The Effectiveness of Stress Management Cognitive-Behavioral Therapy on Caregiver Burden, Psychological Well-being, and Anxiety in Caregivers of Cancer Patients
Determining the effectiveness of cognitive behavioral therapy for stress management on caregiver burden, psychological well-being, and anxiety of caregivers of cancer patients
Design
A randomized controlled clinical trial on 30 caregivers of cancer patients
Settings and conduct
The location of the research sample selection is the Oncology Department of Imam Jafar Sadeq Hospital in Meybod County.
Eligible participants will be randomly assigned to two experimental and control groups. The experimental group will undergo cognitive-behavioral stress management therapy intervention, while the control group will not receive any active intervention.
Data collection will be carried out through questionnaires in three time phases
After the end of the treatment sessions, the questionnaires will be completed again in both groups
Participants/Inclusion and exclusion criteria
Caregivers of cancer patients who have at least one family member with cancer. Be literate.
Not receiving individual counseling or medication
Having a severe mental illness
Intervention groups
In this study, an intervention including cognitive-behavioral stress management therapy will be used for caregivers of cancer patients. This therapy will be based on the book "Cognitive Behavioral Stress Management Guide" by Anthony (2007) and will consist of 8 sessions, with two 90-minute sessions held each week.
Main outcome variables
Caregiving Burden: A relatively complex and general concept, defined as a negative and unpleasant psychological state experienced by the caregiver as a result of providing care
Psychological Well-Being: Psychological well-being can be defined as having a positive attitude towards oneself, constructive interaction with the world around one, and having hope and purpose in life
Anxiety: A multifaceted reaction consisting of cognitive, physical, emotional, and behavioral elements.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260106068570N1
Registration date:2026-01-31, 1404/11/11
Registration timing:prospective
Last update:2026-01-31, 1404/11/11
Update count:0
Registration date
2026-01-31, 1404/11/11
Registrant information
Name
Hamidreza Aryanpour
Name of organization / entity
Ardakan University
Country
Iran (Islamic Republic of)
Phone
+98 35 3390 8250
Email address
hamidaryanpour@ardakan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2026-05-20, 1405/02/30
Actual recruitment start date
2026-03-06, 1404/12/15
Actual recruitment end date
2026-05-20, 1405/02/30
Trial completion date
2026-07-21, 1405/04/30
Scientific title
The Effectiveness of Stress Management Cognitive-Behavioral Therapy on Caregiver Burden, Psychological Well-being, and Anxiety in Caregivers of Cancer Patients
Public title
The Effectiveness of Stress Management Cognitive-Behavioral Therapy on Caregiver Burden, Psychological Well-being, and Anxiety in Caregivers of Cancer Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Caregivers of cancer patients who have at least one family member with cancer
Be literate in reading and writing
Failure to receive individual counseling or medication
Exclusion criteria:
Having a severe mental illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ardakan University Research Ethics Committee/Working Group
Street address
Ardakan - Ayatollah Khatami Boulevard, Ardakan University
City
Ardakan
Province
Yazd
Postal code
8951895491
Approval date
2025-12-07, 1404/09/16
Ethics committee reference number
IR.ARDAKAN.REC.1404.059
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F 41.1
ICD-10 code description
At least six months with significant tension, worry, and feelings of apprehension, about everyday events and problems.At least one symptom out of the following list of items must be present: palpitations or pounding heart, accelerated heart rate, sweating
Primary outcomes
1
Description
Psychological well-being
Timepoint
Pre-test-post-test-follow-up
Method of measurement
It is the score that subjects obtain in the 18-question questionnaire of Riff. (1989). This questionnaire has six components: self-acceptance, positive relationships with others, autonomy, purposeful living, personal growth, and mastery of the environment.
2
Description
Care burden:
Timepoint
Pre-test-post-test-follow-up
Method of measurement
It is the score that respondents give to the 22-item questions of the Zarit Psychological Burden Questionnaire.
3
Description
anxiety
Timepoint
Pre-test-post-test-follow-up
Method of measurement
It is the score that subjects obtain on the Hospital Anxiety and Depression Scale, which consists of 14 items.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral stress management therapy group
Category
Behavior
2
Description
Control group: The control group will be placed on a waiting list and will receive the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Department of Imam Jafar Sadeq Hospital of Meybod