Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01583205
Status:
WITHDRAWN
Last Update Posted:
2014-11-10
First Post:
2012-04-05
Brief Title:
Coping Effectiveness Training for ALS
Sponsor:
Research Foundation for Mental Hygiene Inc
Organization:
Research Foundation for Mental Hygiene Inc
Study Overview
Official Title:
Coping Effectiveness Training for Recently Diagnosed ALS Patients and Care Partners
Status:
WITHDRAWN
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators propose to adapt and pilot test a behavioral intervention for recently diagnosed patients with Amyotrophic Lateral Sclerosis ALS andor a family care partner ALS fatal neurodegenerative disease the diagnosis of which can have a devastating impact on patients and their families Our eight session intervention is derived from Coping Effectiveness Training a manualized intervention based on stress and coping theory It is designed to strengthen coping skills and alleviate distress following diagnosis
Participants patients andor care partners will be recruited from the Eleanor and Lou Gehrig MDAALS Research Center Columbia University The main outcomes are changes in distress level depression and anxiety symptoms and coping self-efficacy
Once the investigators gain preliminary experience with the manual get some sense of feasibility and acceptance and learn about patient and care partner reactions the investigators will be better able to prepare a grant application seeking NIH support for the development of the intervention with the eventual goal of a multisite randomized controlled trial RCT
Participants patients andor care partners will be recruited from the Eleanor and Lou Gehrig MDAALS Research Center Columbia University The main outcomes are changes in distress level depression and anxiety symptoms and coping self-efficacy
Once the investigators gain preliminary experience with the manual get some sense of feasibility and acceptance and learn about patient and care partner reactions the investigators will be better able to prepare a grant application seeking NIH support for the development of the intervention with the eventual goal of a multisite randomized controlled trial RCT
Detailed Description:
ALS is a rare devastating fatal neurodegenerative disease of largely unknown cause Average survival after diagnosis is about 3 years The diagnostic process is often protracted but even though the possibility of ALS may have been mentioned earlier when the diagnosis is confirmed patients and family members are often shocked and overwhelmed
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 andor 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 Folkmans 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
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 andor 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 Folkmans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None