Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD
NCT04251624, Not applicable, Unknown, Homewood Research Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD | ClinicalTrials.gov |
| NCT number | NCT04251624 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 88 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Homewood Research Institute | ClinicalTrials.gov |
| Conditions | Post Traumatic Stress Disorder, Cognitive Deficit | ClinicalTrials.gov |
| Interventions | Goal Management Therapy, Psychosocial Education | ClinicalTrials.gov |
| First posted | 2020-02-05 | ClinicalTrials.gov |
| Last updated | 2024-01-16 | ClinicalTrials.gov |
Registered outcomes 74
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Score on the Delis-Kaplan Executive Function System (D-KEFS) Tower Test | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A neuropsychological assessment of planning, rule learning, response inhibition, and perseveration. Six scores are calculated: i) Total Achievement Score, which is the sum of achievement scores for all items administered. ii) Mean First-Move Time which reflects the average of the examinee's first move times. iii) Time-Per-Move Ratio, which indicates the average time the examinee takes to make each of his or her moves. iv) Move Accuracy Ratio is a means of assessing the efficiency with which the examinee constructed the towers. v) Total Rule Violations represents the total number of rule violations committed by the examinee across all items administered. vi) Rule-Violations-Per Item Ratio, reflects the average number of rule violations made by the examinee relative to the number of items administered. The total number of rule violations across all items administered is divided by the number of items administered. Higher scores indicate greater executive functioning performance. | ClinicalTrials.gov |
| Primary | Change in Score on the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A neuropsychological assessment of processing speed. In a time limit of 120 seconds, the participant copies symbols that are paired with numbers based on a symbol key. The total raw score is calculated by scoring 1 point for each correctly drawn symbol completed within the time limit. Raw scores range between 0 and 135 points. The raw score is converted to a scaled score corrected for age and the scaled score may range between 1 and 19. Higher scaled scores indicate greater processing speed than lower scaled scores. | ClinicalTrials.gov |
| Primary | Change in Score on Conners Continuous Performance Task Third Edition (CPT-3) | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A neuropsychological assessment of inattentiveness, impulsivity, sustained attention, and vigilance. Values include: i) D-prime-discrimination of non targets from targets; ii) Omissions- all missed targets; iii) Commissions- all incorrect responses to non-targets; iv) Perseverations- response in less than 100 milliseconds following the presentation of a stimulus; v) Hit Reaction Time- mean response speed measured in milliseconds for all non-perseverative responses made during the entire administration; vi) Hit Reaction Time SD-consistency of response speed to targets for the entire administration; vii) Variability- response speed consistency; viii) Hit Reaction Time Block Change- slope of change in Hit Reaction Time across the six blocks of the administration; and ix) Hit Reaction Time Inter-Stimulus Interval Change slope of change in reaction time across the three inter-stimulus intervals. All scores are presented in T scores with higher T scores indicating worse performance. | ClinicalTrials.gov |
| Primary | Change in Score on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months | The WHODAS 2.0 is a 12-item self-report measure of six functional domains, including cognition, mobility, self-care, getting along with others, life activities, and participation in the community. The WHODAS 2.0 uses a Likert scale ranging from 0 ("No difficulty") to 4 ("Extreme difficulty or cannot do"). Values across the 12 items are summed, with the total score ranging between 0 and 48. Higher values indicate greater functional impairment. | ClinicalTrials.gov |
| Primary | Change from Baseline in Score on the Cognitive Failures Questionnaire (CFQ) at 3 weeks post-intervention and 3 months post-intervention | Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. | The CFQ is a 25-item self-report measure that captures daily errors in distractibility, blunders, names, and memory. Each item is rated on a Likert scale from 0 ("Never") to 4 ("Very often"). The CFQ has four subscales that include: i) Memory (i.e., sum of scores on items 16, 18, 12, 17, 23, 13, 6, 3 for a total score between 0 and 32); ii) Distractibility (i.e., sum of scores on items 1, 15, 2, 19, 21, 22, 3, 4, 25 for a total score between 0 and 36); iii) Blunders (i.e., sum of scores on items 9, 8, 10, 24, 5, 14, 11 for a total score between 0 and 28); and iv) Names (i.e., sum of scores on items 20 and 7 for a total score between 0 and 8). The CFQ total score is the sum of the 25 items, with total values ranging between 0 and 100. Higher scores indicate greater self-reported impairment in cognitive functioning. | ClinicalTrials.gov |
| Primary | Change in Score on the Return to Work Obstacles and Self-Efficacy Scale - Common Mental Disorders (ROSES-CMD) | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A 46-item questionnaire that assesses readiness to return to work in individuals with common mental disorders on 10 possible dimensions: fears of a relapse, cognitive difficulties, medication-related difficulties, job demands, feeling of organization injustice, difficult relation-immediate supervisor, difficult relations-co-workers, difficult relations-insurance company, difficult work/life balance, and loss of motivation to return to work. Items use a 7-point response scale and include specific questions to assess perceived obstacles (1=not an obstacle, 7=Big obstacle) and self-efficacy beliefs about overcoming the obstacles (1=not at all capable, 7=completely capable). Higher scores on 'obstacles' items and lower scores on 'self-efficacy' items indicate decreased readiness to return-to-work. | ClinicalTrials.gov |
| Primary | Change from Baseline in Score on the VOT Hooper Visual Organization Test at 3 weeks post-intervention | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A neuropsychological assessment of visual integration, the VOT requires individuals to identify common object that have been fragmented by mentally rearranging fragments of the object presented on a card, with a total of 30 cards. The VOT is scored by hand to obtain a single raw score, which is then corrected based on age and level of education. The corrected raw score is used to derive a T score, which is the value of interest. Higher T scores reflect better performance. | ClinicalTrials.gov |
| Primary | Change in Score on the Rey-Osterrieth Complex Figure Test (RCFT) | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A neuropsychological test in which participants are required to copy a complex drawing to provide insight into individuals visuospatial/visuoconstructive abilities and areas of executive functioning (e.g., planning, organization). A single raw score is computed by hand using a manualized procedure which is then converted to a T score. This computed T score is the value of interest for this study, with higher T scores reflecting better performance. | ClinicalTrials.gov |
| Primary | Change in Score on the Depression Anxiety Stress Scale (DASS-21) | Phase 1 (Inpatient): Week 1, Week 3, and Week 6 of intervention, and post-intervention at 3 weeks | The DASS-21 is a self-report measure that assesses the presence and severity of symptoms of depression, anxiety, and stress over the last week. Respondents rate their symptoms on a 4-point scale with 0 representing absence of the symptom and 3 representing a symptom occurring almost all the time. Three scores are computed, one for each subscale (depression, anxiety, and stress), by summing all the values of the items on each respective subscale. The total scores for each subscale are then multiplied by 2. Higher scores reflect greater symptom severity and the calculated scores can be used to qualify the severity of the symptoms (e.g., normal/minimal, mild, moderate, severe, extremely severe). | ClinicalTrials.gov |
| Primary | Change in Score on the Stroop Colour and Word Test (SCWT) | Phase 1 (inpatient): Baseline and post-intervention at 3 weeks | A neuropsychological test where individuals read colour words or names ink colors from different pages as quickly as possible within a time limit. It provides indices of processing speed and areas of executive functioning, such as cognitive flexibility, resistance to interference, and response inhibition. The test includes three stimulus sheets that yield three raw scores that are the number of words or ink colors read within the time limit (min = 0; no max score). Raw scores are converted to T scores using manualized procedures. Higher T scores indicate better performance. | ClinicalTrials.gov |
| Primary | Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) | Phase 1 (inpatient): Baseline only | The TOPF is a word-reading neuropsychological test that estimates an individual's level of cognitive and memory functioning before the onset of injury or illness. The test yields one raw score (total number of words correctly read before the discontinue criteria was met) that is converted to a T score. Higher T scores indicate better performance. | ClinicalTrials.gov |
| Primary | Change from baseline in scores on the PTSD Checklist for DSM-5 (PCL-5) at post-intervention | Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention | A 20-item self-report measure that assesses the severity of PTSD symptoms according to the diagnostic criteria outlined in the DSM-5. Symptom domains are intrusions, avoidance, negative alterations in mood and cognitions, and alterations in arousal and reactivity. | ClinicalTrials.gov |
| Primary | Change from baseline in scores on the Depression and Anxiety Stress Scale (DASS-21) at post-intervention | Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention | A self-report measure that assesses the presence and severity of symptoms of depression, anxiety, and stress over the last week. Respondents rate their symptoms on a 4-point scale with 0 representing absence of the symptom and 3 representing a symptom occurring almost all the time. Three scores are computed, one for each subscale (depression, anxiety, and stress), by summing all the values of the items on each respective subscale. | ClinicalTrials.gov |
| Primary | Change from baseline in scores on the Sustained Attention Response Task (SART) | Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention | Assesses sustained attention by requiring participants to withhold behavioural response to a single, infrequent target presented among a background of frequent non-targets; administered using Inquisit Web by Millisecond (software for administering neuropsychological testing online). | ClinicalTrials.gov |
| Primary | Change from baseline in scores on the Cognitive Failures Questionnaire (CFQ) at post-intervention | Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention | A 25-item measure of self-reported cognitive impairment that captures daily errors in distractibility, blunders, names, and memory. Each item is rated on a Likert scale from 0 ("Never") to 4 ("Very often"). | ClinicalTrials.gov |
| Primary | Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at post-intervention | Phase 3 (fMRI): Baseline and post-intervention at 9 weeks | A 30-item structured, clinician-administered interview used to make a lifetime or current diagnosis of PTSD and to assess PTSD symptoms. Questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms on social and occupational functioning, and specifications for the dissociative subtype. | ClinicalTrials.gov |
| Primary | Functional neurological change from baseline at post-intervention | Phase 3 (fMRI): Baseline and post-intervention at 9 weeks | Functional Magnetic Resonance Imaging (fMRI) scans done at baseline and post-intervention will be compared to determine whether changes are apparent, post-intervention, in the functional organisation of the Central Executive Network (CEN) | ClinicalTrials.gov |
| Primary | Functional neurological change from baseline at post-intervention | Phase 3 (fMRI): Baseline and post-intervention at 9 weeks | Functional Magnetic Resonance Imaging (fMRI) scans done at baseline and post-intervention will be compared to determine whether changes are apparent, post-intervention, in myelin amounts in regions associated with cognitive function | ClinicalTrials.gov |
| Primary | Change from baseline in score on the Sustained Attention Response Task (SART) adapted for functional Magnetic Resonance Imaging (fMRI) at post-intervention | Phase 3 (fMRI): Baseline and post-intervention at 9 weeks | A computer-based 'Go/No-Go' task adapted for fMRI that requires participants to inhibit a behavioural response to a single, infrequent target appearing amidst a presentation of frequent non-targets. Participants will be asked to press a button for every number presented except "3", under two conditions: 1. a randomized presentation of numbers in two sets, each lasting one minute, and, 2. a sequential presentation of numbers. Each condition will be presented three times. The second presentation of the numbers will be preceded by certain specific emotion-evoking 'trauma words' identified by the participant at a prior appointment. | ClinicalTrials.gov |
| Secondary | Demographic Information | Phase 1 (inpatient): administered at baseline only | Self-report of demographic information, including age, sex, race, education, marital status, employment status, and employment type (e.g., active military member, veteran, public safety personnel, first responder, or other). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
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 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
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 |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Continuous Performance Test | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Symbol Scan Task | Secondary outcome | ConductCognition |
| Verbal Learning | 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)