Clinical trial NCT06590038: Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol
Official title: Psychotherapy Feasibility and Acceptability Pilot of the Carolina Recovery From Depression Protocol (CARED): A Novel Rapid Treatment Paradigm for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Keywords: Depression
Major Depressive Disorder
Psychotherapy
Single Session Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: The Foundation of Hope for Research and Treatment of Mental Illness
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are:

Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression?

Participants will complete:

* an in-depth diagnostic screening interview prior to enrollment
* a set of mental health questionnaires at baseline and two weeks post-intervention
* a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Able to provide informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Speak and understand English
* Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
* Meet a cutoff of at least a moderate depression score on the Beck Depression Inventory (BDI-II) (≥ 20)

Exclusion Criteria:

* Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
* Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
* Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
* Participants able to birth must not be pregnant or breastfeeding.
* Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
* Participants may not have undergone prior brain surgery
* Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
* Participants may not have had brain injury or concussion within the last three months
* Participants may not have a history of brain injury requiring current treatment

Primary outcomes:
measure: CARED Treatment Experience Survey
timeFrame: Immediately post-intervention (same day)
Secondary outcomes:
measure: Change from baseline on Behavioral Activation Scale at two weeks post-intervention
timeFrame: Baseline and Two Weeks post-intervention
measure: Change in baseline Repetitive Thinking Questionnaire - 10 item form to two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Snaith-Hamilton Pleasure Scale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Inhibition Subscale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Drive Subscale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Fun Seeking Subscale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Reward Responsiveness Subscale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Quality of Life Enjoyment and Satisfaction Questionnaire at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Dimensional Anhedonia Rating Scale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Intolerance of Uncertainty Scale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Flexibility Subscale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Inflexibility Subscale at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Self-Compassion Scale Short Form at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
measure: Change from baseline on Becks Depression Inventory II at two weeks post-intervention
timeFrame: Baseline and Two weeks post-intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Carolina Center for Neurostimulation
state: North Carolina
Study officials:
affiliation: Univeristy of North Carolina Chapel Hill
name: Flavio Frohlich, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: