The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders

ClinicalTrials.gov ID

NCT04076839

Acronym / sponsor ID

15-29

Conditions

Post-traumatic Stress Disorder, Cognitive Dysfunction

Keywords

cognitive remediation, public safety personnel, Goal Management Training, Group therapy, first responders, military

Study type

Interventional

Recruitment status

Completed

Enrolment

48 participants (actual)

Lead sponsor

Homewood Research InstituteUniversity, hospital or other

Collaborators

McMaster University, St. Joseph's Healthcare Hamilton, Homewood Health Centre

Study start

13 Oct 2017 (actual)

Primary completion

23 Jul 2019 (actual)

Study completion

16 Aug 2019 (actual)

First posted

3 Sep 2019 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Model description

Participants will be randomly assigned to either: 1) a 9-week GMT program or 2) a 9-week wait-list control (WLC) condition. Participants will be tested at baseline prior to group commencement. Once the testing session is complete, the participants will be assigned to (GMT or WLC). Participants enrolled in the GMT program will attend 9-weeks of GMT sessions (2 hours/week for 9 weeks) and a post-intervention testing session date. Participants enrolled in the WLC group will be given a testing session date after 9 weeks has past. Participants will attend a final testing session (in 3 months' time; approximately 3 hours in duration). WLC will be offered a complimentary 9-week GMT program once the final testing session is complete. Following the completion of the complimentary 9-week GMT program, individuals in the WLC will complete post-intervention testing (1-2 weeks following the completion of GMT and again at 3 months, post GMT completion).

Who may qualify

Ages

18 to 70 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change in score on Controlled Oral Word Association Task (COWAT)

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   A neuropsychological assessment of verbal fluency, in which participants are asked to name as many words beginning with "F", "A", and "S" (Subscale: FAS). For each letter, they are given one minute to complete the task. Following this, the participant is required to name as many animals as they can within one minute (Subscale: Animals). Scores are calculated by adding unique words across FAS, and within Animals. These raw scores (i.e., FAS raw and Animals raw) are converted to scaled scores (i.e., FAS Scaled Score and Animals Scaled Score), which range between 0 and 19. The scaled scores are then converted to T scores (i.e., FAS T Score and Animals T Score), which range between 0 and 100. The T scores are corrected for sex, age, education, and ethnicity. Higher T scores indicate greater verbal fluency performance.

2. Change in score on Stroop Colour and Word Test

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   A neuropsychological assessment of processing speed (word and colour reading) and sensitivity to suppress habitual responses.The test produces the following scores: i) Word-Reading Score, which is the raw score that consists of the number of items completed in 45 seconds. ii) Colour-Naming Score, which is the raw score that consists of the number of items completed in 45 seconds. iii) Colour-Word Score, which is the raw score that consists of the number of items completed in 45 seconds, and iv) Interference Score, which is derived by subtracting a Predicted Colour-Word Score (obtained from the Stroop Manual) from the raw Colour-Word Score. Scores are then translated into T scores using a table obtained from the Stroop manual. Values for these T scores range between 3-98, and 21 and 80 for the Predicted Colour-Word Score. Overall, higher T scores indicate greater processing speed and ability to suppress habitual responses.

3. Change in score on Delis-Kaplan Executive Function System (D-KEFS) Tower Test

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   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.

4. Change in score on Trail Making Test Part A & B (TMT A & TMT B)

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   A neuropsychological assessment in which participants are required to sequence two stimulus sets while alternating between them. Scoring is expressed in terms of the time in seconds required for completion of each of the two parts of the test (i.e., TMT A and TMT B). The raw scores for each part of the test are translated to scaled scores (i.e., TMT A Scaled Score and TMT B Scaled Score) and scaled scores may range between 0 and 19. The scaled scores are then translated to T scores (i.e., TMT A T Score and TMT B T Score) corrected for sex, age, education, and ethnicity. The T scores may range between 0 and 100. Individuals with higher T scores indicate better attention, mental flexibility, and speed in comparison to those with lower T scores.

5. Change in score on Wechsler Adult Intelligence Scale-IV (WAIS-IV), Coding Subtest

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   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.

6. Change in score on Conners Continuous Performance Task Third Edition (CPT-III)

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   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.

7. Change in score on California Verbal Learning Test II (CVLT-II)

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   A word list neuropsychological assessment, which provides indices of immediate and delayed memory performance, interference learning, and recognition. Software is utilized to score the CVLT-II, which computes all raw scores and standardized scores, corrected for the examinee's age and gender. Values of interest within the study include: i) Level of Immediate Recall; ii) Level of Delayed Recall, iii)Learning Characteristics, iv) Recall Errors, and v) Delayed Recognition Trials. In general, higher standard scores indicate intact performance; however, in other cases (e.g., Recall Errors) higher standard scores reflect greater deficits.

8. Change in score on Rivermead Behavioural Memory Test Second Edition (RBMT-II) Prospective Memory Tasks

   Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

   Participants will be asked to complete two prospective memory tasks (Belongings and Appointments) where they will be given specific instructions and asked to independently act on these instructions at specific time points throughout the testing. Raw scores for Belongings and Appointments will be assessed. The raw score for Belongings may range between 0 and 8, while the raw score for Appointments may range between 0 and 4. Higher raw scores indicate better recall.

9. Wechsler Abbreviated Scale of Intelligence - II (WASI-II): Vocabulary and Matrix Reasoning Subtests

   Time frame: Administered to GMT participants and Waitlist Participants only at baseline.

   The WASI-II is a brief neuropsychological assessment aimed to provide an estimate of current intellectual functioning. The two-subtest form of the WASI-II consists of Vocabulary and Matrix Reasoning and provides a Full Scale IQ (FSIQ-2). In the Vocabulary subtest, participants give oral definitions for words (total raw scores may range between 0 and 59). For Matrix Reasoning, the participant looks at a matrix with a section missing and identifies the missing section by pointing to or stating the number of their response (total raw scores may range between 0 and 30). The subtests' total raw scores are converted to age-corrected T scores (T scores may range between 20 and 80 for each subtest). The FSIQ-2 is the sum of T scores on Vocabulary and Matrix Reasoning. FSIQ-2 scores may range between 45 and 160, with higher FSIQ-2 scores indicating higher intelligence.

10. Wechsler Test of Adult Reading (WTAR)

    Time frame: Administered to GMT participants and Waitlist Participants only at baseline.

    The WTAR assesses premorbid intellectual functioning in adults. The WTAR requires the participant to read out loud irregularly spelled words. The raw score ranges between 0 and 50. The WTAR raw score is converted to a standard score and the standard score may range between 50 and 134. Intelligence scores are also predicted by WTAR performance and demographics and intelligence scores may range between 89 and 118. Higher intelligence scores indicate greater premorbid intellectual functioning.

11. Change in Score on Multidimensional Scale of Independent Functioning (MSIF)

    Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

    A semi-structured interview assessing participant report of i) work (e.g., competitive, supported, dependent care, volunteer); ii) education (e.g., college, vocational, certificate school, rehabilitation training program); and iii) residential activities (e.g., where the participant is living, what responsibilities the participant has). Each domain (i.e., work, education, and residential activities) is assessed according to role position, support, and performance. Scores for these areas may range between 1 and 7, with higher values indicating greater impairment in functioning. Furthermore, a global rating for role position, support, performance, and overall functioning is given. Scores for the global ratings also may range from 1 to 7, with higher values indicating greater impairment in functioning.

12. Change in Score on World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 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.

13. Change in Score on Sheehan Disability Scale (SDS)

    Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

    The SDS is a 3-item self-report measure of disability in work, social relationships, and family life. The three items, which are scored on a Likert scale between 0 and 10, are summed into a single dimensional measure of global functional impairment. The SDS total score may range from 0 to 30, with higher scores indicating greater impairment.

14. Change in Score on Goal Attainment Scaling (GAS)

    Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

    Description: The GAS is a method for defining individual participant goals and the standardized measurement of progress towards these goals. Overall goal attainment is transformed into a T score, with higher T scores indicating greater goal attainment.

15. Change in Score on Cognitive Failures Questionnaire (CFQ)

    Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9

    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.

16. Change in Score on Dysexecutive Questionnaire (DEX)

    Time frame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)

    The DEX is a 20-item self-report measure that asks participants to rate inhibition, positive and negative affect, memory, and intention. Each item is rated on a Likert scale from 0 ("Never") to 4 ("Very often"). The DEX Total score is the sum of all items and the total score may range from 0 to 80. Higher scores indicate greater self-reported cognitive impairment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
• Background: PubMed 21349277Aupperle RL, Melrose AJ, Stein MB, Paulus MP. Executive function and PTSD: disengaging from trauma. Neuropharmacology. 2012 Feb;62(2):686-94. doi: 10.1016/j.neuropharm.2011.02.008. Epub 2011 Feb 22.
• Background: PubMed 10824502Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.
• Background: PubMed 22310036Polak AR, Witteveen AB, Reitsma JB, Olff M. The role of executive function in posttraumatic stress disorder: a systematic review. J Affect Disord. 2012 Dec 1;141(1):11-21. doi: 10.1016/j.jad.2012.01.001. Epub 2012 Feb 5.
• Background: PubMed 9180650Rockwood K, Joyce B, Stolee P. Use of goal attainment scaling in measuring clinically important change in cognitive rehabilitation patients. J Clin Epidemiol. 1997 May;50(5):581-8. doi: 10.1016/s0895-4356(97)00014-0.
• Background: PubMed 24579831Saunders N, Downham R, Turman B, Kropotov J, Clark R, Yumash R, Szatmary A. Working memory training with tDCS improves behavioral and neurophysiological symptoms in pilot group with post-traumatic stress disorder (PTSD) and with poor working memory. Neurocase. 2015;21(3):271-8. doi: 10.1080/13554794.2014.890727. Epub 2014 Feb 28.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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