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Feasibility, Acceptability, and Preliminary Effectiveness of Character Strength-Integrated Digital Cognitive Behavioral Therapy for Psychological Distress in Adolescents and Young Adults with Gynecologic Cancer: a Pilot Randomized Controlled Trial

Feasibility, Acceptability, and Preliminary Effectiveness of Character Strength-Integrated Digital Cognitive Behavioral Therapy for Psychological Distress in Adolescents and Young Adults with Gynecologic Cancer: a Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113939
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-06
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Psychological Distress

Interventions

Experimental Group 1:Participants in this group received digital Cognitive Behavioral Therapy (CBT) integrated with character strengths, which organically combines character strength intervention with
Week 2: Mindfulness awareness, goal setting, and strength recognition
Week 3: Automatic thoughts, resource inventory, and strength exploration
Week 4: Cognitive restructuring, self-talk, and strength exploration
Week 5: Behavioral activation, self-compassion, and strength application
Week 6: Communication skills, social support, and strength application
Week 7: Problem-solving, hope reconstruction, and strength application
Week 8: Summary and consolidation, and relapse prevention.
Experimental Group 2:Participants received digital Cognitive Behavioral Therapy (CBT), and no character strength intervention was included in the intervention content. The 8-week intervention themes w
Week 2: Mindfulness awareness and goal setting
Week 3: Automatic thoughts and resource inventory
Week 4: Cognitive restructuring and self-talk
Week 5: Behavioral activation and self-compassion
Week 6: Communication skills and social support
Week 7: Problem-solving and hope reconstruction
Control Group:The control group received standardized health education, whose intervention framework and content were reviewed and revised through expert seminars and oncology team discussions.The 8-w

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 39 years at the time of initial diagnosis of primary cancer, with pathological diagnosis of gynecological malignant tumors, including cervical cancer, uterine (endometrial) cancer, ovarian cancer, vaginal cancer, and vulvar cancer; (2) Aware of their own disease diagnosis; (3) Score of Distress Thermometer (DT) >= 4 points; (4) Have a smartphone or tablet with access to the Internet or Wi-Fi; (5) Have normal communication and reading abilities; (6) Be capable of providing informed consent and demonstrate self-reported need for psychological support.

Exclusion criteria

Exclusion criteria: (1) A history of or current psychiatric illness; (2) Comorbidity with other major diseases, such as malignant tumors, heart disease, etc.; (3) Presence of consciousness disturbance, intellectual disability, or inability to communicate normally; (4) Current use of antidepressant or anti-anxiety medications; (5) Severe illness that prevents cooperation; (6) Currently participating in or having participated in psychological and behavioral interventions within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Psychological Distress;Character Strengths;Acceptability, Appropriateness and Feasibility;Feasibility;

Secondary

MeasureTime frame
Depression;Anxiety;Quality of life;

Countries

China

Contacts

Public ContactXie Jianfei

The Third Xiangya Hospital of Central South University

xiejianfei007@163.com+86 135 7496 2861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026