Life Improvement Following Traumatic Brain Injury

Depression Clinical Trial

— LIFT  

Official title:

Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878150
• Other study ID #: 40378 G
• Secondary ID: 1R21HD053736-01A
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: October 16, 2013
• Start date: September 2007
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).

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

1. develop CBT for for Major Depression Disorder (MDD) in persons with TBI that can be delivered in-person or via the telephone

2. conduct a trial of CBT-TBI delivered either in-person or via telephone versus care as usual

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Depression
• Depressive Disorder
• Traumatic Brain Injury

Intervention

Behavioral:
• In-person Cognitive Behavioral Therapy
12 sessions of CBT delivered in-person over 16 weeks
• Telephone Cognitive Behavioral Therapy
12 sessions of telephone-based CBT over 16 weeks

Locations

Country	Name	City	State
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression (HAM-D)		16 weeks, 24 weeks	No
Primary	Symptom Checklist-20 (SCL-20)		16 weeks, 24 weeks	No
Secondary	Patient Health Questionnaire-9 (PHQ-9)		16 weeks, 24 weeks	No
Secondary	Head Injury Symptom Checklist		16 weeks, 24 weeks	No
Secondary	Structured Clinical Interview for DSM-IV (SCID)- Current MDD only		16 weeks, 24 weeks	No
Secondary	Automatic Thoughts Questionnaire		16 weeks	No
Secondary	Dysfunctional Attitudes Scale		16 weeks	No
Secondary	Environmental Reward Observation Scale (EROS)		16 weeks	No
Secondary	Medical Outcome Short Form- 36 (SF-36)		16 weeks, 24 weeks	No
Secondary	Sheehan Disability Scale		16 weeks, 24 weeks	No

External Links

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