NCT06076746

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
Last Updated

May 14, 2025

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

May 9, 2023

Last Update Submit

May 9, 2025

Conditions

Keywords

Nursing Outcomes ClassificationPsychotherapeutic interventionPatient outcomePsychiatric nursingAnxiety GeneralizedCopingSelf esteem

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Experimental: Intervention(s) for ineffective coping in General Anxiety

EXPERIMENTAL

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 CopingBehavioral: psychotherapeutic intervention

Treatment-as-Usual for General Anxiety

ACTIVE COMPARATOR

Patients with nurse diagnosis of ineffective coping will receive the usual treatment for general anxiety.

Behavioral: psychotherapeutic intervention

Interventions

Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).

Experimental: Intervention(s) for ineffective coping in General Anxiety

Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).

Experimental: Intervention(s) for ineffective coping in General AnxietyTreatment-as-Usual for General Anxiety

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Tuğba Aşkan, PhD Student

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It will not be known by the Outcomes Assessor that the patients are in the experimental or usual treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

May 9, 2023

First Posted

October 11, 2023

Study Start

October 14, 2024

Primary Completion

December 27, 2024

Study Completion

December 27, 2024

Last Updated

May 14, 2025

Record last verified: 2024-10

Locations