ClinicalTrials.gg
CompletedNCT07837440Updated Sep 23, 2026

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

An interventional study of Structured Psychoeducational Intervention in Cancer, sponsored by Ardakan University. Completed at 1 site in Iran. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Ardakan University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Sep 2024, registered Sep 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Cancer

Keywords

  • Psychoeducation
  • Anxiety
  • Depression
  • Cognitive Avoidance
  • Sense of Coherence
  • Women with Cancer
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.

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Lead sponsor

Ardakan University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

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 and participating in the study
  • Death of the patient
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Participants in this group receive 6 weekly structured psychoeducational sessions (90 minutes each) focusing on stress management, cognitive restructuring, and emotional regulation.

    Behavioral: Structured Psychoeducational Intervention

  • No intervention
    Control Group

    Participants in this group receive standard care without any psychoeducational intervention.

Interventions

  • BehavioralStructured Psychoeducational Intervention

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

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Anxiety Score

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

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

  2. Change from Baseline in Depression Score

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

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

  3. Change from Baseline in Cognitive Avoidance Score

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

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

  4. Change from Baseline in Sense of Coherence Score

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

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

07

Study locations

1 site
  • Ayatollah Yasrebi Hospital
    Kāshān, Isfahan 8714883745, Iran
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07837440
Lead sponsor
Ardakan University
Responsible party
Zeinab Mollaeifar (Student, Ardakan University) — Principal investigator
First posted
Sep 23, 2026
Start date
Sep 1, 2024
Primary completion
Dec 15, 2024
Completion
Oct 1, 2025
Last update
Sep 23, 2026

Study contacts

Mollaeifar
principal investigator · Ardakan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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