Anxiety GeneralizedNCT06076746
Evaluation of Psychotherapeutic Intervention Model in Nursing
A study testing NIC Psychotherapeutic Intervention(s) for İneffective Coping and psychotherapeutic intervention in people with Anxiety Generalized, run by Tuğba Aşkan at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anxiety Generalized
- What is being tested?
- NIC Psychotherapeutic Intervention(s) for İneffective Coping and psychotherapeutic intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2024to 27 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University
Ankara, Çubuk, 06760
About this study
Official title: Evaluation of Psychotherapeutic Intervention Model in Nursing on Patients With Nursing Diagnosis of Ineffective Coping
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.
- Conditions
- Anxiety Generalized
- Being tested
- NIC Psychotherapeutic Intervention(s) for İneffective Coping, psychotherapeutic intervention
- Keywords
- Nursing Outcomes Classification, Psychotherapeutic intervention, Patient outcome, Psychiatric nursing, Anxiety Generalized, Coping, Self esteem
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIC Psychotherapeutic Intervention(s) for İneffective CopingBehavioural
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).
psychotherapeutic interventionBehavioural
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: NIC Psychotherapeutic Intervention(s) for İneffective Coping; Behavioral: 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. Receives: Behavioral: psychotherapeutic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and through study completion, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start14 Oct 2024
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Aşkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba Aşkan, Ankara Yildirim Beyazıt University
- Investigators
- Tuğba Aşkan, PhD Student, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076746
- Sponsor's protocol ID
- 2022-1081
- Status last verified
- Oct 2024
- First submitted
- 9 May 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Askan T, Ozkan B, Kamis GZ, Ugurlu M. Short-Term Effectiveness of a Psychotherapeutic Intervention Model in Nursing for Ineffective Coping in GAD Outpatients: A Small-Sample Randomized Controlled Trial. Alpha Psychiatry. 2026 Oct 14;27(5):51147. doi: 10.31083/AP51147. eCollection 2026 Oct.
PubMed 42985396
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychotherapeutic Intervention Model in Nursing on Patients With Nursing Diagnosis of Ineffective Coping
- ClinicalTrials.gov ID
- NCT06076746
- Acronym / sponsor ID
- 2022-1081
- Conditions
- Anxiety Generalized
- Keywords
- Nursing Outcomes Classification, Psychotherapeutic intervention, Patient outcome, Psychiatric nursing, Anxiety Generalized, Coping, Self esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tuğba AşkanUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention(s) for ineffective coping in General Anxiety | Experimental | Behavioral: NIC Psychotherapeutic Intervention(s) for İneffective Coping, Behavioral: psychotherapeutic interventionPatients with nurse diagnosis of ineffective coping will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s). |
| Treatment-as-Usual for General Anxiety | Active comparator | Behavioral: psychotherapeutic interventionPatients with nurse diagnosis of ineffective coping will receive the usual treatment for general anxiety. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- Medical diagnosis of dementia or psychotic spectrum disorder,
- Cognitive disorder,
- Confused state of consciousness
- Psychomotor agitation,
- Moderate or severe intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIC Psychotherapeutic Intervention(s) for İneffective CopingPatients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement). | Behavioural | Experimental: Intervention(s) for ineffective coping in General Anxiety |
| psychotherapeutic interventionPatients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement). | Behavioural | Experimental: Intervention(s) for ineffective coping in General Anxiety, Treatment-as-Usual for General Anxiety |
Primary outcome
Coping
Time frame: Baseline and through study completion, an average of 9 weeks
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.
Self esteem
Time frame: Baseline and through study completion, an average of 9 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 42985396Askan T, Ozkan B, Kamis GZ, Ugurlu M. Short-Term Effectiveness of a Psychotherapeutic Intervention Model in Nursing for Ineffective Coping in GAD Outpatients: A Small-Sample Randomized Controlled Trial. Alpha Psychiatry. 2026 Oct 14;27(5):51147. doi: 10.31083/AP51147. eCollection 2026 Oct.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Aşkan, PhD Student principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIC Psychotherapeutic Intervention(s) for İneffective Coping and psychotherapeutic intervention in people with Anxiety Generalized, run by Tuğba Aşkan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping (time frame: Baseline and through study completion, an average of 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.