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CompletedNCT06076746Updated May 14, 2025

Evaluation of Psychotherapeutic Intervention Model in Nursing

An interventional study of NIC Psychotherapeutic Intervention(s) for İneffective Coping and psychotherapeutic intervention in Anxiety Generalized, sponsored by Tuğba Aşkan. Completed at 1 site in Turkey. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Tuğba Aşkan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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 20 patients with anxiety randomized to intervention (n=10) or control groups (n=10). The usual treatment and care will be compared with the application of the psychotherapeutic intervention model previously developed in nursing.

02

Conditions studied

  • Anxiety Generalized

Keywords

  • Nursing Outcomes Classification
  • Psychotherapeutic intervention
  • Patient outcome
  • Psychiatric nursing
  • Anxiety Generalized
  • Coping
  • Self esteem
03

In context

Lead sponsor

This is the only study on the registry with Tuğba Aşkan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

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

    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 · Behavioral: psychotherapeutic intervention

  • Active comparator
    Treatment-as-Usual for General Anxiety

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

    Behavioral: psychotherapeutic intervention

Interventions

  • BehavioralNIC Psychotherapeutic Intervention(s) for İneffective Coping

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

  • Behavioralpsychotherapeutic intervention

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and through study completion, an average of 9 weeks

  2. 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.

    Time frame: Baseline and through study completion, an average of 9 weeks

07

Study locations

1 site
  • Ankara Yildirim Beyazit University
    Ankara, Çubuk 06760, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06076746
Lead sponsor
Tuğba Aşkan
Responsible party
Tuğba Aşkan (Nurse, Ankara Yildirim Beyazıt University) — Sponsor-investigator
First posted
Oct 11, 2023
Start date
Oct 14, 2024
Primary completion
Dec 27, 2024
Completion
Dec 27, 2024
Last update
May 14, 2025

Study contacts

Tuğba Aşkan, PhD Student
principal investigator · Ankara Yildirim Beyazıt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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