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| ID | Type | Description | Link |
|---|---|---|---|
| 171722822 | Other Grant/Funding Number | National Science Foundation |
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| Name | Class |
|---|---|
| Carnegie Mellon University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interpersonal Psychotherapy | Experimental | 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. |
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| Cognitive Behavioral Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Participants will receive 8 one-on-one sessions over 8 to 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Working Alliance Inventory--Short Revised Client Version (WAI-SR-C) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey F Cohn, Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37121279 | Result | Swartz HA, Bylsma LM, Fournier JC, Girard JM, Spotts C, Cohn JF, Morency LP. Randomized trial of brief interpersonal psychotherapy and cognitive behavioral therapy for depression delivered both in-person and by telehealth. J Affect Disord. 2023 Jul 15;333:543-552. doi: 10.1016/j.jad.2023.04.092. Epub 2023 Apr 28. | |
| 41182707 | Derived |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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77 participants completed the baseline assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age: continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Severity | 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 | These analyses only include those who completed the final 12-week post-treatment assessment. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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12 weeks per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interpersonal Psychotherapy | 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. |
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Limitations include the small sample size for each group and COVID-19 pandemic related restrictions necessitated that we conduct the 2nd half of the study virtually: delivery format for both intervention groups consisted of in person for the first phase of the trial (N=49) and virtual for the second phase of the trial (N=26). One participant for CBT and 3 for IPT were active in the study at the time of pandemic lockdown and had to be discontinued because of COVID-19 related safety requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Swartz, MD | University of Pittsburgh School of Medicine | 4122465588 | SwartzHA@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2023 | Dec 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000079062 | Interpersonal Psychotherapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Interpersonal Psychotherapy | Behavioral | Participants will receive 8 one-on-one sessions over 8 to 12 weeks. |
|
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| 12 weeks |
| Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT) | 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). | 12 weeks |
| Girard JM, Yermol DA, Bylsma LM, Cohn JF, Fournier JC, Morency LP, Swartz HA. Dynamic and dyadic relationships between facial behavior, working alliance, and treatment outcomes during depression therapy. J Consult Clin Psychol. 2025 Nov;93(11):749-760. doi: 10.1037/ccp0000980. |
| BG001 | 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 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | gender identity is categorical: male, female, other | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Hamilton Rating Scale for Depression - 17 | 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. Total 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 | Mean | Standard Deviation | units on a scale |
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| OG001 | Cognitive Behavioral Therapy | 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. |
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| Secondary | Working Alliance Inventory--Short Revised Client Version (WAI-SR-C) | 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). | These analyses only include those who completed the WAI measure at all 8 treatment sessions. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| Secondary | Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT) | 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). | These analyses only include those who completed the WAI measure at all 8 treatment sessions. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| 0 |
| 42 |
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| 42 |
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| 42 |
| EG001 | Cognitive Behavioral Therapy | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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