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Completed

NCT Number: NCT07329868

Comparison of ACT and CBSM for Caregivers in Cancer

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emdadgaran-e Ashura Charity Institute

Yazd, Yazd Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Stress Management (CBSM)

Behavioral

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

Acceptance and Commitment Therapy (ACT)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Ardakan University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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