Major Depressive Disorder
Conditions
Brief 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
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
BEHAVIORALInterpersonal Psychotherapy
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Sponsors
Carnegie Mellon University
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 2. Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI) 3. Hamilton Rating Scale for Depression (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 personality disorder (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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Working Alliance Inventory--Short Revised Client Version (WAI-SR-C) | 12 weeks | 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). |
| Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT) | 12 weeks | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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. | 35 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Interpersonal Psychotherapy (IPT) | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|
| Age, Continuous | 32.10 years STANDARD_DEVIATION 14.11 | 31.89 years STANDARD_DEVIATION 13.23 | 32.0 years STANDARD_DEVIATION 13.6 |
| Hamilton Rating Scale for Depression - 17 | 19.51 units on a scale STANDARD_DEVIATION 3.63 | 18.23 units on a scale STANDARD_DEVIATION 3.17 | 18.92 units on a scale STANDARD_DEVIATION 3.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 24 Participants | 53 Participants |
| Sex/Gender, Customized Gender Female | 25 Participants | 26 Participants | 51 Participants |
| Sex/Gender, Customized Gender Male | 14 Participants | 8 Participants | 22 Participants |
| Sex/Gender, Customized Gender Other | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 35 |
| other Total, other adverse events | 0 / 42 | 0 / 35 |
| serious Total, serious adverse events | 0 / 42 | 0 / 35 |
Outcome results
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
Time frame: 12 weeks
Population: These analyses only include those who completed the final 12-week post-treatment assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy | Depression Severity | 11.9 score on a scale | Standard Deviation 6.34 |
| Cognitive Behavioral Therapy | Depression Severity | 11.41 score on a scale | Standard Deviation 5.41 |
p-value: 0.75295% CI: [-3.62, 2.63]t-test, 2 sided
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).
Time frame: 12 weeks
Population: These analyses only include those who completed the WAI measure at all 8 treatment sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy | Working Alliance Inventory--Short Revised Client Version (WAI-SR-C) | 50.07 score on a scale | Standard Deviation 8.08 |
| Cognitive Behavioral Therapy | Working Alliance Inventory--Short Revised Client Version (WAI-SR-C) | 51.33 score on a scale | Standard Deviation 10.59 |
p-value: 0.63395% CI: [-4.01, 6.52]t-test, 2 sided
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).
Time frame: 12 weeks
Population: These analyses only include those who completed the WAI measure at all 8 treatment sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy | Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT) | 42.57 score on a scale | Standard Deviation 5.83 |
| Cognitive Behavioral Therapy | Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT) | 43.52 score on a scale | Standard Deviation 6.55 |
p-value: 0.58695% CI: [-2.53, 4.44]t-test, 2 sided