NCT06553703

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2024

Completed
Last Updated

October 23, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 11, 2024

Last Update Submit

October 19, 2024

Conditions

Keywords

acceptance and commitment therapypsychoeducationnursing studentspsychological flexibilitysomatic symptom

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    screening, baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)

Other Outcomes (2)

  • Inclusion Form

    screening

  • Participant Information Form

    baseline, 8th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)

Study Arms (2)

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.

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.

Interventions

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

Acceptance and commitment therapy based group psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Yildirim

Merkez, Çankırı, 18200, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29166647BACKGROUND
  • Hayes,S.C. (2004). Acceptanceand commitment therapy, relational frametheory and thethird wave of bahavioral and cognitivetherapies. Behavior Therapy, 35, 639-665

    BACKGROUND
  • Hartman,T., Blankenstein. N., Molenaar. B., & Al.E. N.H.G.(2013). Guideline on medically unexplained symptoms (MUS). Huisarts Wet, 56(5):2-18.

    BACKGROUND
  • 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.

    PMID: 23399707BACKGROUND
  • Bond 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.

    PMID: 22035996BACKGROUND
  • Arch, 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.

    BACKGROUND

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tuğba YILDIRIM

    Cankiri Karatekin University, Cankiri, Turkey, 18200

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, it is not possible to blind the researcher implementing the intervention and the participants. To prevent bias in the study, the pretest will be applied before randomization. It is planned to blind the statistical and report writing process in the study. The assignment of students to the intervention and control groups will be made by a statistician independent of the study. The researcher and students will not know which group they are in until the application begins. After applying the follow-up tests, the researcher will code the data as A and B groups and transfer it to SPSS. With this method, it is planned that the statistician will do the analysis and reporting without knowing which group is the intervention and which group is the control group. It is planned to explain the codes of the groups after the analysis and reporting of the data. In this way, detection bias, statistical bias, and reporting bias will be prevented.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In the study, 54 students were taken as sampling, 27 of which were experimental and 27 were control.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 14, 2024

Study Start

April 18, 2024

Primary Completion

June 13, 2024

Study Completion

September 13, 2024

Last Updated

October 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations