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IRCT20240826062875N1 IRCT 2024-09-09 Islamic Azad University, Semnan branch The effectiveness of cognitive behavioral therapy based on mindfulness on the fear of disease progression and post-traumatic growth Evaluation the effectiveness of cognitive behavioral therapy based on mindfulness on the fear of disease progression and post-traumatic growth of women with breast cancer 2024-10-08 anticipated 30 Complete https://irct.ir/trial/78779 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, simple randomization method is used to assign women with breast cancer to intervention and control groups. Each participant first receives a unique ID. These IDs are written on cards that are placed randomly in a large box. The cards are shuffled well and then taken out from the box one by one. In this way, each ID is randomly assigned to one of the intervention or control groups. The cards are divided into two piles and each pile is randomly assigned to one of the groups. This method ensures that the participants are assigned randomly and without bias in the groups and increases the validity of the research results, Blinding description: In this research, blinding is done unilaterally. Participants are unaware of the type of treatment they are receiving. All participants participate in therapy sessions that have similar environment and physical conditions. Therapists, aware of the type of intervention (MBCT), apply a consistent procedure to all groups and there are no apparent differences between sessions. To maintain blinding, participants are not provided with detailed information about the type of treatment and are only informed that they are participating in a study related to the effectiveness of mindfulness-based cognitive therapy. Exact details of the interventions will not be provided to participants until the end of the study to minimize bias effects. This method helps to evaluate the obtained results more accurately and without bias. N/A Breast cancer. Intervention 1: The intervention is based on Williams et al.'s treatment program (1952) in eight group sessions, each one for one and a half hours and during one month. In these sessions, which focus on mindfulness exercises, various mindfulness techniques are taught and participants are encouraged to practice these techniques during and between sessions. The main goal of this intervention is to reduce the fear of disease progression and increase post-traumatic growth in women with breast cancer. To reinforce the effect of the treatment, home exercises are provided between sessions and the participants' questions are answered so that the changes become more stable. Intervention 2: Control group: The control group does not receive any specific intervention and serves only as a comparison group. This group received only usual and standard care and did not participate in mindfulness-based cognitive-behavioral therapy (MBCT). Yes - There is a plan to make this available What will be shared: It is possible to share demographic data and the results of the main outcome of the research after de-identifying and preserving the privacy of individuals. When: Data can be made available one month after results are printed and after removing personally identifiable information. To whom: Research data and documentation will be available to researchers and researchers who are working in academic and scientific institutions. These people can access the data by submitting a request and after reviewing and approving the request. Conditions: Research data and documents can be used for scientific and research purposes. Requests must be submitted in writing and include a full description of the purpose, methods, and type of analysis. After review and approval, users should share the results with the principal investigator to confirm the validity and accuracy of the analyses. Where to obtain: If you need data, contact ailinabbasian99@gmail.com. How to obtain: After receiving the request and checking it by the main researcher, the data will be sent to the requester within 7 days. Comments:
public Ailin Abbasian
Unit 1, Royal Apartment, Darya 6th St., Khazar Blvd., Sari
Sari Iran (Islamic Republic of) 4816813163 +98 11 3339 4700 ailinabbasian99@gmail.com Islamic Azad University, Semnan branch scientific Ali Mohammadbagher
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4040 ambpsych@yahoo.com Islamic Azad University, Semnan branch Iran (Islamic Republic of) Women who have been officially diagnosed with breast cancer. Women with breast cancer age range from 30 to 65 years. People who are not currently undergoing active treatment (such as chemotherapy or radiation therapy) and at least six months have passed since the end of treatment. People who have obtained a high score in the scales related to the fear of disease progression in the initial assessment. Women who are able to speak and understand Farsi language. Volunteers who are willing to participate in group sessions voluntarily and are able to do home exercises. 30 years 65 years Female Women who have been diagnosed with severe mental disorders such as schizophrenia or bipolar disorder The existence of other serious physical diseases that limit the person's ability to participate in meetings People who are participating in other psychotherapy programs at the time of intervention C50 Malignant neoplasm of breast Treatment - Other Treatment - Other The intervention is based on Williams et al.'s treatment program (1952) in eight group sessions, each one for one and a half hours and during one month. In these sessions, which focus on mindfulness exercises, various mindfulness techniques are taught and participants are encouraged to practice these techniques during and between sessions. The main goal of this intervention is to reduce the fear of disease progression and increase post-traumatic growth in women with breast cancer. To reinforce the effect of the treatment, home exercises are provided between sessions and the participants' questions are answered so that the changes become more stable. Control group: The control group does not receive any specific intervention and serves only as a comparison group. This group received only usual and standard care and did not participate in mindfulness-based cognitive-behavioral therapy (MBCT). Fear of cancer progression. Timepoint: Before starting the intervention (pre-test), after completing 8 intervention sessions (post-test). Method of measurement: Hershbach et al.'s fear of cancer progression questionnaire (2005). Post-traumatic growth. Timepoint: Before starting the intervention (pre-test), after completing 8 intervention sessions (post-test). Method of measurement: Post-traumatic growth Tedeschi and Calhoun (1996). Islamic Azad University, Semnan branch Approved 2024-06-24 Ethics committee of Semnan Azad University Islamic Azad University, Daneshgahi town, Semnan Semnan Semnan Iran (Islamic Republic of)