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

Major Depressive Disorder Clinical Trial

— DAPPeR  

Official title:

Dyadic Behavior Informatics for Psychotherapy Process and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594773
• Other study ID #: PRO17110528
• Secondary ID: 171722822
• Status: Completed
• Phase: N/A
• Start date: July 8, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65

2. Meet DSM 5 criteria for major depressive disorder, current episode

3. 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 PD (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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
• Interpersonal Psychotherapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.

Locations

Country	Name	City	State
United States	WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Carnegie Mellon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity	Depression severity will be measured at the visits 1, 4, and 8 via the Hamilton Rating Scale for Depression (HRSD-17), which consists of 17 items with Likert scale of either 0 to 4 or 0 to 2. Scores can range from 0 to 54. We will compare HRSD-17 scores at visits 1, 4, and 8.; Scale ranges 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	Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)	Working Alliance Inventory-Short Revised (WAI-SR), client version, 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.; WAI-SR, client version, has three scales: Goal; Task; Bond Each scale ranges from 4 to 20. Higher scores represent better alliance.; WAI-SR, client version, will be measured at each weekly visit. Score at final visit will be reported.	12 weeks
Secondary	Working Alliance Inventory--Short Revised Therapist Version (WAI-SR-T)	Working Alliance Inventory-Short Revised (WAI-SR), therapist version, 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.; WAI-SR, therapist version, has three scales: Goal (3 items): Range from 3 to 15.; Task (3 items): Range from 3 to 15.; Bond (4 items): Range from 4 to 20. Total score ranges from 10 to 50. Higher scores indicate better alliance.; WAI-SR, therapist version, will be measured at each weekly visit. Score at final visit will be reported.	12 weeks