Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.

University of Pittsburgh77 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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

Interpersonal PsychotherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Depression Severity

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

Time frame: 12 weeks

Secondary Outcomes

Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)

The Working Alliance Inventory-Short Revised (WAI-SR), client version, is a 12-item scale that measures three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Each subscale score for the WAI-SR ranges from 5(min) to 20(max), for a total score range of 15(min) to 60(max). Higher scores represent better alliance. The secondary outcome measure is based on the WAI-SR mean of the total scores measured at the final therapy visit (visit 8).

Time frame: 12 weeks

Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT)

The Working Alliance Inventory-Short Revised (WAI-SRT), therapist version, is a 12-item scale that measures three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Each subscale score for the WAI-SR ranges from 5(min) to 20(max), for a total score range of 15(min) to 60(max). Higher scores represent better alliance. The secondary outcome measure is based on the WAI-SRT mean of the total scores measured at the final therapy visit (visit 8).

Time frame: 12 weeks

Data from ClinicalTrials.gov

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