N/A
Completed N=77
Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.
Source: ClinicalTrials.gov NCT03594773 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Depression Severity — 11.9; 11.41 score on a scale — p=.752
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Severity |
11.9; 11.41 | .752 |
| SECONDARY Working Alliance Inventory--Short Revised Client Version (WAI-SR-C) |
50.07; 51.33 | .633 |
| SECONDARY Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT) |
42.57; 43.52 | .586 |
Eligibility Criteria
Inclusion Criteria
- Age 18-65
- Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI)
- Hamilton Rating Scale for Depression (HRSD-17) score ≥ 14 consistent with at least moderate depressive symptoms
- 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
- Fluent in English
- Capacity to understand and give informed consent
Exclusion Criteria
- 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
- Current depressive episode has psychotic features
- Current depressive episode has been present for > 104 weeks
- 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).
- Meets DSM-5 criteria for prior manic or hypomanic episode (bipolar I or II disorder) or a psychotic disorder including schizoaffective disorder or schizophrenia
- Meets DSM-5 criteria for antisocial personality disorder (MINI)
- 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)
- Significant unstable medical illness that may explain depressive symptoms such as epilepsy, autoimmune disorder, chronic pain, or unstable endocrine disorder
- Cognitive deficits that would preclude completion of study questionnaires or participation in psychotherapy
- Unable to unwilling to comply with study requirements (i.e., complete forms, attend sessions)
Data sourced from ClinicalTrials.gov (NCT03594773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.