ALSNCT01583205
Coping Effectiveness Training for ALS
A study testing Coping Effectiveness Training - ALS in people with ALS and Distress, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Coping Effectiveness Training - ALS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Has a family member or close friend diagnosed with ALS (possible, probable, or definite) in the past year
Show all 9Show fewer
- Expresses distress (4+) on Distress Thermometer, or symptoms of anxiety or depression (VAS scales)
- Speaks English
- Able and willing to give informed consent
Who cannot join
- 1. Untreated or under-treated Major Depressive Disorder
- CARE PARTNERS:
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute, Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Coping Effectiveness Training for Recently Diagnosed ALS Patients and Care Partners
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).
Read the 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.
- Being tested
- Coping Effectiveness Training - ALS
- Keywords
- ALS, Coping Effectiveness Training, Distress, Care Giver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Effectiveness Training - ALSBehavioural
Also called CET
Eight coping effectiveness training counseling sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Coping Effectiveness Training - ALS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The K10 Scale will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: The study was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Judith G. Rabkin, PhD, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Martin C McElhiney, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583205
- Sponsor's protocol ID
- 6514
- Status last verified
- Nov 2014
- First submitted
- 5 Apr 2012
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Effectiveness Training for Recently Diagnosed ALS Patients and Care Partners
- ClinicalTrials.gov ID
- NCT01583205
- Acronym / sponsor ID
- 6514
- Keywords
- ALS, Coping Effectiveness Training, Distress, Care Giver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coping Effectiveness Training | Experimental | Behavioral: Coping Effectiveness Training - ALSCoping 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 1. Untreated or under-treated Major Depressive Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Effectiveness Training - ALSAlso: CETEight coping effectiveness training counseling sessions. | Behavioural | Coping Effectiveness Training |
Primary outcome
Patient Health Questionnaire 9 (PHQ-9)
Time frame: The PHQ-9 will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).
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.
Speilberger State Anxiety Inventory (STAI)
Time frame: The STAI will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).
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.
Coping Self-Efficacy Scale (13-Item)
Time frame: 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).
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.
Kessler 10-Item Screening Scale for Psychological Distress (K10)
Time frame: The K10 Scale will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin C McElhiney, Ph.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Effectiveness Training - ALS in people with ALS and Distress, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (PHQ-9) (time frame: The PHQ-9 will be given at baseline and then after the particpant completes the 8 counseling sessions (on average ~ 4 months after baseline).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.