DepressionNCT01379027
MoodHelper: Internet Cognitive Behavioral Therapy (CBT) for Depression
A study testing Pure self-help Internet CBT for depression, Guided self-help Internet CBT and Stepped-Care Internet CBT condition in people with Depression, run by Kaiser Permanente at 1 site in United States.
Trial summary
Evidence-based treatments (EBTs) for mental health conditions are often not available to persons needing them in the community. Our aim is to test a novel Internet intervention that has the promise of eventually improving the Reach and Implementation of mental health EBTs, speeding the translation of research… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Pure self-help Internet CBT for depression, Guided self-help Internet CBT and Stepped-Care Internet CBT condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,816 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants must have a score ≥ 10 on the self-report Patient Health Questionnaire (PHQ-8), indicative of clinically significant, moderate depression.
- Participants must identify their primary healthcare provider in one of the 8 performance sites, and give permission to contact him or her for the purpose of periodic progress reports as well as a referral contact in case any emergent crises are detected.
- Participant must be 18 years of age have access to a computer with internet and a working email address.
- Participants must also indicate they are planning to continue receiving services from one of the performance site clinics/organizations for at least the next 6 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Internet CBT for Depression: Comparing Pure, Guided, and Stepped Care
Evidence-based treatments (EBTs) for mental health conditions are often not available to persons needing them in the community. Our aim is to test a novel Internet intervention that has the promise of eventually improving the Reach and Implementation of mental health EBTs, speeding the translation of research successes into improved community care.
Read the detailed description
Evidence-based treatments (EBTs) for depression are often not available to persons needing them; this is particularly true of psychotherapies. Even when available, EBTs are often poorly delivered at less-than-optimal quality. High direct and indirect costs also limit the availability of EBTs. Together these barriers contribute to suboptimal treatment of depression in the community. In a preliminary step toward addressing these quality shortcomings, the investigators propose to conduct a blended efficacy- effectiveness randomized controlled trial (RCT) of high fidelity, Internet-delivered cognitive behavioral therapy (CBT) for depression, extending our previous research to maximize treatment availability and quality as well as to reduce costs. Over a 36-month recruitment period, the investigators will enroll 1,800 adults seeking care for depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers (FQHCs), and 2 non-profit HMOs. Participants will be randomized to: (a) a treatment as usual (TAU) control condition, typically antidepressants and/or psychosocial services; (b) TAU plus Pure self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapists; (c) TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists; or (d) a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on. Participants will be followed for one year. The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT. The investigators also expect secondary analyses to reveal this pattern of results: Guided CBT > Pure CBT > TAU. The investigators will conduct cost-effectiveness analyses (CEA), as the investigators project substantial differences in the direct costs of each study arm. The investigators will also examine TAU healthcare utilization (medications, visits, etc) from electronic medical records (EMR), billing systems, and participant report. The investigators hypothesize that cost per depression free days (DFDs) and quality- adjusted life years (QALYs) will be lowest for Pure CBT, relative to Guided and Stepped-Care CBT and TAU. The investigators also hypothesize that cost per unit of improvement in QALYs and DFDs will be better for Stepped-Care compared to Guided CBT. Additional aims include exploratory examination of secondary outcomes, and predictors and moderators of outcomes among the interventions. The investigators also will collect quantitative and qualitative data on patient, provider, and organizational factors that may impede or facilitate implementation of these interventions, to help prepare for future dissemination efforts. Finally, in this reapplication the investigators have added a non-research Reach Estimation Phase to better estimate acceptance and retention rates under conditions that closely match real-world dissemination
- Conditions
- Depression
- Being tested
- Pure self-help Internet CBT for depression, Guided self-help Internet CBT, Stepped-Care Internet CBT condition
- Keywords
- Depression, Website intervention, CBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure self-help Internet CBT for depressionBehavioural
Internet, CBT, Depression
Guided self-help Internet CBTBehavioural
CBT, Depression, Website intervention, coaching
Stepped-Care Internet CBT conditionBehavioural
Depression CBT, Internet intervention
| Study group | Role | What they receive |
|---|---|---|
| a treatment as usual (TAU) control condition | No intervention | Participants will receive recruitment information, go on the study website to enroll and complete assessments over the study web site but will not receive the study intervention. |
| Pure self-help Internet CBT for depression | Experimental | Participants will receive TAU plus access to the study website for the self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapist Receives: Behavioral: Pure self-help Internet CBT for depression |
| Guided self-help Internet CBT | Experimental | Participants will receive TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists Receives: Behavioral: Guided self-help Internet CBT |
| Stepped-Care Internet CBT condition | Experimental | This consists of a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on Receives: Behavioral: Stepped-Care Internet CBT condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT.
We'll enroll 1,800 adults with depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers and 2 non-profit HMO. Participants will be randomized to: TAU only (b) TAU plus Pure self-help Internet CBT for depression (G-CBT), (c) TAU plus G-CBT, plus brief, periodic therapist telephone contacts; or (d) a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on. Participants will be followed for one year.
Measured: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment
Secondary outcomes (1)
secondary analyses will examine healthcare utilization for any signs of shifts in amount or mix of TAU services by study condition.
We will conduct cost-effectiveness analyses, examine TAU healthcare utilization from EMR, participant report and collect quantitative and qualitative data on patient, provider, and organizational factors that may impede or facilitate implementation of these interventions and we have added a non-research Reach Estimation Phase to better estimate acceptance and retention rates under conditions that closely match real-world dissemination
Measured: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Kaiser PermanenteThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Greg N Clarke, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379027
- Sponsor's protocol ID
- 1R01MH087505
- Status last verified
- Mar 2018
- First submitted
- 10 Jun 2011
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sheppler CR, Edelmann AC, Firemark AJ, Sugar CA, Lynch FL, Dickerson JF, Miranda JM, Clarke GN, Asarnow JR. Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106959. doi: 10.1016/j.cct.2022.106959. Epub 2022 Oct 11.
PubMed 36228984
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet CBT for Depression: Comparing Pure, Guided, and Stepped Care
- ClinicalTrials.gov ID
- NCT01379027
- Acronym / sponsor ID
- 1R01MH087505
- Conditions
- Depression
- Keywords
- Depression, Website intervention, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,816 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Oct 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence-based treatments (EBTs) for mental health conditions are often not available to persons needing them in the community. Our aim is to test a novel Internet intervention that has the promise of eventually improving the Reach and Implementation of mental health EBTs, speeding the translation of research successes into improved community care.
Detailed description
Evidence-based treatments (EBTs) for depression are often not available to persons needing them; this is particularly true of psychotherapies. Even when available, EBTs are often poorly delivered at less-than-optimal quality. High direct and indirect costs also limit the availability of EBTs. Together these barriers contribute to suboptimal treatment of depression in the community. In a preliminary step toward addressing these quality shortcomings, the investigators propose to conduct a blended efficacy- effectiveness randomized controlled trial (RCT) of high fidelity, Internet-delivered cognitive behavioral therapy (CBT) for depression, extending our previous research to maximize treatment availability and quality as well as to reduce costs. Over a 36-month recruitment period, the investigators will enroll 1,800 adults seeking care for depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers (FQHCs), and 2 non-profit HMOs. Participants will be randomized to: (a) a treatment as usual (TAU) control condition, typically antidepressants and/or psychosocial services; (b) TAU plus Pure self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapists; (c) TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists; or (d) a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on. Participants will be followed for one year. The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT. The investigators also expect secondary analyses to reveal this pattern of results: Guided CBT > Pure CBT > TAU. The investigators will conduct cost-effectiveness analyses (CEA), as the investigators project substantial differences in the direct costs of each study arm. The investigators will also examine TAU healthcare utilization (medications, visits, etc) from electronic medical records (EMR), billing systems, and participant report. The investigators hypothesize that cost per depression free days (DFDs) and quality- adjusted life years (QALYs) will be lowest for Pure CBT, relative to Guided and Stepped-Care CBT and TAU. The investigators also hypothesize that cost per unit of improvement in QALYs and DFDs will be better for Stepped-Care compared to Guided CBT. Additional aims include exploratory examination of secondary outcomes, and predictors and moderators of outcomes among the interventions. The investigators also will collect quantitative and qualitative data on patient, provider, and organizational factors that may impede or facilitate implementation of these interventions, to help prepare for future dissemination efforts. Finally, in this reapplication the investigators have added a non-research Reach Estimation Phase to better estimate acceptance and retention rates under conditions that closely match real-world dissemination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| a treatment as usual (TAU) control condition | No intervention | –Participants will receive recruitment information, go on the study website to enroll and complete assessments over the study web site but will not receive the study intervention. |
| Pure self-help Internet CBT for depression | Experimental | Behavioral: Pure self-help Internet CBT for depressionParticipants will receive TAU plus access to the study website for the self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapist |
| Guided self-help Internet CBT | Experimental | Behavioral: Guided self-help Internet CBTParticipants will receive TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists |
| Stepped-Care Internet CBT condition | Experimental | Behavioral: Stepped-Care Internet CBT conditionThis consists of a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a score ≥ 10 on the self-report Patient Health Questionnaire (PHQ-8), indicative of clinically significant, moderate depression.
- Participants must identify their primary healthcare provider in one of the 8 performance sites, and give permission to contact him or her for the purpose of periodic progress reports as well as a referral contact in case any emergent crises are detected.
- Participant must be 18 years of age have access to a computer with internet and a working email address.
- Participants must also indicate they are planning to continue receiving services from one of the performance site clinics/organizations for at least the next 6 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pure self-help Internet CBT for depressionInternet, CBT, Depression | Behavioural | Pure self-help Internet CBT for depression |
| Guided self-help Internet CBTCBT, Depression, Website intervention, coaching | Behavioural | Guided self-help Internet CBT |
| Stepped-Care Internet CBT conditionDepression CBT, Internet intervention | Behavioural | Stepped-Care Internet CBT condition |
Primary outcome
The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT.
Time frame: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment
We'll enroll 1,800 adults with depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers and 2 non-profit HMO. Participants will be randomized to: TAU only (b) TAU plus Pure self-help Internet CBT for depression (G-CBT), (c) TAU plus G-CBT, plus brief, periodic therapist telephone contacts; or (d) a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on. Participants will be followed for one year.
1 secondary outcome
secondary analyses will examine healthcare utilization for any signs of shifts in amount or mix of TAU services by study condition.
Time frame: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Derived from this study: PubMed 36228984Sheppler CR, Edelmann AC, Firemark AJ, Sugar CA, Lynch FL, Dickerson JF, Miranda JM, Clarke GN, Asarnow JR. Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106959. doi: 10.1016/j.cct.2022.106959. Epub 2022 Oct 11.
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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.
Greg N Clarke, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure self-help Internet CBT for depression, Guided self-help Internet CBT and Stepped-Care Internet CBT condition in people with Depression, run by Kaiser Permanente 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 4 inclusion and 0 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 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT. (time frame: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment). 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 NCT01379027, 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 Mar 2018.