- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06114316
Recovery of Individuals With Alcohol Use Disorders Based on Roy Adaptation Model
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karabağlar
-
Izmir, Karabağlar, Turkey, 35620
- Izmir Katip Celebi University Ataturk Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- with a psychotic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
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.
|
|
|
Active Comparator: experimental
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
A pretest was administered before starting the study and a posttest was administered 1 month later.
|
|
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.
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A pretest was administered before starting the study and a posttest was administered 1 month later.
|
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dilek AYAKDAŞ DAĞLI, Dr, Izmir Katip Celebi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ayakdasdaglı
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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