Adolescent DepressionNCT07063485
Resilience and Satir Model Training for Adolescent Depression
A study testing Resilience Theory and Satir Model Nursing Skills Training and Routine Nursing Intervention in people with Adolescent Depression, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescent Depression
- What is being tested?
- Resilience Theory and Satir Model Nursing Skills Training and Routine Nursing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 30 Jun 2023
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Diagnosis of bipolar affective disorder.
- Coexistence of other mental illnesses.
- Neurological diseases or substance dependence/abuse.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: A Comprehensive Approach Integrating Resilience Theory and Satir Model Nursing Skills Training for Adolescent Depression: A Randomized Controlled Trial
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.
Read the detailed description
Adolescent depression is a growing mental health concern with significant impacts on academic and social functions. While psychological interventions are crucial, conventional methods may have limitations. This study introduces and evaluates a novel intervention that integrates resilience theory, focusing on patients' strengths and potential, with the Satir model, which addresses psychological issues from individual, family, and social systems. The study randomized 182 adolescents with depression into two groups: a research group receiving the integrated intervention and a control group receiving routine nursing care. The primary objective is to determine if the comprehensive intervention is more effective in alleviating depressive symptoms and improving psychological well-being, including resilience, self-esteem, and coping mechanisms. The findings aim to provide evidence for a new, effective therapeutic strategy for this vulnerable population.
- Conditions
- Adolescent Depression
- Being tested
- Resilience Theory and Satir Model Nursing Skills Training, Routine Nursing Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Theory and Satir Model Nursing Skills TrainingBehavioural
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.
Routine Nursing InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Nursing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
The RSCA is a 27-item scale assessing five dimensions: interpersonal assistance, family support, positive cognition, emotional control, and goal focus. The total score ranges from 27 to 135. Higher scores indicate higher levels of psychological resilience.
Measured: Baseline (at admission) and 3 Months Post-intervention
Change in Self-Esteem Level as measured by the Feelings of Inferiority Scale (FIS)
The FIS is a 36-item scale assessing dimensions of self-esteem, social confidence, learning ability, appearance, and experience, scored from 0-6. A higher score indicates stronger self-esteem.
Measured: Baseline (at admission) and 3 Months Post-intervention
Change in Coping Styles as measured by the Simplified Coping Style Questionnaire (SCSQ)
The SCSQ is a 20-item questionnaire measuring positive coping (12 items) and negative coping (8 items). Scores range from 0-3. Higher scores on each subscale indicate a greater inclination toward that coping style.
Measured: Baseline (at admission) and 3 Months Post-intervention
Change in Medication Compliance as measured by the Medication Adherence Rating Scale (MARS)
The MARS is a 10-item scale assessing medication compliance behaviors and attitudes. The total score ranges from 0 to 10. A higher score indicates better medication compliance.
Measured: Baseline (at admission) and 3 Months Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenan Ren, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063485
- Sponsor's protocol ID
- 2021S00495
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Approach Integrating Resilience Theory and Satir Model Nursing Skills Training for Adolescent Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07063485
- Acronym / sponsor ID
- 2021S00495
- Conditions
- Adolescent Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Jul 2025 (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 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.
Detailed description
Adolescent depression is a growing mental health concern with significant impacts on academic and social functions. While psychological interventions are crucial, conventional methods may have limitations. This study introduces and evaluates a novel intervention that integrates resilience theory, focusing on patients' strengths and potential, with the Satir model, which addresses psychological issues from individual, family, and social systems. The study randomized 182 adolescents with depression into two groups: a research group receiving the integrated intervention and a control group receiving routine nursing care. The primary objective is to determine if the comprehensive intervention is more effective in alleviating depressive symptoms and improving psychological well-being, including resilience, self-esteem, and coping mechanisms. The findings aim to provide evidence for a new, effective therapeutic strategy for this vulnerable population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Resilience Theory and Satir Model Nursing Skills Training Group | Experimental | Behavioral: Resilience Theory and Satir Model Nursing Skills TrainingParticipants 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. |
| Active Comparator: Routine Intervention Group | Active comparator | Behavioral: Routine Nursing InterventionParticipants 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Participants withdrawing prematurely.
- Presence of organic lesions.
- Antidepressant or psychological treatment before enrollment.
- Allergic constitution.
- Depression induced by physical illness.
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 |
|---|---|---|
| Resilience Theory and Satir Model Nursing Skills TrainingA 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. | Behavioural | Experimental: Resilience Theory and Satir Model Nursing Skills Training Group |
| Routine Nursing InterventionStandard nursing care for patients with depression, including illness monitoring, daily life guidance, psychological support, and health education on disease management, emotion regulation, and medication. | Behavioural | Active Comparator: Routine Intervention Group |
Primary outcome
Change in Depressive Symptoms as measured by the 17-item Hamilton Depression Scale (HAMD-17)
Time frame: Baseline (at admission) and 3 Months Post-intervention
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.
Change in Depressive Symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline (at admission) and 3 Months Post-intervention
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.
Change in Depressive Symptoms as measured by the Beck Depression Inventory (BDI)
Time frame: Baseline (at admission) and 3 Months Post-intervention
The BDI is a 13-item self-report questionnaire where items are scored from 0-3. Higher total scores indicate more severe depression.
4 secondary outcomes
Change in Psychological Resilience as measured by the Resilience Scale for Chinese Adolescents (RSCA)
Time frame: Baseline (at admission) and 3 Months Post-intervention
Change in Self-Esteem Level as measured by the Feelings of Inferiority Scale (FIS)
Time frame: Baseline (at admission) and 3 Months Post-intervention
Change in Coping Styles as measured by the Simplified Coping Style Questionnaire (SCSQ)
Time frame: Baseline (at admission) and 3 Months Post-intervention
Change in Medication Compliance as measured by the Medication Adherence Rating Scale (MARS)
Time frame: Baseline (at admission) and 3 Months Post-intervention
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 16 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Theory and Satir Model Nursing Skills Training and Routine Nursing Intervention in people with Adolescent Depression, run by The First Hospital of Hebei Medical University at 1 site in China.
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 7 inclusion and 9 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 16 Jul 2025. 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 China. 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 in Depressive Symptoms as measured by the 17-item Hamilton Depression Scale (HAMD-17) (time frame: Baseline (at admission) and 3 Months Post-intervention). The study lists 3 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 16 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.