AlcoholismNCT02604758
Tidal Model's Effect on Coping and Self-Esteem
A study testing The Psychiatric Nursing Approach Based On The Tidal Model in people with Alcoholism, run by Mahire Olcay Çam.
Trial summary
The aim of the study was to determine the effect of the psychiatric nursing approach based on the Tidal Model on coping and self-esteem in people with alcohol dependency. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- The Psychiatric Nursing Approach Based On The Tidal Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2014
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with alcohol dependency were included in the study who were between 30 and 50 years of age who were admitted for treatment to the Alcohol and Substance Addiction Treatment clinic.
Who cannot join
- People with alcohol dependency who were severely depressed with a Beck Depression score of 41 or more and those with severe anxiety(a Beck Anxiety score of 26 or more) were not included in the study.
About this study
Official title: The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People With Alcohol Dependency: A Randomized Trial
The aim of the study was to determine the effect of the psychiatric nursing approach based on the Tidal Model on coping and self-esteem in people with alcohol dependency.
- Conditions
- Alcoholism
- Being tested
- The Psychiatric Nursing Approach Based On The Tidal Model
- Keywords
- Alcoholics [M01.066]
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Psychiatric Nursing Approach Based On The Tidal ModelBehavioural
To provide individualized care for patients in the experimental group, the One-to-One Sessions were initiated and interventions were performed in line with the goals of the persons and the aims of the research. The interventions were selected from interventions regarding with coping and self-esteem from the Nursing Interventions Classification(NIC) system.The One-to-One sessions help the person recognize change and focus the person on achievement and goals.Taking into account the basic process of the Tidal Model, care stages, the following interview plan was drawn up, containing the details of the interviews to be carried out with people with alcohol dependency, and the One-to-One Sessions were held in line with this plan two times per week.
| Study group | Role | What they receive |
|---|---|---|
| Tidal Model | Experimental | the psychiatric nursing approach based on the Tidal Model Receives: Behavioral: The Psychiatric Nursing Approach Based On The Tidal Model |
| control group | No intervention | The control group received routine treatment and follow-up in the Alcohol and Substance Addiction Treatment Clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Coping Inventory
The Coping Inventory was developed by Carver et al. in 1989, and Turkish validity and reliability were carried out in 2005 by Ağargün et al. Each sub-scale of COPE gives information on a different attitude to coping. The scores on the sub-scales allow an interpretation to be made of which attitude to coping an individual uses most.
Measured: after three months
The Coopersmith Self-Esteem Inventory
The Coopersmith Self-Esteem Inventory was developed by Stanley Coopersmith(1986), and adapted to Turkish by Turan and Tufan(1987), who also carried out the validity and reliability study. It consists of 25 items, which contain statements about the person's outlook on life, family relations, social relations and endurance. Scores range from 0 to 100.
Measured: after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahire Olcay Çam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahire Olcay Çam, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604758
- Sponsor's protocol ID
- 7321
- Status last verified
- Nov 2015
- First submitted
- 9 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People With Alcohol Dependency: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02604758
- Acronym / sponsor ID
- 7321
- Conditions
- Alcoholism
- Keywords
- Alcoholics [M01.066]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mahire Olcay ÇamUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Nov 2015 (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.
The aim of the study was to determine the effect of the psychiatric nursing approach based on the Tidal Model on coping and self-esteem in people with alcohol dependency.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tidal Model | Experimental | Behavioral: The Psychiatric Nursing Approach Based On The Tidal Modelthe psychiatric nursing approach based on the Tidal Model |
| control group | No intervention | –The control group received routine treatment and follow-up in the Alcohol and Substance Addiction Treatment Clinic. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- People with alcohol dependency were included in the study who were between 30 and 50 years of age who were admitted for treatment to the Alcohol and Substance Addiction Treatment clinic.
Key exclusion criteria (1 listed)
- People with alcohol dependency who were severely depressed with a Beck Depression score of 41 or more and those with severe anxiety(a Beck Anxiety score of 26 or more) were not included in the study.
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 |
|---|---|---|
| The Psychiatric Nursing Approach Based On The Tidal ModelTo provide individualized care for patients in the experimental group, the One-to-One Sessions were initiated and interventions were performed in line with the goals of the persons and the aims of the research. The interventions were selected from interventions regarding with coping and self-esteem from the Nursing Interventions Classification(NIC) system.The One-to-One sessions help the person recognize change and focus the person on achievement and goals.Taking into account the basic process of the Tidal Model, care stages, the following interview plan was drawn up, containing the details of the interviews to be carried out with people with alcohol dependency, and the One-to-One Sessions were held in line with this plan two times per week. | Behavioural | Tidal Model |
Primary outcome
The Coping Inventory
Time frame: after three months
The Coping Inventory was developed by Carver et al. in 1989, and Turkish validity and reliability were carried out in 2005 by Ağargün et al. Each sub-scale of COPE gives information on a different attitude to coping. The scores on the sub-scales allow an interpretation to be made of which attitude to coping an individual uses most.
The Coopersmith Self-Esteem Inventory
Time frame: after three months
The Coopersmith Self-Esteem Inventory was developed by Stanley Coopersmith(1986), and adapted to Turkish by Turan and Tufan(1987), who also carried out the validity and reliability study. It consists of 25 items, which contain statements about the person's outlook on life, family relations, social relations and endurance. Scores range from 0 to 100.
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 13 Nov 2015.
Related trials for Alcoholism
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
RecruitingPhase 1
Spironolactone in Alcohol Use Disorder (SAUD)
Alcohol Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Psychiatric Nursing Approach Based On The Tidal Model in people with Alcoholism, run by Mahire Olcay Çam.
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 1 inclusion and 1 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 13 Nov 2015. 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?
The Coping Inventory (time frame: after three months). 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?
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 13 Nov 2015; AzTrials last refreshed its copy on 27 Oct 2026.