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Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer

Primary Purpose

Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Are not participating in any type of psychotherapy, score high in the cognitive impairment questionnaire.

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STUDY GROUP

Control group

Arm Description

After random sampling and dividing patients into two groups of study and control. Patients from the study and control groups will be interviewed individually by the researcher to apply the study tools. Acceptance and Commitment Therapy will be carried out for patients in the study group

Those in the control group will be left without any intervention to undergo the usual unit routine care.

Outcomes

Primary Outcome Measures

Mental Health Continuum-Short Form
The original 14-item Mental Health Continuum-Short was developed by (Keyes & psychology, 2004) in response to demands for a brief self-rating assessment tool that combined the three components of wellbeing: emotional, social, and psychological.
Montreal Cognitive Assessment
The one-page Montreal Cognitive Assessment (MoCA) was used to assess the eight cognitive domains of attention (6 points), visuospatial/executive functions (5 points), short-term memory (5 points), naming (3 points), language (3 points), orientation (6 points), and abstraction (2 points).

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
February 14, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05741255
Brief Title
Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer
Official Title
Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The present study aims to: Determine the effect of acceptance and commitment therapy-based interventions on mental health and cognitive impairment for patients with advanced colorectal cancer. Research Hypothesis: Cancer patients who receive acceptance and commitment therapy-based interventions will exhibit better mental health and lower cognitive impairments than those who didn't receive it.
Detailed Description
6) Patients' medical charts in the unit will be reviewed to identify those who meet the inclusion criteria. Patients who meet the predetermined inclusion criteria will be randomly recruited in the study. After random sampling and dividing patients into two groups of study and control. Patients from the study and control groups will be interviewed individually by the researcher to apply the study tools. Acceptance and Commitment Therapy will be carried out for patients in the study group while those in the control group will be left without any intervention to undergo the usual unit routine care. 7) The researcher was undergoing a period of training on Acceptance and Commitment Therapy (ACT) through online academic training at Association for Contextual Behavioral Science (ACBS) for 8 weeks with 16 credits hours'certificate by (Harris, 2015). Before embarking on the actual study, the researcher passed through independent teaching about acceptance and commitment therapy under the direction, guidance, and supervision of the thesis supervisors. This included a discussion of the theoretical foundation of ACT as well as the accuracy and appropriateness of the exercises used and needed for each session. 8) The therapy consisted of six sessions, each session of acceptance and commitment therapy was developed based on general and specific objectives. An expert professor in the nursing education field revised the ACT sessions' overall objectives and the specific ones. The overall objectives of each session and the content of the sessions were translated into Arabic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STUDY GROUP
Arm Type
Experimental
Arm Description
After random sampling and dividing patients into two groups of study and control. Patients from the study and control groups will be interviewed individually by the researcher to apply the study tools. Acceptance and Commitment Therapy will be carried out for patients in the study group
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Those in the control group will be left without any intervention to undergo the usual unit routine care.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
type of mindful psychotherapy that helps you stay focused on the present moment and accept thoughts and feelings without judgment. It aims to help you move forward through difficult emotions so you can put your energy into healing instead of dwelling on the negative.
Primary Outcome Measure Information:
Title
Mental Health Continuum-Short Form
Description
The original 14-item Mental Health Continuum-Short was developed by (Keyes & psychology, 2004) in response to demands for a brief self-rating assessment tool that combined the three components of wellbeing: emotional, social, and psychological.
Time Frame
2 weeks
Title
Montreal Cognitive Assessment
Description
The one-page Montreal Cognitive Assessment (MoCA) was used to assess the eight cognitive domains of attention (6 points), visuospatial/executive functions (5 points), short-term memory (5 points), naming (3 points), language (3 points), orientation (6 points), and abstraction (2 points).
Time Frame
2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are not participating in any type of psychotherapy, score high in the cognitive impairment questionnaire.
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer

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