Major Depressive DisorderNCT00919932
Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework
A study testing Paper and pen homework and Text message system homework. in people with Major Depressive Disorder and Cognitive Behavior Therapy, run by University of Pittsburgh.
Trial summary
The primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (CBT) for major depressive disorder. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Major Depressive Disorder, Cognitive Behavior Therapy, Text Messaging
- What is being tested?
- Paper and pen homework and Text message system homework.
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jan 2010
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- major depressive disorder
- own a cellular phone with text messaging capabilities
Who cannot join
- history of psychosis
- history of mental retardation
- active suicidal ideation or intent
About this study
Official title: Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework.
The primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (CBT) for major depressive disorder.
Read the detailed description
Adolescent major depressive disorder leads to recurrent episodes, increased rates of attempted and completed suicides, and persistent social impairment between episodes (Weissman et al 1999). Cognitive behavioral therapy (CBT) is an accepted first-line therapy for mild-moderate depression in adolescents. Integral to CBT is "homework" as it enhances mastery of newly learned coping strategies, facilitates generalization of skills to novel situations, increases self-efficacy, and ultimately reduces vulnerability to relapse (Detweiler et al 1999). Adherence to homework is a recognized problem in adults, and is similarly problematic in adolescents. One method of implementing CBT homework in a manner that is centric to current youth culture is through text messaging. By using a modern modality that many adolescents rely on for daily communication, there is the likelihood that they will find it more engaging than traditional modalities. Thus the potential that a text message system can help improve homework compliance in adolescents is significant, because improved homework adherence may ultimately be linked to improved clinical outcomes for these disorders with high rates of chronic morbidity and mortality.
- Being tested
- Paper and pen homework, Text message system homework.
- Keywords
- Depression, CBT, Texting, SMS
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper and pen homeworkBehavioural
Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks.
Text message system homework.Device
Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Paper and pen homework | Active comparator | Treatment as usual: therapy homework is completed by paper and pen. Receives: Behavioral: Paper and pen homework |
| Text-message homework | Experimental | Experimental treatment: therapy homework is completed by text messaging. Receives: Device: Text message system homework. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy Homework Compliance: Percent Homework Completed
Number of thought logs completed over the course of the 4 week trial.
Measured: 1 month
Secondary outcomes (1)
Exit Interview
Verbal interview
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
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.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Responsible party
- Principal investigator, Han-chun Liang, University of Pittsburgh
- Investigators
- Han-chun Liang, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919932
- Sponsor's protocol ID
- ACA-08-001-UPMC
- Status last verified
- Jan 2016
- First submitted
- 11 Jun 2009
- Last updated
- 15 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework.
- ClinicalTrials.gov ID
- NCT00919932
- Acronym / sponsor ID
- ACA-08-001-UPMC
- Keywords
- Depression, CBT, Texting, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (CBT) for major depressive disorder.
Detailed description
Adolescent major depressive disorder leads to recurrent episodes, increased rates of attempted and completed suicides, and persistent social impairment between episodes (Weissman et al 1999). Cognitive behavioral therapy (CBT) is an accepted first-line therapy for mild-moderate depression in adolescents. Integral to CBT is "homework" as it enhances mastery of newly learned coping strategies, facilitates generalization of skills to novel situations, increases self-efficacy, and ultimately reduces vulnerability to relapse (Detweiler et al 1999). Adherence to homework is a recognized problem in adults, and is similarly problematic in adolescents. One method of implementing CBT homework in a manner that is centric to current youth culture is through text messaging. By using a modern modality that many adolescents rely on for daily communication, there is the likelihood that they will find it more engaging than traditional modalities. Thus the potential that a text message system can help improve homework compliance in adolescents is significant, because improved homework adherence may ultimately be linked to improved clinical outcomes for these disorders with high rates of chronic morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper and pen homework | Active comparator | Behavioral: Paper and pen homeworkTreatment as usual: therapy homework is completed by paper and pen. |
| Text-message homework | Experimental | Device: Text message system homework.Experimental treatment: therapy homework is completed by text messaging. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- major depressive disorder
- own a cellular phone with text messaging capabilities
Key exclusion criteria (3 listed)
- history of psychosis
- history of mental retardation
- active suicidal ideation or intent
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 |
|---|---|---|
| Paper and pen homeworkHomework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks. | Behavioural | Paper and pen homework |
| Text message system homework.Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks. | Device | Text-message homework |
Primary outcome
Therapy Homework Compliance: Percent Homework Completed
Time frame: 1 month
Number of thought logs completed over the course of the 4 week trial.
1 secondary outcome
Exit Interview
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Han-chun Liang, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Paper and pen homework and Text message system homework. in people with Major Depressive Disorder and Cognitive Behavior Therapy, run by University of Pittsburgh.
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 2 inclusion and 3 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 15 Feb 2016). 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?
Therapy Homework Compliance: Percent Homework Completed (time frame: 1 month). 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 15 Feb 2016; AzTrials last refreshed its copy on 31 Oct 2026.