Addiction, AlcoholNCT06114316
Recovery of Individuals With Alcohol Use Disorders Based on Roy Adaptation Model
A study testing individualized nursing interventions based on the Roy Adaptation Model /experimental in people with Addiction, Alcohol, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Abstract Aim: This study aimed to determine the effect of individualized nursing interventions based on the Roy Adaptation Model on the recovery of alcohol addicts. Method: This was an experimental study with pretest-posttest, follow-up, and a control group. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Addiction, Alcohol
- What is being tested?
- individualized nursing interventions based on the Roy Adaptation Model /experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2018to 10 Jul 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with alcohol use disorder according to DSM 5 Completed the detoxification phase were able to understand the scales and forms and maintain individual interviews were between 30 and 60 years of age
Who cannot join
- with a psychotic disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University Ataturk Training and Research Hospital
Izmir, Karabağlar, 35620
About this study
Official title: Effect of Interventions Based on Roy Adaptation Model on the Recovery of Individuals With Alcohol Use Disorders: A Randomized Trial
Abstract Aim: This study aimed to determine the effect of individualized nursing interventions based on the Roy Adaptation Model on the recovery of alcohol addicts.
Method: This was an experimental study with pretest-posttest, follow-up, and a control group. It included 64 individuals who completed their detoxification process and met the inclusion criteria. The experimental group was provided with individualized care, and interventions were made in line with the Roy Adaptation Model. The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC).
The data were collected using an introductory information form, the Recovery Assessment Scale (RAS), the Turkish Version of the World Health Organization Quality of Life Instrument (WHOQOL-BREF-TR), and the Penn Alcohol Craving Scale (PACS).
- Conditions
- Addiction, Alcohol
- Being tested
- individualized nursing interventions based on the Roy Adaptation Model /experimental
- Keywords
- recovery, alcohol use disorder, Roy Adapation model, Nursing Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized nursing interventions based on the Roy Adaptation Model /experimentalBehavioural
The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC). A total of 10 individual interviews were made twice a week for about 45 to 60 minutes. The interviews were evaluated by determining the area specific Nursing outcome classification (NOC) (self respect, social support, mood management, role performance).
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | The control group continued to receive routine treatment (pharmacotherapy and psychoeducation) and follow-up in the Alcohol and Substance Addiction Treatment Center, and no intervention was made. |
| experimental | Active comparator | In the first step, the stimuli that led the individuals in the experimental group to drink alcohol were assessed, and the conceptual-theoretical-experimental (CTE) framework of the study was created. The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC). A total of 10 individual interviews were made twice a week for about 45 to 60 minutes. The interviews were evaluated by determining the area specific Nursing outcome classification (NOC) (self respect, social support, mood management, role performance). Receives: Behavioral: individualized nursing interventions based on the Roy Adaptation Model /experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Recovery Assessment Scale (RAS)
The RAS was developed by Corrigan et al. (2004) and tested for validity and reliability in Turkish by Güler and Gürkan (2017). The scale consisted of 24 questions under 5 subscales. It was a five-point Likert type scale scored as follows: 1 = Strongly Disagree; 2 = Disagree; 3 = Not Sure; 4 = Agree; and 5 = Strongly Agree. The titles of the subscales were self-confidence and hope, seeking help, orientation to objectives and success, trust in the environment, and coping with the symptoms. Assessment could be made by scoring each item individually or over the total score. High total scores indicated high recovery. Cronbach's alpha coefficient of the Turkish form of the scale was 0.90.
Measured: A pretest was administered before starting the study and a posttest was administered 1 month later.
World Health Organization Quality of Life Instrument
This health-related quality of life scale was developed by the World Health Organization and tested for validity and reliability in Turkish by Eser et al. The scale consisted of 27 questions that assessed individuals' physical, mental, social, and environmental well-being. Since each area independently represented the quality of life in its own domain, the area scores were calculated as between 4 and 20. High scores indicated a higher quality of life . The scale was selected by the substance addiction institute as the best scale that assessed the recovery of substance addiction. Cronbach's alpha coefficients of the subscales ranged between 0.73 and 0.84.
Measured: A pretest was administered before starting the study and a posttest was administered 1 month later.
Penn Alcohol Craving Scale
This was a five-item question form developed by Flannery et al. (1999) to assess the wish to drink alcohol (frequency, intensity, duration, resistance, and general craving). Each item was scored between 0 and 6. Thus, the maximum total severe craving score was 30. The scale was tested for validity and reliability in Turkish by Evren et al. (2008) with alcohol addicts, and its Cronbach alpha coefficient was found to be 0.94.
Measured: A pretest was administered before starting the study and a posttest was administered after the study was completed. Follow-up testing was performed 1 month and 3 months after the end 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 posted2 Nov 2023
- Study start10 Jun 2018
- Primary completion10 Mar 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction, AlcoholStudies 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
- Model description
- Eighty individuals who alcohol use disorder were assessed for eligibility and 70 individuals (who completed their detoxification process, were able to understand the scales and forms and maintain individual interviews, were between 30 and 60 years of age, were diagnosed with alcohol addiction according to the DSM-5 diagnostic criteria, and voluntarily agreed to participate in the studywere) randomized. An experimental and a control group were formed by assigning persons to each group by using the stratified randomization technique in which a sex factor was involved, according to a random-number table. Four male participants in the experimental group (who were not involved in intervention) and two male participants in the control group (who were discharged) were excluded as they did not continue the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek AYAKDAS DAGLI, Izmir Katip Celebi University
- Investigators
- Dilek AYAKDAŞ DAĞLI, Dr, Study chair, İzmir Katip Çelebi Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114316
- Sponsor's protocol ID
- ayakdasdaglı
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interventions Based on Roy Adaptation Model on the Recovery of Individuals With Alcohol Use Disorders: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06114316
- Acronym / sponsor ID
- ayakdasdaglı
- Conditions
- Addiction, Alcohol
- Keywords
- recovery, alcohol use disorder, Roy Adapation model, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 2 Nov 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.
Abstract Aim: This study aimed to determine the effect of individualized nursing interventions based on the Roy Adaptation Model on the recovery of alcohol addicts.
Method: This was an experimental study with pretest-posttest, follow-up, and a control group. It included 64 individuals who completed their detoxification process and met the inclusion criteria. The experimental group was provided with individualized care, and interventions were made in line with the Roy Adaptation Model. The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC).
The data were collected using an introductory information form, the Recovery Assessment Scale (RAS), the Turkish Version of the World Health Organization Quality of Life Instrument (WHOQOL-BREF-TR), and the Penn Alcohol Craving Scale (PACS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eighty individuals who alcohol use disorder were assessed for eligibility and 70 individuals (who completed their detoxification process, were able to understand the scales and forms and maintain individual interviews, were between 30 and 60 years of age, were diagnosed with alcohol addiction according to the DSM-5 diagnostic criteria, and voluntarily agreed to participate in the studywere) randomized. An experimental and a control group were formed by assigning persons to each group by using the stratified randomization technique in which a sex factor was involved, according to a random-number table. Four male participants in the experimental group (who were not involved in intervention) and two male participants in the control group (who were discharged) were excluded as they did not continue the study.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –The control group continued to receive routine treatment (pharmacotherapy and psychoeducation) and follow-up in the Alcohol and Substance Addiction Treatment Center, and no intervention was made. |
| experimental | Active comparator | Behavioral: individualized nursing interventions based on the Roy Adaptation Model /experimentalIn the first step, the stimuli that led the individuals in the experimental group to drink alcohol were assessed, and the conceptual-theoretical-experimental (CTE) framework of the study was created. The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC). A total of 10 individual interviews were made twice a week for about 45 to 60 minutes. The interviews were evaluated by determining the area specific Nursing outcome classification (NOC) (self respect, social support, mood management, role performance). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed with alcohol use disorder according to DSM 5 Completed the detoxification phase were able to understand the scales and forms and maintain individual interviews were between 30 and 60 years of age
Key exclusion criteria (1 listed)
- with a psychotic disorder
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 |
|---|---|---|
| individualized nursing interventions based on the Roy Adaptation Model /experimentalThe personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC). A total of 10 individual interviews were made twice a week for about 45 to 60 minutes. The interviews were evaluated by determining the area specific Nursing outcome classification (NOC) (self respect, social support, mood management, role performance). | Behavioural | experimental |
Primary outcome
The Recovery Assessment Scale (RAS)
Time frame: A pretest was administered before starting the study and a posttest was administered 1 month later.
The RAS was developed by Corrigan et al. (2004) and tested for validity and reliability in Turkish by Güler and Gürkan (2017). The scale consisted of 24 questions under 5 subscales. It was a five-point Likert type scale scored as follows: 1 = Strongly Disagree; 2 = Disagree; 3 = Not Sure; 4 = Agree; and 5 = Strongly Agree. The titles of the subscales were self-confidence and hope, seeking help, orientation to objectives and success, trust in the environment, and coping with the symptoms. Assessment could be made by scoring each item individually or over the total score. High total scores indicated high recovery. Cronbach's alpha coefficient of the Turkish form of the scale was 0.90.
World Health Organization Quality of Life Instrument
Time frame: A pretest was administered before starting the study and a posttest was administered 1 month later.
This health-related quality of life scale was developed by the World Health Organization and tested for validity and reliability in Turkish by Eser et al. The scale consisted of 27 questions that assessed individuals' physical, mental, social, and environmental well-being. Since each area independently represented the quality of life in its own domain, the area scores were calculated as between 4 and 20. High scores indicated a higher quality of life . The scale was selected by the substance addiction institute as the best scale that assessed the recovery of substance addiction. Cronbach's alpha coefficients of the subscales ranged between 0.73 and 0.84.
Penn Alcohol Craving Scale
Time frame: A pretest was administered before starting the study and a posttest was administered after the study was completed. Follow-up testing was performed 1 month and 3 months after the end of the study.
This was a five-item question form developed by Flannery et al. (1999) to assess the wish to drink alcohol (frequency, intensity, duration, resistance, and general craving). Each item was scored between 0 and 6. Thus, the maximum total severe craving score was 30. The scale was tested for validity and reliability in Turkish by Evren et al. (2008) with alcohol addicts, and its Cronbach alpha coefficient was found to be 0.94.
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 2 Nov 2023.
- 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.
Dilek AYAKDAŞ DAĞLI, Dr study chair
İzmir Katip Çelebi Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individualized nursing interventions based on the Roy Adaptation Model /experimental in people with Addiction, Alcohol, run by Izmir Katip Celebi University 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 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 2 Nov 2023. 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?
The Recovery Assessment Scale (RAS) (time frame: A pretest was administered before starting the study and a posttest was administered 1 month later.). The study lists 3 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 2 Nov 2023.