Gulf War IllnessNCT02161133
Cognitive Rehabilitation for Gulf War Illness
A study testing Problem-Solving Therapy and Health Education in people with Gulf War Illness, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Problem-Solving Therapy and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2015to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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).
Who cannot join
- 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.
- Exclusionary medical illnesses include: Class 3 and 4 heart failure, cancer diagnosed within the past year and/or undergoing active treatment (chemotherapy or radiation therapy), chronic renal insufficiency, hospitalization due to myocardial infarct, stroke in the past year, a neurodegenerative disorder, or another medical or psychiatric disorder that may limit generalizability, limit participants safety or account for the symptoms of GWI at the discretion of the PI.
- a disability that would preclude telephone use.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, 14424
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
About this study
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.
Read the detailed description
Gulf War Illness (GWI) is a complex multi-dimensional illness which causes as much disability as other major medical diseases. Previous clinical trials (i.e. cognitive behavioral therapy and graded exercise) for GWI have sought to improve disability by increasing activity regardless of symptom presentation. These previous trials for GWI have shown limited efficacy and poor adherence. An innovative treatment approach is to target a specific component of GWI, namely problem-solving ability, known to be associated with disability.
Impairment in problem-solving ability affects Gulf War Veterans (GWV) with GWI and is prospectively related to greater risk of disability. This impairment is also related to poorer adherence to medical regimes, making it difficult for GWV to manage other aspects of GWI. Problem-solving is considered one of the most complex of cognitive abilities and is related to complicated behaviors such as setting goals, sequencing and multi-tasking. Despite published reports documenting these deficits there are no treatments that target the problem-solving deficits of GWI in order to reduce disability.
The investigators propose a targeted treatment, Problem-Solving Therapy, to compensate for the problem-solving deficits of GWI and thereby reducing disability. Problem-Solving Therapy, a top down approach, teaches patients skills to overcome problems like cognitive dysfunction or physical symptoms that impact problem-solving. Compensating for problem-solving deficits would reduce disability and provide information on the effect of treating one component of GWI on other symptoms of GWI. This is the first trial of cognitive rehabilitation therapy for GWI.
- Conditions
- Gulf War Illness
- Being tested
- Problem-Solving Therapy, Health Education
- Keywords
- Veterans, neuropsychology, fatigue, Chronic Multisymptom Illness, Gulf War Illness, behavioral treatment
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving TherapyBehavioural
Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
Health EducationBehavioural
Health Education provides didactic information about Gulf War Illness
| Study group | Role | What they receive |
|---|---|---|
| Problem-Solving Therapy | Experimental | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. Receives: Behavioral: Problem-Solving Therapy |
| Health Education | Active comparator | Health education provides didactic information about Gulf War Illness Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Problem-Solving Inventory Change
Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.
Measured: Baseline and 12 weeks
Problem-Solving Ability Change
Neuropsychological Battery includes: Halstead Category Test, Russell Revised Version, The Conner's Continuous Performance Test-3 (CPT-3), Stroop Color and Word Test, Trails Making Test A and B (TMT). Problem-solving ability was be created by standardizing (i.e., converting to z-scores) these neuropsychological tests based on administrative norms and averaging them. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater problem solving.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 6 months
Problem-Solving Inventory Change
Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa M McAndrew, PhD, Principal investigator, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161133
- Sponsor's protocol ID
- SPLD-009-13S
- Status last verified
- Aug 2020
- First submitted
- 9 Jun 2014
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38033143Kane 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.
PubMed 36973578Winograd 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.
PubMed 36822031McAndrew 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.
PubMed 36472870Sullivan 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.
PubMed 31701389
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation for Gulf War Illness
- ClinicalTrials.gov ID
- NCT02161133
- Acronym / sponsor ID
- SPLD-009-13S
- Conditions
- Gulf War Illness
- Keywords
- Veterans, neuropsychology, fatigue, Chronic Multisymptom Illness, Gulf War Illness, behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gulf War Illness (GWI) is a complex multi-dimensional illness which causes as much disability as other major medical diseases. Previous clinical trials (i.e. cognitive behavioral therapy and graded exercise) for GWI have sought to improve disability by increasing activity regardless of symptom presentation. These previous trials for GWI have shown limited efficacy and poor adherence. An innovative treatment approach is to target a specific component of GWI, namely problem-solving ability, known to be associated with disability.
Impairment in problem-solving ability affects Gulf War Veterans (GWV) with GWI and is prospectively related to greater risk of disability. This impairment is also related to poorer adherence to medical regimes, making it difficult for GWV to manage other aspects of GWI. Problem-solving is considered one of the most complex of cognitive abilities and is related to complicated behaviors such as setting goals, sequencing and multi-tasking. Despite published reports documenting these deficits there are no treatments that target the problem-solving deficits of GWI in order to reduce disability.
The investigators propose a targeted treatment, Problem-Solving Therapy, to compensate for the problem-solving deficits of GWI and thereby reducing disability. Problem-Solving Therapy, a top down approach, teaches patients skills to overcome problems like cognitive dysfunction or physical symptoms that impact problem-solving. Compensating for problem-solving deficits would reduce disability and provide information on the effect of treating one component of GWI on other symptoms of GWI. This is the first trial of cognitive rehabilitation therapy for GWI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem-Solving Therapy | Experimental | Behavioral: Problem-Solving TherapyProblem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. |
| Health Education | Active comparator | Behavioral: Health EducationHealth education provides didactic information about Gulf War Illness |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
- Exclusionary medical illnesses include: Class 3 and 4 heart failure, cancer diagnosed within the past year and/or undergoing active treatment (chemotherapy or radiation therapy), chronic renal insufficiency, hospitalization due to myocardial infarct, stroke in the past year, a neurodegenerative disorder, or another medical or psychiatric disorder that may limit generalizability, limit participants safety or account for the symptoms of GWI at the discretion of the PI.
- a disability that would preclude telephone use.
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 |
|---|---|---|
| Problem-Solving TherapyProblem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. | Behavioural | Problem-Solving Therapy |
| Health EducationHealth Education provides didactic information about Gulf War Illness | Behavioural | Health Education |
Primary outcome
Disability - WHO-DAS 2 Change
Time frame: Baseline and 12 weeks
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.
4 secondary outcomes
Problem-Solving Inventory Change
Time frame: Baseline and 12 weeks
Problem-Solving Ability Change
Time frame: Baseline and 12 weeks
Disability - WHO-DAS 2 Change
Time frame: Baseline and 6 months
Problem-Solving Inventory Change
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38033143Sullivan 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.
- Derived from this study: PubMed 36973578Kane 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.
- Derived from this study: PubMed 36822031Winograd 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.
- Derived from this study: PubMed 36472870McAndrew 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.
- Derived from this study: PubMed 31701389Sullivan 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.
- Individual participant dataSharing planned: No
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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.
Lisa M McAndrew, PhD principal investigator
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Therapy and Health Education in people with Gulf War Illness, run by VA Office of Research and Development at 3 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disability - WHO-DAS 2 Change (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161133, which also lists 5 linked publications.
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 26 Aug 2020.