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NCT02161133

Cognitive Rehabilitation for Gulf War Illness

Completed NA Results posted Last updated 26 August 2020
What this trial tests

NA trial testing Problem-Solving Therapy in Gulf War Illness in 268 participants. Completed in 1 September 2019.

Timeline
1 January 2015
Primary endpoint
31 December 2018
1 September 2019

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment268
Start date1 January 2015
Primary completion31 December 2018
Estimated completion1 September 2019
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 80, any sex, with Gulf War Illness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disability - WHO-DAS 2 Change Primary · 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

GroupValue95% CI
Problem-Solving Therapy-2.81± 1.16
Health Education-2.21± 1.12
Problem-Solving Inventory Change Secondary · Baseline and 12 weeks

Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.

GroupValue95% CI
Problem-Solving Therapy-12.77± 1.77
Health Education-6.53± 1.74
Problem-Solving Ability Change Secondary · 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 referenc

GroupValue95% CI
Problem-Solving Therapy13.81± 7.5
Health Education1.58± 7.29
Disability - WHO-DAS 2 Change Secondary · 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

GroupValue95% CI
Problem-Solving Therapy-2.61± 1.45
Health Education1.11± 1.29
Pain Disability Change Secondary · Baseline and 12 weeks

Pain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability.

GroupValue95% CI
Problem-Solving Therapy-2.05± 1.13
Health Education-0.68± 1.09
Multidimensional Pain Inventory - Pain Severity Subscale Change Secondary · baseline and 12 weeks

three items assessing pain severity. scores range 0-18 with higher scores=worse severity

GroupValue95% CI
Problem-Solving Therapy0± 0.10
Health Education-0.06± 0.10
Fatigue Change Secondary · Baseline and 12 weeks

The Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue

GroupValue95% CI
Problem-Solving Therapy-2.71± 0.98
Health Education-0.82± 0.95
Problem-Solving Inventory Change Secondary · Baseline and 6 months

Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.

GroupValue95% CI
Problem-Solving Therapy-7.03± 2.91
Health Education0.26± 1.94

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Problem-Solving Therapy
Serious: 21/135 (16%)
Deaths: 1/135
Health Education
Serious: 31/133 (23%)
Deaths: 0/133

Serious adverse events (31 terms)

ReactionSystemProblem-Solving TherapyHealth Education
ER VisitCardiac disorders
ER VisitSocial circumstances
ER VisitGeneral disorders
ER VisitNervous system disorders
ER VisitPsychiatric disorders
increasing emotionally labile, tearful, disorganized thinkingPsychiatric disorders
increased nightmaresPsychiatric disorders
ER visitGastrointestinal disorders
Admitted to hospital for numbness in armNervous system disorders
Admitted to hospital for severe abdominal painGastrointestinal disorders
Admitted to hospital for pneumoniaRespiratory, thoracic and mediastinal disorders
Scheduled plastic surgeryGeneral disorders
ER VisitRespiratory, thoracic and mediastinal disorders
Kidney removed; no chemo or radiation at this timeSurgical and medical procedures
Unplanned surgery for intestinal blockage.Surgical and medical procedures
Overwhelmed from reflecting about GWI Sx. Felt better after journaling.Psychiatric disorders
Emotional difficulty during QI. Nighmares after Baseline Visit.Psychiatric disorders
Hospitalized for abdominal pain; Dx with hernia and discharged 3 days afterGeneral disorders
Admitted to hospital for passing out on motorcycle.General disorders
Hospitalized for same day posterior cervical laminectomy surgery.Surgical and medical procedures
Increased depression and Suicidal Ideation. Has chronic SI.Psychiatric disorders
Cataract surgery; overnight stay. Increased dizziness.Eye disorders
Hospital same day surgery for cyst removal from lower back.Surgical and medical procedures
Increase in intensity of suicidal ideation without intent. Has a history of SI.Psychiatric disorders
Increased headaches; previous unreported passive SI when experience headache episode.Psychiatric disorders
Other adverse events (29 terms — click to expand)

ReactionSystemProblem-Solving TherapyHealth Education
distressing memoriesPsychiatric disorders
Allergic reactionImmune system disorders
Chest spasmsCardiac disorders
Foot issueMusculoskeletal and connective tissue disorders
Hand numbnessNervous system disorders
Sinusitis/bronchitisRespiratory, thoracic and mediastinal disorders
Herniated diskGeneral disorders
Extreme pain and heat in bodyGeneral disorders
Heartburn, vertigoGeneral disorders
Excessive daytime sleepinessGeneral disorders
Cramping L hand and R footGeneral disorders
Rash on face, affecting eyesSkin and subcutaneous tissue disorders
BronchitisRespiratory, thoracic and mediastinal disorders
TachycardiaCardiac disorders
Left shoulder painNervous system disorders
Rash on left earSkin and subcutaneous tissue disorders
MononucleosisSocial circumstances
Recurrence of IBSGastrointestinal disorders
Pain up R arm and handNervous system disorders
Increased frequency of nightmares as a result of increasing social activitiesPsychiatric disorders
Trouble with memory - signing nameNervous system disorders
Torn bicep muscle playing ballMusculoskeletal and connective tissue disorders
Thrown out back from building shelves and drawers.Musculoskeletal and connective tissue disorders
Increased pain and sciatica due to increased exercise on treadmill/stationary bike.Nervous system disorders
Increasing arthritis pain in foot since car accident 3 months ago.Nervous system disorders
ER VisitGastrointestinal disorders
Increased frequency of nightmares to 1/week from 3-4 times/year.Psychiatric disorders
Passive SI without intent or plan.Psychiatric disorders
PTSD symptomsPsychiatric disorders

Most-reported serious reactions: ER Visit, ER Visit, ER Visit, ER Visit, ER Visit, increasing emotionally labile, tearful, disorganized thinking, increased nightmares, ER visit.

Data from ClinicalTrials.gov NCT02161133 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gulf War Illness: Mechanisms Underlying Brain Dysfunction and Promising Therapeutic Strategies.
    Dickey B, Madhu LN, Shetty AK. · · 2021 · cited 54× · PMID 33164782 · DOI 10.1016/j.pharmthera.2020.107716
  2. Coping with Medically Unexplained Physical Symptoms: the Role of Illness Beliefs and Behaviors.
    Sullivan N, Phillips LA, Pigeon WR, Quigley KS, et al · · 2019 · cited 15× · PMID 31701389 · DOI 10.1007/s12529-019-09817-z
  3. Effect of Problem-solving Treatment on Self-reported Disability Among Veterans With Gulf War Illness: A Randomized Clinical Trial.
    McAndrew LM, Quigley KS, Lu SE, Litke D, et al · · 2022 · cited 9× · PMID 36472870 · DOI 10.1001/jamanetworkopen.2022.45272
  4. Helpful ways providers can communicate about persistent medically unexplained physical symptoms.
    Anastasides N, Chiusano C, Gonzalez C, Graff F, et al · · 2019 · cited 9× · PMID 30651073 · DOI 10.1186/s12875-018-0881-8
  5. Veterans with Gulf War Illness perceptions of management strategies.
    Winograd DM, Sullivan NL, Thien SR, Pigeon WR, et al · · 2021 · cited 8× · PMID 33592197 · DOI 10.1016/j.lfs.2021.119219
  6. Understanding Veterans' Causal Attributions of Physical Symptoms.
    Kimber J, Sullivan N, Anastasides N, Slotkin S, et al · · 2021 · cited 3× · PMID 32691396 · DOI 10.1007/s12529-020-09918-0
  7. Treatment and life goals among veterans with Gulf War illness.
    Sullivan N, Schorpp H, Crosky S, Thien S, et al · · 2023 · cited 2× · PMID 38033143 · DOI 10.1371/journal.pone.0295168
  8. Veteran Beliefs About the Causes of Gulf War Illness and Expectations for Improvement.
    Kane NS, Hassabelnaby R, Sullivan NL, Graff F, et al · · 2024 · PMID 36973578 · DOI 10.1007/s12529-023-10166-1

Verify or expand the search:

Other trials of Problem-Solving Therapy

Trials testing the same drug.

Other recruiting trials for Gulf War Illness

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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