|
|
|
 |
|
Coping Effectiveness Training for Recently Diagnosed ALS Patients and Care Partners |
|
|
| |
|
|
|
|
Study Focus:
The investigators propose to adapt and pilot test a behavioral intervention for recently diagnosed patients with Amyotrophic Lateral Sclerosis (ALS), and/or a family care partner. |
|
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS |
|
Study Category:
Other: Behavioral |
|
Study Status:
Active, currently recruiting |
|
Phase:
Not Applicable |
|
Type:
Interventional Trial
|
|
|
|
Funding Source:
Research Foundation for Mental Hygiene |
|
Study Chair(s)/Principal Investigator(s):
Martin C McElhiney, Ph.D. (New York State Psychiatric Institute) |
|
Clinicaltrials.gov ID:
NCT01583205 |
|
NEALS Affiliated?
No |
|
|
|
|
|
|
|
Study Summary:
After the diagnostic visit, patients (and accompanying family member) are commonly scheduled to return to the clinic or office in 3 to 6 months. At this first routine clinic visit, the focus is generally on assessment and management of mobility issues, diet, occupational adjustments, advance planning directives, insurance coverage and other pressing issues that usually take up the allotted time. Thus, there is often little opportunity to address the emotional impact of the diagnosis at that visit.
Our goal is a manualized intervention suitable for telephone or Skype delivery, for the management of distress and enhancement of coping skills among recently diagnosed ALS patients and/or their family care partner. We are adapting the intervention developed by Chesney, Folkman and colleagues, "Coping Effectiveness Training," as being the most salient and theoretically powerful design for our purpose. We base our work on Folkman's revised model that incorporates meaning-focused coping and the importance of positive emotions, in addition to the original model of problem-focused and emotion-focused coping. The course of ALS entails progressive losses, of mobility, fine and gross motor skills, speech, swallowing, and respiration. Each requires recalibrating emotional response and coping with new challenges. Early intervention to strengthen coping skills may equip patients and care partners to handle new challenges as they arise, although in this initial study we will not follow patients long enough to observe long-term effects, if present. Based on successful findings in this pilot study, the next step will be to conduct a larger RCT of the intervention.
Specific Aims and Hypotheses
AIM 1. To adapt and refine a manual for Coping Effectiveness Training for recently diagnosed ALS patients and their care partners (CET-ALS) based on Coping Effectiveness Training (CET). We will seek input from interviews with patients (whom we know from their participation in our ongoing studies), care partners and ALS clinic staff.
AIM 2. Feasibility and Acceptability: Evaluate acceptability, attrition, participant satisfaction and perceived barriers and facilitators to intervention delivery. |
|
Participant Duration:
Eight coping effectiveness training counseling sessions |
|
# of Subjects:
30 |
|
Enrollment Start Date:
04/01/2012 |
|
Enrollment End Date:
04/01/2014 |
|
Posting Last Modified Date:
04/01/2012 |
|
Date Study Added to alscortium.org:
04/27/2012 |
|
More information:
Participants (patients and/or care partners) will be recruited from the Eleanor and Lou Gehrig MDA/ALS Research Center, Columbia University. The main outcomes are changes in distress level, depression and anxiety symptoms, and coping self-efficacy. |
|
| Eligibility Criteria |
|
Gender:
Male & Female |
|
Minimum Age:
18 |
|
Maximum Age:
80 |
|
Time since Diagnosis:
Less than 12 months |
|
|
|
Coordinating Center
Contact Information |
|
| Martin C McElhiney, Ph.D. |
|
| mcelhin@nyspi.columbia.edu |
|
| 212-543-5331 |
|
| New York State Psychiatric Institute, Columbia University Medical Center |
|
New York , New York 10032
UNITED STATES |
|
|
|
Other Eligibility Criteria:
PATIENTS:
Inclusion Criteria:
ALS diagnosis (possible, probable, or definite) in the past year
Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression (VAS scales)
Speaks English
Able and willing to give informed consent
Speaks clearly enough for telephone communication
Exclusion Criteria:
1. Untreated or under-treated Major Depressive Disorder
CARE PARTNERS:
Inclusion Criteria:
Has a family member or close friend diagnosed with ALS (possible, probable, or definite) in the past year
Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression (VAS scales)
Speaks English
Able and willing to give informed consent
|
|
|
|
|
|
 |
Site Contact Information (Please click to show/hide) |
|
|
|
|
|
|
| New York |
|
New York State Psychiatric Institute, Columbia University Medical Center
Judith G Rabkin, Ph.D.
jgr1@columbia.edu
212.543.5762
New York, New York 10032
UNITED STATES |
|
|
|
|
Familial ALS- ALS cases are inherited from 2 or more family members, affects 5-10% of ALS cases. Sporadic ALS- disease occurs at random with no clearly associated risk factors; most common form of ALS, affects approximately 90-95% ALS cases. Interventional trial- study where exposure, for example a drug, is assigned; used to determine the effectiveness of a treatment or intervention. With drugs and a placebo- One group gets the active treatment, the other gets the placebo. Everything else is held the same between the two groups, so that any difference in their outcome can be attributed to the active treatment. Observational study- study in which patients are observed and where no treatment is given; researcher has no control over the experiment because they are done in a more natural setting than an interventional trial. Trial Phase- objectives are different for each phase of a trial. - Phase I, drug is given to a small number of people to see if it is safe.
- Phase II begins to look at effectiveness of the drug.
- Phase III is considered the definitive test of whether a drug is effective, held at multiple research sites and much larger than the previous phases.
Vital Capacity- the maximum amount of air that can be expelled from the lungs after a maximum drawing of air into the lungs, measured by a spirometer and then scored as a percentage. |
