Depressive SymptomsNCT04111887
Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs
A study testing Group-based therapy in people with Depressive Symptoms, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Group-based therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 13 Dec 2018
- 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 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current student at the University of Oregon
- subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater
Who cannot join
- current diagnosis of major depression
- acute suicidal ideation requiring immediate mental health treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Depression Prevention Programs: A Pilot Trial
The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.
- Conditions
- Depressive Symptoms
- Being tested
- Group-based therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based therapyBehavioural
College students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Change Ahead | Experimental | Each of the 6 weekly 1-hour sessions begins with a voluntary commitment to actively participate and to try something new in the upcoming week; includes a section devoted to selecting and publicly committing to one change focused on reducing negative/increasing positive cognitions and one change focused on increasing pleasant activities; and ends with home practice assignments. Additional exercises designed to increase dissonance induction include (a) group discussions for changing conditions, (b) roleplays to generate quick comebacks to written negative thoughts provided by other group members, (c) in-session writing exercises on the benefits of doing fun activities, (d) discussion of methods for creating internal and external accountability for positive change, (e) home practice assignment of engaging in actions to help someone else' mood, (f) writing a letter to my future self about positive intentions, and (g) providing positive feedback to other group members at the last session. Receives: Behavioral: Group-based therapy |
| Blues Program | Active comparator | The 6 weekly 1-hour sessions begin with a review of concepts and (after Session 1) review of past home practice assignments; all sessions conclude with home practice assignments. Each session has a portion devoted to thought identification/recording and cognitive restructuring and a portion devoted to increased involvement in pleasant activities. We use motivational enhancement exercises to maximize willingness to use the new skills, behavioral techniques to reinforce use of the new skills, and group activities to foster feelings of group cohesion. Receives: Behavioral: Group-based therapy |
| Brochure control | Placebo comparator | NIMH brochure that describes major depression and recommends treatment for depressed youth ("Let's Talk About Depression" NIH Pub. 01-4162), as well as information about local treatment options. Receives: Behavioral: Group-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months
Evaluate change (if any) by using the Kiddie Schedule for Affective Disorders and Schizophrenia at the 6 week, 3 month and 6 month marks.
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Difference in attendance in Change Ahead vs Blues Program groups using group leader notes
Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes.
Measured: Measured at each group therapy session (6 weeks in total).
Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia
Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months.
Measured: Measured at baseline, 6 weeks, 3 months and 6 months.
Secondary outcomes (12)
Activity level
Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).
Measured: Measured at baseline, weeks 2,4 and 6.
Emotions
Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).
Measured: Measured at baseline, weeks 2,4 and 6.
Positive and negative thoughts
Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).
Measured: Measured at baseline, weeks 2,4 and 6.
Assessments using writing samples
Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future.
Measured: Measured at baseline and 6 weeks
Depression and anxiety symptoms using the PHQ-9
Evaluate difference (if any) in self-reported depression and anxiety symptoms
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Depression and anxiety symptoms using the GAD-7
Evaluate difference (if any) in self-reported depression and anxiety symptoms
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Social adjustment in school, work, peer, spare time, and family domains
Evaluate difference (if any) in self-reported social adjustment using 17 items adapted from Social Adjustment Scale-Self Report for Youth (Weissman, Orvaschel, \& Padian, 1980)
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Negative life events
Evaluate difference (if any) in self-reported negative life events
Measured: Measured at baseline
Health care utilization
Evaluate difference (if any) in self-reported utilization of health care services for physical health problems/injuries, mental health problems, and other personal problems.
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Negative automatic thoughts
Evaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon \& Kendall, 1980)
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Negative attributional style
Evaluate difference (if any) in self-reported negative attributional style
Measured: Measured at baseline, 6 weeks, 3 months and 6 months
Substance use
Evaluate difference (in any) in self-reported substance use using 10 items from Stice, Barrera and Chassin (1998). Participants report the frequency of intake of beer/wine/wine coolers and hard liquor, frequency of heavy drinking (5 or more drinks in a row), frequency of times drunk, and frequency of marijuana, stimulants, downers, inhalants, and hallucinogen use.
Measured: Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start10 Oct 2017
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111887
- Sponsor's protocol ID
- Change Ahead
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Prevention Programs: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04111887
- Acronym / sponsor ID
- Change Ahead
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 1 Oct 2019 (actual)
- 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 compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Change Ahead | Experimental | Behavioral: Group-based therapyEach of the 6 weekly 1-hour sessions begins with a voluntary commitment to actively participate and to try something new in the upcoming week; includes a section devoted to selecting and publicly committing to one change focused on reducing negative/increasing positive cognitions and one change focused on increasing pleasant activities; and ends with home practice assignments. Additional exercises designed to increase dissonance induction include (a) group discussions for changing conditions, (b) roleplays to generate quick comebacks to written negative thoughts provided by other group members, (c) in-session writing exercises on the benefits of doing fun activities, (d) discussion of methods for creating internal and external accountability for positive change, (e) home practice assignment of engaging in actions to help someone else' mood, (f) writing a letter to my future self about positive intentions, and (g) providing positive feedback to other group members at the last session. |
| Blues Program | Active comparator | Behavioral: Group-based therapyThe 6 weekly 1-hour sessions begin with a review of concepts and (after Session 1) review of past home practice assignments; all sessions conclude with home practice assignments. Each session has a portion devoted to thought identification/recording and cognitive restructuring and a portion devoted to increased involvement in pleasant activities. We use motivational enhancement exercises to maximize willingness to use the new skills, behavioral techniques to reinforce use of the new skills, and group activities to foster feelings of group cohesion. |
| Brochure control | Placebo comparator | Behavioral: Group-based therapyNIMH brochure that describes major depression and recommends treatment for depressed youth ("Let's Talk About Depression" NIH Pub. 01-4162), as well as information about local treatment options. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- current student at the University of Oregon
- subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater
Key exclusion criteria (2 listed)
- current diagnosis of major depression
- acute suicidal ideation requiring immediate mental health treatment
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 |
|---|---|---|
| Group-based therapyCollege students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms. | Behavioural | Blues Program, Brochure control, Change Ahead |
Primary outcome
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Evaluate change (if any) by using the Kiddie Schedule for Affective Disorders and Schizophrenia at the 6 week, 3 month and 6 month marks.
Difference in attendance in Change Ahead vs Blues Program groups using group leader notes
Time frame: Measured at each group therapy session (6 weeks in total).
Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes.
Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months.
Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months.
12 secondary outcomes
Activity level
Time frame: Measured at baseline, weeks 2,4 and 6.
Emotions
Time frame: Measured at baseline, weeks 2,4 and 6.
Positive and negative thoughts
Time frame: Measured at baseline, weeks 2,4 and 6.
Assessments using writing samples
Time frame: Measured at baseline and 6 weeks
Depression and anxiety symptoms using the PHQ-9
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Depression and anxiety symptoms using the GAD-7
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Social adjustment in school, work, peer, spare time, and family domains
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Negative life events
Time frame: Measured at baseline
Health care utilization
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Negative automatic thoughts
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Negative attributional style
Time frame: Measured at baseline, 6 weeks, 3 months and 6 months
Substance use
Time frame: Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months
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 16 Sep 2020.
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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 Group-based therapy in people with Depressive Symptoms, run by Oregon Research Institute 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 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 16 Sep 2020. 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. 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?
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months (time frame: Measured at baseline, 6 weeks, 3 months and 6 months). 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 16 Sep 2020.