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“Examining the Effectiveness of a Group-Based Psychological Intervention in Reducing Psychological Distress and Stress, Improving Emotion Regulation, and Enhancing Coping with Illness-Related Uncertainty in Women with Breast Cancer”

The effect of Unified Protocol transdiagnostic treatment on psychological distress, emotion regulation, intolerance of uncertainty, and posttraumatic growth in women with breast cancer.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251118068037N1
Enrollment
50
Registered
2026-01-03
Start date
2026-02-14
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group: Intervention group: Participants in this group will receive group therapy based on the “Unified Protocol for Transdiagnostic Treatment of Emotional Disorders” (UP),

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Female gender Age range of 18–55 years A definitive diagnosis of breast cancer confirmed by an oncologist Obtaining a moderate score on the Depression Anxiety Stress Scales (DASS-21) according to the questionnaire guidelines (scores of 14–20 for Depression, 10–14 for Anxiety, and 19–25 for Stress) Literacy (reading and writing skills) and the ability to comprehend the concepts presented in the therapy sessions Willingness to participate voluntarily in the study and signing the informed consent form Ability to attend regular group therapy sessions during the 8-week intervention period History of receiving at least one course of chemotherapy, radiotherapy, or mastectomy

Exclusion criteria

Exclusion criteria: Emergence of acute psychiatric symptoms such as suicidal ideation, psychotic disorders, or severe emotional instability that render the continuation of group therapy impossible Receiving concurrent psychological interventions (such as other individual or group therapies) during the study period Initiation of new psychiatric medications or significant changes in the dosage of current medications during the treatment period

Design outcomes

Primary

MeasureTime frame
Primary Outcome 1: The total score obtained by participants on the Psychological Distress Scale (DASS-21) at the post-test and follow-up stages.Primary Outcome 2: The total score obtained by participants on the Posttraumatic Growth Inventory (PTGI) at the post-test and follow-up stages.Secondary Outcome 1: The total score obtained by participants on the Difficulties in Emotion Regulation Scale (DERS) at the post-test and follow-up stages.Secondary Outcome 2: The total score obtained by participants on the Intolerance of Uncertainty Scale (IUS) at the post-test and follow-up stages. Timepoint: The measurement time points for all primary and secondary outcome variables in this study are identical and will be conducted at three stages as follows:Before the start of the first therapeutic intervention session (Baseline / Pre-test)Immediately after the completion of the final (eighth) therapy session (Post-test)Two months after the completion of the therapeutic intervention (Follow-up). Method of measurement: Primary Outcome 1 (Psychological Distress): Measurement will be conducted using the 21-item version of the Depression, Anxiety and Stress Scale.Primary Outcome 2 (Posttraumatic Growth): Measurement will be conducted using the Posttraumatic Growth Inventory, designed by Tedeschi and Calhoun (1996).Secondary Outcome 1 (Emotion Regulation): Measurement will be conducted using the Difficulties in Emotion Regulation Scale, developed by Gratz and Roemer (2004).Secondary Outcome 2 (Intolerance of Uncertainty): Measurement will be conducted using the Intolerance of Uncertainty Scale, developed by Freeston et al. (1994).

Secondary

MeasureTime frame
Secondary OutcomesSecondary Outcome 1: The total score obtained by participants on the Difficulties in Emotion Regulation Scale (DERS) at the post-test and follow-up stages.Secondary Outcome 2: The total score obtained by participants on the Intolerance of Uncertainty Scale (IUS) at the post-test and follow-up stages. Timepoint: The measurement time points for all primary and secondary outcome variables in this study are identical and will be conducted at three stages as follows:Before the start of the first therapeutic intervention session (Baseline / Pre-test)Immediately after the completion of the final (eighth) therapy session (Post-test)Two months after the completion of the therapeutic intervention (Follow-up). Method of measurement: Secondary Outcome 1 (Emotion Regulation): Measurement will be conducted using the Difficulties in Emotion Regulation Scale, developed by Gratz and Roemer (2004).Secondary Outcome 2 (Intolerance of Uncertainty): Measurement will be conducted using the Intolerance of Uncertainty Scale, developed by Freeston et al. (1994).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Javad Ghafoori

Kashan University of Medical Sciences

javadghafooriii@gmail.com+98 31 5510 9999

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026