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

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT05741255
Collaborator
(none)
40
1
2
13
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance and Commitment Therapy
N/A

Detailed Description

  1. 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.

  2. 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.

  3. 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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer
Actual Study Start Date :
Jan 5, 2022
Actual Primary Completion Date :
Jan 5, 2022
Actual Study Completion Date :
Feb 5, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Mental Health Continuum-Short Form [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. Montreal Cognitive Assessment [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Nursing Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Khedr, Lecturer, Alexandria University
ClinicalTrials.gov Identifier:
NCT05741255
Other Study ID Numbers:
  • 1322023
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023