Stepped Telemental Health Care Intervention for Depression
2 other identifiers
interventional
312
1 country
1
Brief Summary
This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT) with a therapist to a "Stepped Care" intervention for depression treatment (iCBT with support from a telephone coach with the possibility of being stepped up to receiving T-CBT with a therapist).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Feb 2015
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedResults Posted
Study results publicly available
April 2, 2020
CompletedFebruary 8, 2023
February 1, 2023
3.2 years
July 17, 2013
April 9, 2019
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression
To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up
Cost-Effectiveness
Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.
Baseline to end of treatment
Study Arms (2)
Stepped Care
EXPERIMENTALParticipants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
Telephone Cognitive Behavior Therapy
ACTIVE COMPARATORParticipants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Interventions
Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Eligibility Criteria
You may qualify if:
- Has a DSM-IV diagnosis of non-psychotic major depressive disorder (MDD) as assessed using the Mini International Neuropsychiatric Interview (MINI), plus a score of 12 or greater on the Quick Inventory of Depressive Symptomatology - Clinician Rated (QIDS-C)
- Has a phone, access to the Internet, and basic internet skills
- Is at least 18 years of age
- Is able to speak and read English
- If currently taking an antidepressant medication, participant must have been on a stable dose for at least two weeks, and have no plans to change the dose
You may not qualify if:
- Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use or other diagnosis for which participation in this trial is either inappropriate or dangerous
- Is severely suicidal (has ideation, plan, and intent)
- Is currently receiving or planning to begin psychotherapy during the study treatment period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (1)
Mohr DC, Lattie EG, Tomasino KN, Kwasny MJ, Kaiser SM, Gray EL, Alam N, Jordan N, Schueller SM. A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT. Behav Res Ther. 2019 Dec;123:103485. doi: 10.1016/j.brat.2019.103485. Epub 2019 Sep 30.
PMID: 31634738DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Kwasny
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
David C Mohr, Ph.D.
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine
Study Record Dates
First Submitted
July 17, 2013
First Posted
July 24, 2013
Study Start
February 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
February 8, 2023
Results First Posted
April 2, 2020
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share