Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

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: 
      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.
    

Intervention name(s): Cognitive Behavioral Therapy; Interpersonal Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive 8 one-on-one sessions over 8 to 12 weeks.; Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Other intervention name(s): CBT; IPT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment