DepressionNCT01906476
Stepped Telemental Health Care Intervention for Depression
A study testing Stepped Care and Telephone Cognitive Behavior Therapy in people with Depression, run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Stepped Care and Telephone Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Major depressive disorder (MDD) is common, with 12-month prevalence rates estimated to be between 6.6-10.3%. While many depressed patients state they would prefer psychological treatment to pharmacotherapy, substantial barriers to care exist, including cost, practical barriers such as time constraints and transportation, emotional barriers such as stigma, decreased motivation associated with depression itself, physical disability, and lack of availability of services. Telemental health has been proposed as a method of overcoming barriers to treatment. Research has focused primarily on two formats: the telephone and the Internet. Use of the telephone as a delivery medium produces reductions in depression equivalent to face-to-face psychological treatments, while also significantly reducing attrition. However, its success in outreach can also significantly increase costs for healthcare providing organizations. Internet interventions have the potential to produce moderate gains when supported by therapist or coach via brief telephone calls or e-mail but are also less expensive than standard therapy. Developing healthcare models that integrate treatment delivery media holds the promise of harnessing the advantages of each media, while minimizing the disadvantages. Stepped care models are a potentially useful framework for achieving such an integration. The stepped care model we will test initiates treatment with a validated, guided Internet cognitive behavioral therapy program. If patients fail to respond, they will be stepped up to a validated telephone-cognitive behavior therapy (T-CBT). The stepped care model will be compared to T-CBT in a randomized trial. Patients will be recruited from primary care and treated for up to 20 weeks, or until sustained remission is achieved.
- Conditions
- Depression
- Being tested
- Stepped Care, Telephone Cognitive Behavior Therapy
- Keywords
- Depression, Telephone Cognitive Behavior Therapy, Internet Cognitive Behavioral Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareBehavioural
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
Telephone Cognitive Behavior TherapyBehavioural
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care | Experimental | 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 Receives: Behavioral: Stepped Care |
| Telephone Cognitive Behavior Therapy | Active comparator | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Receives: Behavioral: Telephone Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startFeb 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David C Mohr, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906476
- Sponsor's protocol ID
- R01MH095753-01A1-RCTTH
- Other IDs
- R01MH095753-01A1
- Status last verified
- Feb 2023
- First submitted
- 17 Jul 2013
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31634738
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Telemental Health Care Intervention for Depression
- ClinicalTrials.gov ID
- NCT01906476
- Acronym / sponsor ID
- R01MH095753-01A1-RCTTH
- Conditions
- Depression
- Keywords
- Depression, Telephone Cognitive Behavior Therapy, Internet Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Major depressive disorder (MDD) is common, with 12-month prevalence rates estimated to be between 6.6-10.3%. While many depressed patients state they would prefer psychological treatment to pharmacotherapy, substantial barriers to care exist, including cost, practical barriers such as time constraints and transportation, emotional barriers such as stigma, decreased motivation associated with depression itself, physical disability, and lack of availability of services. Telemental health has been proposed as a method of overcoming barriers to treatment. Research has focused primarily on two formats: the telephone and the Internet. Use of the telephone as a delivery medium produces reductions in depression equivalent to face-to-face psychological treatments, while also significantly reducing attrition. However, its success in outreach can also significantly increase costs for healthcare providing organizations. Internet interventions have the potential to produce moderate gains when supported by therapist or coach via brief telephone calls or e-mail but are also less expensive than standard therapy. Developing healthcare models that integrate treatment delivery media holds the promise of harnessing the advantages of each media, while minimizing the disadvantages. Stepped care models are a potentially useful framework for achieving such an integration. The stepped care model we will test initiates treatment with a validated, guided Internet cognitive behavioral therapy program. If patients fail to respond, they will be stepped up to a validated telephone-cognitive behavior therapy (T-CBT). The stepped care model will be compared to T-CBT in a randomized trial. Patients will be recruited from primary care and treated for up to 20 weeks, or until sustained remission is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Behavioral: Stepped CareParticipants 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 comparator | Behavioral: Telephone Cognitive Behavior TherapyParticipants will receive telephone-administered cognitive behavioral therapy (T-CBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped CareParticipants 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 | Behavioural | Stepped Care |
| Telephone Cognitive Behavior TherapyParticipants will receive telephone-administered cognitive behavioral therapy (T-CBT). | Behavioural | Telephone Cognitive Behavior Therapy |
Primary outcome
Depression
Time frame: Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up
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.
Cost-Effectiveness
Time frame: Baseline to end of treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31634738Mohr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Mohr, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care and Telephone Cognitive Behavior Therapy in people with Depression, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.