Comparison of ACT and CBSM for Caregivers in Cancer

December 29, 2025 updated by: Fatemeh Al-Sadat Hosseini, Ardakan University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
    • Yazd Province
      • Yazd, Yazd Province, Iran
        • Emdadgaran-e Ashura Charity Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Stress Management (CBSM)
Participants in this group receive Cognitive Behavioral Stress Management (CBSM)
Behavioral: Cognitive Behavioral Stress Management (CBSM)
consisted of eight in-person sessions, twice a week for 90 minutes each
Experimental: Acceptance and Commitment Therapy (ACT)
Participants in this group receive Acceptance and Commitment Therapy (ACT)
Behavioral: Acceptance and Commitment Therapy (ACT)
consisted of eight in-person sessions, twice a week for 90 minutes each
No Intervention: Control
The control group receives no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Actual)

July 22, 2024

Study Completion (Actual)

September 22, 2024

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.YAZD.REC.1403.058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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