Caregiver Burden
Conditions
Keywords
Acceptance and Commitment Therapy, Cognitive Behavioral Sress Management, Fatigue, Quality of Life, Fear of Recurrence, Psychological Distress, Caregivers
Brief summary
The goal of this clinical trial is to compare the effectiveness of cognitive-behavioral stress management (CBSM) and acceptance and commitment therapy (ACT) on the fear of recurrence, quality of life, psychological distress, and fatigue of caregivers of cancer patients. Researchers compare the effectiveness of CBSM and ACT to a Control(without receiving intervention) to see if treatment works to improve the health of caregivers of cancer patients. A comparison between the two treatments was also conducted to determine if there was a difference in their effectiveness. Participants: In this study, 66 participants were randomly assigned to one of three groups: the CBSM group, the ACT group, or the control group. The CBSM and ACT groups each attended eight 90-minute, in-person sessions twice a week.
Interventions
consisted of eight in-person sessions, twice a week for 90 minutes each
BEHAVIORALAcceptance and Commitment Therapy (ACT)
consisted of eight in-person sessions, twice a week for 90 minutes each
Sponsors
Ardakan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a randomized controlled trial with three parallel groups. Participants are randomly assigned to one of three groups. The first group receives Cognitive-Behavioral Stress Management (CBSM), the second group receives Acceptance and Commitment Therapy (ACT), and the third group (the control group) receives no intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in the study, caregivers had to be 18 years or older, literate, and provide informed consent. A key requirement was that participants either lived with the patient or visited them at least twice a week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Cancer Recurrence Inventory-caregiver (FCRI-c) | assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up. | This scale, developed by Lin et al., (2018), consists of 42 items measured on a 5-point Likert scale, encompassing seven subscales related to triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping Strategy. |
| Depression Anxiety and Stress (DASS) | assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up. | This scale, developed by Lovibond and Lovibond (1995), consists of 21 items measured on a 4-point Likert scale, encompassing three subscales for depression, anxiety, and stress. |
| Caregiver Quality of Life-Cancer (CQOLC) | assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up. | This scale, developed by Weitzner et al., (1999), consists of 35 items measured on a 5-point Likert scale, encompassing four subscales for burden, disruptiveness, positive adaptation, and financial concern, along with eight additional items. |
| Multidimensional Fatigue Inventory (MFI) | assessments at three distinct time points: at baseline (pre-intervention), immediately following the four-week intervention period (post-test), and at a two-month follow-up. | This scale, developed by Smets et al., (1995), consists of 20 items measured on a 5-point Likert scale, encompassing five subscales: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. |
Countries
Iran
Outcome results
None listed