Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02215187|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injuries||Behavioral: Problem-Solving Training (PST) Behavioral: Attention Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive Behavioral Therapy (CBT) for Caregivers of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Service Members With Combat-Related Traumatic Brain Injuries (TBI)|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Problem-Solving Training
PST is a cognitive-behavioral intervention. Delivery of the PST + usual care condition will be administered to caregivers over the course of 6 one-hour per week, telephone calls/sessions that will entail education related to problem-solving skills/problem-solving model and application to caregiving and managing caregiver related problems.
Behavioral: Problem-Solving Training (PST)
Training in problem-solving skills to be applied to military caregiver problems.
Sham Comparator: Attention Control
Attention/social contact control. Health education (non-skill focused).
Behavioral: Attention Control
Social contact control (health education/no skill training)
Other Name: Social contact control
- Patient Health Questionnaire-9 [ Time Frame: Change from baseline in PHQ-9 scores at post-program (3-months follow-up) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215187
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35243|
|Principal Investigator:||Laura Dreer, Ph.D.||University of Alabama at Birmingham|