Reward Function and Therapy for Late-Life Depression
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03688139|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Engage Therapy Behavioral: Supportive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Positive Valence System Function and Reward Exposure Therapy for Late-Life Depression|
|Actual Study Start Date :||March 14, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Engage Therapy
Participants receive Engage therapy for 9 weeks.
Behavioral: Engage Therapy
Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
Active Comparator: Supportive Therapy
Participants receive supportive therapy for 9 weeks.
Behavioral: Supportive Therapy
Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
- Change in neural response to rewarding stimuli [ Time Frame: Change from baseline to week 9 ]Neural responses will be measured using electroencephalographic (EEG) activity recorded during tasks with rewarding stimuli.
- Change in behavioral activation [ Time Frame: Change from baseline to week 9 ]Behavioral activation will be measured using the Behavioral Activation for Depression Scale (BADS), a 25-item measure of behaviors targeted in behavioral activation therapies such as Engage. Higher scores on this measure indicate more participation in activities and social interactions, and lower scores indicate more social isolation, rumination, and avoidance of activities.
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): NCT03688139
|Contact: Jennifer N Bress, PhDfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|White Plains, New York, United States, 10605|
|Contact: Jennifer N Bress, PhD 914-997-8683 email@example.com|
|Principal Investigator:||Jennifer N Bress, PhD||Weill Medical College of Cornell University|