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Positive Psychotherapy-Based Counseling (PPT)

Primary Purpose

Chronic Urticaria, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Positive Psychotherapy Based Counseling
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Urticaria focused on measuring Positive Psychotherapy (PPT), Chronic Urticaria, Anxiety, Life quality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Those diagnosed with chronic urticaria Those between the ages of 18-50 Patients without cognitive clouding Anyone with a smartphone/computer who can participate in positive psychotherapy (PPT) sessions Patients who can speak Turkish Patients without hearing and vision problems will be included in the study.

Exclusion Criteria:

Those over 50 or under 18 Having a psychiatric illness and taking medication Have any other chronic disease Those with hearing, vision, speech and cognitive dysfunction, Those who do not speak Turkish Writing fields can be extended as needed Patients who do not accept the procedure will not be included in the study.

Sites / Locations

  • Erciyes Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention Group

Arm Description

Individuals in the control group agreed to participate in the study after being explained about the research. Verbal and written consent will be obtained from individuals who do so. Initial interview with individuals who agreed to participate in the study Introductory Information Form, Trait Anxiety Scale, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. Patients in this group have routine chronic No application will be made other than the treatment of urticaria. 5 months after the pre-test Trait State Anxiety Scale, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. After the study is completed, individuals in the control group can also request it. counseling will be provided.

Positive psychotherapy counseling sessions, specialist psychiatry who completed positive psychotherapy training will be done by the nurse. The first one face-to-face with each individual in the intervention group. A total of 8 sessions will be held, theothers being online. Audio and video with attendees Other sessions will be completed through a program that allows sharing (WhatsAap, zoom etc.). Each session will be applied once a week, lasting 45-50 minutes. Interviews with individuals No audio or video recording will be taken during the recording.

Outcomes

Primary Outcome Measures

State Trait Anxiety Scale
The total score obtained from both scales varies between 20 and 80. big score high anxiety A low score indicates a low level of anxiety.
Dermatological Quality of Life Scale
The total score obtained varies between 0-44, and the high total score is associated with the survival of the patients. indicates a decrease in quality.

Secondary Outcome Measures

Urticaria Activity Score
Scoring is evaluated between 0-42 points. Seven-day urticaria activity score; Total (minimum 0-maximum 42) UAS7 score of ≤6 is well-controlled, between 7-15 is mild, 16-27 Between 28 and 42 is considered as moderate urticaria.

Full Information

First Posted
August 22, 2022
Last Updated
August 23, 2022
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05513079
Brief Title
Positive Psychotherapy-Based Counseling (PPT)
Official Title
The Effect of Positive Psychotherapy-Based Counseling (PPT) on Anxiety Levels and Quality of Life of Patients With Chronic Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic urticaria is a condition that impairs the patient's quality of life, interferes with routine daily activities, and is often associated with anxiety. It constitutes a significant burden associated with psychiatric comorbidities such as Fundamentals of Positive Psychotherapy (PPT) The aim is to help the individual to develop his/her core capacities and in his/her daily life in four areas of life (body, success, relationships and the future) to help them achieve balance. In patients with chronic urticaria, especially problems with the body occur and this can affect other areas of life. Literature When examined, it is seen that psychological interventions in chronic urticaria are very few and in ancient times. In addition, it is recommended that psychological interventions based on conversation should be performed with these patients. PPT, conversational and balancing the dimensions of "body, achievement, relationships and future" It is a working approach. Body and future in the disease process of chronic urticaria patients Considering that there is a balance change in the dimensions of the PPT, it will contribute to the literature. is considered. Intervention Group Positive psychotherapy counseling sessions, specialist psychiatry who completed positive psychotherapy training will be done by the nurse. Contact information of the volunteers will be obtained at the outpatient clinic and individuals will be randomized. will be divided into intervention and control groups. The first one face-to-face with each individual in the intervention group. A total of 8 sessions will be held, the others being online. Individuals who agreed to participate in the study were first Introductory Information Form, Continuity Anxiety Scale, face-to-face during the interview, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. Audio and video with volunteers Other sessions will be completed through a program that allows sharing (WhatsAap, zoom etc.). Each session will be applied once a week, lasting 45-50 minutes. Interviews with individuals No audio or video recording will be taken during the recording. This information was given to the volunteers included in the intervention group. will be announced before the meeting begins. After the eight-week counseling program 3 months later (pretest-posttest when including the 8-week program to be applied after the pretest) There will be a total of 5 months between Project Title Positive Psychotherapy Based Counseling (PPT) Diagnosed with Chronic Urticaria Anxiety Levels of Patients and Its Effect on Quality of Life Project Coordinator Assoc. Dr. Nuray SIMSEK Researcher(s) Res. See. Eda Albayrak Project Type Ph.D. Thesis Project Project Group ( ) Science and Engineering Sciences ( X) Medicine and Health Sciences ( ) Social Sciences Writing fields can be extended as needed Quality Scale, Urticaria Activity Score will be applied. Control Group Individuals in the control group agreed to participate in the study after being explained about the research. Verbal and written consent will be obtained from individuals who do so. Initial interview with individuals who agreed to participate in the study Introductory Information Form, Trait Anxiety Scale, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. Patients in this group are routinely chronically ill. No application will be made other than the treatment of urticaria. 5 months after the pre-test Trait State Anxiety Scale, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. After the study is completed, individuals in the control group can also request it. counseling will be provided.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria, Anxiety
Keywords
Positive Psychotherapy (PPT), Chronic Urticaria, Anxiety, Life quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Individuals in the control group agreed to participate in the study after being explained about the research. Verbal and written consent will be obtained from individuals who do so. Initial interview with individuals who agreed to participate in the study Introductory Information Form, Trait Anxiety Scale, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. Patients in this group have routine chronic No application will be made other than the treatment of urticaria. 5 months after the pre-test Trait State Anxiety Scale, Dermatological Quality of Life Scale, Urticaria Activity Score will be applied. After the study is completed, individuals in the control group can also request it. counseling will be provided.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Positive psychotherapy counseling sessions, specialist psychiatry who completed positive psychotherapy training will be done by the nurse. The first one face-to-face with each individual in the intervention group. A total of 8 sessions will be held, theothers being online. Audio and video with attendees Other sessions will be completed through a program that allows sharing (WhatsAap, zoom etc.). Each session will be applied once a week, lasting 45-50 minutes. Interviews with individuals No audio or video recording will be taken during the recording.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychotherapy Based Counseling
Other Intervention Name(s)
Positive Psychotherapy (PPT)
Intervention Description
The main purpose in Positive Psychotherapy is to develop the individual's main capacities. and to maintain balance in the four areas of life (body, success, relationships and future) in daily life. to help provide. The essence of Positive Psychotherapy is a five-step process: 1. Observation/distance phase, 2. Inventory phase, 3. Situational encouragement phase, 4. Verbalization phase, 5. Expanding the objectives phase. Shaping five-step model therapy It is a helpful guide.
Primary Outcome Measure Information:
Title
State Trait Anxiety Scale
Description
The total score obtained from both scales varies between 20 and 80. big score high anxiety A low score indicates a low level of anxiety.
Time Frame
Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
Title
Dermatological Quality of Life Scale
Description
The total score obtained varies between 0-44, and the high total score is associated with the survival of the patients. indicates a decrease in quality.
Time Frame
Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
Secondary Outcome Measure Information:
Title
Urticaria Activity Score
Description
Scoring is evaluated between 0-42 points. Seven-day urticaria activity score; Total (minimum 0-maximum 42) UAS7 score of ≤6 is well-controlled, between 7-15 is mild, 16-27 Between 28 and 42 is considered as moderate urticaria.
Time Frame
Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those diagnosed with chronic urticaria Those between the ages of 18-50 Patients without cognitive clouding Anyone with a smartphone/computer who can participate in positive psychotherapy (PPT) sessions Patients who can speak Turkish Patients without hearing and vision problems will be included in the study. Exclusion Criteria: Those over 50 or under 18 Having a psychiatric illness and taking medication Have any other chronic disease Those with hearing, vision, speech and cognitive dysfunction, Those who do not speak Turkish Writing fields can be extended as needed Patients who do not accept the procedure will not be included in the study.
Facility Information:
Facility Name
Erciyes Universty
City
Kayseri
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda Albayrak

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Positive Psychotherapy-Based Counseling (PPT)

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