Trial Outcomes & Findings for Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome. (NCT NCT03594773)

Last Updated: 2024-07-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-07-22

Participant Flow

Phase 1 recruitment (in person delivery) began July 2018 and concluded in February 2020. Recruitment for Phase 2 (telehealth delivery) began July 2020 and concluded March 2021. Phase 2 recruitment: Phase 2 procedures was conducted virtually via Zoom to comply with COVID safety protocols. Recruitment took place at the University of Pittsburgh Medical Center using the Pitt+Me research registry.

No enrolled participants were excluded from the study prior to assignment to group as the assignment was done at the time of enrollment. Some participants were enrolled and assigned to a group but participated in no therapy sessions (lost to follow-up). Thus, the final numbers included in data analysis are slightly smaller than the total number initially enrolled.

Participant milestones

Participant milestones
Measure	Interpersonal Psychotherapy (IPT) Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in interpersonal psychotherapy (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.	Cognitive Behavioral Therapy (CBT) Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in cognitive-behavioral therapy (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.
Overall Study STARTED	42	35
Overall Study COMPLETED	36	29
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Interpersonal Psychotherapy (IPT) Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in interpersonal psychotherapy (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.	Cognitive Behavioral Therapy (CBT) Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in cognitive-behavioral therapy (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.
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interpersonal Psychotherapy (IPT) n=42 Participants 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. Interpersonal Psychotherapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.	Cognitive Behavioral Therapy (CBT) n=35 Participants 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. Cognitive Behavioral Therapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.	Total n=77 Participants Total of all reporting groups
Age, Continuous	32.10 years STANDARD_DEVIATION 14.11 • n=5 Participants	31.89 years STANDARD_DEVIATION 13.23 • n=7 Participants	32.0 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex/Gender, Customized Gender · Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Sex/Gender, Customized Gender · Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Hamilton Rating Scale for Depression - 17	19.51 units on a scale STANDARD_DEVIATION 3.63 • n=5 Participants	18.23 units on a scale STANDARD_DEVIATION 3.17 • n=7 Participants	18.92 units on a scale STANDARD_DEVIATION 3.46 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: These analyses only include those who completed the final 12-week post-treatment assessment.

Outcome measures

Outcome measures
Measure	Interpersonal Psychotherapy n=31 Participants 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. Interpersonal Psychotherapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.	Cognitive Behavioral Therapy n=27 Participants 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. Cognitive Behavioral Therapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Depression Severity	11.9 score on a scale Standard Deviation 6.34	11.41 score on a scale Standard Deviation 5.41

SECONDARY outcome

Timeframe: 12 weeks

Population: These analyses only include those who completed the WAI measure at all 8 treatment sessions.

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).

Outcome measures

Outcome measures
Measure	Interpersonal Psychotherapy n=27 Participants 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. Interpersonal Psychotherapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.	Cognitive Behavioral Therapy n=24 Participants 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. Cognitive Behavioral Therapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)	50.07 score on a scale Standard Deviation 8.08	51.33 score on a scale Standard Deviation 10.59

SECONDARY outcome

Timeframe: 12 weeks

Population: These analyses only include those who completed the WAI measure at all 8 treatment sessions.

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).

Outcome measures

Outcome measures
Measure	Interpersonal Psychotherapy n=28 Participants 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. Interpersonal Psychotherapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.	Cognitive Behavioral Therapy n=23 Participants 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. Cognitive Behavioral Therapy: Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT)	42.57 score on a scale Standard Deviation 5.83	43.52 score on a scale Standard Deviation 6.55

Adverse Events

Interpersonal Psychotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Holly Swartz, MD

University of Pittsburgh School of Medicine

Phone: 4122465588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place