Caregiver BurdenNCT07329868
Comparison of ACT and CBSM for Caregivers in Cancer
A study testing Cognitive Behavioral Stress Management (CBSM) and Acceptance and Commitment Therapy (ACT) in people with Caregiver Burden, run by Ardakan University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Cognitive Behavioral Stress Management (CBSM) and Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIran
- Study dates
- 24 Jun 2024to 22 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria were applied to ensure the integrity of the study. Participants were excluded if they missed more than two sessions, were currently receiving other psychological interventions, had a major psychiatric or cognitive disorder that would prevent them from providing informed consent, or if the patient passed away.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Acceptance and Commitment Therapy and Cognitive Behavioral Stress Management on Fear of Recurrence, Quality of Life, Psychological Distress, and Fatigue of Caregivers of Cancer Patients
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.
Read more
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.
- Conditions
- Caregiver Burden
- Being tested
- Cognitive Behavioral Stress Management (CBSM), Acceptance and Commitment Therapy (ACT)
- Keywords
- Acceptance and Commitment Therapy, Cognitive Behavioral Sress Management, Fatigue, Quality of Life, Fear of Recurrence, Psychological Distress, Caregivers
- Medical subject headings
- Caregiver Burden, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Stress Management (CBSM)Behavioural
consisted of eight in-person sessions, twice a week for 90 minutes each
Acceptance and Commitment Therapy (ACT)Behavioural
consisted of eight in-person sessions, twice a week for 90 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Stress Management (CBSM) | Experimental | Participants in this group receive Cognitive Behavioral Stress Management (CBSM) Receives: Behavioral: Cognitive Behavioral Stress Management (CBSM) |
| Acceptance and Commitment Therapy (ACT) | Experimental | Participants in this group receive Acceptance and Commitment Therapy (ACT) Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Control | No intervention | The control group receives no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Cancer Recurrence Inventory-caregiver (FCRI-c)
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.
Measured: 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.
Depression Anxiety and Stress (DASS)
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.
Measured: 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.
Caregiver Quality of Life-Cancer (CQOLC)
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.
Measured: 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.
Multidimensional Fatigue Inventory (MFI)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start24 Jun 2024
- Primary completion22 Jul 2024
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatemeh Al-Sadat Hosseini, Ardakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329868
- Sponsor's protocol ID
- IR.YAZD.REC.1403.058
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hosseini FA, Choobforoushzadeh A, Mortazavizadeh SMR, Mirsaleh YR. A comparison of the efficacy of cognitive-behavioral stress management and acceptance and commitment therapy on the quality of life and fatigue of caregivers of patients with cancer: a randomized controlled trial. Support Care Cancer. 2026 Sep 28;34(10):1028. doi: 10.1007/s00520-026-11205-9.
PubMed 42806152
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Acceptance and Commitment Therapy and Cognitive Behavioral Stress Management on Fear of Recurrence, Quality of Life, Psychological Distress, and Fatigue of Caregivers of Cancer Patients
- ClinicalTrials.gov ID
- NCT07329868
- Acronym / sponsor ID
- IR.YAZD.REC.1403.058
- Conditions
- Caregiver Burden
- Keywords
- Acceptance and Commitment Therapy, Cognitive Behavioral Sress Management, Fatigue, Quality of Life, Fear of Recurrence, Psychological Distress, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ardakan UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Stress Management (CBSM) | Experimental | Behavioral: Cognitive Behavioral Stress Management (CBSM)Participants in this group receive Cognitive Behavioral Stress Management (CBSM) |
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)Participants in this group receive Acceptance and Commitment Therapy (ACT) |
| Control | No intervention | –The control group receives no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria were applied to ensure the integrity of the study. Participants were excluded if they missed more than two sessions, were currently receiving other psychological interventions, had a major psychiatric or cognitive disorder that would prevent them from providing informed consent, or if the patient passed away.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Stress Management (CBSM)consisted of eight in-person sessions, twice a week for 90 minutes each | Behavioural | Cognitive Behavioral Stress Management (CBSM) |
| Acceptance and Commitment Therapy (ACT)consisted of eight in-person sessions, twice a week for 90 minutes each | Behavioural | Acceptance and Commitment Therapy (ACT) |
Primary outcome
Fear of Cancer Recurrence Inventory-caregiver (FCRI-c)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Derived from this study: PubMed 42806152Hosseini FA, Choobforoushzadeh A, Mortazavizadeh SMR, Mirsaleh YR. A comparison of the efficacy of cognitive-behavioral stress management and acceptance and commitment therapy on the quality of life and fatigue of caregivers of patients with cancer: a randomized controlled trial. Support Care Cancer. 2026 Sep 28;34(10):1028. doi: 10.1007/s00520-026-11205-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Stress Management (CBSM) and Acceptance and Commitment Therapy (ACT) in people with Caregiver Burden, run by Ardakan University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Cancer Recurrence Inventory-caregiver (FCRI-c) (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.