Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal CancerNCT05741255
Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal Cancer, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal Cancer
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2022to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Are not participating in any type of psychotherapy, score high in the cognitive impairment questionnaire.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Psychological Well-Being, Cognitive Dysfunction, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Experimental | 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 Receives: Behavioral: Acceptance and Commitment Therapy |
| Control group | Active comparator | Those in the control group will be left without any intervention to undergo the usual unit routine care. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start5 Jan 2022
- Primary completion5 Jan 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741255
- Sponsor's protocol ID
- 1322023
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acceptance and Commitment Therapy Based Interventions on Mental Health and Cognitive Impairment for Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05741255
- Acronym / sponsor ID
- 1322023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 23 Feb 2023 (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.
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
- 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.
- 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.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Experimental | Behavioral: Acceptance and Commitment TherapyAfter 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 |
| Control group | Active comparator | Behavioral: Acceptance and Commitment TherapyThose in the control group will be left without any intervention to undergo the usual unit routine care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Are not participating in any type of psychotherapy, score high in the cognitive impairment questionnaire.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapytype 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. | Behavioural | Control group, STUDY GROUP |
Primary outcome
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.
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).
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 23 Feb 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy, Mental Health, Cognitive Impairment,Colorectal Cancer, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Continuum-Short Form (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.