NCT07063485

Brief Summary

This randomized controlled trial aims to assess the effectiveness of an intervention combining resilience theory with Satir model nursing skills training compared to routine nursing care for adolescents with depression. The study evaluates changes in depressive symptoms, psychological resilience, self-esteem, coping styles, and medication adherence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

July 3, 2025

Last Update Submit

July 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Depressive Symptoms as measured by the 17-item Hamilton Depression Scale (HAMD-17)

    The HAMD-17 is a clinician-rated scale with 17 items scored on a 0-4 or 0-2 point scale. A higher total score indicates more severe depressive symptoms.

    Baseline (at admission) and 3 Months Post-intervention

  • Change in Depressive Symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)

    The MADRS is a 10-item clinician-rated scale, with each item scored from 0-6. The total score ranges from 0-60, with higher scores indicating more severe depression.

    Baseline (at admission) and 3 Months Post-intervention

  • Change in Depressive Symptoms as measured by the Beck Depression Inventory (BDI)

    The BDI is a 13-item self-report questionnaire where items are scored from 0-3. Higher total scores indicate more severe depression.

    Baseline (at admission) and 3 Months Post-intervention

Secondary Outcomes (4)

  • Change in Psychological Resilience as measured by the Resilience Scale for Chinese Adolescents (RSCA)

    Baseline (at admission) and 3 Months Post-intervention

  • Change in Self-Esteem Level as measured by the Feelings of Inferiority Scale (FIS)

    Baseline (at admission) and 3 Months Post-intervention

  • Change in Coping Styles as measured by the Simplified Coping Style Questionnaire (SCSQ)

    Baseline (at admission) and 3 Months Post-intervention

  • Change in Medication Compliance as measured by the Medication Adherence Rating Scale (MARS)

    Baseline (at admission) and 3 Months Post-intervention

Study Arms (2)

Experimental: Resilience Theory and Satir Model Nursing Skills Training Group

EXPERIMENTAL

Participants in this group received routine nursing care plus a specialized intervention combining resilience theory and Satir model nursing skills training. The intervention was delivered in a hospital setting and included 15 group activity sessions (2 hours each). Activities were conducted in a workshop format with fixed themes such as "I am a unique existence," "resilient beliefs," and "identifying inner sources of resilience." The sessions incorporated experiential interactive learning, progressive muscle relaxation training, and guided imagery. After each activity, participants completed tasks and shared experiences. Post-discharge follow-up was conducted to monitor progress.

Behavioral: Resilience Theory and Satir Model Nursing Skills Training

Active Comparator: Routine Intervention Group

ACTIVE COMPARATOR

Participants in this group received routine nursing intervention. This included observation of the illness condition, guidance on daily life and diet, psychological care, and health education about the disease for both patients and their families. They were also guided on emotion regulation, sleep, and medication routines, with encouragement for regular outpatient follow-ups.

Behavioral: Routine Nursing Intervention

Interventions

A structured psychological and nursing intervention program based on resilience theory and the Satir model. It consists of 15 two-hour group sessions during hospitalization, focusing on enhancing resilience, communication, and self-efficacy through themed activities, interactive learning, relaxation techniques, and guided training. The intervention is led by psychologists and psychiatric nurses and includes post-discharge follow-up.

Experimental: Resilience Theory and Satir Model Nursing Skills Training Group

Standard nursing care for patients with depression, including illness monitoring, daily life guidance, psychological support, and health education on disease management, emotion regulation, and medication.

Active Comparator: Routine Intervention Group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis aligning with the ICD-10 criteria for depressive episodes.
  • First onset with a course between 4 weeks and 12 months.
  • Age between 13 and 18 years.
  • Normal communication ability.
  • No antidepressant use in the four weeks preceding admission, and no prior psychological treatment.
  • HAMD-24 score exceeding 20 points.
  • Informed consents from family members or guardians.

You may not qualify if:

  • Participants withdrawing prematurely.
  • Presence of organic lesions.
  • Antidepressant or psychological treatment before enrollment.
  • Allergic constitution.
  • Depression induced by physical illness.
  • Suicide ideation score ≥4 points in MADRS with suicidal tendency.
  • Diagnosis of bipolar affective disorder.
  • Coexistence of other mental illnesses.
  • Neurological diseases or substance dependence/abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

February 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations