Protocol summary
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Study aim
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Determining the effect of logo therapy with and without yoga on anxiety and depression in patients with breast cancer after treatment
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Design
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Clinical trial work of two arm parallel, with blinded, randomized intervention groups on 90 patients with breast cancer is used to block randomization .
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Settings and conduct
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This study is performed in Jihad University breast cancer clinic. Samples are selected from patients with depression (depression score above 14). By random block method, 15 blocks of 6, are extracted and allocated by simple random method in two intervention groups; logo therapy alone and the logo therapy and yoga groups.
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Participants/Inclusion and exclusion criteria
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Age between 18-65 years; Stage 1-3;Completion of breast cancer conventional treatments;Had a minimum score of 10 based on a beck Inventory; Have a minimum of literacy
Possibility to attend meetings; Willingness to cooperate
The criteria for not entering the study are as follows:
Mental or physical disability;Treating psychiatric illness
Taking antidepressants; Performing yoga activities or attending yoga classes and receiving psychological treatments from the time of diagnosis ;Physical / medical limitations in performing yoga activities
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Intervention groups
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Group 1: Psychological training of logo therapy with yoga: Based on the approach of logo therapy and then yoga , 8 sessions are performed as a treatment group on 45 patients, patients. Group 2: Psychological training of logo therapy without yoga: Based on the approach of logo therapy,performed for 8 sessions as a treatment group on 45 patients.
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Main outcome variables
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Anxiety and depression
General information
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Reason for update
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Added happiness
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200422047170N2
Registration date:
2020-07-25, 1399/05/04
Registration timing:
prospective
Last update:
2021-08-04, 1400/05/13
Update count:
1
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Registration date
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2020-07-25, 1399/05/04
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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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2020-08-10, 1399/05/20
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Expected recruitment end date
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2021-08-11, 1400/05/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of logo-therapy with and without yoga education on anxiety, depression, happiness in breast cancer survivors: a randomized controlled trial
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Public title
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Yoga and logo therapy in breast cancer
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
18-65y
Stage1-3
End of breast cancer treatment
Have a minimum depression score of 10 from the Beck Depression Inventory
Have a minimum of literacy
Ability to participate in intervention sessions
Would Like to attend intervention sessions
Exclusion criteria:
Mental or physical disability ِ and;
Treatment of psychiatric illness
Use of antidepressants
Doing or attending yoga classes
Receiving psychological treatment from the time the disease is diagnosed
Physical / medical limitations in performing yoga activities
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Age
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From 18 years old to 65 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, the Beck Depression Inventory is used for screening, then scores above 14 (meaning depression) are selected. By Permuted Block Randomization method;
depending on the sample size of 90 people, 15 blocks of six are selected. In 6 blocks, a simple random method is used to assign to the intervention groups. This means that 45 people in each group are replaced by a simple random method.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, it is not possible to blind in the group of patients and interventions. It is only possible to blind the result evaluator and the analyzer
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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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2018-02-04, 1396/11/15
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Ethics committee reference number
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1396.16.RE.IR.ACECR.IBCRC.REC
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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Reduction of depression based on Beck questionnaire
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Timepoint
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Before and after the intervention
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Method of measurement
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Beck Depression Inventory
2
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Description
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Increasing happiness
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Timepoint
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Before and after the intervention
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Method of measurement
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Oxford Happiness Questionnaire
Intervention groups
1
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Description
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Intervention group1: Based on the logo therapy approach, interventions are performed on patients of intervention groups for 8 sessions. In these 8 sessions, using the main concepts of logo therapy such as freedom, responsibility and finding meaning in suffering and using contradictory techniques, Correction of attitudes and reflexes helped to help clients cope with their anxiety, as well as help reduce depression and anxiety. And yoga training for eight weeks and sixty minutes will be performed in the form of physical, aerobic and relaxation movements for this group. It is necessary to explain that these two interventions are performed consecutively.
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Category
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Behavior
2
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Description
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Intervention group2: Intervention group: Based on the logo therapy approach, interventions are performed on patients of intervention groups for 8 sessions. In these 8 sessions, using the main concepts of logo therapy such as freedom, responsibility and finding meaning in suffering and using contradictory techniques, Correction of attitudes and reflexes helped to help clients cope with their anxiety, as well as help reduce depression and anxiety.
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Category
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Behavior
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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Iranian academic center for education culture and research
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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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Public
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable