Depression / Major Depressive Disorder
Conditions
Keywords
Depression, Major Depressive Disorder, Major Depressive Episode
Brief summary
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care. ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly. As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
Interventions
BEHAVIORALAugmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized multiple baseline case series design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 -65 2. Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First \& Williams, 2021) 3. Scoring \> 10 on the PHQ-9 4. Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
Exclusion criteria
1. Diagnosis of a psychotic or bipolar disorder 2. History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders) 3. Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment 4. Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame 5. Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible. 6. Presence of another psychiatric disorder judged to be primary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | From enrollment to the end of treatment at 82 weeks | Patient ratings of treatment acceptability |
| Attrition | From enrollment to the end of treatment at 82 weeks. | Patient attendance records |
| Adverse Events | From enrollment to the end of treatment at 82 weeks. | Self-reported adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | From enrollment to the end of treatment at 82 weeks. | The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time. Min=0, Max=60, higher scores indicate worse depression. |
| Patient Health Questionnaire - 9 Item Version (PHQ-9) | From enrollment to the end of treatment at 82 weeks. | The PHQ-9 is a 9-item self-report measure of depression severity. Min=0, Max=27, higher scores indicate worse depression. |
| Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) | From enrollment to the end of treatment at 82 weeks. | The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning. Min=14, Max=70, higher scores indicate higher levels of wellbeing. |
Countries
United States
Contacts
CONTACTJay Fournier, Ph.D.
Outcome results
None listed