Augmented Depression Therapy (ADepT) Case Series
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 -65
Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
Scoring > 10 on the PHQ-9
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.
Disqualifiers
Diagnosis of a psychotic or bipolar disorder
History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
Trial design
Design model
Single group
Treatments tested in this trial
Augmented Depression Therapy (ADepT)
BehavioralADepT 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.
Treatment groups
40 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 3 week baseline + ADepTExperimental treatment 1 intervention
Group B: 4 week baseline + ADepTExperimental treatment 1 intervention
Group C: 5 week baseline + ADepTExperimental treatment 1 intervention
Group D: 6 week baseline + ADepTExperimental treatment 1 intervention
Group E: 7 week baseline + ADepTExperimental treatment 1 intervention
Group F: 8 week baseline + ADepTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability
Patient ratings of treatment acceptability
Time frame
From enrollment to the end of treatment at 82 weeks2
Attrition
Patient attendance records
Time frame
From enrollment to the end of treatment at 82 weeks.3
Adverse Events
Self-reported adverse events
Time frame
From enrollment to the end of treatment at 82 weeks.Secondary outcomes
1
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Time frame
From enrollment to the end of treatment at 82 weeks.2
Patient Health Questionnaire - 9 Item Version (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depression severity. Min=0, Max=27, higher scores indicate worse depression.
Time frame
From enrollment to the end of treatment at 82 weeks.3
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
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.
Time frame
From enrollment to the end of treatment at 82 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: