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Completed

NCT Number: NCT03594773

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Other names: CBT

interpersonal psychotherapy

Behavioral

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

Other names: IPT

Primary outcomes

  1. 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

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

    Time frame: 12 weeks

    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).

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

    Time frame: 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Carnegie Mellon University

Registry information

Official study title

Dyadic Behavior Informatics for Psychotherapy Process and Outcome

Acronym: DAPPeR

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2018
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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