Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02909387 |
| Other study ID # |
GRANT11643642 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2016 |
| Est. completion date |
September 30, 2019 |
Study information
| Verified date |
June 2020 |
| Source |
Morehouse School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Evaluate the efficacy of Project UPLIFT for reducing symptoms of depression and anxiety among
African Americans at immediate posttest and after 3 months.
Description:
Project UPLIFT is a manualized intervention that includes a script for use by the telephone
facilitators in leading activities and discussions; use of a script is possible because the
delivery is not face-to-face. Activities and discussions are designed to increase knowledge
about epilepsy and mental health; monitoring, challenging, and changing of thoughts; coping
and relaxing; attention and mindfulness; focusing on pleasure; the importance of
reinforcement; and preventing relapse. Sessions are designed to last one hour by telephone,
and are comprised of a check-in period, teaching on the topic of that week's session, group
discussion, a skill-building exercise, and a recommended practice for the week. They are
co-facilitated by a research staff and an UPLIFT trained adult with epilepsy. The same
facilitators lead all eight sessions of a particular group. Facilitators will receive
training in delivery of the program, including delivery of a practice session, from the
Co-PI, a Georgia-licensed clinical psychologist. She will also supervise the facilitators
throughout the program delivery. As noted above, spiritualism and religion; oral,
interpersonal communication; and appreciation of intuition and experience are commonly held
values in the African American community. This suggests that Project UPLIFT, with its
activities based in experiential, meditative exercises, and oral, group discussion over the
telephone may be a good fit.
Design. The outcome evaluation of the efficacy of the Project UPLIFT telephone intervention
groups will be assessed using a cross-over design.
Participants/Procedure. A total of 60 participants will be recruited. Participants must
self-identify as black or African American. All participants must be English-speaking, age 18
or older, mentally stable as assessed by the T-MMSE, have been diagnosed with epilepsy for at
least three months, and screen positive for depression or anxiety on the Patient Health
Questionnaire for Depression and Anxiety (PHQ-4). They must also have access to a telephone,
be willing to attend eight hour-long telephone groups, and be willing to be audio-recorded.
Individuals who are on antidepressant medication will not be excluded from this study, since
CBT has been demonstrated to have a greater effect on relapse prevention than antidepressant
medication. Once recruited, participants will be randomly assigned to one of two strata, each
comprised of five 6-person groups. After each 12-participant cohort is recruited, they will
be randomly assigned to Stratum 1 (intervention) or Stratum 2 (treatment-as-usual waitlist).
During weeks 1-4, all participants will be pre-tested. During weeks 5-10, participants in
Stratum 1 will receive Project UPLIFT, while participants in Stratum 2 are called weekly for
a brief check-in. During weeks 11-14, all participants will receive interim testing. During
weeks 15-22, participants in Stratum 2 will receive Project UPLIFT. During weeks 23-26, all
participants will be post-tested. Five months after the completion of their final UPLIFT
session, participants will be contacted for a follow-up assessment.
During the intervention in stratum 1, stratum 2 will serve as a control. In addition, the
design allows a replication of the results in the initial intervention group (stratum 1) by
the delayed intervention group (stratum 2). By the end of the intervention, all 10 6-person
groups will have received the intervention.
Research Strategy Conferencing Methods. In order for the participants to communicate with one
another as well as the facilitators, the telecommunicated group intervention sessions will
use GoToMeeting. This conferencing method allows the moderator to not only record the call
but also to screening participants waiting to join the call with the option to accept or
reject those waiting, dismiss in-meeting participants, lock the meeting as well as dial out
to participants. Use of this service is free of charge to MSM faculty.
Measures
Screening Measures will include the following:
Mental Stability will be assessed using the T-MMSE. The T-MMSE measures cognitive status,
based on questions regarding orientation to time and place, recall, attention, naming,
repetition, and a three-stage command. It was adapted from the Mini-Mental State Examination,
takes about 5-10 minutes to administer, and has been shown to be a valid form of the
assessment.
Symptoms of Anxiety or Depression will be assessed using the Patient Health Questionnaire-4
(PHQ-4).This is a very brief self-report instrument containing 2 depression items and 2
anxiety items. It is a compilation of the PHQ-2111 and the GAD-2.
Suicidal Intent or Planning will be assessed with the following items revised from the Youth
Risk Behavior Survey to include only the past month: (1) During the past month, did you ever
seriously consider attempting suicide? (2) During the past month, did you make a plan about
how you would attempt suicide?
Evaluation Measures will include the following:
Acceptability will be assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8),
which has been demonstrated to correlate with number of psychotherapy sessions attended, and
therapy outcome.
Cost and Health Outcomes will be assessed at baseline using the self-report survey instrument
developed by Lairson and colleagues.
Effectiveness of the intervention will be assessed by comparing changes in knowledge, skills,
and epilepsy self management from pretest to interim test to posttest across the strata.
Changes in anxiety, depression, or PTSD symptom scores will also be evaluated using the
methods described below.
Knowledge and Skills will be assessed using a measure in prior studies of Project UPLIFT.This
instrument includes two sections, one for knowledge and one for skills. The knowledge items
have true-false responses. The skills items have Likert-scaled response options measuring the
value of each skill and the frequency of use of that skill.
Self management will be assessed using the latest version of the Epilepsy Self Management
Scale (ESMS). The current version of this instrument includes 38-items and takes about 10
minutes to complete. IT includes subscales for Medication Management, Information Management,
Safety Management, Seizure Management, and Lifestyle Management.
Depressive Symptoms will be assessed using two different measures. The mBDI, a modified form
of the Beck Depression Inventory (BDI), will be used as one measure of depressive symptoms at
pretest,interim, posttest, and follow-up. The mBDI is a measure of depression severity during
the past 2 weeks. It contains the original 21 items of the BDI, but adds a positive response
category for each item, such that the responses are scaled from 0 (positive) to 4 (severe).
As a result, the mBDI is better at detecting differences in depression when depression scores
are low. The 21-item BDI has also been shown to be valid for assessing depression among
persons with epilepsy. Administration takes 5 to 10 minutes. The second measure of depressive
symptoms will be the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 10-item
instrument that closely follows diagnostic criteria for Major Depression as cited in the
Diagnostic and Statistical Manual of Psychiatric Disorders. The PHQ-9 has been validated for
diagnosing Major Depressive Disorder in primary care and in obstetric-gynecologic patients.
The PHQ-9 can also be used to identify Major Depressive Disorder.
Symptoms of Anxiety will be assessed using two measures that are parallel to those used for
depressive symptoms. Like the BDI, the Beck Anxiety Inventory (BAI) is another 21-item,
self-report instrument, but it asks about the past week. Response choices range from 0 (not
at all) to 3 (severe). As with the BDI, administration takes 5 to 10 minutes. The second
anxiety measure will be the 7-item General Anxiety Disorder (GAD-7), a 7-item scale developed
and validated within a primary care setting. The scale can also be completed by the patient.
Symptoms of Post-traumatic Stress Disorder (PTSD) will be assess using the PTSD-8. It is
comprised of 4 Intrusive items, 2 Avoidance items, and 2 Hypervigilance items, for a total of
8 items. Item responses are on a 4-point Likert scale from 1 (not at all) to 4 (all the
time). Likert-scale scoring permits measurement of symptom severity. This instrument has been
tested across a range of diverse trauma samples including whiplash patients, rape victims,
and disaster victims.
Evaluation. Process evaluation data will be obtained from the attendance records of each
intervention session. Outcome evaluation measures will include changes in knowledge, skills,
self-efficacy, and symptoms of depression, anxiety, and PTSD. Data from the pretest, interim
test, and post-test will be entered by a Research Assistant, using SPSS. Changes in
knowledge, skills, and mental health symptoms will be assessed using repeated measures
multivariate analyses of variance (MANOVAs) across the variable of time (pretest, interim).
Maintenance will be assessed comparing follow-up to pretest, and follow-up to immediate post
(interim for stratum 1, post-test for stratum 2).
