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Completed

NCT Number: NCT07837440

Psychoeducation for Anxiety, Depression, Cognitive Avoidance, and Sense of Coherence in Women With Cancer

This study evaluates the effectiveness of a structured psychoeducational intervention on anxiety, depression, cognitive avoidance, and sense of coherence in women with cancer. In this randomized controlled trial, 40 women with cancer were assigned to either an intervention group or a control group. The intervention group received 6 weekly structured psychoeducational sessions (90 minutes each) focusing on stress management, cognitive restructuring, and emotional regulation. The control group received standard care. All four outcomes (anxiety, depression, cognitive avoidance, and sense of coherence) were assessed at baseline, after the 6-week intervention, and at a 2-month follow-up using the Hospital Anxiety and Depression Scale (HADS), Cognitive Avoidance Questionnaire (CAQ), and Sense of Coherence Scale (SOC-13).The study aims to provide evidence for integrating psychoeducational support into routine cancer care to improve mental health outcomes.

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Key information

Conditions

Cancer Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ayatollah Yasrebi Hospital

Kāshān, Isfahan, 8714883745, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minimum age of 20 years
  • Diagnosis of cancer in stages 1 or 2 confirmed by a physician
  • Having completed at least one course of cancer treatment
  • Not currently receiving any other psychological treatment or intervention
  • Minimum literacy (ability to read and write)
  • Written informed consent to participate in the study

Exclusion criteria

  • Unwillingness to continue participation
  • Absence from more than two sessions
  • Receiving other psychological interventions concurrently with cancer treatment
  • Major psychiatric or cognitive disorder that prevents providing informed consent and participating in the study
  • Death of the patient

Treatment and study plan

Structured Psychoeducational Intervention

Behavioral

6 weekly 90-minute group sessions including stress management, cognitive restructuring, and emotional regulation techniques.

Primary outcomes

  1. Change from Baseline in Anxiety Score

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale.

  2. Change from Baseline in Depression Score

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) - Depression Subscale.

  3. Change from Baseline in Cognitive Avoidance Score

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Cognitive avoidance will be assessed using the Cognitive Avoidance Questionnaire (CAQ).

  4. Change from Baseline in Sense of Coherence Score

    Time frame: Baseline, 6 weeks, and 2-month follow-up

    Sense of coherence will be assessed using the Sense of Coherence Scale (SOC-13).

Sponsors and collaborators

Lead sponsor

Ardakan University

Other

Registry information

Official study title

Effectiveness of a Structured Psychoeducational Intervention on Anxiety, Depression, Cognitive Avoidance, and Sense of Coherence in Women With Cancer

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 23, 2026
Registry last updated
Sep 23, 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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