NCT00211835

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

5.1 years

First QC Date

September 13, 2005

Last Update Submit

September 20, 2013

Conditions

Traumatic Brain InjuryDepression

Keywords

TBItraumatic brain injurydepressioncognitive behavioral therapysupportive psychotherapypsychotherapy

Outcome Measures

Primary Outcomes (4)

  • Remission of depression (DSM-IV diagnosis no longer met)

    baseline

  • Remission of depression (DSM-IV diagnosis no longer met)

    one week after treatment completion

  • Remission of depression (DSM-IV diagnosis no longer met)

    six months after treatment completion

  • Remission of depression (DSM-IV diagnosis no longer met)

    one year after treatment completion

Secondary Outcomes (8)

  • Increased participation (Participation Objective, Participation Subjective)

    baseline

  • Improved quality of life (Life-3).

    baseline

  • Increased participation (Participation Objective, Participation Subjective)

    one week after treatment completion

  • Increased participation (Participation Objective, Participation Subjective)

    six months after treatment completion

  • Increased participation (Participation Objective, Participation Subjective)

    one year after treatment completion

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Supportive psychotherapy

Interventions

Cognitive behavioral therapyBEHAVIORAL

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.

Treatment Arm 1
Supportive psychotherapyBEHAVIORAL

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.

Treatment Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

Related Publications (1)

  • 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.

    PMID: 25370439DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Wayne Gordon, Ph.D.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(1)