Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.

• Sponsor: Baycrest (Other)
• Overall Status: Completed
• CT.gov ID: NCT01163279
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Healthy older adults with self-reported cognitive difficulties who receive strategy training will demonstrate greater performance benefits on measures of real-world activities, relative to those receiving a control intervention, immediately post treatment and at follow-up.

Condition or Disease	Intervention/Treatment	Phase
Aging	Behavioral: Real world strategy approach; Behavioral: Psychosocial Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Training	Behavioral: Real world strategy approach; The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.; Other Names: Adopted Cognitive Orientation to Occupational Performance (CO-OP)
Active Comparator: Psychosocial Education	Behavioral: Psychosocial Education; The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.

Outcome Measures

Primary Outcome Measures

1. Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) [Immediately post intervention (2 months) and 3 months later]

   COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.

Secondary Outcome Measures

1. General Self Efficacy Scale (GSE) [Baseline, Immediately post intervention (2 months) and 3 months later]

   GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy

2. Stanford Patient Education Research Center- General Health Subscale [Baseline, Immediately post intervention (2 months) and 3 months later]

   Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health

3. Stanford Patient Education Research Center- Health Distress Subscale [Baseline, Immediately post intervention (2 months) and 3 months later]

   Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.

4. Stanford Patient Education Research Center- Physical Activity Subscale [Baseline, Immediately post intervention (2 months) and 3 months later]

   Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week

5. Stanford Patient Education Research Center- Communication With Physicians Subscale [Baseline, Immediately post intervention (2 months) and 3 months later]

   Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions

6. Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale [Baseline, Immediately post intervention (2 months) and 3 months later]

   Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.

7. Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time [Baseline, Immediately post intervention (2 months) and 3 months later]

   This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move

8. DKEFS Tower Test- Achievement Score [Baseline, Immediately post intervention (2 months) and 3 months later]

   This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.

9. DKEFS Word Fluency [Baseline, Immediately post intervention (2 months) and 3 months later]

   This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds

10. DKEFS Trail Making- Condition 4: Number-letter Switching [Baseline, Immediately post intervention (2 months) and 3 months later]

    DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All participants must score within 1.5 standard deviation (SD) of age and education-corrected normative data for the Montreal Cognitive Assessment and on a battery of neuropsychological tests of attention, memory and executive function (which will insure that participants are unlikely to meet the criteria for Mild Cognitive Impairment (MCI)).

• No clinically relevant depression (scores ≤22) on the Center for Epidemiologic Studies Depression Scale (CES-D)

• Fluent in written and spoken English

• Self-reported complains about cognitive function

Exclusion Criteria:

• Recent bereavement (within last 6 months)

• History of neurological disease

• Psychiatric illness requiring hospitalization and/or history or current substance abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baycrest	Toronto	Ontario	Canada	M6A 2E1

Sponsors and Collaborators

• Baycrest

Investigators

• Principal Investigator: Deirdre Dawson, PhD, Rotman Research Institute, Baycrest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Deirdre Dawson, Senior Scientist, Baycrest
• ClinicalTrials.gov Identifier: NCT01163279
• Other Study ID Numbers: REB1021
• First Posted: Jul 15, 2010
• Last Update Posted: Dec 18, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Dr. Deirdre Dawson, Senior Scientist, Baycrest: Age-related changes

Study Results

Participant Flow

Recruitment Details	Participants were recruited from a research subject pool and a community psycho-education program at Baycrest.
Pre-assignment Detail	A total of 96 participants were assessed for study eligibility. 60 participants were excluded after a phone screening interview and 17 were excluded after a more detailed baseline assessment which included cognitive paper and pencil tasks. The remaining 19 participants were randomized to either the experimental arm or the control arm.

Arm/Group Title	Cogntive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Period Title: Overall Study
STARTED	10	9
COMPLETED	8	9
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Cognitive Training	Psychosocial Education	Total
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.	Total of all reporting groups
Overall Participants	10	9	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	10 100%	9 100%	19 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.10 (8.77)	73.67 (5.43)	73.94 (7.18)
Sex: Female, Male (Count of Participants)
Female	9 90%	7 77.8%	16 84.2%
Male	1 10%	2 22.2%	3 15.8%
Region of Enrollment (participants) [Number]
Canada	10 100%	9 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)
Description	COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.
Time Frame	Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
Measure Participants	10	9
Measure Total number of goals	52	46
post intervention performance	50	19.6
post intervention satisfaction	50	32.6
3-month follow up performance	36.4	26.1
3-month follow up satisfaction	45.5	28.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Statistical analysis applies to post intervention performance category
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments	Statistical analysis applies to post intervention satisfaction category
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments	Statistical analysis applies to 3-month follow up performance category
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments	Statistical analysis applies to 3-month follow up satisfaction category
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	General Self Efficacy Scale (GSE)
Description	GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	29.10 (3.41)	32.56 (3.40)
Immediately post intervention (2 months)	30.90 (3.98)	33.56 (4.28)
3 months post intervention	30.50 (4.12)	33.56 (3.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to immediately post intervention and 3 months post intervention categories
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Stanford Patient Education Research Center- General Health Subscale
Description	Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	2.20 (0.63)	1.89 (0.78)
Immediately post intervention (2 months)	2.20 (0.42)	1.78 (0.83)
3 months post intervention	2.20 (0.92)	2.00 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Statistical analysis applies to immediately post intervention and 3 months post intervention categories
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Stanford Patient Education Research Center- Health Distress Subscale
Description	Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	2.70 (2.21)	4.22 (2.77)
Immediately post intervention (2 months)	3.80 (3.46)	3.67 (4.21)
3 months post intervention	3.70 (3.37)	4.11 (2.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Statistical analysis applies to immediately post intervention and 3 months post intervention categories
	Method	ANOVA
	Comments

5. Secondary Outcome

Title	Stanford Patient Education Research Center- Physical Activity Subscale
Description	Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	4.08 (2.22)	5.31 (1.47)
Immediately post intervention (2 months)	4.45 (2.53)	3.64 (1.35)
3 months post intervention	4.15 (1.83)	3.19 (1.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to immediately post intervention and 3 months post intervention categories
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Stanford Patient Education Research Center- Communication With Physicians Subscale
Description	Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	8.40 (3.84)	11.00 (3.04)
Immediately post intervention (2 months)	9.50 (4.17)	9.11 (3.33)
3 months post intervention	10.00 (3.80)	8.89 (4.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.1
	Comments	Statistical analysis applies to immediately post intervention category
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to 3 months post intervention category
	Method	ANOVA
	Comments

7. Secondary Outcome

Title	Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale
Description	Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	2.30 (0.95)	2.78 (3.07)
Immediately post intervention (2 months)	1.50 (0.97)	3.33 (4.00)
3 months post intervention	2.00 (1.24)	2.33 (2.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to immediately post intervention category
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Statistical analysis applies to 3 months post intervention category
	Method	ANOVA
	Comments

8. Secondary Outcome

Title	Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time
Description	This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	5.48 (3.72)	6.13 (5.83)
Immediately post intervention (2 months)	3.00 (1.72)	3.69 (2.89)
3 months post intervention	2.47 (1.78)	1.72 (0.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.1
	Comments	Statistical analysis applies to immediately post intervention category
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to 3 months post intervention category
	Method	ANOVA
	Comments

9. Secondary Outcome

Title	DKEFS Tower Test- Achievement Score
Description	This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	17.10 (3.57)	15.78 (4.09)
Immediately post intervention (2 months)	18.30 (3.59)	19.44 (4.07)
3 months post intervention	20.90 (4.31)	18.89 (3.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to immediately post intervention and 3 months post intervention categories
	Method	ANOVA
	Comments

10. Secondary Outcome

Title	DKEFS Word Fluency
Description	This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	55.30 (15.25)	48.56 (11.74)
Immediately post intervention (2 months)	56.40 (18.38)	50.33 (9.12)
3 months post intervention	57.40 (16.34)	50.11 (13.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Statistical analysis applies to immediately post intervention category
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Statistical analysis applies to 3 months post intervention category
	Method	ANOVA
	Comments

11. Secondary Outcome

Title	DKEFS Trail Making- Condition 4: Number-letter Switching
Description	DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence
Time Frame	Baseline, Immediately post intervention (2 months) and 3 months later

Outcome Measure Data

Analysis Population Description

Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).

Arm/Group Title	Cognitive Training	Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.	The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
Measure Participants	10	9
Baseline	104.50 (43.87)	91.11 (19.19)
Immediately post intervention (2 months)	88.40 (28.55)	80.56 (25.37)
3 months post intervention	94.10 (32.70)	84.44 (31.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Training, Psychosocial Education
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Statistical analysis applies to immediately post intervention and 3 months post intervention categories
	Method	ANOVA
	Comments

Adverse Events

Time Frame	2 months-during the intervention phase of the study
Arm/Group Title	Cognitive Training		Psychosocial Education
Arm/Group Description	Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.		Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
All Cause Mortality
	Cognitive Training		Psychosocial Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cognitive Training		Psychosocial Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Cognitive Training		Psychosocial Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.