Chronic UrticariaNCT05513079
Positive Psychotherapy-Based Counseling (PPT)
A study testing Positive Psychotherapy Based Counseling in people with Chronic Urticaria and Anxiety, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Urticaria, Anxiety
- What is being tested?
- Positive Psychotherapy Based Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2022to Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Positive Psychotherapy-Based Counseling (PPT) on Anxiety Levels and Quality of Life of Patients With Chronic Urticaria
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.
Read more
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.
- Conditions
- Chronic Urticaria, Anxiety
- Being tested
- Positive Psychotherapy Based Counseling
- Keywords
- Positive Psychotherapy (PPT), Chronic Urticaria, Anxiety, Life quality
- Medical subject headings
- Chronic Urticaria, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychotherapy Based CounselingBehavioural
Also called Positive Psychotherapy (PPT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Intervention Group | Experimental | 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. Receives: Behavioral: Positive Psychotherapy Based Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
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.
Measured: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
Secondary outcomes (1)
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.
Measured: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Albayrak, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513079
- Sponsor's protocol ID
- ErciyesUnı
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Psychotherapy-Based Counseling (PPT) on Anxiety Levels and Quality of Life of Patients With Chronic Urticaria
- ClinicalTrials.gov ID
- NCT05513079
- Acronym / sponsor ID
- ErciyesUnı
- Conditions
- Chronic Urticaria, Anxiety
- Keywords
- Positive Psychotherapy (PPT), Chronic Urticaria, Anxiety, Life quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Aug 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Intervention Group | Experimental | Behavioral: Positive Psychotherapy Based CounselingPositive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Positive Psychotherapy Based CounselingAlso: Positive Psychotherapy (PPT)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. | Behavioural | Intervention Group |
Primary outcome
State Trait Anxiety Scale
Time frame: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
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
Time frame: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
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.
1 secondary outcome
Urticaria Activity Score
Time frame: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychotherapy Based Counseling in people with Chronic Urticaria and Anxiety, run by TC Erciyes 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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?
Results are not available in the source record.
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?
State Trait Anxiety Scale (time frame: Timeframe: Change: [Timeframe: 5 months: Initial interview (Time 1), 5 months later (Time 2)]). The study lists 2 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 26 Aug 2022.