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

NCT03594773 | Completed Results

• 2 other identifiers: PRO17110528171722822
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (2)

Interpersonal Psychotherapy

EXPERIMENTAL

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.

Behavioral: Interpersonal Psychotherapy

Cognitive Behavioral Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Also known as: CBT

Cognitive Behavioral Therapy

Interpersonal Psychotherapy BEHAVIORAL

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

Also known as: IPT

Interpersonal Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Carnegie Mellon University: collaborator

Study Sites (1)

WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 37121279 RESULT

• Girard JM, Yermol DA, Bylsma LM, Cohn JF, Fournier JC, Morency LP, Swartz HA. Dynamic and dyadic relationships between facial behavior, working alliance, and treatment outcomes during depression therapy. J Consult Clin Psychol. 2025 Nov;93(11):749-760. doi: 10.1037/ccp0000980.

  PMID: 41182707 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Limitations include the small sample size for each group and COVID-19 pandemic related restrictions necessitated that we conduct the 2nd half of the study virtually: delivery format for both intervention groups consisted of in person for the first phase of the trial (N=49) and virtual for the second phase of the trial (N=26). One participant for CBT and 3 for IPT were active in the study at the time of pandemic lockdown and had to be discontinued because of COVID-19 related safety requirements.

Results Point of Contact

• Title: Holly Swartz, MD
• Organization: University of Pittsburgh School of Medicine

SwartzHA@upmc.edu

4122465588

Study Officials

• Jeffrey F Cohn, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 20, 2018
• Study Start: July 8, 2018
• Primary Completion: March 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)