Coping Effectiveness Training for ALS

Brief Title

Coping Effectiveness Training for ALS

Official Title

Coping Effectiveness Training for Recently Diagnosed ALS Patients and Care Partners

Brief Summary

      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.
      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 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.

      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
      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 Type

Interventional


Primary Outcome

Patient Health Questionnaire 9 (PHQ-9)


Condition

ALS

Intervention

Coping Effectiveness Training - ALS

Study Arms / Comparison Groups

 Coping Effectiveness Training
Description:  Coping Effectiveness Training -ALS (CET-ALS) is an eight session intervention derived from Coping Effectiveness Training (CET), a manualized intervention based on stress and coping theory. It is designed to strengthen coping skills and alleviate distress for either the patient or care partner following a diagnosis of ALS.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

0

Start Date

April 2012

Completion Date

November 2013

Primary Completion Date

November 2013

Eligibility Criteria

        PATIENTS:

        Inclusion Criteria:

          1. ALS diagnosis (possible, probable, or definite) in the past year

          2. Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression
             (VAS scales)

          3. Speaks English

          4. Able and willing to give informed consent

          5. Speaks clearly enough for telephone communication

        Exclusion Criteria:

        1. Untreated or under-treated Major Depressive Disorder

        CARE PARTNERS:

        Inclusion Criteria:

          1. Has a family member or close friend diagnosed with ALS (possible, probable, or
             definite) in the past year

          2. Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression
             (VAS scales)

          3. Speaks English

          4. Able and willing to give informed consent
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Martin C McElhiney, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01583205

Organization ID

6514


Responsible Party

Principal Investigator

Study Sponsor

Research Foundation for Mental Hygiene, Inc.

Collaborators

 Columbia University

Study Sponsor

Martin C McElhiney, Ph.D., Principal Investigator, New York State Psychiatric Institute


Verification Date

November 2014