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

Major Depressive Disorder Clinical Trial

Official title: Dyadic Behavior Informatics for Psychotherapy Process and Outcome

Status Completed

Clinical Trial 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.

Clinical Trial Description

In response to Covid, 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.

Phase 1 recruitment: We received 638 referrals through a centralized registry system (Pitt + Me) and assessed 191 for protocol eligibility. We were unable to reach 447 of those referred. Sixty percent of those reached for preliminary screening failed to meet inclusion criteria (n=63), lacked interest in the study once all details were explained (n=37), or were lost to follow-up (n=15). Seventy-six individuals gave informed consent documents and completed a baseline assessment for eligibility; 64% (49/76) were randomized to one of the two psychotherapy conditions: Brief Cognitive Behavior Therapy (CBT; n=24) or Brief Interpersonal Psychotherapy (IPT; n=25).

Following randomization, four assigned to CBT and six assigned to IPT failed to receive the intervention because they withdrew from the study (n=6) or were lost to follow-up (n=4). Seventy-five percent (18/24) of CBT participants and 56% (14/25) of IPT participants completed the 12-week protocol. Of note, one CBT participant and three IPT participants were active in the study at the time of COVID-19 lockdown and had to be discontinued because of COVID related safety requirements.

Phase 2 recruitment: Phase 2 procedures was conducted virtually via Zoom to comply with COVID safety protocols. We received 149 referrals through the centralized registry system used in Phase 1 and assessed 41 for protocol eligibility. We were unable to reach 108 of those referred. Fifteen percent (6/41) of those reached for preliminary screening were ineligible due to lack of interest once all details were explained (n=2) or lost to follow-up (n=4). Thirty-five individuals signed informed consent documents and completed a baseline assessment for eligibility, of whom 74% (26/35) were randomized to one of the two psychotherapy conditions: CBT (n=9) or IPT (n=17). The unequal sizes of the two cells was likely caused randomization stratified on depression severity and gender and the small sample size. Following randomization, three assigned to CBT failed withdrew from the study or were lost to follow-up. Sixty-seven percent (6/9) of CBT participants and 94% percent (16/17) of IPT participants completed the 12-week protocol.

We will 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. ;

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT03594773
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: July 8, 2018
• Completion date: July 31, 2021