NCT04961463

Brief Summary

The physical, social and psychological effects of Behcet's disease necessitate the patient's adaptation in many areas. This study was conducted to examine the effect of psychoeducation given to Behcet's patients in the context of the Roy Adaptation Model on illness adjustment, dyadic adjustment, self-esteem, and psychiatric symptoms. The study is a control group quasi-experimental study with a pre-test, post-test and follow-up design. The study was conducted with 70 Behcet's patients including 35 interventions and 35 controls. The data of the study were collected using the "Patient Information Form", " Adaptation to Chronic Illness Scale", "Dyadic Adjustment Scale", "Rosenberg Self-Esteem Scale" and "Brief Symptom Inventory" in pre-test, post-test and follow-up measurements. A 7-session psychoeducation program was applied to the intervention group.

Trial Health

100
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 Sep 2016

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

September 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

June 11, 2021

Last Update Submit

July 13, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Evaluation of change in disease compliance

    Adaptation to chronic ilness scale was used to assess disease compliance. The minimum score that can be obtained from the scale is 25 and the maximum score is 125. As the total scale score increases, disease compliance also increases.

    1 week before psychoeducation (pre-test), After the psychoeducation (posttest) and 1 month after posttest

  • Evaluation of change in psychiatric symptoms

    Brief symptom inventory was used to assess Psychiatric symptoms The minimum score that can be obtained from the scale is 0 and the maximum score is 212. As the total scale score increases, the level of psychiatric symptoms also increases.

    1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

  • Evaluation of change in dyadic adjustment

    Dyadic adjustment scale was used to assess dyadic adjustment The minimum score that can be obtained from the scale is 0 and the maximum score is 151. Higher total adjustment score indicates better marital adjustment.

    1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

  • Evaluation of change in Self-esteem

    Rosenberg self-esteem scale was used to assess self-esteem. The minimum score that can be obtained from the scale is 0 and the maximum score is 6. As the total scale score decreases, self-esteem increases

    1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

Study Arms (2)

İnterventions group

EXPERIMENTAL

İnterventions group:The 7-session psychoeducation program prepared on the basis of the Roy Adaptation Model was applied to the intervention group once a week for 90-120 minutes

Behavioral: psychoeducation

Control group

NO INTERVENTION

Except for the routine hospital controls, no intervention was made to the control group

Interventions

psychoeducationBEHAVIORAL
İnterventions group

Eligibility Criteria

Age23 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Married or had a partner life,
  • Were 18 years old

You may not qualify if:

  • Hearing and speech impairment
  • A psychiatric diagnosis
  • Neurological involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Officials

  • Nermin Erdoğan

    Ulucanlar Eye Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is a control group quasi-experimental study with a pre-test, post-test and follow-up design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2021

First Posted

July 14, 2021

Study Start

September 15, 2016

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share