A Hybrid Psychological Intervention for Depression in Adolescents

NCT07104851 | Completed

• 1 other identifier: 2021-S00443
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Depression

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 12 weeks, 6-month follow-up

Secondary Outcomes (7)

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

  Baseline, 12 weeks, 6-month follow-up

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

  Baseline, 12 weeks, 6-month follow-up

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

  Baseline, 12 weeks, 6-month follow-up

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

  Baseline, 12 weeks, 6-month follow-up

• Change in Family Function as Measured by the Family APGAR Index

  Baseline, 12 weeks, 6-month follow-up

Study Arms (2)

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.

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.

Other: Treatment as Usual (TAU)

Interventions

Resilience-Satir Hybrid Intervention 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.

Experimental: Resilience-Satir Hybrid Intervention Group

Treatment as Usual (TAU) OTHER

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

Active Comparator: Treatment as Usual (TAU) Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)