NCT06114316

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 2, 2023

Last Update Submit

October 27, 2023

Conditions

Keywords

recoveryalcohol use disorderRoy Adapation modelNursing Intervention

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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.

Study Arms (2)

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).

Behavioral: individualized nursing interventions based on the Roy Adaptation Model /experimental

Interventions

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).

experimental

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • with a psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Katip Çelebi University Ataturk Training and Research Hospital

Izmir, Karabağlar, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Dilek AYAKDAŞ DAĞLI, Dr

    İzmir Katip Çelebi Üniversity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2023

First Posted

November 2, 2023

Study Start

June 10, 2018

Primary Completion

March 10, 2019

Study Completion

July 10, 2019

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations