DepressionNCT02134678
Assessing Change in Short Term Therapy for Depression
A study testing self-system therapy and cognitive therapy in people with Depression, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
This study will compare mechanisms of action in two forms of brief psychotherapy for major depressive disorder in adults. A treatment that targets deficits in motivation in depression is expected to show greater improvements in motivation and pursuit of personal goals compared to a second treatment that targets… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- self-system therapy and cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary diagnoses of major depressive disorder or dysthymia
- age 18-60
Who cannot join
- bipolar
- substance abuse
- acute suicidality
- antisocial or borderline personality disorder
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Change in Short Term Therapy for Depression Using ESM
This study will compare mechanisms of action in two forms of brief psychotherapy for major depressive disorder in adults. A treatment that targets deficits in motivation in depression is expected to show greater improvements in motivation and pursuit of personal goals compared to a second treatment that targets irrational thoughts that are typical in depression.
Read the detailed description
Outcome studies have shown that several forms of psychotherapy are effective for depression, but questions about how, why, and when these treatments work remain. The proposed study answers the call for innovative research designs that allow for more intensive, individualized data collection that can address complex questions about the dynamic nature of treatment-related change. In this R21 application, we propose a proof-of-concept study using an innovative application of experience sampling methodology (ESM) that combines the idiographic advantages of single-subject research with the statistical advantages associated with larger samples and multilevel analyses. ESM involves sampling aspects of behavior occurring in the participant's everyday environment, thereby enhancing ecological validity and reducing retrospective bias. Thirtyfour adults with primary major depressive disorder will be randomly assigned to 16 weeks of either selfsystem therapy (SST), a new short-term, empirically-supported psychotherapy for depression that targets deficits in incentive motivation and goal pursuit, or treatment-as-usual (TAU). Participants will complete a battery of individual difference and diagnostic measures at pretreatment. One week of intensive ESM will be collected at both pre- and post-treatment, during which participants will be signaled at random times during each day to answer questions about current functioning in several domains (e.g., affect, cognition, and goal pursuit) delivered via a phone-based interactive voice response (IVR) system. Throughout the 16 weeks of treatment, participants will complete similar IVR assessments on two randomly-selected days per week. The proposed study will test three main hypotheses. (1) Patients in SST will show greater increases in engagement with promotion goals and activities as well as greater increases in goal-related daily experiences of positive affect over the course of treatment compared to patients in TAU. (2) Patients in SST will show greater decreases in engagement with prevention goals and activities as well as greater decreases in goal- related daily experiences of negative affect over the course of treatment compared to patients in TAU. (3) Within the SST condition, a history of failure to pursue or achieve promotion goals and individual differences in chronic regulatory orientation (i.e., strength of orientation toward promotion and prevention goals) will moderate the effects of SST on changes in depressive symptoms and on daily experiences of promotion goal engagement. The proposed research will have a significant impact on an important public health problem and will expand our knowledge of how psychotherapy for depression works. The data to be obtained from this study will provide a sound empirical and theoretical framework for largerscale programmatic research on the nature of treatment-induced change processes in patients with depression.
- Conditions
- Depression
- Being tested
- self-system therapy, cognitive therapy
- Keywords
- self-system therapy, cognitive therapy, depression, psychotherapy, mechanisms of action
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-system therapyBehavioural
cognitive therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| self-system therapy | Experimental | self-system therapy for depression Receives: Behavioral: self-system therapy |
| cognitive therapy | Active comparator | cognitive therapy for depression Receives: Behavioral: cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive symptoms - Beck Depression Inventory-II
Measured: post-treatment and 6 month follow up
Secondary outcomes (1)
Change in Anxiety - Beck Anxiety Inventory
Measured: post-treatment and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari M Eddington, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134678
- Sponsor's protocol ID
- 1R21MH090414-01A1
- Status last verified
- Apr 2015
- First submitted
- 5 May 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eddington KM, Silvia PJ, Foxworth TE, Hoet A, Kwapil TR. Motivational deficits differentially predict improvement in a randomized trial of self-system therapy for depression. J Consult Clin Psychol. 2015 Jun;83(3):602-616. doi: 10.1037/a0039058. Epub 2015 Apr 13.
PubMed 25867448
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Change in Short Term Therapy for Depression Using ESM
- ClinicalTrials.gov ID
- NCT02134678
- Acronym / sponsor ID
- 1R21MH090414-01A1
- Conditions
- Depression
- Keywords
- self-system therapy, cognitive therapy, depression, psychotherapy, mechanisms of action
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 May 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.
This study will compare mechanisms of action in two forms of brief psychotherapy for major depressive disorder in adults. A treatment that targets deficits in motivation in depression is expected to show greater improvements in motivation and pursuit of personal goals compared to a second treatment that targets irrational thoughts that are typical in depression.
Detailed description
Outcome studies have shown that several forms of psychotherapy are effective for depression, but questions about how, why, and when these treatments work remain. The proposed study answers the call for innovative research designs that allow for more intensive, individualized data collection that can address complex questions about the dynamic nature of treatment-related change. In this R21 application, we propose a proof-of-concept study using an innovative application of experience sampling methodology (ESM) that combines the idiographic advantages of single-subject research with the statistical advantages associated with larger samples and multilevel analyses. ESM involves sampling aspects of behavior occurring in the participant's everyday environment, thereby enhancing ecological validity and reducing retrospective bias. Thirtyfour adults with primary major depressive disorder will be randomly assigned to 16 weeks of either selfsystem therapy (SST), a new short-term, empirically-supported psychotherapy for depression that targets deficits in incentive motivation and goal pursuit, or treatment-as-usual (TAU). Participants will complete a battery of individual difference and diagnostic measures at pretreatment. One week of intensive ESM will be collected at both pre- and post-treatment, during which participants will be signaled at random times during each day to answer questions about current functioning in several domains (e.g., affect, cognition, and goal pursuit) delivered via a phone-based interactive voice response (IVR) system. Throughout the 16 weeks of treatment, participants will complete similar IVR assessments on two randomly-selected days per week. The proposed study will test three main hypotheses. (1) Patients in SST will show greater increases in engagement with promotion goals and activities as well as greater increases in goal-related daily experiences of positive affect over the course of treatment compared to patients in TAU. (2) Patients in SST will show greater decreases in engagement with prevention goals and activities as well as greater decreases in goal- related daily experiences of negative affect over the course of treatment compared to patients in TAU. (3) Within the SST condition, a history of failure to pursue or achieve promotion goals and individual differences in chronic regulatory orientation (i.e., strength of orientation toward promotion and prevention goals) will moderate the effects of SST on changes in depressive symptoms and on daily experiences of promotion goal engagement. The proposed research will have a significant impact on an important public health problem and will expand our knowledge of how psychotherapy for depression works. The data to be obtained from this study will provide a sound empirical and theoretical framework for largerscale programmatic research on the nature of treatment-induced change processes in patients with depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-system therapy | Experimental | Behavioral: self-system therapyself-system therapy for depression |
| cognitive therapy | Active comparator | Behavioral: cognitive therapycognitive therapy for depression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary diagnoses of major depressive disorder or dysthymia
- age 18-60
Key exclusion criteria (5 listed)
- bipolar
- substance abuse
- acute suicidality
- antisocial or borderline personality disorder
- cognitive impairment
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 |
|---|---|---|
| self-system therapy | Behavioural | self-system therapy |
| cognitive therapy | Behavioural | cognitive therapy |
Primary outcome
Change in Depressive symptoms - Beck Depression Inventory-II
Time frame: post-treatment and 6 month follow up
1 secondary outcome
Change in Anxiety - Beck Anxiety Inventory
Time frame: post-treatment and 6 month follow up
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 1 May 2015.
- Derived from this study: PubMed 25867448Eddington KM, Silvia PJ, Foxworth TE, Hoet A, Kwapil TR. Motivational deficits differentially predict improvement in a randomized trial of self-system therapy for depression. J Consult Clin Psychol. 2015 Jun;83(3):602-616. doi: 10.1037/a0039058. Epub 2015 Apr 13.
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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 self-system therapy and cognitive therapy in people with Depression, run by University of North Carolina, Greensboro 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 5 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 1 May 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 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.
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 in Depressive symptoms - Beck Depression Inventory-II (time frame: post-treatment and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134678, which also lists 1 linked publication.
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 1 May 2015.