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Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT

Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01941706
Enrollment
130
Registered
2013-09-13
Start date
2009-10-31
Completion date
2012-06-30
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Symptoms, Epilepsy, Seizure Disorder

Keywords

Epilepsy, Seizure, Cognitive Behavioral Therapy, Mindfulness, Depression, Depressive symptoms, prevention, Coping skills, Quality of life, Telehealth, Phone intervention, Internet-based intervention

Brief 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. 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.

Interventions

BEHAVIORALProject UPLIFT

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.

Sponsors

University of Michigan
CollaboratorOTHER
University of Washington
CollaboratorOTHER
The University of Texas Health Science Center, Houston
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Depressive SymptomsBaseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI).

Secondary

MeasureTime frameDescription
Changes in seizure severityBaseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)Changes in seizure severity measured using the Liverpool Seizure Severity.
Changes in Depression and Mindfulness Knowledge and SkillsBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)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.
Changes in Depressive Symptomsbaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)Changes in depressive symptoms are measured using the Beck Depression Inventory (BDI).
Change in Seizure ActivityBaseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)Change measured using self-reported number of seizures in the past 4 weeks.

Other

MeasureTime frameDescription
Changes in Satisfaction with LifeBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)Changes are measured using the Satisfaction with Life Scale (Denier, E., et al., The satisfaction with life scale. Journal of Personality Assessment, 1985)
Changes in Sleep QualityBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)The study uses the Pittsburgh Sleep Quality Index to assess changes in sleep quality.
Changes in Depression Coping Self-EfficacyBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)The study uses Perraud, S., Development of the Depression Coping Self-Efficacy Scale (DCSES). Archives of Psychiatric Nursing, 2000 to assess changes in depression coping self-efficacy.
Changes in Self CompassionBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)The study uses Neff, K.D. and R. Vonk, Self-compassion versus global self-esteem: two different ways of relating to oneself. J Pers, 2009. 77(1): p. 23-50.. to assess changes in self compassion.
Changes in Physical and Mental Health Quality of LifeBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)The study uses the Centers for Disease Control's Behavioral Risk Factors Surveillance System (BRFSS) questionnaire to assess changes in physical and mental health quality of life.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026