Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy[Mindfullnes]NCT05995938
Mindfullnes-Based Cognitive Therapy Effect
A study testing Mindfullnes-Based Cognitive Therapy in people with Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy, run by SEMRA BÜLBÜLOĞLU at 1 site in Turkey (Türkiye).
Trial summary
Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was conducted the study in a randomized controlled type with n=120 participation of liver transplant recipients of a transplant hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy
- What is being tested?
- Mindfullnes-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 Jan 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
- Inclusion Criteria involved (i) being a liver transplant recipient, (ii) currently having immunosuppressive treatment, (iii) being 18 years or older (iv) having no language or communication barrier and (v) agreeing to participate in the study.
- Liver transplant recipients
Who cannot join
- The exact opposite of the inclusion criteria the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
the Liver Transplant Hospital affiliated with Turgut Özal Medical Center of İnönü University of Malatya/Turkey.
Malatya
About this study
Official title: Mindfullnes-Based in Surgery Patients for Cognitive Therapy Effect
Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was conducted the study in a randomized controlled type with n=120 participation of liver transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive therapy to liver recipients in the experimental group.
Read the detailed description
It was used simple random sampling method in assigning liver recipients to the experimental and control groups. Discharged liver transplant patients are informed about the use of immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.
- Being tested
- Mindfullnes-Based Cognitive Therapy
- Keywords
- Liver Recipients, Transplantation, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfullnes-Based Cognitive TherapyBehavioural
Also called [Mindfulness]
Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 1 Receives: Behavioral: Mindfullnes-Based Cognitive Therapy |
| Control | No intervention | 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Mindfulness-Based Cognitive after Liver Transplantation
It will be measure Therapy on Liver Transplant Recipients' Adherence to Immunosuppressive Therapy
Measured: Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.
Secondary outcomes (1)
Mindfullnes-Based Cognitive Therapy
le level of Mindfulness-Based Cognitive
Measured: total of six month.from 1 october 2022 to 30 Jan 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Aug 2022
- Primary completion1 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive TherapyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Experimental
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEMRA BÜLBÜLOĞLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEMRA BÜLBÜLOĞLU, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995938
- Sponsor's protocol ID
- 2022/3884
- Acronym
- [Mindfullnes]
- Status last verified
- Aug 2023
- First submitted
- 28 Feb 2023
- Last updated
- 16 Aug 2023
- 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfullnes-Based in Surgery Patients for Cognitive Therapy Effect
- ClinicalTrials.gov ID
- NCT05995938
- Acronym / sponsor ID
- [Mindfullnes] / 2022/3884
- Keywords
- Liver Recipients, Transplantation, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- SEMRA BÜLBÜLOĞLUUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 16 Aug 2023 (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.
Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was conducted the study in a randomized controlled type with n=120 participation of liver transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive therapy to liver recipients in the experimental group.
Detailed description
It was used simple random sampling method in assigning liver recipients to the experimental and control groups. Discharged liver transplant patients are informed about the use of immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mindfullnes-Based Cognitive Therapy1 |
| Control | No intervention | –1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion Criteria involved (i) being a liver transplant recipient, (ii) currently having immunosuppressive treatment, (iii) being 18 years or older (iv) having no language or communication barrier and (v) agreeing to participate in the study.
- Liver transplant recipients
Key exclusion criteria (1 listed)
- The exact opposite of the inclusion criteria the exclusion criteria.
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 |
|---|---|---|
| Mindfullnes-Based Cognitive TherapyAlso: [Mindfulness]Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients | Behavioural | Experimental |
Primary outcome
The Effect of Mindfulness-Based Cognitive after Liver Transplantation
Time frame: Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.
It will be measure Therapy on Liver Transplant Recipients' Adherence to Immunosuppressive Therapy
1 secondary outcome
Mindfullnes-Based Cognitive Therapy
Time frame: total of six month.from 1 october 2022 to 30 Jan 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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 Mindfullnes-Based Cognitive Therapy in people with Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy, run by SEMRA BÜLBÜLOĞLU 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 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: finished, as of the sponsor's last update on 16 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Effect of Mindfulness-Based Cognitive after Liver Transplantation (time frame: Both groups experiment and control. It was used Mindfullnes scale and immunosuppressive terapy adherence scale. It was done measure before and after Mindfullnes-Based Cognitive Therapy.). 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 16 Aug 2023.