Reward Function and Therapy for Late-Life Depression

Study Overview
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Brief Summary
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The goal of this study is to learn about changes in the brain that occur during Engage, a psychotherapy for depression in older adults, and how they may differ from changes that occur during supportive therapy. Older adults with depression will receive 9 weeks of either Engage or supportive therapy and will complete research assessments before the therapy begins and at weeks 3, 6, and 9 of treatment. Research assessments will include questionnaires, computer tasks, and recordings of electrical brain activity (also called electroencephalography or EEG).

Detailed Description
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Late-life depression is prevalent and devastating, and response rates to even the most effective treatments are low. Outcomes may be improved by developing targeted interventions such as Engage - a new, easily disseminated, neurobiologically informed psychotherapy for late-life depression designed to restore impaired function of neural reward systems. This study will use event-related potentials and a panel of other reward system measures to assess target engagement in depressed older adults receiving Engage therapy, with a comparison group of depressed peers receiving supportive therapy. Participants will be randomly assigned to either Engage or supportive therapy and will complete research assessments at baseline and weeks 3, 6, and 9 (end of treatment).

Official Title
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Positive Valence System Function and Reward Exposure Therapy for Late-Life Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Engage Therapy
* Behavioral: Supportive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 60 years. Diagnosis of unipolar major depressive disorder without psychotic features, determined by Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID). Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 20. Mini Mental State Exam (MMSE) score greater than or equal to 24. Off antidepressants or on a stable dose of an antidepressant for 12 weeks and no intent to change the dose in the next 10 weeks. Capacity to provide written consent for both research assessment and treatment. Exclusion Criteria: Intent or plan to attempt suicide in the near future. Presence of current psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia. History of past psychiatric diagnoses other than major depressive disorder without psychotic features or anxiety disorders (separation anxiety disorder, specific phobia, social phobia, panic disorder, agoraphobia, or generalized anxiety disorder). Use of psychotropic drugs or cholinesterase inhibitors other than use of less than or equal to 0.5 mg of lorazepam daily up to five times per week. Neurological disorders (dementias, history of stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses that may either influence neural systems of interest or ability to participate in the study.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Engage Therapy<br>Participants receive Engage therapy for 9 weeks. | Behavioral: Engage Therapy<br>* 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.<br>|
| Active Comparator: Supportive Therapy<br>Participants receive supportive therapy for 9 weeks. | Behavioral: Supportive Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neural response to rewarding stimuli | Neural responses will be measured using electroencephalographic (EEG) activity recorded during tasks with rewarding stimuli. | Change from baseline to week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in behavioral activation | 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. | Change from baseline to week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, major depressive disorder, mental health, mood disorder, geriatric, late-life