Major Depressive DisorderNCT01990053
Pilot Study Assessing Computerized Cognitive Behavioral Therapy for Depression
A study testing Beating the Blues in people with Major Depressive Disorder, run by Ohio State University at 1 site in United States.
Trial summary
Standard treatments for depression in specialty care settings are effective but resources for delivering empirically supported psychotherapies are often limited. Computerized cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that might help expand services in psychiatric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Beating the Blues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2014to 1 May 2017
- 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
- Diagnosis of Major Depressive Disorder (MDD) according to Diagnostic and Statistical Manual Fourth Edition criteria
- Able and willing to give informed consent
- Have access to a computer with an internet connection at home
Who cannot join
- History of bipolar affective disorder or psychosis
- Current Axis I disorder other than MDD if it constitutes the predominate aspect of the clinical presentation and if it requires treatment other than that being offered
- History of substance dependence in the past six months
- Subnormal intellectual potential (IQ below 80)
- Clear indication of secondary gain (e.g., court ordered treatment or compensation issues)
- Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
Show all 10Show fewer
- Discharge within six moths from a higher level of care (inpatient, partial hospital, or intensive outpatient treatment)
- Currently undergoing outpatient psychotherapy
- Current antidepressant medication treatment if the individual has had a change in medication over the past month or is planning a change in medication during the duration of the study
- Inability to read and write English
Trial locations and contacts
1 site in 1 country.
About this study
Standard treatments for depression in specialty care settings are effective but resources for delivering empirically supported psychotherapies are often limited. Computerized cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that might help expand services in psychiatric settings, however, little is known about its efficacy in this population. The present study aims to establish the efficacy of a internet-delivered cCBT program ("Beating the Blues") plus email and telephone support for depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an assessment procedure designed to identify moderators of treatment effectiveness.
Read the detailed description
Currently, outpatient psychiatric settings are plagued by long wait times and are often unable to accommodate all individuals seeking services. Furthermore, a lack of trained therapists in these settings means that many treatment seekers do not have access to empirically supported psychotherapeutic treatments such as cognitive behavioral therapy. "Beating the Blues" (BtB) is a computerized, internet-delivered, cognitive behavioral treatment for depression. BtB is highly scalable and might enable a larger proportion of individuals to receive cognitive behavioral therapy in a psychiatric setting while also reducing therapist time. Although computerized CBT interventions have proven effective in primary care settings, there is no research demonstrating the effectiveness of cCBT in secondary care settings in the United States. Thus the primary goal of the proposed research is to test the efficacy of BtB in a specialty care sample.
Patients presenting to these settings tend to have more severe and complex psychopathology than those presenting to primary care. Although BtB is likely effective, computerized treatments do carry a higher risk of dropout and non-response. Therefore, reliable and valid predictors of response are needed to determine who is most likely to respond to the treatment, versus who is likely to fail or drop out. Thus the second aim of the current proposal is to pilot an assessment procedure containing a number of potential predictors of cCBT response and investigate these predictors for inclusion in a larger validation study.
The current trial is a pilot study with a randomized waitlist control design with optional delayed treatment for individuals randomized to the waitlist condition. For the first phase, the investigators will enroll 90 treatment-seeking adults 18 or older recruited from a pool of individuals seeking outpatient psychiatric services at a hospital clinic. Sixty (n=60) individuals will be assigned immediate treatment group with BtB plus telephone and email support, and n=30 to the waitlist/delayed BtB plus telephone and email support group. Efficacy will be assessed over 8 weeks using the Hamilton Rating Scale for Depression (pre to post treatment) and the PHQ9 (measured at weeks 1-8). There will also be a 1-year follow-up survey with biweekly symptom assessments throughout the year for treatment responders (weeks 9-61). Potential predictors of outcome include demographics, CBT skills, personality measures, cognitive functioning, measures of attitudes and beliefs, social functioning, psychiatric comorbidity and depression illness characteristics, and psychophysiological measures. A second phase will enroll sixty individuals (n=60), who will be assigned immediate treatment group in order to validate the predictive model constructed during Phase 1.
- Conditions
- Major Depressive Disorder
- Being tested
- Beating the Blues
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beating the BluesBehavioural
Also called Beating the Blues (BtB)
The BtB program guides patients through a series of 8 fully automated online lessons intended to help them identify and change problematic patterns of thinking and behavior that maintain depression. Support will be provided by licensed professional therapists over the phone or via email.
| Study group | Role | What they receive |
|---|---|---|
| Beating the Blues | Experimental | Beating the Blues plus helper support. Receives: Behavioral: Beating the Blues |
| Waitlist Condition | No intervention | Eight week waitlist condition group parallel to the immediate treatment condition with optional entrance into the Beating the Blues after the first eight weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression (HRSD) from 0 to 8 weeks
The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.
Measured: week 0, week 8
Secondary outcomes (1)
Change in Patient Health Questionnaire-9 (PHQ9) over 8 weeks
The PHQ9 is a 9-item self-report measure based on the diagnostic criteria for major depression from the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: weeks 0-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start14 Apr 2014
- Primary completion3 May 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel R. Strunk, Ohio State University
- Investigators
- Daniel R Strunk, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990053
- Sponsor's protocol ID
- 2013B0307
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2013
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing Computerized Cognitive Behavioral Therapy for Depression
- ClinicalTrials.gov ID
- NCT01990053
- Acronym / sponsor ID
- 2013B0307
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- 3 May 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 21 Nov 2013 (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.
Standard treatments for depression in specialty care settings are effective but resources for delivering empirically supported psychotherapies are often limited. Computerized cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that might help expand services in psychiatric settings, however, little is known about its efficacy in this population. The present study aims to establish the efficacy of a internet-delivered cCBT program ("Beating the Blues") plus email and telephone support for depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an assessment procedure designed to identify moderators of treatment effectiveness.
Detailed description
Currently, outpatient psychiatric settings are plagued by long wait times and are often unable to accommodate all individuals seeking services. Furthermore, a lack of trained therapists in these settings means that many treatment seekers do not have access to empirically supported psychotherapeutic treatments such as cognitive behavioral therapy. "Beating the Blues" (BtB) is a computerized, internet-delivered, cognitive behavioral treatment for depression. BtB is highly scalable and might enable a larger proportion of individuals to receive cognitive behavioral therapy in a psychiatric setting while also reducing therapist time. Although computerized CBT interventions have proven effective in primary care settings, there is no research demonstrating the effectiveness of cCBT in secondary care settings in the United States. Thus the primary goal of the proposed research is to test the efficacy of BtB in a specialty care sample.
Patients presenting to these settings tend to have more severe and complex psychopathology than those presenting to primary care. Although BtB is likely effective, computerized treatments do carry a higher risk of dropout and non-response. Therefore, reliable and valid predictors of response are needed to determine who is most likely to respond to the treatment, versus who is likely to fail or drop out. Thus the second aim of the current proposal is to pilot an assessment procedure containing a number of potential predictors of cCBT response and investigate these predictors for inclusion in a larger validation study.
The current trial is a pilot study with a randomized waitlist control design with optional delayed treatment for individuals randomized to the waitlist condition. For the first phase, the investigators will enroll 90 treatment-seeking adults 18 or older recruited from a pool of individuals seeking outpatient psychiatric services at a hospital clinic. Sixty (n=60) individuals will be assigned immediate treatment group with BtB plus telephone and email support, and n=30 to the waitlist/delayed BtB plus telephone and email support group. Efficacy will be assessed over 8 weeks using the Hamilton Rating Scale for Depression (pre to post treatment) and the PHQ9 (measured at weeks 1-8). There will also be a 1-year follow-up survey with biweekly symptom assessments throughout the year for treatment responders (weeks 9-61). Potential predictors of outcome include demographics, CBT skills, personality measures, cognitive functioning, measures of attitudes and beliefs, social functioning, psychiatric comorbidity and depression illness characteristics, and psychophysiological measures. A second phase will enroll sixty individuals (n=60), who will be assigned immediate treatment group in order to validate the predictive model constructed during Phase 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beating the Blues | Experimental | Behavioral: Beating the BluesBeating the Blues plus helper support. |
| Waitlist Condition | No intervention | –Eight week waitlist condition group parallel to the immediate treatment condition with optional entrance into the Beating the Blues after the first eight weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Major Depressive Disorder (MDD) according to Diagnostic and Statistical Manual Fourth Edition criteria
- Able and willing to give informed consent
- Have access to a computer with an internet connection at home
Key exclusion criteria (10 listed)
- History of bipolar affective disorder or psychosis
- Current Axis I disorder other than MDD if it constitutes the predominate aspect of the clinical presentation and if it requires treatment other than that being offered
- History of substance dependence in the past six months
- Subnormal intellectual potential (IQ below 80)
- Clear indication of secondary gain (e.g., court ordered treatment or compensation issues)
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 |
|---|---|---|
| Beating the BluesAlso: Beating the Blues (BtB)The BtB program guides patients through a series of 8 fully automated online lessons intended to help them identify and change problematic patterns of thinking and behavior that maintain depression. Support will be provided by licensed professional therapists over the phone or via email. | Behavioural | Beating the Blues |
Primary outcome
Change in Hamilton Rating Scale for Depression (HRSD) from 0 to 8 weeks
Time frame: week 0, week 8
The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.
1 secondary outcome
Change in Patient Health Questionnaire-9 (PHQ9) over 8 weeks
Time frame: weeks 0-8
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 24 Mar 2023.
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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.
Daniel R Strunk, PhD principal investigator
Ohio State 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 Beating the Blues in people with Major Depressive Disorder, run by Ohio State 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 3 inclusion and 10 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 24 Mar 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?
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?
Change in Hamilton Rating Scale for Depression (HRSD) from 0 to 8 weeks (time frame: week 0, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.