Comparison of ACT and CBSM for Caregivers in Cancer

NCT07329868 | Completed

• 1 other identifier: IR.YAZD.REC.1403.058
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

Acceptance and Commitment Therapy; Cognitive Behavioral Sress Management; Fatigue; Quality of Life; Fear of Recurrence; Psychological Distress; Caregivers

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

Study Arms (3)

Cognitive Behavioral Stress Management (CBSM)

EXPERIMENTAL

Participants in this group receive Cognitive Behavioral Stress Management (CBSM)

Behavioral: Cognitive Behavioral Stress Management (CBSM)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Participants in this group receive Acceptance and Commitment Therapy (ACT)

Behavioral: Acceptance and Commitment Therapy (ACT)

Control

NO INTERVENTION

The control group receives no intervention.

Interventions

Cognitive Behavioral Stress Management (CBSM) BEHAVIORAL

consisted of eight in-person sessions, twice a week for 90 minutes each

Cognitive Behavioral Stress Management (CBSM)

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

consisted of eight in-person sessions, twice a week for 90 minutes each

Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ardakan University: lead

Study Sites (1)

Emdadgaran-e Ashura Charity Institute

Yazd, Yazd Province, Iran

Location

MeSH Terms

Conditions

Caregiver Burden; Fatigue

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: June 24, 2024
• Primary Completion: July 22, 2024
• Study Completion: September 22, 2024
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)