Cognitive Rehabilitation for Gulf War Illness
1 other identifier
interventional
268
1 country
3
Brief Summary
There are almost 700,000 Gulf War Veterans (GWV) with 25-30% suffering from a devastating multi-symptom illness coined Gulf War Illness (GWI). GWV with GWI report significant activity limitations and chronic cognitive problems consistent with problem-solving deficits. Problem-solving is considered the most complex of cognitive abilities and is what enables us to conduct complicated behaviors such as setting goals, sequencing and multi-tasking. As a result studies have found that problem-solving deficits are prospectively related to a greater risk of disability. Despite published reports documenting these problems there are no treatments that target the problem-solving deficits of GWI. This proposal seeks to determine whether Problem-Solving Therapy, a patient centered cognitive rehabilitation therapy, can reduce disability by compensating for problem-solving deficits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
June 4, 2020
CompletedAugust 26, 2020
August 1, 2020
4 years
June 9, 2014
March 2, 2020
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disability - WHO-DAS 2 Change
World Health Organization Disability Assessment Schedule. The WHO-DAS 2.0 measures disability due to physical and mental health conditions. The WHO-DAS 2.0 is a 36 item measure that focuses upon six life tasks: * Understanding and communicating * Self-care * Mobility (getting around) * Interpersonal relationships (getting along with others) * Work and household roles (life activities) * Community and civic roles (participation) These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability.
Baseline and 12 weeks
Secondary Outcomes (4)
Problem-Solving Inventory Change
Baseline and 12 weeks
Problem-Solving Ability Change
Baseline and 12 weeks
Disability - WHO-DAS 2 Change
Baseline and 6 months
Problem-Solving Inventory Change
Baseline and 6 months
Other Outcomes (3)
Pain Disability Change
Baseline and 12 weeks
Multidimensional Pain Inventory - Pain Severity Subscale Change
baseline and 12 weeks
Fatigue Change
Baseline and 12 weeks
Study Arms (2)
Problem-Solving Therapy
EXPERIMENTALProblem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
Health Education
ACTIVE COMPARATORHealth education provides didactic information about Gulf War Illness
Interventions
Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
Health Education provides didactic information about Gulf War Illness
Eligibility Criteria
You may qualify if:
- deployed to first Gulf War and meets Kansas definition for GWI (see definition in measures section);
- scores at least a half a standard deviation worse than the mean on the World Health Organization Disability Schedule (WHO-DAS II).
You may not qualify if:
- current suicidal/homicide intent or plan assessed by The Columbia Suicide Severity Rating Scale, schizophrenia or current psychotic symptoms
- self-reported diagnosis of a degenerative brain disorder or serious psychiatric or medical illness which may limit generalizability of the findings, limit safety or account for the symptoms of GWI.
- a disability that would preclude telephone use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730, United States
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018, United States
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, 14424, United States
Related Publications (5)
Sullivan N, Schorpp H, Crosky S, Thien S, Helmer DA, Litke DR, Pigeon WR, Quigley KS, McAndrew LM. Treatment and life goals among veterans with Gulf War illness. PLoS One. 2023 Nov 30;18(11):e0295168. doi: 10.1371/journal.pone.0295168. eCollection 2023.
PMID: 38033143DERIVEDKane NS, Hassabelnaby R, Sullivan NL, Graff F, Litke DR, Quigley KS, Pigeon WR, Rath JF, Helmer DA, McAndrew LM. Veteran Beliefs About the Causes of Gulf War Illness and Expectations for Improvement. Int J Behav Med. 2024 Feb;31(1):169-174. doi: 10.1007/s12529-023-10166-1. Epub 2023 Mar 27.
PMID: 36973578DERIVEDWinograd DM, Hyde JK, Bloeser K, Santos SL, Anastasides N, Petrakis BA, Pigeon WR, Litke DR, Helmer DA, McAndrew LM. Exploring the acceptability of behavioral interventions for veterans with persistent "medically unexplained" physical symptoms. J Psychosom Res. 2023 Apr;167:111193. doi: 10.1016/j.jpsychores.2023.111193. Epub 2023 Feb 14.
PMID: 36822031DERIVEDMcAndrew LM, Quigley KS, Lu SE, Litke D, Rath JF, Lange G, Santos SL, Anastasides N, Petrakis BA, Greenberg L, Helmer DA, Pigeon WR. Effect of Problem-solving Treatment on Self-reported Disability Among Veterans With Gulf War Illness: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2245272. doi: 10.1001/jamanetworkopen.2022.45272.
PMID: 36472870DERIVEDSullivan N, Phillips LA, Pigeon WR, Quigley KS, Graff F, Litke DR, Helmer DA, Rath JF, McAndrew LM. Coping with Medically Unexplained Physical Symptoms: the Role of Illness Beliefs and Behaviors. Int J Behav Med. 2019 Dec;26(6):665-672. doi: 10.1007/s12529-019-09817-z.
PMID: 31701389DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa McAndrew
- Organization
- Veterans Affairs New Jersey Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa M McAndrew, PhD
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 11, 2014
Study Start
January 1, 2015
Primary Completion
December 31, 2018
Study Completion
September 1, 2019
Last Updated
August 26, 2020
Results First Posted
June 4, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share