Acceptance and Commitment Therapy Based Group Psychoeducation for Nursing Students

October 19, 2024 updated by: Tugba Yildirim

Effect of Acceptance and Commitment Therapy Based Group Psychoeducatıon Applied to Nursing Students on Psychological Flexibility and Somatic Symptoms

In this study, the effects of acceptance and commitment therapy-based group psychoeducation applied to nursing students on psychological flexibility and somatic symptoms will be examined. The research will be carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The stress factors that nursing students encounter differ from other students. One of the reasons for this is that the nursing curriculum includes working simultaneously in both theoretical and clinical environments. In a study, it was determined that nursing students' lack of stress coping skills caused internal stressors to turn into external stressors. When these individuals cannot cope with situations that cause stress, they can express the stress they experience with somatic symptoms. Somatic symptom disorder is defined as the state of seeking help for mental problems with somatic symptoms. The inability to treat these somatic symptoms of individuals forces them to live with these symptoms for years and sometimes for a lifetime and continue to seek treatment. Acceptance and Commitment Therapy, which provides a new perspective for individuals to cope with stressful life events, aims to gain psychological flexibility, which is the capacity for individuals to experience challenging conditions at the moment they are in and to behave in a way that is compatible with their value areas under these conditions. The opposite of psychological flexibility is psychological inflexibility. Experiential avoidance is one of the basic components of the concept of psychological inflexibility. The state of escape and avoidance and actions that occur when an individual does not want to be in contact with situations that stress them are defined as experiential avoidance. When the relevant literature is examined, it has been reported that somatic symptoms are seen as experiential avoidance behaviors in individuals. The continuity of somatic symptoms as a reaction to stress, their inability to intervene, and their chronicity cause them to turn into a somatic somatic symptom disorder. Since nursing students are a highly stressed group, their reactions to stress should be observed, somatic symptoms in these students should be evaluated, and psychological flexibility should be increased before somatic symptoms turn into disorders and students start their professions, and healthier members of the profession should be trained in terms of mental and physical health. However, psychosocial intervention studies that will help with somatic symptoms continue to be the subject of very little research.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Çankırı
      • Merkez, Çankırı, Turkey, 18200
        • Tuğba Yildirim

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • No problems understanding and speaking Turkish
  • Having moderate and high-level somatic symptoms (Scoring 26 or higher on the Bradford Somatic Inventory)

Exclusion Criteria:

  • Scoring 25 or less on the Bradford Somatic Inventory
  • Having been diagnosed with a chronic/systemic physical illness
  • Having been diagnosed with a psychiatric illness
  • Being on medication for a current physical or psychiatric illness
  • Have received or are receiving individual or group psychotherapy/counseling programs within the last two years
  • Being a foreign national
  • Being pregnant

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acceptance and commitment therapy based group psychoeducation
Acceptance and commitment therapybased group psychoeducation to be carried out with the experimental group is planned as 8 sessions. The sessions are planned to be held in 3 groups of 9 people each. The duration of a session is planned to be approximately 90 minutes. Group psychoeducation with the experimental group will be carried out face-to-face every week. The appropriate day for the sessions will be decided together with themembers of each group. The same group session will be held on the same day and time every week.
Other: Acceptance and commitment therapy based group psychoeducation
Acceptance and commitment therapy-based group psychoeducation aimed at increasing nursing students' psychological flexibility and reducing their somatic symptoms.
No Intervention: No Intervention: Waiting list group

After the follow-up tests were completed, it was planned to apply the 8-session group psychoeducation applied to the intervention group in the same way to the control group, upon their request.

Intervention: Acceptance and commitment therapy-based group psychoeducation aimed at increasing students' psychological flexibility and reducing their somatic symptoms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Psychological Flexibility Scale
Time Frame: Baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design
The Psychological Flexibility Scale consists of 28 items and five sub-dimensions. The sub-dimensions of the scale are: "Values and committed action", "Contact with the present moment", "Acceptance", "Self as Context" and "Defusion." The increase in the scores obtained from the sub-dimensions and total scores of the scale means that individuals are psychologically flexible. The lowest score that can be obtained from the scale is 28, and the highest is 196.
Baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bradford Somatic Symptom Inventory Change
Time Frame: screening, baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)
Bradford Somatic Inventory consists of 44 items. It questions the individual's experience of a wide variety of somatic symptoms on less than 15 days or more than 15 days during the previous month. In the total score of the scale, 0-25 is the low range, 26-40 is the medium range, and>40 is the high range.
screening, baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inclusion Form
Time Frame: screening
The inclusion form is a seven-question form prepared by the researcher to determine the disease status of nursing students (physical and psychiatric disease diagnosis, treatment, psychotherapy, or psychological counseling status) and sociodemographic characteristics (nationality and pregnancy status).
screening
Participant Information Form
Time Frame: baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)
The participant information form is a ten-question form prepared by the researcher to determine the sociodemographic characteristics of nursing students (age, gender, class information, marital status, mother's education status, father's education status, family income status, family type, where they lived before starting university and who they currently live with).
baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tugba Yildirim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tuğba YILDIRIM, Cankiri Karatekin University, Cankiri, Turkey, 18200

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tuğba YILDIRIM

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

product manufactured in and exported from the U.S.

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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