Coping Effectiveness Training for ALS

NCT01583205 | Withdrawn

• 1 other identifier: 6514
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

ALS; Distress

Keywords

ALS; Coping Effectiveness Training; Distress; Care Giver

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire 9 (PHQ-9)

  The Patient Health Questionnaire includes 9 items, each representing one of the 9 diagnostic criteria for major depressive disorder (DSM-IV) plus follow-up probes to ascertain duration, and functional impairment if any. The 4 response options refer to frequency, if present. The scale generates both a numerical score with cut-offs and a diagnostic approximation. It will be clinician-administered, as we have done in other ALS studies, and we will add follow-up queries re: past episodes, if any, as well as ongoing or previous mental health treatment.

  The PHQ-9 will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).

• Speilberger State Anxiety Inventory (STAI)

  This 20-item scale assesses current levels of anxiety, excluding somatic symptoms. It is not meant as a diagnostic measure. The response format is a 4-point Likert scale. Items are summed to provide a total severity score. Cut-offs are provided. It has been used successfully in another study of recently diagnosed ALS patients.

  The STAI will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).

• Coping Self-Efficacy Scale (13-Item)

  The 26-item scale originally developed by Chesney et al. for CET was subsequently subjected to psychometric analyses using data from 2 randomized trials, and a 13-item version was found to have 3 factors: use of problem-focused coping; stopping unpleasant emotions and thoughts, and getting support from family/friends. The factors showed strong internal consistency reliability and test-retest reliability. The scale is intended to assess a person's ability to cope effectively with life challenges, as well as to assess change in CSE over time in coping-focused intervention research.

  The Coping Self-Efficacy Scale will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).

• Kessler 10-Item Screening Scale for Psychological Distress (K10)

  The K10 is a quick 10-item screen that is used to assess distress and is shown to be a sensitive screen for DSM-IV anxiety and depressive disorders. The response format is a 5-point Likert scale. Items are summed to provide a total severity score.

  The K10 Scale will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).

Study Arms (1)

Coping Effectiveness Training

EXPERIMENTAL

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.

Behavioral: Coping Effectiveness Training - ALS

Interventions

Coping Effectiveness Training - ALS BEHAVIORAL

Eight coping effectiveness training counseling sessions.

Also known as: CET

Coping Effectiveness Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Untreated or under-treated Major Depressive Disorder
• CARE PARTNERS:
• 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

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• Columbia University: collaborator

Study Sites (1)

New York State Psychiatric Institute, Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

• Martin C McElhiney, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

US (1)