Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Martin C McElhiney, Ph.D. (New York State Psychiatric Institute)
Clinicaltrials.gov ID:
NCT01583205
Neals Affiliated?
No
Coordinating Center Contact Information
New York State Psychiatric Institute, Columbia University Medical Center
Martin C McElhiney, Ph.D. / email hidden; JavaScript is required / 212-543-5331
New York, New York, 10032 United States
Full Study Summary:
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.
Study Sponsor:
Research Foundation for Mental Hygiene
Participant Duration:
Eight coping effectiveness training counseling sessions
Estimated Enrollment:
30
Estimated Study Start Date:
03 / 31 / 2012
Estimated Study Completion Date:
03 / 31 / 2014
Posting Last Modified Date:
03 / 31 / 2012
Date Study Added to neals.org:
04 / 26 / 2012
Minimum Age:
18
Maximum Age:
80
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
New York State Psychiatric Institute, Columbia University Medical Center
Judith G Rabkin, Ph.D. / 212.543.5762 / email hidden; JavaScript is required
New York, New York
10032
United States