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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941706
• Other study ID #: IRB00026786
• Secondary ID: 5RC1MD004563-020
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: February 11, 2014
• Start date: October 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms
• Epilepsy
• Seizure Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Rollins School of Public Health	Atlanta	Georgia
United States	University of Texas Health Science Center	Houston	Texas
United States	University of Washington	Seattle	Washington

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Satisfaction with Life	Changes are measured using the Satisfaction with Life Scale (Denier, E., et al., The satisfaction with life scale. Journal of Personality Assessment, 1985)	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Other	Changes in Sleep Quality	The study uses the Pittsburgh Sleep Quality Index to assess changes in sleep quality.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Other	Changes in Depression Coping Self-Efficacy	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.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Other	Changes in Self Compassion	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.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Other	Changes in Physical and Mental Health Quality of Life	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.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Primary	Changes in Depressive Symptoms	Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI).	Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)	No
Secondary	Changes in seizure severity	Changes in seizure severity measured using the Liverpool Seizure Severity.	Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Secondary	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.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Secondary	Changes in Depressive Symptoms	Changes in depressive symptoms are measured using the Beck Depression Inventory (BDI).	baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Secondary	Changes in Depressive Symptoms	Changes in depressive symptoms are measured using the Patient Health Questionnaire (PHQ-9).	baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Secondary	Changes in Depressive Symptoms	Changes in depressive symptoms are measured using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).	baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No
Secondary	Change in Seizure Activity	Change measured using self-reported number of seizures in the past 4 weeks.	Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)	No

External Links

•   For more information about Project UPLIFT