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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-08

Study Completion Date

2021-07-31

Brief Summary

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This is a short-term longitudinal study of psychotherapy process. Participants will be treated with 8 sessions of psychotherapy over the course of 8 to 12 weeks.

Detailed Description

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Enrolled participants were randomized to one of two psychotherapy conditions: 8 sessions of Brief Cognitive Behavior Therapy or Brief Interpersonal Psychotherapy (IPT) over a 12 week protocol.

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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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Interpersonal Psychotherapy

Participants will receive 8 one-on-one sessions over 8 to 12 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT IPT

Eligibility Criteria

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Inclusion Criteria

1. Age 18-65
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

1. At high risk for suicide, that, in the clinical opinion of the investigator, would warrant a higher level of care such as hospitalization or intensive outpatient programs
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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carnegie Mellon University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Cohn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type RESULT
PMID: 37121279 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

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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