CancerNCT07837440
Psychoeducation for Anxiety, Depression, Cognitive Avoidance, and Sense of Coherence in Women With Cancer
A study testing Structured Psychoeducational Intervention in people with Cancer, run by Ardakan University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Structured Psychoeducational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Structured Psychoeducational Intervention on 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.
- Conditions
- Cancer
- Being tested
- Structured Psychoeducational Intervention
- Keywords
- Psychoeducation, Anxiety, Depression, Cognitive Avoidance, Sense of Coherence, Women with Cancer
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Psychoeducational InterventionBehavioural
6 weekly 90-minute group sessions including stress management, cognitive restructuring, and emotional regulation techniques.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group receive 6 weekly structured psychoeducational sessions (90 minutes each) focusing on stress management, cognitive restructuring, and emotional regulation. Receives: Behavioral: Structured Psychoeducational Intervention |
| Control Group | No intervention | Participants in this group receive standard care without any psychoeducational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Anxiety Score
Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale.
Measured: Baseline, 6 weeks, and 2-month follow-up
Change from Baseline in Depression Score
Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) - Depression Subscale.
Measured: Baseline, 6 weeks, and 2-month follow-up
Change from Baseline in Cognitive Avoidance Score
Cognitive avoidance will be assessed using the Cognitive Avoidance Questionnaire (CAQ).
Measured: Baseline, 6 weeks, and 2-month follow-up
Change from Baseline in Sense of Coherence Score
Sense of coherence will be assessed using the Sense of Coherence Scale (SOC-13).
Measured: Baseline, 6 weeks, and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Sep 2024
- Primary completion15 Dec 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Mollaeifar, Ardakan University
- Investigators
- Mollaeifar, Principal investigator, Ardakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837440
- Sponsor's protocol ID
- IR.ARDAKAN.REC.1404.001
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Structured Psychoeducational Intervention on Anxiety, Depression, Cognitive Avoidance, and Sense of Coherence in Women With Cancer
- ClinicalTrials.gov ID
- NCT07837440
- Acronym / sponsor ID
- IR.ARDAKAN.REC.1404.001
- Conditions
- Cancer
- Keywords
- Psychoeducation, Anxiety, Depression, Cognitive Avoidance, Sense of Coherence, Women with Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ardakan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Structured Psychoeducational InterventionParticipants in this group receive 6 weekly structured psychoeducational sessions (90 minutes each) focusing on stress management, cognitive restructuring, and emotional regulation. |
| Control Group | No intervention | –Participants in this group receive standard care without any psychoeducational intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Psychoeducational Intervention6 weekly 90-minute group sessions including stress management, cognitive restructuring, and emotional regulation techniques. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mollaeifar principal investigator
Ardakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Psychoeducational Intervention in people with Cancer, run by Ardakan University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Anxiety Score (time frame: Baseline, 6 weeks, and 2-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.