DepressionNCT00381979
Supportive Expressive Therapy for Depressed and Anxious Adolescents
A study testing Supportive Expressive Therapy in people with Depression and Anxiety, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of the study is to investigate the effectiveness of providing Supportive Expressive Therapy to adolescents who are depressed and/or anxious. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Supportive Expressive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Oct 2007
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-24 year old, male \& female adolescents, primary diagnosis of depression or anxiety disorder.
- Clients with co-morbid diagnoses, suicidal ideation or taking medication would not necessarily be excluded if deemed able to partake in the proposed therapy.
- Medication dose needs to be stable for 4-6 weeks prior to starting therapy.
Who cannot join
- Clients who are actively psychotic, developmentally delayed, or have a diagnosis of bipolar disorder.
- Clients who are not fluent in English.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the effectiveness of providing Supportive Expressive Therapy to adolescents who are depressed and/or anxious.
Read the detailed description
Supportive Expressive Therapy (SET; a 16 session manualized form of psychodynamic therapy) has been well utilized with adult clients. To date, there is no known systematic study into the benefit of this method of therapy with adolescents who are depressed and/or anxious. It is thought that SET would be useful for this population as it is similar in principle to Interpersonal Relationship Therapy (IPT), which has been shown to be effective for use with depressed adults and youth. Both IPT and SET help clients explore the role they play within challenging relationships in their lives. SET, however, allows for the exploration of more relationships within the adolescents' circle. Moreover, SET explores the adolescents' perceptions of themselves, others, and their wish in relationships. Further, the SET method is more easily individualized in that it affords greater flexibility in design and possibility for change over time. Accordingly, the purpose of this study is to explore the feasibility of utilizing this method of therapy with adolescents who are depressed and anxious. We will be exploring the effectiveness of SET through the resolution of depressed and/or anxious adolescents' conflictual relationships thereby reducing their symptomatology.
- Conditions
- Depression, Anxiety
- Being tested
- Supportive Expressive Therapy
- Keywords
- Depression, Anxiety, Adolescents, Treatment, Supportive Expressive Therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Expressive TherapyOther
Also called therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | set Receives: Other: Supportive Expressive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDI
Measured: pre and post
MASC
Measured: pre and post
Measures collected at pre, post, and follow-up
Measured: pre and post
Secondary outcomes (6)
YSR
Measured: pre and post
CBCL
Measured: pre and post
FAM
Measured: pre and post
CRI
Measured: pre and post
SSRS
Measured: pre and post
Measures collected at pre, post, and follow-up
Measured: pre and post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startJan 2004
- Primary completionOct 2007
- Study completionOct 2007
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 Centre for Addiction and Mental HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Wilansky-Traynor, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381979
- Sponsor's protocol ID
- 169/2003
- Status last verified
- Sep 2015
- First submitted
- 26 Sep 2006
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Expressive Therapy for Depressed and Anxious Adolescents
- ClinicalTrials.gov ID
- NCT00381979
- Acronym / sponsor ID
- 169/2003
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Adolescents, Treatment, Supportive Expressive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Sep 2006 (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 the study is to investigate the effectiveness of providing Supportive Expressive Therapy to adolescents who are depressed and/or anxious.
Detailed description
Supportive Expressive Therapy (SET; a 16 session manualized form of psychodynamic therapy) has been well utilized with adult clients. To date, there is no known systematic study into the benefit of this method of therapy with adolescents who are depressed and/or anxious. It is thought that SET would be useful for this population as it is similar in principle to Interpersonal Relationship Therapy (IPT), which has been shown to be effective for use with depressed adults and youth. Both IPT and SET help clients explore the role they play within challenging relationships in their lives. SET, however, allows for the exploration of more relationships within the adolescents' circle. Moreover, SET explores the adolescents' perceptions of themselves, others, and their wish in relationships. Further, the SET method is more easily individualized in that it affords greater flexibility in design and possibility for change over time. Accordingly, the purpose of this study is to explore the feasibility of utilizing this method of therapy with adolescents who are depressed and anxious. We will be exploring the effectiveness of SET through the resolution of depressed and/or anxious adolescents' conflictual relationships thereby reducing their symptomatology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Supportive Expressive Therapyset |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 15-24 year old, male \& female adolescents, primary diagnosis of depression or anxiety disorder.
- Clients with co-morbid diagnoses, suicidal ideation or taking medication would not necessarily be excluded if deemed able to partake in the proposed therapy.
- Medication dose needs to be stable for 4-6 weeks prior to starting therapy.
Key exclusion criteria (2 listed)
- Clients who are actively psychotic, developmentally delayed, or have a diagnosis of bipolar disorder.
- Clients who are not fluent in English.
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 |
|---|---|---|
| Supportive Expressive TherapyAlso: therapy | Other | 1 |
Primary outcome
BDI
Time frame: pre and post
MASC
Time frame: pre and post
Measures collected at pre, post, and follow-up
Time frame: pre and post
6 secondary outcomes
YSR
Time frame: pre and post
CBCL
Time frame: pre and post
FAM
Time frame: pre and post
CRI
Time frame: pre and post
SSRS
Time frame: pre and post
Measures collected at pre, post, and follow-up
Time frame: pre and post
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 22 Oct 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.
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 study testing Supportive Expressive Therapy in people with Depression and Anxiety, run by Centre for Addiction and Mental Health 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 3 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: finished, as of the sponsor's last update on 22 Oct 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 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?
BDI (time frame: pre and post). The study lists 3 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 22 Oct 2015.