Skip to main content
Clinical Trials/NCT03594773
NCT03594773
Completed
Not Applicable

Dyadic Behavior Informatics for Psychotherapy Process and Outcome

University of Pittsburgh1 site in 1 country77 target enrollmentJuly 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of Pittsburgh
Enrollment
77
Locations
1
Primary Endpoint
Depression Severity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2018
End Date
July 31, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Cohn

Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI)
  • Hamilton Rating Scale for Depression (HRSD-17) score ≥ 14 consistent with at least moderate depressive symptoms
  • 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
  • Fluent in English
  • Capacity to understand and give informed consent

Exclusion Criteria

  • 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
  • Current depressive episode has psychotic features
  • Current depressive episode has been present for \> 104 weeks
  • 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).
  • Meets DSM-5 criteria for prior manic or hypomanic episode (bipolar I or II disorder) or a psychotic disorder including schizoaffective disorder or schizophrenia
  • Meets DSM-5 criteria for antisocial personality disorder (MINI)
  • 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)
  • Significant unstable medical illness that may explain depressive symptoms such as epilepsy, autoimmune disorder, chronic pain, or unstable endocrine disorder
  • Cognitive deficits that would preclude completion of study questionnaires or participation in psychotherapy
  • Unable to unwilling to comply with study requirements (i.e., complete forms, attend sessions)

Outcomes

Primary Outcomes

Depression Severity

Time Frame: 12 weeks

Our primary outcome measure of depression symptom severity was based on the Hamilton Rating Scale for Depression (HRSD-17) obtained at the final study visit (12 weeks). The HRSD-17 consists of 17 items with Likert scale of either 0 to 4 or 0 to 2. Scores can range from 0(min) to 54(max), with higher scores indicating higher depression symptoms. Clinical interpretation of scale ranges of the HRSD-17 are as follows: 0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression \>=23 = Very Severe Depression

Secondary Outcomes

  • Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)(12 weeks)
  • Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT)(12 weeks)

Study Sites (1)

Loading locations...

Similar Trials