Comparing the effectiveness of online mindfulness-integrated CBT and acceptance and commitment on psychological symptoms of cancer caregivers with control group
Comparing the effectiveness of online mindfulness-integrated CBT and acceptance and commitment on psychological symptoms of cancer caregivers with control group
Design
A clinical trial with a control group, with parallel groups including two intervention groups and one group without treatment, without blinding, randomized, on 45 patients, random number generator software was used for randomization
Settings and conduct
The current clinical trial was conducted at a university medical center with the available sampling method. The study's objectives were explained to the participants. Invitees will undergo screening for inclusion criteria, and those who meet the criteria will be randomly assigned to one of three groups, each consisting of 15 people. The first group will receive 4 sessions of cognitive behavioral psychotherapy based on mindfulness, the second group will receive 6 sessions of psychotherapy based on acceptance and commitment, and the third group will not receive any treatment. Survey scales will be completed before and after the treatment.
Participants/Inclusion and exclusion criteria
Being caregiver of a cancer patient; Age between 18 and 50 years; At least a diploma education; Ability to use smartphones; Have no neurological disorders
Intervention groups
Cognitive behavioral therapy is based on mindfulness in 4 sessions of 75 minutes once a week, and psychotherapy is based on acceptance and commitment in 6 sessions of 60 minutes.
Main outcome variables
Severity of depressive symptoms; Severity of anxiety symptoms; Severity of stress; The amount of quality of life; Severity of caregiver burdon
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220316054306N5
Registration date:2024-09-26, 1403/07/05
Registration timing:prospective
Last update:2024-09-26, 1403/07/05
Update count:0
Registration date
2024-09-26, 1403/07/05
Registrant information
Name
Shahab Lotfinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
lotfiniashahab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of online mindfulness-integrated CBT and acceptance and commitment on psychological symptoms of cancer caregivers with control group
Public title
Cognitive behavioral therapy and psychotherapy based on acceptance and commitment for caregivers of cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being caregiver of a cancer patient
Age between 18 and 50 years
At least a diploma education
Ability to use smartphones
Have no neurological disorders
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
All the people who entered the study were given a code, then these codes were entered into the Randomly assign online software (https://www.graphpad.com/quickcalcs/randomize1.cfm) and the software randomly assigned each code to a group.
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
Ethics committe of Shahid Beheshti University of Medical Science
Street address
Bldg No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2024-07-21, 1403/04/31
Ethics committee reference number
IR.SBMU.MSP.REC.1403.219
Health conditions studied
1
Description of health condition studied
Caregivers of cancer patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of depressive symptoms
Timepoint
Before and after intervention
Method of measurement
Based on the score obtained in Depression Anxiety Stress Scale
2
Description
Severity of anxiety symptoms
Timepoint
Before and after intervention
Method of measurement
Depression Anxiety Stress Scales
3
Description
Severity of stress
Timepoint
Before and after intervention
Method of measurement
Depression Anxiety Stress Scales
4
Description
The amount of quality of life
Timepoint
Before and after intervention
Method of measurement
Based on the score obtained in the World Health Organization Quality of Life Scale
5
Description
Severity of caregiver burdon
Timepoint
Before and after intervention
Method of measurement
Based on Caregiver Burden Inventory (CBI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive behavioral therapy based on mindfulness will be conducted in 4 sessions of 75 minutes once a week, structured as follows:Session 1: Introduction to MiCBT treatment, explanation of its structure, introduction of three learning methods to clients, identification and adjustment of treatment goals with clients, emphasis on the need for regular practice of exercises and homework, introduction of PMR progressive muscle relaxation, introduction of physical mindfulness, explanation of homework and distribution of worksheets. Session 2: Introduction to breathing mindfulness and its rationale for clients, discussion of obstacles to mindfulness practice, cognitive mindfulness exercises, review of homework and progress, deepening of the experience, explanation of homework, and distribution of worksheets. Session 3: Review homework and progress, explain the physical examination rationale, introduce the four characteristics of bodily sensations, explain the homework, and distribute the worksheets. Session 4: Review of homework and progress, the introduction of silent practice, the introduction of stillness and immobility, measurement of composure and projection, explanation of homework, and distribution of worksheets.
Category
Treatment - Other
2
Description
Intervention group: Psychotherapy based on acceptance and commitment: First session: Establishing communication and introducing the intervention topic. Second session: Exploring and reviewing therapeutic and educational methods, evaluating their effectiveness, and discussing temporary and ineffective methods using parables. Third session: Identifying ineffective strategies and accepting painful personal events without conflict using metaphors. Fourth session: Explaining how to avoid painful experiences and understand the consequences, followed by step-by-step teaching of acceptance. Fifth session: Introducing the three-dimensional behavioral model to illustrate the relationship between behavior/emotions, psychological functions, and observable behavior. Discussing efforts to change behavior based on this model. Sixth session: Explaining the concepts of role and context, introducing the idea of values, creating motivation for change, and fostering commitment to action.