Adolescent DepressionNCT07104851
A Hybrid Psychological Intervention for Depression in Adolescents
A study testing Resilience-Satir Hybrid Intervention and Treatment as Usual (TAU) in people with Adolescent Depression, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This multi-center, randomized controlled trial was conducted to evaluate the efficacy and long-term effects of a novel hybrid psychological intervention, which combines Resilience Theory with the Satir Model, for adolescents diagnosed 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-Satir Hybrid Intervention and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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 of a major depressive episode according to DSM-5 criteria, confirmed by two independent psychiatrists.
- First episode, with a duration of 4 weeks to 12 months.
- Age between 13 and 18 years.
- HAMD-17 score ≥ 17.
- Capable of normal communication.
- Provision of informed consent by both the adolescent and legal guardians.
Who cannot join
- Lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
- Depression secondary to a general medical condition or substance use.
- Acute suicidal risk (score ≥ 4 on MADRS item 10) requiring immediate intensive care.
- Currently receiving structured psychotherapy.
- Severe neurological or physical illness that could interfere with participation.
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: Efficacy and Sustainability of a Hybrid Psychological Intervention Integrating Resilience Theory and the Satir Model on Depression, Resilience, and Quality of Life in Adolescents: A Multi-center, Randomized Controlled Trial
This multi-center, randomized controlled trial was conducted to evaluate the efficacy and long-term effects of a novel hybrid psychological intervention, which combines Resilience Theory with the Satir Model, for adolescents diagnosed with depression. The study compared this intervention to treatment as usual (TAU) to determine its impact on depressive symptoms, psychological resilience, self-esteem, and overall quality of life.
Read the detailed description
Adolescent depression is a significant and growing public health concern. Traditional therapies have limitations, highlighting a need for innovative, engaging interventions. This study was designed to address this gap by developing and testing a hybrid model that integrates the strengths-based approach of Resilience Theory with the systemic, humanistic principles of the Satir Model. The study hypothesized that this combined intervention would be more effective than standard care in not only alleviating depressive symptoms but also in building lasting psychosocial resources. A total of 420 adolescents with depression were randomized to either the 12-week hybrid intervention group or a control group receiving treatment as usual. The intervention program was structured in three modules focusing on self-awareness, skill-building, and future-orientation. Outcomes were assessed at baseline, immediately post-intervention (12 weeks), and at a 6-month follow-up to evaluate the sustainability of the effects.
- Conditions
- Adolescent Depression
- Being tested
- Resilience-Satir Hybrid Intervention, Treatment as Usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-Satir Hybrid InterventionBehavioural
A structured, 12-week, group-based psychological intervention integrating principles from Resilience Theory and the Satir Model to enhance coping skills, self-esteem, communication, and family dynamics.
Treatment as Usual (TAU)Other
Standard care for adolescent depression, including pharmacotherapy and routine nursing support, without structured psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Resilience-Satir Hybrid Intervention Group | Experimental | In addition to treatment as usual (TAU), participants received a structured 12-week group nursing intervention program. The program consisted of one 90-minute session per week, co-facilitated by trained psychiatric nurses. The intervention included three modules: Module 1 (Weeks 1-4) focused on safety and identifying emotions using Satir's "Iceberg" metaphor and personal strengths; Module 2 (Weeks 5-8) focused on building skills in problem-solving, cognitive reframing, and congruent communication; Module 3 (Weeks 9-12) focused on integrating skills and future-planning. Receives: Behavioral: Resilience-Satir Hybrid Intervention |
| Active Comparator: Treatment as Usual (TAU) Group | Active comparator | Participants received standard care, which included regular psychiatric assessments, pharmacotherapy as deemed appropriate by the treating psychiatrist (primarily SSRIs), and routine nursing care. Routine care consisted of general health education, basic supportive communication, and monitoring of symptoms and side effects. No structured psychotherapy was provided. Receives: Other: Treatment as Usual (TAU) |
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 Rating Scale (HAMD-17)
A clinician-rated scale assessing the severity of depression. Total scores range from 0 to 52. A lower score indicates a better outcome.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Depressive Symptoms as Measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
A clinician-rated scale sensitive to changes in core depressive symptoms. Total scores range from 0 to 60. A lower score indicates a better outcome.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Depressive Symptoms as Measured by the Beck Depression Inventory-II (BDI-II)
A 21-item self-report questionnaire assessing the severity of depression. A lower score indicates a better outcome.
Measured: Baseline, 12 weeks, 6-month follow-up
Secondary outcomes (7)
Change in Psychological Resilience as Measured by the Resilience Scale for Chinese Adolescents (RSCA)
A 27-item self-report scale assessing personal strength and support strength. A higher score indicates better resilience.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Self-Esteem as Measured by the Feelings of Inferiority Scale (FIS)
A 36-item self-report scale measuring self-esteem. A higher score indicates higher self-esteem and a better outcome.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Coping Styles as Measured by the Simplified Coping Style Questionnaire (SCSQ)
A 20-item self-report measure assessing positive and negative coping styles. An increase in the positive coping subscale score indicates a better outcome.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Medication Adherence as Measured by the Medication Adherence Rating Scale (MARS)
A 10-item self-report scale assessing medication compliance behavior and attitudes. A higher score indicates better adherence.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Family Function as Measured by the Family APGAR Index
A 5-item screening tool to assess an individual's perception of family function (Adaptation, Partnership, Growth, Affection, Resolve). A higher score indicates better family function.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Social Support as Measured by the Perceived Social Support Scale (PSSS)
A 12-item scale measuring perceived support from family, friends, and significant others. A higher score indicates better perceived social support.
Measured: Baseline, 12 weeks, 6-month follow-up
Change in Quality of Life as Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
A 26-item self-report a measure assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Higher scores indicate a better quality of life.
Measured: Baseline, 12 weeks, 6-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 posted5 Aug 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 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
- NCT07104851
- Sponsor's protocol ID
- 2021-S00443
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Sustainability of a Hybrid Psychological Intervention Integrating Resilience Theory and the Satir Model on Depression, Resilience, and Quality of Life in Adolescents: A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07104851
- Acronym / sponsor ID
- 2021-S00443
- Conditions
- Adolescent Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Aug 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 multi-center, randomized controlled trial was conducted to evaluate the efficacy and long-term effects of a novel hybrid psychological intervention, which combines Resilience Theory with the Satir Model, for adolescents diagnosed with depression. The study compared this intervention to treatment as usual (TAU) to determine its impact on depressive symptoms, psychological resilience, self-esteem, and overall quality of life.
Detailed description
Adolescent depression is a significant and growing public health concern. Traditional therapies have limitations, highlighting a need for innovative, engaging interventions. This study was designed to address this gap by developing and testing a hybrid model that integrates the strengths-based approach of Resilience Theory with the systemic, humanistic principles of the Satir Model. The study hypothesized that this combined intervention would be more effective than standard care in not only alleviating depressive symptoms but also in building lasting psychosocial resources. A total of 420 adolescents with depression were randomized to either the 12-week hybrid intervention group or a control group receiving treatment as usual. The intervention program was structured in three modules focusing on self-awareness, skill-building, and future-orientation. Outcomes were assessed at baseline, immediately post-intervention (12 weeks), and at a 6-month follow-up to evaluate the sustainability of the effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Resilience-Satir Hybrid Intervention Group | Experimental | Behavioral: Resilience-Satir Hybrid InterventionIn addition to treatment as usual (TAU), participants received a structured 12-week group nursing intervention program. The program consisted of one 90-minute session per week, co-facilitated by trained psychiatric nurses. The intervention included three modules: Module 1 (Weeks 1-4) focused on safety and identifying emotions using Satir's "Iceberg" metaphor and personal strengths; Module 2 (Weeks 5-8) focused on building skills in problem-solving, cognitive reframing, and congruent communication; Module 3 (Weeks 9-12) focused on integrating skills and future-planning. |
| Active Comparator: Treatment as Usual (TAU) Group | Active comparator | Other: Treatment as Usual (TAU)Participants received standard care, which included regular psychiatric assessments, pharmacotherapy as deemed appropriate by the treating psychiatrist (primarily SSRIs), and routine nursing care. Routine care consisted of general health education, basic supportive communication, and monitoring of symptoms and side effects. No structured psychotherapy was provided. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of a major depressive episode according to DSM-5 criteria, confirmed by two independent psychiatrists.
- First episode, with a duration of 4 weeks to 12 months.
- Age between 13 and 18 years.
- HAMD-17 score ≥ 17.
- Capable of normal communication.
Key exclusion criteria (5 listed)
- Lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
- Depression secondary to a general medical condition or substance use.
- Acute suicidal risk (score ≥ 4 on MADRS item 10) requiring immediate intensive care.
- Currently receiving structured psychotherapy.
- Severe neurological or physical illness that could interfere with participation.
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-Satir Hybrid InterventionA structured, 12-week, group-based psychological intervention integrating principles from Resilience Theory and the Satir Model to enhance coping skills, self-esteem, communication, and family dynamics. | Behavioural | Experimental: Resilience-Satir Hybrid Intervention Group |
| Treatment as Usual (TAU)Standard care for adolescent depression, including pharmacotherapy and routine nursing support, without structured psychotherapy. | Other | Active Comparator: Treatment as Usual (TAU) Group |
Primary outcome
Change in Depressive Symptoms as Measured by the 17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Baseline, 12 weeks, 6-month follow-up
A clinician-rated scale assessing the severity of depression. Total scores range from 0 to 52. A lower score indicates a better outcome.
Change in Depressive Symptoms as Measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline, 12 weeks, 6-month follow-up
A clinician-rated scale sensitive to changes in core depressive symptoms. Total scores range from 0 to 60. A lower score indicates a better outcome.
Change in Depressive Symptoms as Measured by the Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, 12 weeks, 6-month follow-up
A 21-item self-report questionnaire assessing the severity of depression. A lower score indicates a better outcome.
7 secondary outcomes
Change in Psychological Resilience as Measured by the Resilience Scale for Chinese Adolescents (RSCA)
Time frame: Baseline, 12 weeks, 6-month follow-up
Change in Self-Esteem as Measured by the Feelings of Inferiority Scale (FIS)
Time frame: Baseline, 12 weeks, 6-month follow-up
Change in Coping Styles as Measured by the Simplified Coping Style Questionnaire (SCSQ)
Time frame: Baseline, 12 weeks, 6-month follow-up
Change in Medication Adherence as Measured by the Medication Adherence Rating Scale (MARS)
Time frame: Baseline, 12 weeks, 6-month follow-up
Change in Family Function as Measured by the Family APGAR Index
Time frame: Baseline, 12 weeks, 6-month follow-up
Change in Social Support as Measured by the Perceived Social Support Scale (PSSS)
Time frame: Baseline, 12 weeks, 6-month follow-up
Change in Quality of Life as Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Baseline, 12 weeks, 6-month follow-up
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 5 Aug 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-Satir Hybrid Intervention and Treatment as Usual (TAU) 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 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 5 Aug 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 Rating Scale (HAMD-17) (time frame: Baseline, 12 weeks, 6-month follow-up). 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 5 Aug 2025.