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

February 14, 2023 updated by: Mahmoud Khedr, Alexandria University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STUDY GROUP
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
Behavioral: Acceptance and Commitment Therapy
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.
Active Comparator: Control group
Those in the control group will be left without any intervention to undergo the usual unit routine care.
Behavioral: Acceptance and Commitment Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health Continuum-Short Form
Time Frame: 2 weeks
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.
2 weeks
Montreal Cognitive Assessment
Time Frame: 2 weeks
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).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

February 5, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1322023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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