A Hybrid Psychological Intervention for Depression in Adolescents

NCT ID: NCT07104851

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

Brief 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. 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.

Conditions

Adolescent Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Resilience-Satir Hybrid Intervention Group

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.

Group Type: EXPERIMENTAL

Resilience-Satir Hybrid Intervention

Intervention Type: BEHAVIORAL

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.

Active Comparator: Treatment as Usual (TAU) Group

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: OTHER

Standard care for adolescent depression, including pharmacotherapy and routine nursing support, without structured psychotherapy.

Interventions

Resilience-Satir Hybrid Intervention

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.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Standard care for adolescent depression, including pharmacotherapy and routine nursing support, without structured psychotherapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kenan Ren

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2021-S00443

Identifier Type: -

Identifier Source: org_study_id