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Completed

NCT Number: NCT01941706

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

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.

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Key information

Conditions

Epilepsy Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Depressive Symptoms Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizure Disorder Seizures Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rollins School of Public Health, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project UPLIFT

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Changes in seizure severity

    Time frame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

    Changes in seizure severity measured using the Liverpool Seizure Severity.

  2. Changes in Depression and Mindfulness Knowledge and Skills

    Time frame: Baseline (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.

  3. Changes in Depressive Symptoms

    Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

    Changes in depressive symptoms are measured using the Beck Depression Inventory (BDI).

  4. Changes in Depressive Symptoms

    Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

    Changes in depressive symptoms are measured using the Patient Health Questionnaire (PHQ-9).

  5. Changes in Depressive Symptoms

    Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

    Changes in depressive symptoms are measured using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).

  6. Change in Seizure Activity

    Time frame: Baseline (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 outcomes

  1. Changes in Satisfaction with Life

    Time frame: Baseline (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)

  2. Changes in Sleep Quality

    Time frame: Baseline (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.

  3. Changes in Depression Coping Self-Efficacy

    Time frame: Baseline (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.

  4. Changes in Self Compassion

    Time frame: Baseline (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.

  5. Changes in Physical and Mental Health Quality of Life

    Time frame: Baseline (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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • The University of Texas Health Science Center, Houston
  • University of Michigan
  • University of Washington

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 13, 2013
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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