Mental Health IssueNCT06675773
The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers
A study testing Conscious Awareness Development Psychoeducation Program in people with Mental Health Issue, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to increase the conscious awareness of caregivers and reduce work stress and compassion fatigue. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Conscious Awareness Development Psychoeducation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years of age,
- Being actively working as a care worker in relevant institutions.
Who cannot join
- Having received similar training before
- Having been diagnosed with a mental illness
- Wanting to leave the study at any stage.
- Not having attended more than two sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Faculty of Health Sciences Kafkas University
Kars, Merkez, 36100
Nilüfer KIRANŞAL, Lecturer, +905053573304, nkiransal@hotmail.com
About this study
Official title: The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers on Conscious Awareness, Job Stress and Compassion Fatigue.
This study aimed to increase the conscious awareness of caregivers and reduce work stress and compassion fatigue.
Read the detailed description
This study was planned in an experimental design with pre-test post-test follow-up measurements, experimental and control groups. The universe of the study consisted of care personnel working in institutions affiliated to the Provincial Directorate of Family, Labor and Social Services located in a city center in the east of Turkey. The sample calculation was made using the G-Power program (Experiment 14, Control 14). Since there may be omissions, the experimental group was determined as 20 participants and the control group as 20 participants. In this study, a nine-session training program will be applied to the experimental group. No application will be made to the control group. The conscious awareness development psychoeducation program will be applied once a week and for 90 minutes. Each session will be conducted in line with certain objectives. The sessions will be conducted by the investigator. Ethics committee approval was obtained before starting the study. Institutional permissions and written informed consent will be obtained for the participants. Informed consent will include information about the research and information that will ensure confidentiality.
- Conditions
- Mental Health Issue
- Being tested
- Conscious Awareness Development Psychoeducation Program
- Keywords
- Mindfulness,, Work stress, Compassion Fatigue, Psychoeducation
- Medical subject headings
- Occupational Stress, Compassion Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious Awareness Development Psychoeducation ProgramOther
The Conscious Awareness Development Psychoeducation Program consists of nine sessions. The sessions will be applied once a week and last 90 minutes. The psychoeducation program is prepared based on conscious awareness. Conscious awareness and self-compassion techniques will be used in the sessions. Homework will be given to the participants in each session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The Conscious Awareness Development Psychoeducation Program will be applied to the experimental group. Conscious awareness and self-compassion techniques will be used in the psychoeducation program sessions. Homework will be given to the participants in each session. The psychoeducation program is prepared based on conscious awareness. Receives: Other: Conscious Awareness Development Psychoeducation Program |
| Control Group | No intervention | No application will be made to the Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mindful Attention Awareness Scale-MAAS
Originally named The Mindful Attention Awareness Scale-MAAS, it measures the attention and present time awareness of an individual in their daily lives. It consists of 15 items and a single sub-dimension. The scale is in the form of a 6-point Likert and is evaluated as a single total score. Individuals who score high on the scale show that their conscious awareness levels are high (Brown and Rayn 2003, Özyeşil et al. 2011)
Measured: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Secondary outcomes (2)
General Work Stress Scale
The General Job Stress Scale evaluates the level of stress that an individual experiences or perceives in relation to work in general. The scale, which consists of 9 items and a single dimension, is in the form of a 5-point Likert. High scores on the scale indicate high job stress, and low scores indicate low job stress (Teleş 2021).
Measured: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Compassion Fatigue Scale- Short Scale Form
The scale consists of 13 items and two sub-dimensions: secondary trauma and occupational burnout. The lowest score possible from the 10-point Likert-type scale is 13 and the highest is 130. As the scores increase, the level of compassion fatigue experienced by individuals also increases (Dinç and Ekinci, 2019).
Measured: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups were mindfulness-based psychoeducation controls.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilüfer KIRANŞAL, Kafkas University
- Investigators
- Nilüfer KIRANŞAL, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675773
- Sponsor's protocol ID
- KAÜ-SBF-NK 01
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers on Conscious Awareness, Job Stress and Compassion Fatigue.
- ClinicalTrials.gov ID
- NCT06675773
- Acronym / sponsor ID
- KAÜ-SBF-NK 01
- Conditions
- Mental Health Issue
- Keywords
- Mindfulness,, Work stress, Compassion Fatigue, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 5 Nov 2024 (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.
This study aimed to increase the conscious awareness of caregivers and reduce work stress and compassion fatigue.
Detailed description
This study was planned in an experimental design with pre-test post-test follow-up measurements, experimental and control groups. The universe of the study consisted of care personnel working in institutions affiliated to the Provincial Directorate of Family, Labor and Social Services located in a city center in the east of Turkey. The sample calculation was made using the G-Power program (Experiment 14, Control 14). Since there may be omissions, the experimental group was determined as 20 participants and the control group as 20 participants. In this study, a nine-session training program will be applied to the experimental group. No application will be made to the control group. The conscious awareness development psychoeducation program will be applied once a week and for 90 minutes. Each session will be conducted in line with certain objectives. The sessions will be conducted by the investigator. Ethics committee approval was obtained before starting the study. Institutional permissions and written informed consent will be obtained for the participants. Informed consent will include information about the research and information that will ensure confidentiality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two groups were mindfulness-based psychoeducation controls.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Conscious Awareness Development Psychoeducation ProgramThe Conscious Awareness Development Psychoeducation Program will be applied to the experimental group. Conscious awareness and self-compassion techniques will be used in the psychoeducation program sessions. Homework will be given to the participants in each session. The psychoeducation program is prepared based on conscious awareness. |
| Control Group | No intervention | –No application will be made to the Control Group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over 18 years of age,
- Being actively working as a care worker in relevant institutions.
Key exclusion criteria (4 listed)
- Having received similar training before
- Having been diagnosed with a mental illness
- Wanting to leave the study at any stage.
- Not having attended more than two sessions.
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 |
|---|---|---|
| Conscious Awareness Development Psychoeducation ProgramThe Conscious Awareness Development Psychoeducation Program consists of nine sessions. The sessions will be applied once a week and last 90 minutes. The psychoeducation program is prepared based on conscious awareness. Conscious awareness and self-compassion techniques will be used in the sessions. Homework will be given to the participants in each session. | Other | Experimental Group |
Primary outcome
The Mindful Attention Awareness Scale-MAAS
Time frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Originally named The Mindful Attention Awareness Scale-MAAS, it measures the attention and present time awareness of an individual in their daily lives. It consists of 15 items and a single sub-dimension. The scale is in the form of a 6-point Likert and is evaluated as a single total score. Individuals who score high on the scale show that their conscious awareness levels are high (Brown and Rayn 2003, Özyeşil et al. 2011)
2 secondary outcomes
General Work Stress Scale
Time frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Compassion Fatigue Scale- Short Scale Form
Time frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- the General Work Stress ScaleLink provided by the sponsor.
- Compassion Fatigue Short ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nilüfer KIRANŞAL principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscious Awareness Development Psychoeducation Program in people with Mental Health Issue, run by Kafkas 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilüfer KIRANŞAL (+905053573304, nkiransal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mindful Attention Awareness Scale-MAAS (time frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)). 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 13 Nov 2024.