Trial Outcomes & Findings for Cognitive Rehabilitation for Gulf War Illness (NCT NCT02161133)
NCT ID: NCT02161133
Last Updated: 2020-08-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
268 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-08-26
Participant Flow
Participant milestones
| Measure |
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.
|
Health Education
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
133
|
|
Overall Study
COMPLETED
|
116
|
122
|
|
Overall Study
NOT COMPLETED
|
19
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Rehabilitation for Gulf War Illness
Baseline characteristics by cohort
| Measure |
Problem-Solving Therapy
n=135 Participants
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.
|
Health Education
n=133 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
135 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
World Health Organization DIsability Assessment Schedule 2.0
|
46 units on a scale
STANDARD_DEVIATION 18.1 • n=5 Participants
|
44.8 units on a scale
STANDARD_DEVIATION 19.1 • n=7 Participants
|
45.4 units on a scale
STANDARD_DEVIATION 18.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksWorld 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.
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Disability - WHO-DAS 2 Change
|
-2.81 score on a scale
Standard Error 1.16
|
-2.21 score on a scale
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksSelf-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Problem-Solving Inventory Change
|
-12.77 score on a scale
Standard Error 1.77
|
-6.53 score on a scale
Standard Error 1.74
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who were unable to come in person did not complete this measure, as a result the overall number analyzed was smaller.
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.
Outcome measures
| Measure |
Problem-Solving Therapy
n=75 Participants
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.
|
Health Education
n=86 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Problem-Solving Ability Change
|
13.81 score on a scale
Standard Error 7.5
|
1.58 score on a scale
Standard Error 7.29
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsWorld 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.
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Disability - WHO-DAS 2 Change
|
-2.61 score on a scale
Standard Error 1.45
|
1.11 score on a scale
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsSelf-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Problem-Solving Inventory Change
|
-7.03 score on a scale
Standard Error 2.91
|
0.26 score on a scale
Standard Error 1.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability.
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Pain Disability Change
|
-2.05 score on a scale
Standard Error 1.13
|
-0.68 score on a scale
Standard Error 1.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 weeksthree items assessing pain severity. scores range 0-18 with higher scores=worse severity
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Multidimensional Pain Inventory - Pain Severity Subscale Change
|
0 score on a scale
Standard Error 0.10
|
-0.06 score on a scale
Standard Error 0.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksThe Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue
Outcome measures
| Measure |
Problem-Solving Therapy
n=116 Participants
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.
|
Health Education
n=122 Participants
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Fatigue Change
|
-2.71 score on a scale
Standard Error 0.98
|
-0.82 score on a scale
Standard Error 0.95
|
Adverse Events
Problem-Solving Therapy
Serious events: 21 serious events
Other events: 15 other events
Deaths: 1 deaths
Health Education
Serious events: 31 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Problem-Solving Therapy
n=135 participants at risk
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.
|
Health Education
n=133 participants at risk
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Psychiatric disorders
increasing emotionally labile, tearful, disorganized thinking
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
increased nightmares
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
ER visit
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.75%
1/133 • Number of events 2 • 9 months
|
|
General disorders
ER Visit
|
3.0%
4/135 • Number of events 4 • 9 months
|
3.0%
4/133 • Number of events 4 • 9 months
|
|
Nervous system disorders
Admitted to hospital for numbness in arm
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Gastrointestinal disorders
Admitted to hospital for severe abdominal pain
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Admitted to hospital for pneumonia
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
General disorders
Scheduled plastic surgery
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Nervous system disorders
ER Visit
|
0.00%
0/135 • 9 months
|
1.5%
2/133 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
ER Visit
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Kidney removed; no chemo or radiation at this time
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Unplanned surgery for intestinal blockage.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Overwhelmed from reflecting about GWI Sx. Felt better after journaling.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Emotional difficulty during QI. Nighmares after Baseline Visit.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
General disorders
Hospitalized for abdominal pain; Dx with hernia and discharged 3 days after
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
General disorders
Admitted to hospital for passing out on motorcycle.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Hospitalized for same day posterior cervical laminectomy surgery.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Increased depression and Suicidal Ideation. Has chronic SI.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Eye disorders
Cataract surgery; overnight stay. Increased dizziness.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Surgical and medical procedures
Hospital same day surgery for cyst removal from lower back.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Increase in intensity of suicidal ideation without intent. Has a history of SI.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Increased headaches; previous unreported passive SI when experience headache episode.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Psychiatric disorders
ER Visit
|
0.00%
0/135 • 9 months
|
1.5%
2/133 • Number of events 2 • 9 months
|
|
Surgical and medical procedures
Hysterectomy surgery and overnight stay at hospital. ER on different day for abnormal amount of blee
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Dx with Kidney cancer; operation to remove cancer - hospitalized 2 days.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
General disorders
Hip replacement and diagnosed with heart disease approx. 1 month after hip replacement
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Surgical and medical procedures
Right nephrectomy due to mass found in kidney. Hospitalized for 2 days and discharged.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Psychiatric disorders
Increased suicidal ideation
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Cardiac disorders
ER Visit
|
0.00%
0/135 • 9 months
|
4.5%
6/133 • Number of events 6 • 9 months
|
|
Social circumstances
ER Visit
|
4.4%
6/135 • Number of events 6 • 9 months
|
0.00%
0/133 • 9 months
|
|
Immune system disorders
ER Visit
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
Problem-Solving Therapy
n=135 participants at risk
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.
|
Health Education
n=133 participants at risk
Health education provides didactic information about Gulf War Illness
Health Education: Health Education provides didactic information about Gulf War Illness
|
|---|---|---|
|
Psychiatric disorders
distressing memories
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Immune system disorders
Allergic reaction
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Cardiac disorders
Chest spasms
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Foot issue
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Nervous system disorders
Hand numbness
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis/bronchitis
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
General disorders
Herniated disk
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
General disorders
Extreme pain and heat in body
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
General disorders
Heartburn, vertigo
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
General disorders
Excessive daytime sleepiness
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
General disorders
Cramping L hand and R foot
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash on face, affecting eyes
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Nervous system disorders
Left shoulder pain
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash on left ear
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Social circumstances
Mononucleosis
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Recurrence of IBS
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Nervous system disorders
Pain up R arm and hand
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Psychiatric disorders
Increased frequency of nightmares as a result of increasing social activities
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Nervous system disorders
Trouble with memory - signing name
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Torn bicep muscle playing ball
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Thrown out back from building shelves and drawers.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Nervous system disorders
Increased pain and sciatica due to increased exercise on treadmill/stationary bike.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Nervous system disorders
Increasing arthritis pain in foot since car accident 3 months ago.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Gastrointestinal disorders
ER Visit
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Psychiatric disorders
Increased frequency of nightmares to 1/week from 3-4 times/year.
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Passive SI without intent or plan.
|
0.74%
1/135 • Number of events 1 • 9 months
|
0.00%
0/133 • 9 months
|
|
Psychiatric disorders
PTSD symptoms
|
0.00%
0/135 • 9 months
|
0.75%
1/133 • Number of events 1 • 9 months
|
Additional Information
Lisa McAndrew
Veterans Affairs New Jersey Healthcare System
Phone: 862-400-3317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place