Major Depressive DisorderiTADNCT01582581
Study of Technology-assisted Treatment of Adolescent Depression
A study testing Telephonic CBT in people with Major Depressive Disorder, run by iHope Network, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate a computer-guided, telephone-based therapy for adolescent depression, delivered in a pediatric primary setting in the community. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Telephonic CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Dec 2014
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Major Depressive Disorder
- Age 12-17 years, inclusive, at time of first study visit
- Ability to receive care as an outpatient
- Ability to participate in at least 1 session by phone per week for approximately 12 weeks
- Ability to participate in at least 1 session by phone per week for approximately 12-16 weeks
- Ability to speak English fluently and to provide written and/or verbal feedback on the instrument and the process.
- Pediatrician impression of normal IQ for developmental level
Who cannot join
- Current or past diagnosis of: bipolar disorder, severe conduct disorder, pervasive developmental disorders, of thought disorder
- Current treatment with Cognitive Behavioral Therapy (CBT)
- Confounding medical condition (such as pregnancy, Lyme disease, etc.)
- Non-English speaking patient or parent/guardian
- No access to phones
- Dangerousness to self or others if they have been hospitalized for dangerousness within three months of consent
Show all 9Show fewer
- Deemed to be "high risk" because of a suicide attempt requiring medical attention within 6 months of consent or clear intent or an active plan to commit suicide
- History of self-harm, suicidal attempts, or suicidal ideation
- Specialty care for substance abuse (i.e. without participation of primary care providers)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030
Woburn Pediatric Associates
Woburn, Massachusetts, 01801
About this study
Official title: Information Technology Enabled Treatment of Adolescent Depression
The purpose of this study is to evaluate a computer-guided, telephone-based therapy for adolescent depression, delivered in a pediatric primary setting in the community.
Read the detailed description
This Phase II SBIR project represents the continuing development of an Information Technology Enabled Disease Management System for Treatment of Adolescent Depression (iTAD) following a highly successful Phase I award in which all Specific Aims were met. The need for this system innovation arises from the substantial costs that inadequately treated adolescent Major Depressive Disorder (MDD) has on the course of adolescent development and society as a whole. Effective treatments involving the combined use of a Selective Serotonin Reuptake Inhibitor (SSRI) and the administration of Cognitive Behavioral Therapy (CBT) is considered the "modal treatment" for adolescent MM. Yet, multiple barriers interfere with the implementation and dissemination of this "gold standard' of care. These barriers include: under recognition of depressive symptoms by parents and pediatricians, inability to assess adolescent depression accurately and reliably in primary care settings, safety concerns related to pharmacologic treatment, monitoring of symptom changes and adverse treatment effects, such as irritability and suicidal behavior, treatment non-compliance, lack of access to an integrated medical and treatment history; and an alarming shortage of properly trained child and adolescent psychiatrists capable of implementing optimal treatment safely, reliably, and effectively.
In this current project, the investigators are making tailored forms of CBT broadly and easily accessible to the community, using the iTAD (previously "ITEMS-TAD") which is intended to address these problems. Development of the system has continued and we have modified the existing prototype that was created with funding from federal sources (Phase 1). The technological infrastructure of the prototype includes a Computer Assisted Telephone Interview (CATI) platform, a database consisting of patients' real time medical and treatment history, and an underlying set of intelligent algorithms that tailors the intensity of the treatment resources and approaches administered in individual cases, with a special focus on identifying those enrolled adolescents needing more intensive or urgent care. When interacting with patients over the telephone, primary care nurses use the CATI to facilitate the reliable assessment of patient status and administer manualized, empirically informed interventions. The programming for the platform that delivers this intervention is complete and the debugging and refinement underway. The content for the remaining iTAD program has been developed and is being programmed. A Rapid Iterative Evaluation \& Testing (RITE) study was undertaken to refine the content of the application and assess the usability of the technology involved in its delivery; A field trial is underway to evaluate empirically indicators of efficacy and patient acceptance related to the ITEMS-TAD approach. The clinical trial of iTAD will begin in early April 2012. The investigators are currently enrolling depressed adolescents who will begin the trial shortly.
- Conditions
- Major Depressive Disorder
- Being tested
- Telephonic CBT, Wait List Control
- Keywords
- mental health, depression, behavioral health, cognitive behavioral therapy, CBT, computer-assisted psychotherapy
- Medical subject headings
- Depressive Disorder, Major, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic CBTBehavioural
Also called iTAD, ITEMS-TAD, Computer-guided CBT, TAD
Cognitive behavioral therapy, guided by computer, using the TAD protocol for treatment of Adolescent Depression, modified for delivery by a nurse or master's level clinician over the telephone in 15-18 sessions lasting 30-45 minutes at weekly intervals. Includes regular and standardized weekly monitoring by the treating clinician of depressive symptoms and factors affecting suicide risk.
Wait List ControlBehavioural
Wait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5.
| Study group | Role | What they receive |
|---|---|---|
| Telephonic CBT | Active comparator | Computer guided, cognitive behavioral therapy (CBT) delivered by a clinician-administered telephone intervention. Receives: Behavioral: Telephonic CBT |
| Wait List Control | Sham comparator | Randomized wait list control with measurement of study outcomes at week 0, 3 and 5 after the initiation of waiting. Receives: Behavioral: Wait List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder.
The measure used is the PHQ-9 (Kroenke, et al.), a standard and validated measure for use in screening for or monitoring adolescent depression. Teens that score positively on Item #9 (a self-harm risk item), will be further evaluated by the clinician using two interactive and validated methods for standardized assessment of suicide risk: a brief version of the Beck Hopelessness scale and the C-CASA (Columbia University). Teens needing referral to a behavioral health specialist will be referred by the nurse and/or the pediatrician for further evaluation and treatment.
Measured: 12 weeks
Secondary outcomes (5)
Evidence of program efficacy as indicate by changes in subjects' knowledge of depression.
A Depression Knowledge Test (DKT) will be used to assess changes in the level of knowledge teens have about depression and its treatment. The DKT consists of 10 open response questions based on materials from the TADS Adolescent Workbook. Sample questions include "We know there are four main causes of depression. List as many as you can," and "There are some learned patterns that people need to change to overcome depression. List as many patterns as you can."
Measured: 12 weeks
Evidence of program efficacy as indicated by development of self-efficacy skills.
A Skill Self-Efficacy Questionnaire (SSEQ) will be used to assess changes in the level of self-confidence teens have in their ability to use the cognitive behavioral skills taught in the demo program. Using the same assessment schedule as the DKT, teens will be asked to rate self-confidence in their ability to "set goals," "achieve goals," "know what they are feeling," "know how intensely they feel something," and "know what causes their feelings."
Measured: 12 weeks
Evidence of program efficacy as indicated by the establishment of therapeutic alliance.
Therapeutic alliance between adolescents and nurse managers will be measured by the Therapeutic Alliance Scale for Adolescents (TASA; Shrink et al., 2008. The TASA is explicitly designed to measure the strength of the therapeutic alliance among teens participating in CBT treatments. A maximum score is 6.0 based on a Likert scale from one to six. The list of items for this measure of therapeutic alliance indicates very high bonding between counselors and patients.
Measured: 12weeks
Evidence of program efficacy as indicated by fidelity and treatment quality.
The Cognitive Therapy Scale (CTR) will be used as a measure of treatment quality and fidelity of the calls by and interactions of the study nurses with the teens. The CTR has been considered a standard measure of competence in cognitive therapy for more than 20 years,(Young JE 1980; Dobson, Shaw et al. 1985; Vallis, Shaw et al. 1986). Recorded sessions will be rated on the scale by certified raters from the American Academy of Cognitive Therapy (ACT).
Measured: 12 weeks
Evidence of program efficacy as indicated by program acceptance.
An acceptance questionnaire will be administered to teens to determine their overall perception and acceptance of the program. The questionnaire contains 9 questions, asking the subject to rate the usefulness of the program; comment on its quality, and suggest areas for improvement. The acceptance questionnaire uses a 7-point Likert scale for rating purposes ranging from (1 = not at all to 7 = extremely). It also includes three open-ended questions to capture what teens like the best or the least about the program, and their suggestions for improving the program.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- iHope Network, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Woburn Pediatric Associates, UConn Health
- Responsible party
- Sponsor
- Investigators
- Steven E Locke, MD, Principal investigator, iHope Network, Inc.Thomas J. McLaughlin, ScD, Principal investigator, iHope Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582581
- Sponsor's protocol ID
- VHS 85350-02
- Acronym
- iTAD
- Status last verified
- Apr 2015
- First submitted
- 19 Apr 2012
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Technology Enabled Treatment of Adolescent Depression
- ClinicalTrials.gov ID
- NCT01582581
- Acronym / sponsor ID
- iTAD / VHS 85350-02
- Conditions
- Major Depressive Disorder
- Keywords
- mental health, depression, behavioral health, cognitive behavioral therapy, CBT, computer-assisted psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- iHope Network, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Woburn Pediatric Associates, UConn Health
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Apr 2012 (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.
The purpose of this study is to evaluate a computer-guided, telephone-based therapy for adolescent depression, delivered in a pediatric primary setting in the community.
Detailed description
This Phase II SBIR project represents the continuing development of an Information Technology Enabled Disease Management System for Treatment of Adolescent Depression (iTAD) following a highly successful Phase I award in which all Specific Aims were met. The need for this system innovation arises from the substantial costs that inadequately treated adolescent Major Depressive Disorder (MDD) has on the course of adolescent development and society as a whole. Effective treatments involving the combined use of a Selective Serotonin Reuptake Inhibitor (SSRI) and the administration of Cognitive Behavioral Therapy (CBT) is considered the "modal treatment" for adolescent MM. Yet, multiple barriers interfere with the implementation and dissemination of this "gold standard' of care. These barriers include: under recognition of depressive symptoms by parents and pediatricians, inability to assess adolescent depression accurately and reliably in primary care settings, safety concerns related to pharmacologic treatment, monitoring of symptom changes and adverse treatment effects, such as irritability and suicidal behavior, treatment non-compliance, lack of access to an integrated medical and treatment history; and an alarming shortage of properly trained child and adolescent psychiatrists capable of implementing optimal treatment safely, reliably, and effectively.
In this current project, the investigators are making tailored forms of CBT broadly and easily accessible to the community, using the iTAD (previously "ITEMS-TAD") which is intended to address these problems. Development of the system has continued and we have modified the existing prototype that was created with funding from federal sources (Phase 1). The technological infrastructure of the prototype includes a Computer Assisted Telephone Interview (CATI) platform, a database consisting of patients' real time medical and treatment history, and an underlying set of intelligent algorithms that tailors the intensity of the treatment resources and approaches administered in individual cases, with a special focus on identifying those enrolled adolescents needing more intensive or urgent care. When interacting with patients over the telephone, primary care nurses use the CATI to facilitate the reliable assessment of patient status and administer manualized, empirically informed interventions. The programming for the platform that delivers this intervention is complete and the debugging and refinement underway. The content for the remaining iTAD program has been developed and is being programmed. A Rapid Iterative Evaluation \& Testing (RITE) study was undertaken to refine the content of the application and assess the usability of the technology involved in its delivery; A field trial is underway to evaluate empirically indicators of efficacy and patient acceptance related to the ITEMS-TAD approach. The clinical trial of iTAD will begin in early April 2012. The investigators are currently enrolling depressed adolescents who will begin the trial shortly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephonic CBT | Active comparator | Behavioral: Telephonic CBTComputer guided, cognitive behavioral therapy (CBT) delivered by a clinician-administered telephone intervention. |
| Wait List Control | Sham comparator | Behavioral: Wait List ControlRandomized wait list control with measurement of study outcomes at week 0, 3 and 5 after the initiation of waiting. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of Major Depressive Disorder
- Age 12-17 years, inclusive, at time of first study visit
- Ability to receive care as an outpatient
- Ability to participate in at least 1 session by phone per week for approximately 12 weeks
- Ability to participate in at least 1 session by phone per week for approximately 12-16 weeks
Key exclusion criteria (9 listed)
- Current or past diagnosis of: bipolar disorder, severe conduct disorder, pervasive developmental disorders, of thought disorder
- Current treatment with Cognitive Behavioral Therapy (CBT)
- Confounding medical condition (such as pregnancy, Lyme disease, etc.)
- Non-English speaking patient or parent/guardian
- No access to phones
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 |
|---|---|---|
| Telephonic CBTAlso: iTAD, ITEMS-TAD, Computer-guided CBT, TADCognitive behavioral therapy, guided by computer, using the TAD protocol for treatment of Adolescent Depression, modified for delivery by a nurse or master's level clinician over the telephone in 15-18 sessions lasting 30-45 minutes at weekly intervals. Includes regular and standardized weekly monitoring by the treating clinician of depressive symptoms and factors affecting suicide risk. | Behavioural | Telephonic CBT |
| Wait List ControlWait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5. | Behavioural | Wait List Control |
Primary outcome
Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder.
Time frame: 12 weeks
The measure used is the PHQ-9 (Kroenke, et al.), a standard and validated measure for use in screening for or monitoring adolescent depression. Teens that score positively on Item #9 (a self-harm risk item), will be further evaluated by the clinician using two interactive and validated methods for standardized assessment of suicide risk: a brief version of the Beck Hopelessness scale and the C-CASA (Columbia University). Teens needing referral to a behavioral health specialist will be referred by the nurse and/or the pediatrician for further evaluation and treatment.
5 secondary outcomes
Evidence of program efficacy as indicate by changes in subjects' knowledge of depression.
Time frame: 12 weeks
Evidence of program efficacy as indicated by development of self-efficacy skills.
Time frame: 12 weeks
Evidence of program efficacy as indicated by the establishment of therapeutic alliance.
Time frame: 12weeks
Evidence of program efficacy as indicated by fidelity and treatment quality.
Time frame: 12 weeks
Evidence of program efficacy as indicated by program acceptance.
Time frame: 12 weeks
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 30 Apr 2015.
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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.
Steven E Locke, MD principal investigator
iHope Network, Inc.
Thomas J. McLaughlin, ScD principal investigator
iHope Network, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephonic CBT in people with Major Depressive Disorder, run by iHope Network, Inc. at 2 sites 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 7 inclusion and 9 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder. (time frame: 12 weeks). 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 30 Apr 2015.