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Multiple SclerosisNCT05840653

The Effect of Hope Placement Program on Dıagnosed Wıth MS

A study testing psychotherapeutic intervention in people with Multiple Sclerosis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multiple Sclerosis (MS), causing damage to myelin sheath and axons; It is a chronic disease with diffuse demyelinating lesion of the Central Nervous System (CNS) that often affects young adults, progresses with attacks and remissions, and may bring about functional limitation, disability or decrease in quality of… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
psychotherapeutic intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2023to 1 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

  • Having been diagnosed with MS for at least 6 months,
  • Not having a chronic disease diagnosis other than Multiple Sclerosis,
  • Not having any diagnosed psychotic illness,
  • Ability to read and write
  • Being between the ages of 18-65,
  • Not having a verbal or hearing disability that may affect communication,
Show all 19Show fewer
  • Owning a smart phone or computer,
  • Ability to use the Internet, participate in online programs,
  • Regular follow-up of psychoeducations,
  • Participating in and completing all psychoeducational trainings,
  • Filling the pretest and posttest questionnaires,
  • Volunteering to participate in the study.
  • Having an EDSS score of 6.5 and below. Exclusion Criteria
  • Having a chronic disease other than Multiple Sclerosis,
  • Not having any diagnosed psychotic illness,
  • Having a verbal or hearing disability that may affect communication,
  • Not having a smart phone or computer,
  • Not having the ability to use the Internet or participate in online programs,
  • Having an EDSS score of 6.5 and above.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Kübra GÜLIRMAK, MSc contact

095538501324

k_1058_g@hotmail.com

Serap GÜLEÇ KESKİN, PhD contact

095536539101

dr.seraps@gmail.com

Turkey (Türkiye)1 site
  • SAMSUN

    Samsun, 55000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Posıtıve Psychotherapy-Based Hope Placement Program On The Level Of Determınatıon Of Hope And Lıve Goals In Indıvıduals Dıagnosed Wıth Multıple Sclerosıs

Multiple Sclerosis (MS), causing damage to myelin sheath and axons; It is a chronic disease with diffuse demyelinating lesion of the Central Nervous System (CNS) that often affects young adults, progresses with attacks and remissions, and may bring about functional limitation, disability or decrease in quality of life. The fact that Multiple Sclerosis is chronic and irreversible, the uncertainty and destructiveness of the disease process affect individuals physically over time, but it can also cause many negative symptoms from a mental perspective. Studies have shown that MS disease; anxiety, depression, loss of life purpose, intense hopelessness and suicide. Life purpose has been defined as struggling to achieve one's goals and creating meaning against existential neurosis. Having a life purpose increases the subjective well-being, life satisfaction and hope level of individuals. According to the Turkish Language Association, hope, which is defined as "the feeling of trust arising from hope" and which indicates the feeling of having positive expectations for the future, positively affects mental health by giving people the feeling that they can cope with negative experiences that they may encounter in the future. Hopelessness, which is the opposite of hope, is a feeling that causes mental problems such as depression and suicide as well as negatively affecting the mental health of the individual and is a part of these clinical pictures. Setting a life purpose has positive effects on hope. While a purposeful life increases the level of hope in people, it reduces hopelessness and causes the person to live a more meaningful life. The decrease or loss of hope and the purpose of life can cause significant problems for people such as depression, addiction or suicide may occur in people who have lost their life purpose and hope. Positive psychotherapy (PPT), one of the psychosocial-based intervention methods, is a therapy method with a humanistic approach, the theoretical foundations of which were established by Pesesschkian in 1970. There are three basic principles of therapy: hope, balance and consultation. In Positive Psychotherapy, the symptoms and ailments in the person; It is positively reinterpreted, emphasizing real talents. Sharing the function of the existing symptom with the client increases the client's acceptance and hope for himself and his situation, which in turn activates the hope principle.

Read the detailed description

Multiple Sclerosis (MS), causing damage to myelin sheath and axons; It is a chronic disease with diffuse demyelinating lesion of the Central Nervous System (CNS) that often affects young adults, progresses with attacks and remissions, and may bring about functional limitation, disability or decrease in quality of life (Ertekin et al., 2012; Kuşçu et al., 2012; Milanlıoğlu et al., 2014; Daniel et al., 2018). Although the exact etiology of Multiple Sclerosis is not known, it is thought that many genetic and environmental factors may be effective (Veauthier, 2015; Brownlee et al., 2016). Multiple Sclerosis is more common in women than in men (Mitchell et al., 2019). An average of 50 thousand individuals diagnosed with Multiple Sclerosis inTurkey, It is reported that there are more than 2.5 million worldwide (Evans et al., 2013; Kalıncık et al., 2013; Akdemir et al. 2017; Mitchell et al., 2019). According to the data of the Turkish Statistical Institute (TUIK, 2018), MS ranks sixth among the causes of death with 4.1%, and ranks first among the diseases that cause disability. As it can be understood from the high rates of disability and death, it is a disease that imposes great burdens on a person's life (Gümüş, 2018; Tuncay, 2018; Öz \& Öz, 2019).

The chronic and irreversible nature of Multiple Sclerosis disease, the uncertainty and destructiveness of the disease process affect individuals physically over time, and can also cause many negative symptoms in terms of mental health. Studies have shown that MS disease; anxiety, depression, loss of life purpose, intense hopelessness and suicide (1-2-3-4).

Life purpose has been defined as struggling to achieve one's goals and creating meaning against existential neurosis. Goals reflect the meaning, goals, and life tasks that are central to the psychological well-being perspective. Kasser and Ryan (1996) defined Life Goals as long-term goals that an individual hopes to achieve. Emmons (1992) defined life goals as situations that individuals try to achieve through cognitive and behavioral strategies. If individuals have set goals for themselves in different branches, it can be said that individuals have clarified their life goals. Nair (2003) states that life goals are also affected by previous positive or negative experiences. Looking at the literature, it is seen that life goals are handled with different classifications. For example, Pesesschkian's (1996) classification of life goals can be cited in the context of positive psychotherapy. Pesesschkian states that people set life goals in the areas of body (via senses), achievement (through career-mind), relationship (through traditions) and spirituality (via intuition). According to Pesesschkian (1996), people benefit from the resolution of conflicts in life by trying to achieve the goals they set in these four areas. Having a life purpose increases the subjective well-being, life satisfaction and hope level of individuals 5).

According to the Turkish Language Association, hope, which is defined as "the feeling of trust arising from hope" and which indicates the feeling of having positive expectations for the future, positively affects mental health by giving people the feeling that they can cope with negative experiences that they may encounter in the future. Hopelessness, which is the opposite of hope, is a feeling that causes mental problems such as depression and suicide as well as negatively affecting the mental health of the individual and is a part of these clinical pictures. Despair was also approved as a nursing diagnosis by the North American Nursing Diagnostic Association in 1986. Hope, which is important for human life, is perceived as a healing factor that empowers people to cope with momentary difficulties and overcome grief, and paves the way for finding meaning in life.

Setting a life purpose has positive effects on hope. While a purposeful life increases the level of hope in people, it reduces hopelessness and causes the person to live a more meaningful life. The decrease or loss of hope and the purpose of life can cause significant problems for people. Negative symptoms such as depression, addiction or suicide may occur in people who have lost their life purpose and hope. In such cases, in addition to the biological treatment methods applied to the person, the application of psychosocial-based interventions allows the symptoms to be resolved more easily.

The fact that Multiple Sclerosis is a chronic, uncertain, and exacerbating disease causes a decrease in the level of determination of life purpose from time to time or permanently, and hopelessness in the person. Therefore, focusing on problems such as "hopelessness and decreased life purpose" in individuals diagnosed with MS, teaching how to recognize and cope with symptoms, Positive psychotherapy (PPT), one of the psychosocial-based intervention methods, is a therapy method with a humanistic approach, the theoretical foundations of which were established by Pesesschkian. There are three basic principles of therapy: hope, balance and consultation. It is believed that real and existing things are not just conflicts and illnesses, but that there are innate abilities in every human being that accompany these conflicts and symptoms. In Positive Psychotherapy, the symptoms and ailments in the person; It is positively reinterpreted, emphasizing real talents. Sharing the function of the existing symptom with the client increases the client's acceptance and hope for himself and his situation, which in turn activates the hope principle (6). Again, starting from the principle of hope, there is this positive starting point, the principle of hope, related to each individual and situation at the center of PPT. Being talent and capacity oriented activates hope in the client and forms the basis of the healing process (7). The two important concepts mentioned, "hopelessness and life goals are among the main concepts of PPT. Therefore, it is thought that PPT-based psychoeducation will have a positive effect on situations such as hopelessness and low life purpose level.

When the international and national literature is examined, it is seen that the studies on PPT are limited. In addition, it has been found that most of the studies are related to depression, substance use disorder or university students (8-9-10-11-12). Studies using positive psychotherapy in patients diagnosed with Multiple Sclerosis are quite limited (13). In this respect, the research provides an opportunity for an up-to-date approach to the psychosocial problems of MS patients, and provides originality and importance in terms of contributing especially to the field of nursing and not having encountered a similar research topic in the literature.

Being tested
psychotherapeutic intervention
Keywords
multiple sclerosis, hope, life purpose, Psychiatric Nursing, positive psychotherapy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychotherapeutic interventionOther

    The group that will receive 5-week positive psychotherapy-based hope placement psychoeducation

Study groups in NCT05840653
Study groupRoleWhat they receive
experimental 1: Intervention groupExperimentalExperiment 1 group will first be given a pre-test, then a 5-week hope placement program will be applied. The final test will be administered after the program is completed.
Receives: Other: psychotherapeutic intervention
experimental 2 group; Intervention groupExperimentalA 5-week hope placement program will be applied to the experimental 2 group without the pre-test application. After the program is completed, the final test will be administered.
Receives: Other: psychotherapeutic intervention
control 1 group; not Intervention groupNo interventiononly the pre-test will be applied, other than that, no intervention will be applied in the 5-week period. Then the final test will be applied.
control 2 group; not Intervention groupNo interventionNo intervention will be applied during the pre-test application and the 5-week period. then the final test will be administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. experiment 1 and experiment 2 group level of determination of life purpose

    In the experimental 1 and 2 groups, it is expected that there will be a significant increase in the total score of the life goals determination scale compared to the first test.

    Measured: 5 weeks

  2. experiment 1 and experiment 2 group hopelessness is to decrease.

    It is expected that there will be a significant decrease in the beck hopelessness scale total score in the experimental 1 and 2 groups compared to the first test.

    Measured: 5 weeks

  3. control1 and control 2 group hopelessness is to decrease.

    No change in life purpose and hopelessness level in Experiment 2 and Experiment 2 groups

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This research is planned to be carried out as a Solomon Four-Group Experimental model. In the Solomon 2x2 designs, two of the four groups consisting of randomly assigned members by randomization constitute the experimental group and the other two constitute the control group. In the Solomon model, for statistical operations, pretesting is performed on two groups, one for the experimental group and the other for the control group, while the posttest process is performed on all four groups (Erkuş, 2011). The Solomon model is formed by using the pretest-posttest control group model and the posttest control group model together. In this way, the Solomon four-group experimental model is the strongest experimental model that preserves both internal and external validity (Karasar, 2011).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840653
Sponsor's protocol ID
B.30.2.ODM.0.20.08/305
Status last verified
Apr 2023
First submitted
20 Nov 2021
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cope, T. (2010). The inherently integrative approach of Positive psychotherapy. The Journal of Psychotherapy Integration 20(2), 203-250.

Questions about this trial

What is this clinical trial studying?

A study testing psychotherapeutic intervention in people with Multiple Sclerosis, run by Ondokuz Mayıs 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 19 inclusion and 0 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 3 May 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kübra GÜLIRMAK, MSc (095538501324, k_1058_g@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

experiment 1 and experiment 2 group level of determination of life purpose (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840653, which also lists 1 linked publication.

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 3 May 2023.

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