Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.
NCT ID: NCT03594773
Last Updated: 2024-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2018-07-08
2021-07-31
Brief Summary
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Detailed Description
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In response to the COVID-19 pandemic, we completed the study in two phases. Phase 1 procedures were conducted entirely in-person and Phase 2 procedures were conducted via telehealth. Phase 1 recruitment began July 2018 and concluded in February 2020. Recruitment for Phase 2 began July 2020 and concluded March 2021.
This project aims to model the dynamics of individual and dyadic behavior on a moment-by-moment basis within each therapy session and over the course of treatment. These models will be used to test hypotheses about multimodal behavior dynamics, psychotherapy process, type of treatment, and treatment outcome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Interpersonal Psychotherapy
Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in IPT. Participants will complete brief questionnaires before and after treatment sessions. Before each session, they will report on their psychological distress. Following each session, participants and therapists will both complete assessments of the working alliance and rate their own and the other person's affective and interpersonal behavior.
Interpersonal Psychotherapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Cognitive Behavioral Therapy
Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in CBT. Participants will complete brief questionnaires before and after treatment sessions. Before each session, they will report on their psychological distress. Following each session, participants and therapists will both complete assessments of the working alliance and rate their own and the other person's affective and interpersonal behavior.
Cognitive Behavioral Therapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Interventions
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Cognitive Behavioral Therapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Interpersonal Psychotherapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI)
3. Hamilton Rating Scale for Depression (HRSD-17) score ≥ 14 consistent with at least moderate depressive symptoms
4. If currently on antidepressant medication, must be on a stable dose for at least one month at the time of study entry and agree to remain on that dose for study duration
5. Fluent in English
6. Capacity to understand and give informed consent
Exclusion Criteria
2. Current depressive episode has psychotic features
3. Current depressive episode has been present for \> 104 weeks
4. Meets criteria for substance use disorders, as defined by DSM-5, in the past 3 months, except for caffeine or nicotine. (Limited substance use, not meeting criteria for substance use disorders, is not exclusionary).
5. Meets DSM-5 criteria for prior manic or hypomanic episode (bipolar I or II disorder) or a psychotic disorder including schizoaffective disorder or schizophrenia
6. Meets DSM-5 criteria for antisocial personality disorder (MINI)
7. Significant, unstable, psychiatric co-morbidity that, in the opinion of the investigators, requires an alternative treatment approach (i.e., unstable eating disorder, unstable borderline personality disorder)
8. Significant unstable medical illness that may explain depressive symptoms such as epilepsy, autoimmune disorder, chronic pain, or unstable endocrine disorder
9. Cognitive deficits that would preclude completion of study questionnaires or participation in psychotherapy
10. Unable to unwilling to comply with study requirements (i.e., complete forms, attend sessions)
18 Years
65 Years
ALL
No
Sponsors
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Carnegie Mellon University
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Jeffrey Cohn
Professor
Principal Investigators
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Jeffrey F Cohn, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program
Pittsburgh, Pennsylvania, United States
Countries
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References
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Swartz HA, Bylsma LM, Fournier JC, Girard JM, Spotts C, Cohn JF, Morency LP. Randomized trial of brief interpersonal psychotherapy and cognitive behavioral therapy for depression delivered both in-person and by telehealth. J Affect Disord. 2023 Jul 15;333:543-552. doi: 10.1016/j.jad.2023.04.092. Epub 2023 Apr 28.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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171722822
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRO17110528
Identifier Type: -
Identifier Source: org_study_id
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