DepressionPhase 1/2NCT00073359
Effects of Therapist Behavior on the Treatment of Depressed Adolescents
A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Depression and Depressive Disorder, run by University of Denver at 1 site in United States.
Trial summary
The purpose of this study is to identify and evaluate therapist behaviors that affect how well and how long adolescent patients stay in treatment for depression. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression, Depressive Disorder, Dysthymic Disorder
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Nov 2005
- Phase
- Phase 1/2
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Major depression or dysthymic disorder
- Referred by school
Who cannot join
- Comorbid psychosis, bipolar disorder, or mental retardation
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Public Schools Health Clinics
Denver, Colorado, 80208
About this study
Official title: Engagement and Alliance in CBT for Depressed Adolescents
The purpose of this study is to identify and evaluate therapist behaviors that affect how well and how long adolescent patients stay in treatment for depression.
Read the detailed description
Early patient drop out, sporadic attendance, and minimal participation have hindered the development and administration of effective treatments for adolescent depression. Adolescents who do not receive adequate exposure to active treatment are unlikely to benefit from experimentally supported treatments. Certain therapist behaviors may influence the attendance, drop-out, and overall participation of adolescents with depression. This study will evaluate the effect of engagement interventions and alliance on attendance, participation, completion, and outcome in depressed adolescents.
Participants in this study will have 12 weekly sessions of cognitive behavioral therapy (CBT) at a school-based health clinic. Audio recordings from the completed CBT sessions will be replayed and evaluated to identify therapist engagement interventions, therapy alliance, and treatment participation.
- Conditions
- Depression, Depressive Disorder, Dysthymic Disorder
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Adolescent
- Medical subject headings
- Depression, Depressive Disorder, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2003 (estimated)
- Study startFeb 2003
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073359
- Sponsor's protocol ID
- R21MH065988
- Other IDs
- R21MH065988, DSIR CT-S
- Status last verified
- Apr 2019
- First submitted
- 19 Nov 2003
- Last updated
- 19 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement and Alliance in CBT for Depressed Adolescents
- ClinicalTrials.gov ID
- NCT00073359
- Acronym / sponsor ID
- R21MH065988
- Conditions
- Depression, Depressive Disorder, Dysthymic Disorder
- Keywords
- Adolescent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 21 Nov 2003 (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 identify and evaluate therapist behaviors that affect how well and how long adolescent patients stay in treatment for depression.
Detailed description
Early patient drop out, sporadic attendance, and minimal participation have hindered the development and administration of effective treatments for adolescent depression. Adolescents who do not receive adequate exposure to active treatment are unlikely to benefit from experimentally supported treatments. Certain therapist behaviors may influence the attendance, drop-out, and overall participation of adolescents with depression. This study will evaluate the effect of engagement interventions and alliance on attendance, participation, completion, and outcome in depressed adolescents.
Participants in this study will have 12 weekly sessions of cognitive behavioral therapy (CBT) at a school-based health clinic. Audio recordings from the completed CBT sessions will be replayed and evaluated to identify therapist engagement interventions, therapy alliance, and treatment participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Major depression or dysthymic disorder
- Referred by school
Key exclusion criteria (1 listed)
- Comorbid psychosis, bipolar disorder, or mental retardation
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 |
|---|---|---|
| Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 19 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Depression and Depressive Disorder, run by University of Denver 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 2 inclusion and 1 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 19 Apr 2019. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 19 Apr 2019.