Psychological FlexibilityNCT06553703
Acceptance and Commitment Therapy Based Group Psychoeducation for Nursing Students
A study testing Acceptance and commitment therapy based group psychoeducation in people with Psychological Flexibility and Somatic Symptom, run by Tugba Yildirim at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Flexibility, Somatic Symptom
- What is being tested?
- Acceptance and commitment therapy based group psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2024to 13 Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Flexibility, Somatic Symptom
- Being tested
- Acceptance and commitment therapy based group psychoeducation
- Keywords
- acceptance and commitment therapy, psychoeducation, nursing students, psychological flexibility, somatic symptom
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapy based group psychoeducationOther
Acceptance and commitment therapy-based group psychoeducation aimed at increasing nursing students' psychological flexibility and reducing their somatic symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy based group psychoeducation | Experimental | 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. Receives: Other: Acceptance and commitment therapy based group psychoeducation |
| No Intervention: Waiting list group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in the Psychological Flexibility Scale
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.
Measured: Baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design
Secondary outcomes (1)
Bradford Somatic Symptom Inventory Change
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.
Measured: screening, baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start18 Apr 2024
- Primary completion13 Jun 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Psychological FlexibilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, 54 students were taken as sampling, 27 of which were experimental and 27 were control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tugba Yildirim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tugba Yildirim, Çankırı Karatekin University
- Investigators
- Tuğba YILDIRIM, Principal investigator, Cankiri Karatekin University, Cankiri, Turkey, 18200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553703
- Sponsor's protocol ID
- Tuğba YILDIRIM
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Üzar Özçetin, Y.S. (2020).Somatik belirti bozukluğu ve ilişkili bozukluklar ve hemşirelik bakımı. (Ed: Akgün Çıtak E, Hiçdurmaz, D). Psikiyatri Hemşireliği Akıl Notları. 1. Baskı. Ankara: Güneş Tıp Kitabevleri. s:229-245.
Towsend, M. (2016). Ruh Sağlığı ve Psikiyatri Hemşireliğinin Temelleri Kanıta Dayalı Uygulama Bakım Kavramları. (Çev.Ed: Tangül Özcan, C., Gürhan, N.) Ankara: Akademisyen Kitabevi. 6. Baskı. s: 516-544.
Köse,S.,Tekintas, N.S., Durmus,F. B., Akın,E., & Sayar, K. (2017). Reliability, validity,and factorial structure of the Turkish version of the Bradford Somatic Inventory (Turkish BSI-44) in a university student sample. Psychiatry and Clinical Psychopharmacology, 27(1), 62-69.
Kotan, Z. (2021).Somatik belirti bozukluğu ve ilişkili bozukluklarda grup terapileri. Coşar B, editör. (Ed: Coşar, B.) Somatik Belirti ve İlişkili Bozukluklar. 1. Baskı. Ankara: Türkiye Klinikleri. s: 68-73.
Kabadayı Şahin, E. (2017). Bedensel belirti bozukluğu ve oksidatif stres. Yıldırım Beyazıt Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Ana Bilim Dalı Tıpta Uzmanlık tezi, Ankara.
Ishizu K, Shimoda Y, Ohtsuki T. The reciprocal relations between experiential avoidance, school stressor, and psychological stress response among Japanese adolescents. PLoS One. 2017 Nov 22;12(11):e0188368. doi: 10.1371/journal.pone.0188368. eCollection 2017.
PubMed 29166647Hayes,S.C. (2004). Acceptanceand commitment therapy, relational frametheory and thethird wave of bahavioral and cognitivetherapies. Behavior Therapy, 35, 639-665
Hartman,T., Blankenstein. N., Molenaar. B., & Al.E. N.H.G.(2013). Guideline on medically unexplained symptoms (MUS). Huisarts Wet, 56(5):2-18.
Crary P. Beliefs, behaviors, and health of undergraduate nursing students. Holist Nurs Pract. 2013 Mar-Apr;27(2):74-88. doi: 10.1097/HNP.0b013e318280f75e.
PubMed 23399707Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
PubMed 22035996Arch, J. J., & Craske, M. G. (2008). Acceptance and commitment therapy and cognitive behavioral therapy for anxiety disorders: Different treatments, similar mechanisms? Clinical Psychology: Science and Practice, 15(4), 263-279.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acceptance and Commitment Therapy Based Group Psychoeducatıon Applied to Nursing Students on Psychological Flexibility and Somatic Symptoms
- ClinicalTrials.gov ID
- NCT06553703
- Acronym / sponsor ID
- Tuğba YILDIRIM
- Conditions
- Psychological Flexibility, Somatic Symptom
- Keywords
- acceptance and commitment therapy, psychoeducation, nursing students, psychological flexibility, somatic symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tugba YildirimUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 14 Aug 2024 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In the study, 54 students were taken as sampling, 27 of which were experimental and 27 were control.
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy based group psychoeducation | Experimental | Other: Acceptance and commitment therapy based group psychoeducationAcceptance 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. |
| No Intervention: Waiting list group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 therapy based group psychoeducationAcceptance and commitment therapy-based group psychoeducation aimed at increasing nursing students' psychological flexibility and reducing their somatic symptoms. | Other | Acceptance and commitment therapy based group psychoeducation |
Primary outcome
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.
1 secondary outcome
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)
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 Oct 2024.
- BackgroundÜzar Özçetin, Y.S. (2020).Somatik belirti bozukluğu ve ilişkili bozukluklar ve hemşirelik bakımı. (Ed: Akgün Çıtak E, Hiçdurmaz, D). Psikiyatri Hemşireliği Akıl Notları. 1. Baskı. Ankara: Güneş Tıp Kitabevleri. s:229-245.
- BackgroundTowsend, M. (2016). Ruh Sağlığı ve Psikiyatri Hemşireliğinin Temelleri Kanıta Dayalı Uygulama Bakım Kavramları. (Çev.Ed: Tangül Özcan, C., Gürhan, N.) Ankara: Akademisyen Kitabevi. 6. Baskı. s: 516-544.
- BackgroundKöse,S.,Tekintas, N.S., Durmus,F. B., Akın,E., & Sayar, K. (2017). Reliability, validity,and factorial structure of the Turkish version of the Bradford Somatic Inventory (Turkish BSI-44) in a university student sample. Psychiatry and Clinical Psychopharmacology, 27(1), 62-69.
- BackgroundKotan, Z. (2021).Somatik belirti bozukluğu ve ilişkili bozukluklarda grup terapileri. Coşar B, editör. (Ed: Coşar, B.) Somatik Belirti ve İlişkili Bozukluklar. 1. Baskı. Ankara: Türkiye Klinikleri. s: 68-73.
- BackgroundKabadayı Şahin, E. (2017). Bedensel belirti bozukluğu ve oksidatif stres. Yıldırım Beyazıt Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Ana Bilim Dalı Tıpta Uzmanlık tezi, Ankara.
- Background: PubMed 29166647Ishizu K, Shimoda Y, Ohtsuki T. The reciprocal relations between experiential avoidance, school stressor, and psychological stress response among Japanese adolescents. PLoS One. 2017 Nov 22;12(11):e0188368. doi: 10.1371/journal.pone.0188368. eCollection 2017.
- BackgroundHayes,S.C. (2004). Acceptanceand commitment therapy, relational frametheory and thethird wave of bahavioral and cognitivetherapies. Behavior Therapy, 35, 639-665
- BackgroundHartman,T., Blankenstein. N., Molenaar. B., & Al.E. N.H.G.(2013). Guideline on medically unexplained symptoms (MUS). Huisarts Wet, 56(5):2-18.
- Background: PubMed 23399707Crary P. Beliefs, behaviors, and health of undergraduate nursing students. Holist Nurs Pract. 2013 Mar-Apr;27(2):74-88. doi: 10.1097/HNP.0b013e318280f75e.
- Background: PubMed 22035996Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
- BackgroundArch, J. J., & Craske, M. G. (2008). Acceptance and commitment therapy and cognitive behavioral therapy for anxiety disorders: Different treatments, similar mechanisms? Clinical Psychology: Science and Practice, 15(4), 263-279.
- Individual participant dataSharing planned: No
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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.
Tuğba YILDIRIM principal investigator
Cankiri Karatekin University, Cankiri, Turkey, 18200
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 based group psychoeducation in people with Psychological Flexibility and Somatic Symptom, run by Tugba Yildirim at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 Oct 2024. 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 Turkey (Türkiye). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553703, which also lists 11 linked publications.
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 Oct 2024.