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
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
Design
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.
Settings and conduct
interventions will be applied in Mashhad hospitals. interventions will apply in 10 sessions 90 minutes with theraputic protocols of refrences.
Participants/Inclusion and exclusion criteria
not using psychiatric drugs, age between 30 to 60, education at least high school diploma, going under cancer therapy (except chemotherapy), being married and living with spouse
Intervention groups
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
Main outcome variables
Cancer Psychological Distress and Outcomes, Illness's Transdiagnostic Cognitive Processes and Cortisol Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210128050165N1
Registration date:2021-06-26, 1400/04/05
Registration timing:registered_while_recruiting
Last update:2021-06-26, 1400/04/05
Update count:1
Registration date
2021-06-26, 1400/04/05
Registrant information
Name
Fatemeh Ghayour Kazemi
Name of organization / entity
Azad University of Birjand and Mashhad Medicine University
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 1093
Email address
fgkazemi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-26, 1400/04/05
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The Effectiveness of Transdiagnostic Intervention and Mindfulness Based Schema Therapy on Patients with Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
not using psychiatric drugs
age between 30 to 60
education at least high school diploma
going under cancer therapy (except chemotherapy)
being married and living with spouse
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
Age
From 30 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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).
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2021-04-24, 1400/02/04
Ethics committee reference number
IR.MUMS.REC.1400.026
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Cancer Psychological Outcomes
Timepoint
pretest, post test, follow up
Method of measurement
Impact Of Breast Cancer questionnaire, Cancer Survivors Resilience Scale, Breast Cancer Self-Efficacy Scale
2
Description
Psychological Distress
Timepoint
pretest, post test, follow up
Method of measurement
Psychological Impact of Cancer, Spiritual Distress Scale, Depression, Anxiety and Stress Scale-21
3
Description
Illness's Transdiagnostic Cognitive Processes
Timepoint
pretest, post test, follow up
Method of measurement
Acceptance and Action Questionnaire, Posttrumatic Avoidance Scale, Chronic illness-related cognitive fusion questionnaire, Rumination in response to illness scale
4
Description
cortisol
Timepoint
pretest, post test
Method of measurement
blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 groups, one will receive Transdiagnostic therapy and the other will receive Mindfulness based Schema therapy. 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.
Category
Treatment - Other
2
Description
Control group: 1 group that is list waiting and later will receive 2 education sessions about life style behaviors.