment condition. Evaluation instruments will be administered at baseline and at three points of follow-up: one week, six months, and one year after treatment. A detailed manual describing treatment methods will be developed based on the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Behavioral: Cognitive behavioral therapyIndividual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant. |
| Treatment Arm 2 | Experimental | Behavioral: Supportive psychotherapyA client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Being at least 18years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury)
- Being at least 6 months post injury
- Being English-speaking
- Having residential telephone service
Key exclusion criteria (7 listed)
- Pre-existing neurological disorder, including brain injury from an etiology other than trauma
- History of mental retardation
- Lack of capacity to sign informed consent
- Taking antidepressant medications for less than six months
- Having any changes in antidepressant medications in the last six months
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 therapyIndividual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant. | Behavioural | Treatment Arm 1 |
| Supportive psychotherapyA client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness. | Behavioural | Treatment Arm 2 |
Primary outcome
Remission of depression (DSM-IV diagnosis no longer met)
Time frame: baseline
Remission of depression (DSM-IV diagnosis no longer met)
Time frame: one week after treatment completion
Remission of depression (DSM-IV diagnosis no longer met)
Time frame: six months after treatment completion
Remission of depression (DSM-IV diagnosis no longer met)
Time frame: one year after treatment completion
8 secondary outcomes
Increased participation (Participation Objective, Participation Subjective)
Time frame: baseline
Improved quality of life (Life-3).
Time frame: baseline
Increased participation (Participation Objective, Participation Subjective)
Time frame: one week after treatment completion
Increased participation (Participation Objective, Participation Subjective)
Time frame: six months after treatment completion
Increased participation (Participation Objective, Participation Subjective)
Time frame: one year after treatment completion
Improved quality of life (Life-3).
Time frame: one week after treatment completion
Improved quality of life (Life-3).
Time frame: six months after treatment completion
Improved quality of life (Life-3).
Time frame: one year after treatment completion
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 Sep 2013.
- Derived from this study: PubMed 25370439Ashman T, Cantor JB, Tsaousides T, Spielman L, Gordon W. Comparison of cognitive behavioral therapy and supportive psychotherapy for the treatment of depression following traumatic brain injury: a randomized controlled trial. J Head Trauma Rehabil. 2014 Nov-Dec;29(6):467-78. doi: 10.1097/HTR.0000000000000098.
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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.
Wayne Gordon, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
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 and Supportive psychotherapy in people with Traumatic Brain Injury and Depression, run by Icahn School of Medicine at Mount Sinai 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 12 inclusion and 7 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 Sep 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?
Remission of depression (DSM-IV diagnosis no longer met) (time frame: baseline). The study lists 4 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 NCT00211835, which also lists 1 linked publication.
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 Sep 2013.