EpilepsyNCT01941706
Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
A study testing Project UPLIFT in people with Epilepsy and Depressive Symptoms, run by Emory University at 4 sites in United States.
Trial summary
Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Epilepsy, Depressive Symptoms, Depression
- What is being tested?
- Project UPLIFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Jun 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of epilepsy
- at least three months post initial diagnosis of epilepsy and either on medication or permission of the physician
- symptoms of depression, but absence of moderate-to-severe depression, (8 < CES-D < 27)
- 21 years of age and older
- English speaking
- had access to a telephone
Show all 9Show fewer
- mentally stable, as determined by a score of > 26 on the Telephone Mini-Mental Status Exam (T-MMSE)
- willing to participate
- willing to complete assessments three times
Who cannot join
- no diagnosis of epilepsy
- less than 3 months since diagnosis of epilepsy
- no depressive symptom (CES-D <8)
- severe depression (CES-D > 27)
- suicidal ideation
- previous participation in Project UPLIFT
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Rollins School of Public Health
Atlanta, Georgia, 30322
University of Texas Health Science Center
Houston, Texas, 77030
University of Washington
Seattle, Washington, 98104
About this study
Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. This project will assess whether the materials are also effective for preventing depression among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas, and Washington.
Read the detailed description
The study is a pilot test of Project UPLIFT for depression prevention during which the acceptability and estimates of effectiveness of the intervention, presented in the Web and telephone modes, are assessed.
- Conditions
- Epilepsy, Depressive Symptoms, Depression, Seizure Disorder
- Being tested
- Project UPLIFT
- Keywords
- Epilepsy, Seizure, Cognitive Behavioral Therapy, Mindfulness, Depression, Depressive symptoms, prevention, Coping skills, Quality of life, Telehealth, Phone intervention, Internet-based intervention
- Medical subject headings
- Epilepsy, Depression, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project UPLIFTBehavioural
Developed for home-based treatment of depression in people with epilepsy, Project UPLIFT is based upon Mindfulness-based Cognitive Therapy for depression. It includes 8 modules, group-delivered by either telephone or Web. Trainees and people with epilepsy co-facilitate the groups, supervised by a licensed mental health professional.The co-facilitators are trained and supervised by the Principal Investigator, a Georgia-licensed clinical psychologist and Associate Professor of Behavioral Science and of Epidemiology in public health. Activities are designed to increase knowledge about depression; monitoring, challenging, and changing thoughts; coping and relaxing; attention and mindfulness; focusing on pleasure; the importance of reinforcement, and preventing relapse.
| Study group | Role | What they receive |
|---|---|---|
| Project UPLIFT (Treatment) | Experimental | Participants randomly assigned to the Treatment group receive the UPLIFT Intervention immediately after completing the Baseline Assessment. Participants can chose to participate in the Web- or phone-delivery of UPLIFT. Receives: Behavioral: Project UPLIFT |
| Project UPLIFT (TAU Waitlist Control) | Experimental | Participants randomly assigned to the Treatment-as Usual (TAU) Waitlist Control group will also receive the UPLIFT intervention. However, TAU Waitlist Control participants will begin the Intervention 8 weeks after completing the Baseline Assessment. During the initial 8 weeks, participants in this group will continue whatever treatment they are currently undergoing to prevent or treat mild depressive symptoms. Participants can chose to participate in the Web- or phone-delivery of UPLIFT. Receives: Behavioral: Project UPLIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI).
Measured: Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)
Secondary outcomes (6)
Changes in seizure severity
Changes in seizure severity measured using the Liverpool Seizure Severity.
Measured: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depression and Mindfulness Knowledge and Skills
The changes are measured using an internally consistent scale assessing knowledge and skills associated with depression and mindfulness. The scale includes 18 true-false items assessing knowledge of depression based on the content of the UPLIFT modules. The scale also includes 13 Likert-scale assessing mindfulness skills based on the content of the UPLIFT modules.
Measured: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the Beck Depression Inventory (BDI).
Measured: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the Patient Health Questionnaire (PHQ-9).
Measured: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
Measured: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Change in Seizure Activity
Change measured using self-reported number of seizures in the past 4 weeks.
Measured: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of Washington, The University of Texas Health Science Center, Houston, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Nancy J Thompson, PhD, Emory University
- Investigators
- Nancy J Thompson, MPH, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941706
- Sponsor's protocol ID
- IRB00026786
- Other IDs
- 5RC1MD004563-02, 09042433
- Status last verified
- Feb 2014
- First submitted
- 5 Sep 2013
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
- ClinicalTrials.gov ID
- NCT01941706
- Acronym / sponsor ID
- IRB00026786
- Conditions
- Epilepsy, Depressive Symptoms, Depression, Seizure Disorder
- Keywords
- Epilepsy, Seizure, Cognitive Behavioral Therapy, Mindfulness, Depression, Depressive symptoms, prevention, Coping skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, University of Washington, The University of Texas Health Science Center, Houston, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Sep 2013 (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.
Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. This project will assess whether the materials are also effective for preventing depression among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas, and Washington.
Detailed description
The study is a pilot test of Project UPLIFT for depression prevention during which the acceptability and estimates of effectiveness of the intervention, presented in the Web and telephone modes, are assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project UPLIFT (Treatment) | Experimental | Behavioral: Project UPLIFTParticipants randomly assigned to the Treatment group receive the UPLIFT Intervention immediately after completing the Baseline Assessment. Participants can chose to participate in the Web- or phone-delivery of UPLIFT. |
| Project UPLIFT (TAU Waitlist Control) | Experimental | Behavioral: Project UPLIFTParticipants randomly assigned to the Treatment-as Usual (TAU) Waitlist Control group will also receive the UPLIFT intervention. However, TAU Waitlist Control participants will begin the Intervention 8 weeks after completing the Baseline Assessment. During the initial 8 weeks, participants in this group will continue whatever treatment they are currently undergoing to prevent or treat mild depressive symptoms. Participants can chose to participate in the Web- or phone-delivery of UPLIFT. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- diagnosis of epilepsy
- at least three months post initial diagnosis of epilepsy and either on medication or permission of the physician
- symptoms of depression, but absence of moderate-to-severe depression, (8 < CES-D < 27)
- 21 years of age and older
- English speaking
Key exclusion criteria (6 listed)
- no diagnosis of epilepsy
- less than 3 months since diagnosis of epilepsy
- no depressive symptom (CES-D <8)
- severe depression (CES-D > 27)
- suicidal ideation
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 |
|---|---|---|
| Project UPLIFTDeveloped for home-based treatment of depression in people with epilepsy, Project UPLIFT is based upon Mindfulness-based Cognitive Therapy for depression. It includes 8 modules, group-delivered by either telephone or Web. Trainees and people with epilepsy co-facilitate the groups, supervised by a licensed mental health professional.The co-facilitators are trained and supervised by the Principal Investigator, a Georgia-licensed clinical psychologist and Associate Professor of Behavioral Science and of Epidemiology in public health. Activities are designed to increase knowledge about depression; monitoring, challenging, and changing thoughts; coping and relaxing; attention and mindfulness; focusing on pleasure; the importance of reinforcement, and preventing relapse. | Behavioural | Project UPLIFT (TAU Waitlist Control), Project UPLIFT (Treatment) |
Primary outcome
Changes in Depressive Symptoms
Time frame: Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)
Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI).
6 secondary outcomes
Changes in seizure severity
Time frame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depression and Mindfulness Knowledge and Skills
Time frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depressive Symptoms
Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depressive Symptoms
Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depressive Symptoms
Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Change in Seizure Activity
Time frame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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 12 Feb 2014.
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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.
Nancy J Thompson, MPH, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project UPLIFT in people with Epilepsy and Depressive Symptoms, run by Emory University at 4 sites 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 9 inclusion and 6 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 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Changes in Depressive Symptoms (time frame: Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)). 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 12 Feb 2014.