Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
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|ClinicalTrials.gov Identifier: NCT04487730|
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: "Engage & Connect" Psychotherapy Behavioral: Symptom Review and Psychoeducation (SRP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) Psychotherapy|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression|
|Actual Study Start Date :||October 15, 2020|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Experimental: "Engage & Connect" Psychotherapy
"Engage & Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.
Behavioral: "Engage & Connect" Psychotherapy
9-weeks of weekly psychotherapy sessions focused on social reward exposure
Active Comparator: Symptom Review and Psychoeducation (SRP)
In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.
Behavioral: Symptom Review and Psychoeducation (SRP)
9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
- Change in Resting State fMRI Connectivity of the Positive Valence System [ Time Frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) ]Calculated from fMRI scan. Validation of target engagement.
- Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) ]10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).
- Change in Behavioral Activation for Depression Scale (BADS) [ Time Frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) ]25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).
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): NCT04487730
|Contact: Nili Solomonov, PhD||914-682-9100 ext firstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Nili Solomonov, PhD 914-682-9100 ext 1012497 email@example.com|
|Principal Investigator: Nili Solomonov, PhD|
|Principal Investigator:||Nili Solomonov, PhD||Weill Medical College of Cornell University|