Major Depressive Disorder Clinical Trial
— DAPPeROfficial title:
Dyadic Behavior Informatics for Psychotherapy Process and Outcome
Verified date | January 2022 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Carnegie Mellon University |
United States,
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 |
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