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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Problem-Solving Therapy | Experimental | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. |
|
| Health Education | Active Comparator | Health education provides didactic information about Gulf War Illness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-Solving Therapy | Behavioral | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Problem-Solving Inventory Change | Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability. | Baseline and 12 weeks |
| Problem-Solving Ability Change |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Disability Change | Pain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability. | Baseline and 12 weeks |
| Multidimensional Pain Inventory - Pain Severity Subscale Change |
Inclusion Criteria:
Inclusion:
Exclusion Criteria:
Exclusion:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M McAndrew, PhD | East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA | Bedford | Massachusetts | 01730 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38033143 | Derived | 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. | |
| 36973578 | Derived | Kane 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Problem-Solving Therapy | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. |
| FG001 | Health Education | Health education provides didactic information about Gulf War Illness Health Education: Health Education provides didactic information about Gulf War Illness |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Problem-Solving Therapy | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. |
| BG001 | Health Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Problem-Solving Therapy | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increasing emotionally labile, tearful, disorganized thinking | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| distressing memories | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa McAndrew | Veterans Affairs New Jersey Healthcare System | 862-400-3317 | lisa.mcandrew@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2018 | Mar 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Health Education | Behavioral | Health Education provides didactic information about Gulf War Illness |
|
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.
| 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:
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 6 months |
| Problem-Solving Inventory Change | Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability. | Baseline and 6 months |
three items assessing pain severity. scores range 0-18 with higher scores=worse severity
| baseline and 12 weeks |
| Fatigue Change | The Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue | Baseline and 12 weeks |
| 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 |
| 36822031 | Derived | Winograd 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. |
| 36472870 | Derived | McAndrew 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. |
| 31701389 | Derived | Sullivan 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. |
Health education provides didactic information about Gulf War Illness Health Education: Health Education provides didactic information about Gulf War Illness |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| World Health Organization DIsability Assessment Schedule 2.0 | World Health Organization Disability Assessment Schedule. The WHO-DAS 2.0 measures disability due to physical and mental health conditions. It reflects two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Health Education | Health education provides didactic information about Gulf War Illness Health Education: Health Education provides didactic information about Gulf War Illness |
|
|
|
| Secondary | Problem-Solving Inventory Change | Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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. | Participants who were unable to come in person did not complete this measure, as a result the overall number analyzed was smaller. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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:
These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability. | Posted | Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
|
| Other Pre-specified | Pain Disability Change | Pain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Multidimensional Pain Inventory - Pain Severity Subscale Change | three items assessing pain severity. scores range 0-18 with higher scores=worse severity | Posted | Mean | Standard Error | score on a scale | baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Fatigue Change | The Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Problem-Solving Inventory Change | Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability. | Posted | Mean | Standard Error | score on a scale | Baseline and 6 months |
|
|
|
|
| 1 |
| 135 |
| 21 |
| 135 |
| 15 |
| 135 |
| EG001 | Health Education | Health education provides didactic information about Gulf War Illness Health Education: Health Education provides didactic information about Gulf War Illness | 0 | 133 | 31 | 133 | 14 | 133 |
| increased nightmares | Psychiatric disorders | Non-systematic Assessment |
|
| ER visit | Gastrointestinal disorders | Non-systematic Assessment |
|
| ER Visit | General disorders | Non-systematic Assessment |
|
| Admitted to hospital for numbness in arm | Nervous system disorders | Non-systematic Assessment |
|
| Admitted to hospital for severe abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Admitted to hospital for pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Scheduled plastic surgery | General disorders | Non-systematic Assessment |
|
| ER Visit | Nervous system disorders | Non-systematic Assessment |
|
| ER Visit | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Kidney removed; no chemo or radiation at this time | Surgical and medical procedures | Non-systematic Assessment |
|
| Unplanned surgery for intestinal blockage. | Surgical and medical procedures | Non-systematic Assessment |
|
| Overwhelmed from reflecting about GWI Sx. Felt better after journaling. | Psychiatric disorders | Non-systematic Assessment |
|
| Emotional difficulty during QI. Nighmares after Baseline Visit. | Psychiatric disorders | Non-systematic Assessment |
|
| Hospitalized for abdominal pain; Dx with hernia and discharged 3 days after | General disorders | Non-systematic Assessment |
|
| Admitted to hospital for passing out on motorcycle. | General disorders | Non-systematic Assessment |
|
| Hospitalized for same day posterior cervical laminectomy surgery. | Surgical and medical procedures | Non-systematic Assessment |
|
| Increased depression and Suicidal Ideation. Has chronic SI. | Psychiatric disorders | Non-systematic Assessment |
|
| Cataract surgery; overnight stay. Increased dizziness. | Eye disorders | Non-systematic Assessment |
|
| Hospital same day surgery for cyst removal from lower back. | Surgical and medical procedures | Non-systematic Assessment |
|
| Increase in intensity of suicidal ideation without intent. Has a history of SI. | Psychiatric disorders | Non-systematic Assessment |
|
| Increased headaches; previous unreported passive SI when experience headache episode. | Psychiatric disorders | Non-systematic Assessment |
|
| ER Visit | Psychiatric disorders | Non-systematic Assessment |
|
| Hysterectomy surgery and overnight stay at hospital. ER on different day for abnormal amount of blee | Surgical and medical procedures | Non-systematic Assessment |
|
| Dx with Kidney cancer; operation to remove cancer - hospitalized 2 days. | Surgical and medical procedures | Non-systematic Assessment |
|
| Hip replacement and diagnosed with heart disease approx. 1 month after hip replacement | General disorders | Non-systematic Assessment |
|
| Right nephrectomy due to mass found in kidney. Hospitalized for 2 days and discharged. | Surgical and medical procedures | Non-systematic Assessment |
|
| Increased suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| ER Visit | Cardiac disorders | Non-systematic Assessment |
|
| ER Visit | Social circumstances | Non-systematic Assessment |
|
| ER Visit | Immune system disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Chest spasms | Cardiac disorders | Non-systematic Assessment |
|
| Foot issue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hand numbness | Nervous system disorders | Non-systematic Assessment |
|
| Sinusitis/bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Herniated disk | General disorders | Non-systematic Assessment |
|
| Extreme pain and heat in body | General disorders | Non-systematic Assessment |
|
| Heartburn, vertigo | General disorders | Non-systematic Assessment |
|
| Excessive daytime sleepiness | General disorders | Non-systematic Assessment |
|
| Cramping L hand and R foot | General disorders | Non-systematic Assessment |
|
| Rash on face, affecting eyes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Left shoulder pain | Nervous system disorders | Non-systematic Assessment |
|
| Rash on left ear | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Mononucleosis | Social circumstances | Non-systematic Assessment |
|
| Recurrence of IBS | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain up R arm and hand | Nervous system disorders | Non-systematic Assessment |
|
| Increased frequency of nightmares as a result of increasing social activities | Psychiatric disorders | Non-systematic Assessment |
|
| Trouble with memory - signing name | Nervous system disorders | Non-systematic Assessment |
|
| Torn bicep muscle playing ball | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Thrown out back from building shelves and drawers. | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Increased pain and sciatica due to increased exercise on treadmill/stationary bike. | Nervous system disorders | Non-systematic Assessment |
|
| Increasing arthritis pain in foot since car accident 3 months ago. | Nervous system disorders | Non-systematic Assessment |
|
| ER Visit | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased frequency of nightmares to 1/week from 3-4 times/year. | Psychiatric disorders | Non-systematic Assessment |
|
| Passive SI without intent or plan. | Psychiatric disorders | Non-systematic Assessment |
|
| PTSD symptoms | Psychiatric disorders | Non-systematic Assessment |
|
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