Protocol summary
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Study aim
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Examine the Effectiveness of Transdiagnostic Intervention and Mindfulness Based Schema Therapy on Cancer Psychological Distress and Outcomes, Illness's Transdiagnostic Cognitive Processes and Cortisol Level in Patients with Breast Cancer
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Design
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This study with practical goal is Quasi-Experimental Design with pretest, post test and follow up period that will be performed on 2 intervention and control groups with random assignment. targeted sampling will be based on entrance criteria from Mashhad hospitals. study situations will be explained for participants and letter of satisfaction will be taken with consideration of human sciences ethicals and with emphasis on confidential data. the necessary information for cooperation (including attending to sessions, doing tasks, blood sampling) will be explained with the right to cancel in any step of the study. Study includes 60 participants in waiting list control group (2 session will be presented for them) and 2 intervention groups that will receive transdiagnostic intervention or mindfulness based schema therapy.
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Settings and conduct
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interventions will be applied in Mashhad hospitals. interventions will apply in 10 sessions 90 minutes via internet digital space with theraputic protocols of refrences.
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Participants/Inclusion and exclusion criteria
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not using psychiatric drugs, age between 30 to 60, education at least elementary school, going under cancer therapy (except chemotherapy)
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Intervention groups
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Study includes a waiting list control group (2 session will be presented for them) and 2 intervention groups and will receive transdiagnostic intervention or mindfulness based schema therapy
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Main outcome variables
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Cancer Psychological Distress and Outcomes, Illness's Transdiagnostic Cognitive Processes and Cortisol Level
General information
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Reason for update
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because of problems and limitations in sampling process such as not participating in breast cancer patients and COVID-19 crisis and it's picks duration limitations in Mashhad city, the entering criteria changed to accepting not married and under diploma graduated patients and group therapy interventions was also performed through internet and digital space.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210128050165N1
Registration date:
2021-06-26, 1400/04/05
Registration timing:
prospective
Last update:
2022-01-31, 1400/11/11
Update count:
1
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Registration date
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2021-06-26, 1400/04/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-26, 1400/04/05
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Expected recruitment end date
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2021-08-22, 1400/05/31
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Actual recruitment start date
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2021-07-21, 1400/04/30
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Actual recruitment end date
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2021-09-23, 1400/07/01
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Trial completion date
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2022-01-20, 1400/10/30
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Scientific title
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The Effectiveness of Transdiagnostic Intervention and Mindfulness Based Schema Therapy on Cancer Psychological Distress and Outcomes, Illness's Transdiagnostic Cognitive Processes and Cortisol Level in Patients with Breast Cancer
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Public title
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The Effectiveness of Transdiagnostic Intervention and Mindfulness Based Schema Therapy on Patients with Breast Cancer
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
not using psychiatric drugs
age between 30 to 60
education at least end of elementary school
going under cancer therapy (except chemotherapy)
Exclusion criteria:
using psychiatric drugs or psychotherapies in the last 6 months
absence in group therapy more than 2 sessions
graduate from psychology major or related to that
experienced trauma pressures or crisis in the grouptherapy for instance mourn
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Age
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From 30 years old to 60 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
60
Actual sample size reached:
41
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the first stage based on entrance criteria, the intended sample will be identified from Mashhad hospitals and in the second stage, 60 patients from them will be choose randomly from the number codes assigned to them. number codes will be assigned to each person and randomly will be taken out from drawing without replacement and the sequence will be noted for each participant. In the second stage, number codes will be assigned to one of the three groups and randomly will be taken out from drawing without replacement and control or intervention groups will be drawn. In the third stage, each person will be assigned to each group randomly and this process will continue to the last person. It's necessary to be noted that dividing to the 3 groups will be done separately for each person and at last it will also be determined randomly that each one of the groups will receive which intervention or will be control group. One of the groups of intervention or control with using random numbers table sampling and assigning number code to each person (2 intervention groups and 1 control group). simple randomization way will be done (divide to 3 groups in sequence and concealment and assiging interventions with random concealment allocation).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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participants in groups won't be informed about the other groups and the type and difference of other interventions with their own and they won't have communication with each other out of sessions. Execution of the questionnaires will be performed in pretest, post test and follow up by research's assistants who won't be informed about the type of groups and difference between interventions participants will receive or have received. data analysis will be done by someone else who won't know about the types of groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-24, 1400/02/04
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Ethics committee reference number
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IR.MUMS.REC.1400.026
Health conditions studied
1
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Description of health condition studied
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Breast cancer
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ICD-10 code
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C50
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ICD-10 code description
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Malignant neoplasm of breast
Primary outcomes
1
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Description
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Cancer Psychological Outcomes
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Timepoint
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pretest, post test, follow up
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Method of measurement
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Impact Of Breast Cancer questionnaire, Cancer Survivors Resilience Scale, Breast Cancer Self-Efficacy Scale
2
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Description
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Psychological Distress
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Timepoint
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pretest, post test, follow up
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Method of measurement
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Psychological Impact of Cancer, Spiritual Distress Scale, Depression, Anxiety and Stress Scale-21
3
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Description
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Illness's Transdiagnostic Cognitive Processes
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Timepoint
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pretest, post test, follow up
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Method of measurement
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Acceptance and Action Questionnaire, Posttrumatic Avoidance Scale, Chronic illness-related cognitive fusion questionnaire, Rumination in response to illness scale
4
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Description
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cortisol
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Timepoint
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pretest, post test
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Method of measurement
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blood sampling
Intervention groups
1
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Description
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Intervention group: 2 groups, one will receive Transdiagnostic therapy and the other will receive Mindfulness based Schema therapy via internet. the period of each group therapy will be 10 session in group therapy format and 90 minutes. standard therapy sessions' protocols for mindfulness based schema therapy are from book with the same name (Vreeswijk, Broersen, J. Schurink, 2014) and Unified transdiagnostic therapy for emotional disorders (Barlow and others, 2016) and related scientific articles. the goal of Transdiagnostic therapy is for emotion processing and emotional experiences regulation and mindfulness based schema therapy is to becoming aware of schemas and mentalities, other attention domains such as monitoring emotions, body sensations and schema related coping mechanisms.
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Category
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Treatment - Other
2
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Description
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Control group: 1 group that is list waiting and later will receive 2 education sessions about life style behaviors.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University of Birjand
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Demographic information and variables' measuring data will be shared in thesis and science journals' articles.
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When the data will become available and for how long
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start from six months after collecting data
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To whom data/document is available
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researchers from universities and science journals
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Under which criteria data/document could be used
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using data is acceptable in other science interventions for refrences
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From where data/document is obtainable
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science journals articles, Azad University of Birjand
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What processes are involved for a request to access data/document
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sending emails to authors of article and thesis or sending request to Azad University of Birjand
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Comments
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