AnxietyNCT02930473
Evaluation of a Psychotherapeutic Intervention Model in Nursing
A study testing NIC Psychotherapeutic Intervention(s) for Anxiety and Psychopharmaceuticals (any drugs prescribed by the psychiatrist) in people with Anxiety, run by Francisco Miguel Correia Sampaio.
Trial summary
This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis "Anxiety". A randomised controlled trial will be carried out to do so. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anxiety
- What is being tested?
- NIC Psychotherapeutic Intervention(s) for Anxiety and Psychopharmaceuticals (any drugs prescribed by the psychiatrist)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2017
- 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;
- Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version);
- Elementary education (completed).
Who cannot join
- Psychiatric diagnosis of dementia or psychotic spectrum disorder;
- Being in therapy provided by a psychologist (at the moment of the session 0);
- Cognitive impairment (assessment using Mini-Mental State Examination);
- Moderate or severe intellectual disability;
- Confusional state;
- Psychomotor agitation.
About this study
Official title: Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial
This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis "Anxiety". A randomised controlled trial will be carried out to do so.
Read the detailed description
This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on nursing diagnosis "Anxiety" (according to International Classification for Nursing Practice (ICNP)/North American Nursing Diagnoses Association (NANDA) standardized nursing language). A randomised controlled trial will be carried out to do so. In a single-blinded nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in Portugal, approximately 60 patients with anxiety will be randomised to the intervention (n=30) or control groups (n=30). The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention model in nursing previously developed (5 sessions), which will be evaluated using Nursing Outcomes Classification (NOC) outcomes "Anxiety Level" and "Anxiety Self-Control" (Portuguese version).
- Conditions
- Anxiety
- Being tested
- NIC Psychotherapeutic Intervention(s) for Anxiety, Psychopharmaceuticals (any drugs prescribed by the psychiatrist)
- Keywords
- Psychotherapy, Nursing, Nursing Care, Nursing Model, Randomised Controlled Trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIC Psychotherapeutic Intervention(s) for AnxietyBehavioural
Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.
Psychopharmaceuticals (any drugs prescribed by the psychiatrist)Drug
Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapeutic Intervention(s) for Anxiety | Experimental | People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s) for anxiety (plus psychopharmaceuticals). Receives: Behavioral: NIC Psychotherapeutic Intervention(s) for Anxiety; Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist) |
| Treatment-as-Usual for Anxiety | Active comparator | People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals). Receives: Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
Measured: At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionMay 2017
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 AnxietyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Miguel Correia Sampaio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Miguel Correia Sampaio, Universidade do Porto
- Investigators
- Francisco Sampaio, MSc, Principal investigator, Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930473
- Sponsor's protocol ID
- ICBAS 1988
- Status last verified
- May 2017
- First submitted
- 5 Feb 2016
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sampaio FMC, Araujo O, Sequeira C, Lluch Canut MT, Martins T. A randomized controlled trial of a nursing psychotherapeutic intervention for anxiety in adult psychiatric outpatients. J Adv Nurs. 2018 May;74(5):1114-1126. doi: 10.1111/jan.13520. Epub 2018 Jan 25.
PubMed 29288510
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02930473
- Acronym / sponsor ID
- ICBAS 1988
- Conditions
- Anxiety
- Keywords
- Psychotherapy, Nursing, Nursing Care, Nursing Model, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Francisco Miguel Correia SampaioUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Oct 2016 (estimated)
- 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 "Anxiety". A randomised controlled trial will be carried out to do so.
Detailed description
This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on nursing diagnosis "Anxiety" (according to International Classification for Nursing Practice (ICNP)/North American Nursing Diagnoses Association (NANDA) standardized nursing language). A randomised controlled trial will be carried out to do so. In a single-blinded nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in Portugal, approximately 60 patients with anxiety will be randomised to the intervention (n=30) or control groups (n=30). The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention model in nursing previously developed (5 sessions), which will be evaluated using Nursing Outcomes Classification (NOC) outcomes "Anxiety Level" and "Anxiety Self-Control" (Portuguese version).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapeutic Intervention(s) for Anxiety | Experimental | Behavioral: NIC Psychotherapeutic Intervention(s) for Anxiety, Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s) for anxiety (plus psychopharmaceuticals). |
| Treatment-as-Usual for Anxiety | Active comparator | Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-64 years old;
- Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version);
- Elementary education (completed).
Key exclusion criteria (6 listed)
- Psychiatric diagnosis of dementia or psychotic spectrum disorder;
- Being in therapy provided by a psychologist (at the moment of the session 0);
- Cognitive impairment (assessment using Mini-Mental State Examination);
- Moderate or severe intellectual disability;
- Confusional state;
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 AnxietyPatients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist. | Behavioural | Psychotherapeutic Intervention(s) for Anxiety |
| Psychopharmaceuticals (any drugs prescribed by the psychiatrist)Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist. | Drug | Psychotherapeutic Intervention(s) for Anxiety, Treatment-as-Usual for Anxiety |
Primary outcome
Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
Time frame: At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)
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 16 May 2017.
- Derived from this study: PubMed 29288510Sampaio FMC, Araujo O, Sequeira C, Lluch Canut MT, Martins T. A randomized controlled trial of a nursing psychotherapeutic intervention for anxiety in adult psychiatric outpatients. J Adv Nurs. 2018 May;74(5):1114-1126. doi: 10.1111/jan.13520. Epub 2018 Jan 25.
- Individual participant dataSharing planned: No
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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.
Francisco Sampaio, MSc principal investigator
Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto
Questions about this trial
What is this clinical trial studying?
A study testing NIC Psychotherapeutic Intervention(s) for Anxiety and Psychopharmaceuticals (any drugs prescribed by the psychiatrist) in people with Anxiety, run by Francisco Miguel Correia Sampaio.
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 3 inclusion and 6 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version) (time frame: At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)). 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 NCT02930473, 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 16 May 2017.