Clinical trial NCT03594773: Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.
Official title: Dyadic Behavior Informatics for Psychotherapy Process and Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2018-07-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Depression Severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)
timeFrame: 12 weeks
measure: Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jeffrey F Cohn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.