Evaluation of Psychotherapeutic Intervention Model in Nursing

Anxiety Generalized Clinical Trial

Official title:

Evaluation of Psychotherapeutic Intervention Model in Nursing on Patients With Nursing Diagnosis of Ineffective Coping

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06076746
• Other study ID #: 2022-1081
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Ankara Yildirim Beyazit University
• Contact: Tugba Askan, PhD Student
• Phone: 0312 552 60 00
• Email: tgbskn14[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis ineffective coping. For this purpose, validity and reliability studies of the assessment tools will be carried out initially, and then a randomized controlled study will be conducted.

Description:

This study aims to evaluate the efficacy of the psychotherapeutic intervention model in nursing on patients with nursing diagnosis of ineffective coping (International Classification of Nursing Practices (ICNP)/North American Nursing Diagnostic Association (NANDA)). For this purpose, first of all, validity and reliability studies of "Coping" and "Self-Esteem", which are the results of NOC (Nursing Outcomes Classification), will be conducted, and then a randomized controlled study will be conducted (Turkish version). 200 patients will be included in the validity and reliability phase of the study, which was conducted in a hospital outpatient psychiatric setting in Turkey. The randomized controlled second phase will be carried out, single-blind, nurse-led, with approximately 26 patients with anxiety randomized to intervention (n=13) or control groups (n=13). The usual treatment and care will be compared with the application of the psychotherapeutic intervention model previously developed in nursing.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 18-64 years old,
• Literacy,
• Having applied to the psychiatry outpatient clinic,
• Being regularly treated in a psychiatry outpatient clinic,
• Having a medical diagnosis of generalized anxiety disorder,
• Having at least one of the defining characteristics of the nursing diagnosis of ineffective coping according to the nursing process.

Exclusion Criteria:

• Medical diagnosis of dementia or psychotic spectrum disorder,
• Cognitive disorder,
• Confused state of consciousness
• Psychomotor agitation,
• Moderate or severe intellectual disability
• Expressing suicidal thoughts
• Suicide attempt in the last month
• Continuing psychological counseling at the moment.

Related Conditions & MeSH terms

• Anxiety Generalized

Intervention

Behavioral:
• NIC Psychotherapeutic Intervention(s) for Ineffective Coping
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).
• psychotherapeutic intervention
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara	Çubuk

Sponsors (1)

Lead Sponsor	Collaborator
Tugba Askan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coping	Nursing Outcomes Classification (Coping (1302)) The scale consists of 19 items. A minimum of 19 and a maximum of 95 points can be obtained from the scale. Increasing scale scores indicate good results.	Baseline and through study completion, an average of 9 weeks
Primary	Self esteem	Nursing Outcomes Classification (Self-Esteem (1205)) The scale consists of 20 items. A minimum of 20 and a maximum of 100 points can be obtained from the scale. An increase in scale scores indicates good results.	Baseline and through study completion, an average of 9 weeks