DepressionNCT02115737
Group Treatment for Adolescents With Depression
A study testing Dialectical Behavior Therapy Skills Group and Psychoeducation group treatment in people with Depression, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Youth with depressive symptoms are at risk for a range of problems later in life. This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Depression
- What is being tested?
- Dialectical Behavior Therapy Skills Group and Psychoeducation group treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Nov 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking
- male or female, ages 14 to 19, all races and ethnicities
- Current depression as assessed by an ALIFE - PSR score equal to or greater than 4
- Has a treating psychiatrist at Sunnybrook Health Sciences Centre
Who cannot join
- Current manic episode
- current psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Youth with depressive symptoms are at risk for a range of problems later in life. This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders. The main purpose of this study is to test how effective two types of group therapy are at reducing depressive symptoms in youth. A focus on group therapy is important because group therapy allows for many youth to be treated in a short amount of time. Group therapy is also helpful because youth can get social support and feel less alone in their symptoms when they participate in group. This study compares two groups, one that targets skills for managing difficult emotional experiences (dialectical behavior therapy skills group) and another group focuses on psychoeducation and is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh. The results of this study will provide insights regarding the comparative efficacy of these two treatments, and regarding predictors of treatment response.
- Conditions
- Depression
- Being tested
- Dialectical Behavior Therapy Skills Group, Psychoeducation group treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy Skills GroupBehavioural
Psychoeducation group treatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy Skills Group | Experimental | Twelve week skills based group therapy include four modules: mindfulness, emotion regulation, distress tolerance, and walking the middle path Receives: Behavioral: Dialectical Behavior Therapy Skills Group |
| Psychoeducation group treatment | Experimental | The comparison group used in the present study is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh Receives: Behavioral: Psychoeducation group treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Rating Scale - Revise (CDRS-R)
Measure mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score
Measured: Change from baseline to endpoint (assessed at weeks 0, 12, 24)
The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE)
Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.
Measured: Change from baseline to endpoint (assessed at weeks 0, 12 and 24)
Secondary outcomes (5)
The Adverse Childhood Experiences
Used to measure adverse events that have happened up until the 18th year of life
Measured: Assessed at baseline
The Children's Affective Lability Scale
Used to ascertain adolescent and parent reported affect regulation, during the preceding year or time since last assessment
Measured: Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)
The Stressful Life Events Schedule
Used to ascertain 80 adolescent and parent reported negative life events, during the preceding year or time since last assessment
Measured: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
The DBT Ways of Coping Checklist
This is a self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
Measured: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
The Life Problems Inventory
This is a self-reported questionnaire (adolescent-reported) used to assess emotion dysregulation in the adolescent.
Measured: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Insufficient recruitment
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.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre
- Investigators
- Benjamin I Goldstein, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115737
- Sponsor's protocol ID
- 213-2012
- Status last verified
- Nov 2015
- First submitted
- 14 Apr 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Treatment for Adolescents With Depression
- ClinicalTrials.gov ID
- NCT02115737
- Acronym / sponsor ID
- 213-2012
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Apr 2014 (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.
Youth with depressive symptoms are at risk for a range of problems later in life. This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders. The main purpose of this study is to test how effective two types of group therapy are at reducing depressive symptoms in youth. A focus on group therapy is important because group therapy allows for many youth to be treated in a short amount of time. Group therapy is also helpful because youth can get social support and feel less alone in their symptoms when they participate in group. This study compares two groups, one that targets skills for managing difficult emotional experiences (dialectical behavior therapy skills group) and another group focuses on psychoeducation and is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh. The results of this study will provide insights regarding the comparative efficacy of these two treatments, and regarding predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy Skills Group | Experimental | Behavioral: Dialectical Behavior Therapy Skills GroupTwelve week skills based group therapy include four modules: mindfulness, emotion regulation, distress tolerance, and walking the middle path |
| Psychoeducation group treatment | Experimental | Behavioral: Psychoeducation group treatmentThe comparison group used in the present study is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- English speaking
- male or female, ages 14 to 19, all races and ethnicities
- Current depression as assessed by an ALIFE - PSR score equal to or greater than 4
- Has a treating psychiatrist at Sunnybrook Health Sciences Centre
Key exclusion criteria (2 listed)
- Current manic episode
- current psychosis
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 |
|---|---|---|
| Dialectical Behavior Therapy Skills Group | Behavioural | Dialectical Behavior Therapy Skills Group |
| Psychoeducation group treatment | Behavioural | Psychoeducation group treatment |
Primary outcome
Children's Depression Rating Scale - Revise (CDRS-R)
Time frame: Change from baseline to endpoint (assessed at weeks 0, 12, 24)
Measure mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score
The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE)
Time frame: Change from baseline to endpoint (assessed at weeks 0, 12 and 24)
Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.
5 secondary outcomes
The Adverse Childhood Experiences
Time frame: Assessed at baseline
The Children's Affective Lability Scale
Time frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)
The Stressful Life Events Schedule
Time frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
The DBT Ways of Coping Checklist
Time frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
The Life Problems Inventory
Time frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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.
Benjamin I Goldstein, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy Skills Group and Psychoeducation group treatment in people with Depression, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 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: stopped early, as of the sponsor's last update on 17 Nov 2015. 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 Canada. 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 was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
Children's Depression Rating Scale - Revise (CDRS-R) (time frame: Change from baseline to endpoint (assessed at weeks 0, 12, 24)). The study lists 2 primary outcomes in all. 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 17 Nov 2015.