Evaluation of Psychotherapeutic Intervention Model in Nursing

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Anxiety Generalized

Intervention / Treatment
-----------------
* Behavioral: NIC Psychotherapeutic Intervention(s) for İneffective Coping
* Behavioral: psychotherapeutic intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Intervention(s) for ineffective coping in General Anxiety<br>Patients with nurse diagnosis of ineffective coping will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s). | Behavioral: NIC Psychotherapeutic Intervention(s) for İneffective Coping<br>* Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).<br>Behavioral: psychotherapeutic intervention<br>* Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).<br>|
| Active Comparator: Treatment-as-Usual for General Anxiety<br>Patients with nurse diagnosis of ineffective coping will receive the usual treatment for general anxiety. | Behavioral: psychotherapeutic intervention<br>* Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nursing Outcomes Classification, Psychotherapeutic intervention, Patient outcome, Psychiatric nursing, Anxiety Generalized, Coping, Self esteem