: Comparison of Effectiveness of Meta cognitive Therapy and Acceptance and commitment Therapy(ACT) on Depression& Post Traumatic Growth &Blood presher in Hemodialysis patients.
Determining of effectiveness of Meta cognitive Therapy and Acceptance and commitment Therapy on depression, post-traumatic growth and hypertension in dialysis patients
Design
Clinical trial with control group and in parallel, without blinding and randomized, phase 3 on 54 women who write numbers on small papers by simple random method and will be selected by lot in three groups.
Settings and conduct
This research will be performed as a clinical trial with control and experimental groups. Pre-test, intervention, post-test and follow-up will be performed.The venue will be in the dialysis ward of Alborz Imam Ali and Shahid Rajaei Hospital.
Participants/Inclusion and exclusion criteria
log in:Age over 30 years
At least 3 months have passed since they started dialysis
No entry:Reluctance to enter into cooperation
Do not have informed written consent
No severe mental disorders
Existence of verbal,hearing and dementia problems
Intervention groups
Pre-test will be taken from the intervention and control group, then the metacognitive therapy intervention group will receive 8 sessions 60-minute and the acceptance and commitment intervention group will receive 8 sessions 90-minute training individually.
Main outcome variables
Depression, Post Traumatic growth and Blood preshe
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201118049430N1
Registration date:2020-12-10, 1399/09/20
Registration timing:registered_while_recruiting
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Saied Malihialzackerini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3418 2367
Email address
saied.malihi@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Comparison of Effectiveness of Meta cognitive Therapy and Acceptance and commitment Therapy(ACT) on Depression& Post Traumatic Growth &Blood presher in Hemodialysis patients.
Public title
The effect of psychocho therapy dialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 30 years
At least 3 months have passed since they started dialysis
Exclusion criteria:
Reluctance to enter into cooperation
Do not have informed written consent
No severe mental disorders
Existence of verbal,hearing and dementia problems
Age
From 30 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Among the individuals, we write the numbers on small pieces of paper in a simple random way and place them in three groups, two intervention groups and one control group by drawing lots.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Parand Branch
Street address
Unit5,No. 27,13 West St,Rajai Shahr,Karaj
City
Karaj
Province
Alborz
Postal code
3148953378
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.IAU.REC.1399.006
Health conditions studied
1
Description of health condition studied
Kidney dialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, immediately after the intervention and three months after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Post-traumatic growth
Timepoint
Before the intervention, immediately after the intervention and three months after the intervention
Method of measurement
Post-traumatic growth scale
3
Description
Blood pressure
Timepoint
Before each intervention, immediately after each intervention and three months after the intervention
Method of measurement
Hand barometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In order to observe the principles of ethics, the control group will receive educational content based on metacognitive therapy approach and treatment based on acceptance and commitment after the intervention process in the experimental group in the form of educational booklets.
Category
Prevention
2
Description
Intervention group1: Acceptance and commitment therapy that uses the processes of acceptance, mental focus, commitment, and behavioral change processes to create flexibility.Acceptance and commitment therapy based on the theoretical foundations of treatment (Izadi and Abedi, 2014) will be performed in 8 sessions of 90 minutes. The first session establishes a therapeutic relationship, acquaintance and general explanation of the therapeutic approach, concluding a therapeutic contract, psychological training, discussing experiences and evaluating them, efficiency as a measure, creating creative frustration of the therapist based on acceptance and commitment. The client should give up feeling better and thinking differently. The second session examines patients' problems from an ACT perspective (extracting the experience of avoidance, integration, and individual values, and that control is the problem, not the solution). Creative frustration refers to abandoning behaviors or strategies that the client's experience has shown to be ineffective. The third session expresses control as a problem, clarifying the inefficiency of controlling negative events using metaphors, introducing tendency as another response, engaging in purposeful actions (ie, general and desirable directions of life that are verbally set). Session 4: Applying Cognitive Fault Techniques (One of the less invasive ways of presenting fault techniques is to introduce thoughts as thoughts or products of the mind. See as thoughts: The purpose of breaking is not all thoughts, but the breaking of those thoughts that cause problems when they are considered reality.The fourth session is the observation of the self as the context of the "self" and the attachment in which events are experienced, but at the same time distinct from those events (weakening of self-concept and self-expression as an observer, showing separation between oneself, experiences Internal and Behavior) Continuous non-judgmental contact with psychological and environmental events, as they are. Session 5 Application of mental techniques, modeling exit from the mind, learning to experience inner experiences as a process. Session 6 :Identifying patients' life values and measuring values based on their importance in life, showing the dangers of focusing on results, discovering practical life values. Session 7: Determining patterns of action commensurate with values (the step-by-step process of creating a complete and integrated life, based on one's deepest desires and aspirations to use metaphors), planning for a commitment to pursuing values. The eighth session :summarizes the concepts explored during the sessions, asking patients to explain their achievements in treatment and their plan for survival.
Category
Prevention
3
Description
Intervention group2: : Enabling the patient to interact with their thoughts differently and to develop flexible metacognitive control and awareness, and to prevent processing through worry and rumination and threat review.Cognitive therapy derived from the theoretical foundations of treatment (Malihi Al-Dhakerini, 2016, Lena Jelink et al., 2016) will be performed in 8 sessions of 60 minutes. The first session of establishing a therapeutic relationship, familiarity and general explanation of the therapeutic approach, concluding a treatment contract, familiarity with depressive disorder and mental refinement (identifying negative points), over-generalization (using the word all and nothing) and changing views and correcting cognitive assessment.The second session of conceptualizing depression based on metacognitive model, examining memory and concentration, practicing attention training technique, presenting homework and discussing its importance in the treatment process. Session 3 Homework Review, Introduction to Dictatorship Technique / Phrase "Must" Analyze Profit and Loss Strict Criteria, Devaluing Positive Points (Expecting Negative Feedback, Rejecting Positive Feedback), Thinking Black and White, Finding the Right Balance, Homework Presentation. Session 4: Reviewing members' homework, identifying values (observable behaviors, invisible states), strategies for living with values (identifying positive points), practicing self-esteem enhancement techniques, and homework. Fifth session of homework review, zoom in and out, document style (for negative event and positive event), homework presentation. Sixth session of homework review, discussion about the importance of rumination in the continuation of the disorder and postponement of mental rumination and its practice, practice of relaxation search technique and breathing exercises, relaxation exercises,.withdrawal and use of strategies to break withdrawal and rumination Provide homework. Session 7 Presenting a summary of sessions, hasty conclusions, mind reading, catastrophic prediction, reviewing possible outcomes, and re-evaluating probabilities. Session 8: Understanding emotions, reasoning emotion, understanding non-verbal cues, examining emotions and practicing identifying it and presenting homework, performing a relapse prevention program (identifying the factors that will cause recurrence and ways to deal with it).