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Effekten av mindfulness-basert stressreduksjonsprogram (Mindfulness)

5. oktober 2026 oppdatert av: Munevver Bogahan, Mersin University

Effekten av mindfulness-basert stressreduksjonsprogram på mental status og omsorgsbyrde for psykotiske pasienters familier

This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. The hypothesis of this study is that the Mindfulness-Based Stress Reduction Program improves the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Introduction: One of the chronic mental diseases, psychosis causes social and economic losses by negatively affecting the patient's feelings, thoughts and behaviors, interpersonal relations, work and social harmony, and the patient and family may experience different difficulties. With the transition to the community-based model in the provision of mental health services, the relatives of the patients have become the primary caregivers in the care of the patient and their responsibilities have increased even more.When the family is considered as a system, there is a constant interaction between the parts of the system and the change in the patient in case of illness can affect the whole family.When the disease occurs, one of the family members has to take care of the sick individual and caregivers experience emotional (decreased self-esteem, restlessness, depression, insomnia, social isolation, etc.), social (restriction of entertaining, relaxing and leisure time activities, reduction in the role of self-care, etc.). ) and economically (expenses not covered by social security creating an additional burden, reducing working hours, etc.). It is emphasized that psychosocial interventions for families increase the perception of social support, self-efficacy and satisfaction with treatment among caregivers, and reduce the perceived burden and recurrence of the disease.However, the high level of emotional expression and perceived stress of the families may trigger the recurrence of the disease. For this reason, family is naturally emphasized as an important factor in the recovery of the individual with a psychotic illness. Therefore, rehabilitation processes should be aimed not only at patients, but also towards caregivers. One of the interventions used for this purpose today is the Mindfulness-Based Stress Reduction (MBSR) program, which is an evidence-based intervention that teaches skills to reduce stress and manage challenging emotions in a group setting. Although the MBSR intervention is usually aimed at people with chronic physical and mental illnesses, the purpose of the intervention is not to replace medical treatment, but can be used as a supplement, supportive, preventive, complementary or simply a stand-alone method to heal patients. In this respect, it is thought that it is important for psychiatric nurses to use the MBSR program, which is a complementary, supportive, preventive and protective program, in the protection and strengthening of mental health in family members who care for psychosis patients. When the literature is examined, it is emphasized that the MBSR program has positive effects on caregiver family members. In this context, this study is planned to determine the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Methods: In the study, 60 family members caring for an individual with psychotic illness were randomly assigned to the study and control groups. 11-week MBSR program will be apply to study group (n = 28). No intervention will be made to the control group (n = 28). The primary outcome of the study is the effect of MBSR on the state-trait anxiety, hopelessness, and self-compassion levels of caregiver family members. The secondary outcome of the study is the effect of MBSR on the caregiving burden of family members. Data will be collected pre-intervention, post-intervention, 3 and 6 months after the intervention.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Mersin
      • Mersin, Mersin, Tyrkia (Türkiye), 33343
        • Mersin University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Above 18 years old
  • Able to read and understand Turkish
  • Taking care of the sick individual at home
  • Living in the same house with the sick individual
  • No psychiatric illness
  • No problems with movement, sight, hearing or understanding
  • Volunteer to participate in the study
  • Able to access the internet with their phone or computer
  • Those who did not receive any other psychological therapy during their working dates
  • No previous meditation experience
  • Having no practice in daily mind-body practices

Exclusion Criteria:

  • Under 18 years old
  • Can't read and understand Turkish
  • Any psychiatric illness receiving another psychological therapy on working dates
  • Meditation experience before the study; having practice in daily mind-body practices
  • Having problems with movement, vision, hearing, understanding
  • Not willing to participate in the study
  • Participants who participated in more than 50% of a mindfulness-based intervention prior to the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MBSR Intervention

The intervention group will take part in mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. The MBSR program was structured as 11 weeks, taking into account the characteristics of the participants.

The intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence.

Andre navn:
  • MBSR
Ingen inngripen: Control

No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety will be evaluated using the State-Trait Anxiety Scale
Tidsramme: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Care burden will be assessed using the Caregiver Burden Scale.
Tidsramme: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

A score between 22 and 110 is taken from the scale. Obtained points; It is evaluated by grading as "light load" between 22-46, "medium load" between 47-55, "severe load" between 56-110.

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Hopelessness will be measured using the Beck Hopelessness Scale.
Tidsramme: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

The score range of the scale is 0-20. When the scores obtained are high, hopelessness in the individual is considered high

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Self-compassion will be assessed using the Self-Compassion Scale.
Tidsramme: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

To calculate the total self-compassion score, the "self-judgmental", "social isolation" and "over-identification" subscale items are reverse coded.

Then, the self-compassion level is calculated by taking the average of all the items.

The higher the score for each sub-dimension, the higher the level of self-compassion.

Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Focus Group Interview Questionnaire I
Tidsramme: Within 1 week postintervention

Focus Group Interview Questionnaire I was created by the researcher in order to evaluate the experiences of the individuals in the study group regarding the MBSR program. There are five questions in the form.

Within 1 week postintervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Münevver Boğahan, Assistant, Mersin University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2022

Primær fullføring (Faktiske)

15. mai 2022

Studiet fullført (Faktiske)

28. februar 2023

Datoer for studieregistrering

Først innsendt

24. januar 2022

Først innsendt som oppfylte QC-kriteriene

8. februar 2022

Først lagt ut (Faktiske)

17. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • munevverbghn
  • Münevver Boğahan (Registeridentifikator: Münevver Boğahan)

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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