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

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ClinicalTrials.gov Identifier: NCT01941706
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : February 12, 2014
Sponsor:
Collaborators:
University of Michigan
University of Washington
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Nancy J Thompson, PhD, Emory University

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.

Condition or disease Intervention/treatment Phase
Epilepsy Depressive Symptoms Depression Seizure Disorder Behavioral: Project UPLIFT Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
Study Start Date : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Project UPLIFT (Treatment)
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.
Behavioral: Project 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.

Experimental: Project UPLIFT (TAU Waitlist Control)
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.
Behavioral: Project 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941706


Locations
United States, Georgia
Rollins School of Public Health
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Emory University
University of Michigan
University of Washington
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Nancy J Thompson, MPH, PhD Emory University

Additional Information:
Responsible Party: Nancy J Thompson, PhD, Associate Professor, Behavioral Sciences and Health Education, Emory University
ClinicalTrials.gov Identifier: NCT01941706     History of Changes
Other Study ID Numbers: IRB00026786
5RC1MD004563-02 ( U.S. NIH Grant/Contract )
09042433 ( Other Identifier: Other )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Nancy J Thompson, PhD, Emory University:
Epilepsy
Seizure
Cognitive Behavioral Therapy
Mindfulness
Depression
Depressive symptoms
prevention
Coping skills
Quality of life
Telehealth
Phone intervention
Internet-based intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Seizures
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms