Cognitive Rehabilitation for Gulf War Illness
NCT02161133, Not applicable, Completed, VA Office of Research and Development; results first posted 2020-06-04
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Rehabilitation for Gulf War Illness | ClinicalTrials.gov |
| NCT number | NCT02161133 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 268 participants, actual | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Gulf War Illness | ClinicalTrials.gov |
| Interventions | Problem-Solving Therapy, Health Education | ClinicalTrials.gov |
| First posted | 2014-06-11 | ClinicalTrials.gov |
| Last updated | 2020-08-26 | ClinicalTrials.gov |
| Results first posted | 2020-06-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Disability - WHO-DAS 2 Change | 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. | ClinicalTrials.gov |
| Secondary | Problem-Solving Inventory Change | Baseline and 12 weeks | Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability. | ClinicalTrials.gov |
| Secondary | Problem-Solving Ability Change | Baseline and 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Disability - WHO-DAS 2 Change | Baseline and 6 months | 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. | ClinicalTrials.gov |
| Secondary | Problem-Solving Inventory Change | Baseline and 6 months | Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability. | ClinicalTrials.gov |
| Other | Pain Disability Change | Baseline and 12 weeks | Pain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability. | ClinicalTrials.gov |
| Other | Multidimensional Pain Inventory - Pain Severity Subscale Change | baseline and 12 weeks | three items assessing pain severity. scores range 0-18 with higher scores=worse severity | ClinicalTrials.gov |
| Other | Fatigue Change | Baseline and 12 weeks | The Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue | ClinicalTrials.gov |
Outcomes 8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Disability - WHO-DAS 2 Change | Baseline and 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Problem-Solving Inventory Change | Baseline and 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Problem-Solving Ability Change | Baseline and 12 weeks | Participants who were unable to come in person did not complete this measure, as a result the overall number analyzed was smaller. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Disability - WHO-DAS 2 Change | Baseline and 6 months | score on a scale | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | Pain Disability Change | Baseline and 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | Multidimensional Pain Inventory - Pain Severity Subscale Change | baseline and 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | Fatigue Change | Baseline and 12 weeks | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Problem-Solving Inventory Change | Baseline and 6 months | score on a scale | MEAN | ClinicalTrials.gov |
Results by group 16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Disability - WHO-DAS 2 Change | Problem-Solving Therapy | -2.81 | Standard Error 1.16 | score on a scale | ClinicalTrials.gov | |
| Disability - WHO-DAS 2 Change | Health Education | -2.21 | Standard Error 1.12 | score on a scale | ClinicalTrials.gov | |
| Problem-Solving Inventory Change | Problem-Solving Therapy | -12.77 | Standard Error 1.77 | score on a scale | ClinicalTrials.gov | |
| Problem-Solving Inventory Change | Health Education | -6.53 | Standard Error 1.74 | score on a scale | ClinicalTrials.gov | |
| Problem-Solving Ability Change | Problem-Solving Therapy | 13.81 | Standard Error 7.5 | score on a scale | ClinicalTrials.gov | |
| Problem-Solving Ability Change | Health Education | 1.58 | Standard Error 7.29 | score on a scale | ClinicalTrials.gov | |
| Disability - WHO-DAS 2 Change | Problem-Solving Therapy | -2.61 | Standard Error 1.45 | score on a scale | ClinicalTrials.gov | |
| Disability - WHO-DAS 2 Change | Health Education | 1.11 | Standard Error 1.29 | score on a scale | ClinicalTrials.gov | |
| Pain Disability Change | Problem-Solving Therapy | -2.05 | Standard Error 1.13 | score on a scale | ClinicalTrials.gov | |
| Pain Disability Change | Health Education | -0.68 | Standard Error 1.09 | score on a scale | ClinicalTrials.gov | |
| Multidimensional Pain Inventory - Pain Severity Subscale Change | Problem-Solving Therapy | 0 | Standard Error 0.10 | score on a scale | ClinicalTrials.gov | |
| Multidimensional Pain Inventory - Pain Severity Subscale Change | Health Education | -0.06 | Standard Error 0.10 | score on a scale | ClinicalTrials.gov | |
| Fatigue Change | Problem-Solving Therapy | -2.71 | Standard Error 0.98 | score on a scale | ClinicalTrials.gov | |
| Fatigue Change | Health Education | -0.82 | Standard Error 0.95 | score on a scale | ClinicalTrials.gov | |
| Problem-Solving Inventory Change | Problem-Solving Therapy | -7.03 | Standard Error 2.91 | score on a scale | ClinicalTrials.gov | |
| Problem-Solving Inventory Change | Health Education | 0.26 | Standard Error 1.94 | score on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Problem-Solving Therapy | 135 | ClinicalTrials.gov | |
| Overall Study | STARTED | Health Education | 133 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Problem-Solving Therapy | 116 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Health Education | 122 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Problem-Solving Therapy | 19 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Health Education | 11 | ClinicalTrials.gov |
Adverse events 120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | distressing memories | Psychiatric disorders | Problem-Solving Therapy | 1 | 135 | 1 | ClinicalTrials.gov |
| other | distressing memories | Psychiatric disorders | Health Education | 0 | 133 | 0 | ClinicalTrials.gov |
| other | Allergic reaction | Immune system disorders | Problem-Solving Therapy | 1 | 135 | 1 | ClinicalTrials.gov |
| other | Allergic reaction | Immune system disorders | Health Education | 0 | 133 | 0 | ClinicalTrials.gov |
| other | Chest spasms | Cardiac disorders | Problem-Solving Therapy | 0 | 135 | 0 | ClinicalTrials.gov |
| other | Chest spasms | Cardiac disorders | Health Education | 1 | 133 | 1 | ClinicalTrials.gov |
| other | Foot issue | Musculoskeletal and connective tissue disorders | Problem-Solving Therapy | 0 | 135 | 0 | ClinicalTrials.gov |
| other | Foot issue | Musculoskeletal and connective tissue disorders | Health Education | 1 | 133 | 1 | ClinicalTrials.gov |
| other | Hand numbness | Nervous system disorders | Problem-Solving Therapy | 1 | 135 | 1 | ClinicalTrials.gov |
| other | Hand numbness | Nervous system disorders | Health Education | 0 | 133 | 0 | ClinicalTrials.gov |
| other | Sinusitis/bronchitis | Respiratory, thoracic and mediastinal disorders | Problem-Solving Therapy | 0 | 135 | 0 | ClinicalTrials.gov |
| other | Sinusitis/bronchitis | Respiratory, thoracic and mediastinal disorders | Health Education | 1 | 133 | 1 | ClinicalTrials.gov |
| other | Herniated disk | General disorders | Problem-Solving Therapy | 0 | 135 | 0 | ClinicalTrials.gov |
| other | Herniated disk | General disorders | Health Education | 1 | 133 | 1 | ClinicalTrials.gov |
| other | Extreme pain and heat in body | General disorders | Problem-Solving Therapy | 0 | 135 | 0 | ClinicalTrials.gov |
| other | Extreme pain and heat in body | General disorders | Health Education | 1 | 133 | 1 | ClinicalTrials.gov |
| other | Heartburn, vertigo | General disorders | Problem-Solving Therapy | 1 | 135 | 1 | ClinicalTrials.gov |
| other | Heartburn, vertigo | General disorders | Health Education | 0 | 133 | 0 | ClinicalTrials.gov |
| other | Excessive daytime sleepiness | General disorders | Problem-Solving Therapy | 1 | 135 | 1 | ClinicalTrials.gov |
| other | Excessive daytime sleepiness | General disorders | Health Education | 0 | 133 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Problem-Solving Therapy | 1 | 135 | ClinicalTrials.gov |
| Total, all-cause mortality | Health Education | 0 | 133 | ClinicalTrials.gov |
| Total, other adverse events | Problem-Solving Therapy | 15 | 135 | ClinicalTrials.gov |
| Total, other adverse events | Health Education | 14 | 133 | ClinicalTrials.gov |
| Total, serious adverse events | Problem-Solving Therapy | 21 | 135 | ClinicalTrials.gov |
| Total, serious adverse events | Health Education | 31 | 133 | ClinicalTrials.gov |
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Problem-Solving Therapy vs Health Education: deaths from any cause | Trial comparisons |
| Problem-Solving Therapy vs Health Education: serious adverse events | Trial comparisons |
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)