Clinical trial NCT05797428: The Effects of Logotherapy in Adolescents With Mood Disorders
Official title: The Effects of Logotherapy on Meaning in Life, Depression, Anxiety and Suicidal Ideation in Adolescents With Mood Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorder of Depressed Type
Keywords: logotherapy
depression
anxiety
suicidal ideation
adolescent
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Kaoshiung Chang Gung Memorial Hospital
First posted: 2023-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Logotherapy can help people find their meaning in life and help people reduce their suicidal ideation. Suicide was the second leading cause of death for 15-24 year-olds. Logotherapy can increase exploration of meaning in life for adolescents and prevent them from attempting suicide. However, most research only explored the effects of logotherapy on meaning in life and depression in adolescents with mood disorders. There is a lack of research to explore the effects of logotherapy on anxiety and suicidal ideation in adolescents. Therefore, this study will explore the effects of logotherapy on meaning in life, depression, anxiety and suicidal ideation in adolescents with mood disorders. This study will carry on for two years and the sample will be recruited from the adolescents' outpatient clinic of psychiatric department in hospitals. The first and second year of the study will use a single-blind randomized controlled trial approach, the aim is to evaluate the short-term and longitudinal effects of logotherapy meaning in life, depression, anxiety and suicidal ideation in adolescents with mood disorders, the sample will collect 120 adolescents with mood disorders, and will use four instruments for testing the logotherapy intervention. The four instruments are: (1) Purpose in life Test, (2) Beck Depression Inventory II, (3) Beck Anxiety Inventory, (4) Beck Scale for Suicide Ideation. Data will be analyzed using the Statistic Package for the Social Science. The result of this study will be applied to the mental health team in the clinical psychiatric department for taking care of patients, and help adolescents with mood disorders to find their meaning in life, further, to reduce their depression, anxiety and suicidal ideation.

Detailed description: Logotherapy can help people find their meaning in life and help people reduce their suicidal ideation. Suicide was the second leading cause of death for 15-24 year-olds. Logotherapy can increase exploration of meaning in life for adolescents and prevent them from attempting suicide. However, most research only explored the effects of logotherapy on meaning in life and depression in adolescents with mood disorders. There is a lack of research to explore the effects of logotherapy on anxiety and suicidal ideation in adolescents. Therefore, this study will explore the effects of logotherapy on meaning in life, depression, anxiety and suicidal ideation in adolescents with mood disorders. This study will carry on for two years and the sample will be recruited from the adolescents' outpatient clinic of psychiatric department in hospitals. The first and second year of the study will use a single-blind randomized controlled trial approach, the aim is to evaluate the short-term and longitudinal effects of logotherapy meaning in life, depression, anxiety and suicidal ideation in adolescents with mood disorders, the sample will collect 120 adolescents with mood disorders, and will use four instruments for testing the logotherapy intervention. The four instruments are: (1) Purpose in life Test, (2) Beck Depression Inventory II, (3) Beck Anxiety Inventory, (4) Beck Scale for Suicide Ideation. Data will be analyzed using the Statistic Package for the Social Science.

The research process includes:

1. Participant acceptance and signing consent: Referral by doctors from Chang Gung Hospitals and National Taiwan University Hospitals. Full-time research assistants will explain the purpose of the research, the research process, the confidentiality of data processing, and allow the individual to freely decide whether to participate without being forced, obtaining a signed consent form. Those who are under twenty-years-old will also obtain the consent of the legal representative.
2. Pre-test: data collectors blinded single-blind study, the work-students who did not participate in the intervention measures will collect the patient's basic data sheet and four scales.
3. Random assignment: The psychologist (co-host) randomly assigns the cases to the experimental group or the control group, and assigns the groups by means of a computer-generated random assignment table.
4. Intervention: The experimental group received 6 interventions of logotherapy given by a full-time assistant, while the control group received routine outpatient treatment of general adolescent psychiatry.
5. Posttest: Both the experimental group and the control group will collect the same four scales three times by the work-study students.

The result of this study will be applied to the mental health team in the clinical psychiatric department for taking care of patients, and help adolescents with mood disorders to find their meaning in life, further, to reduce their depression, anxiety and suicidal ideation.

Eligibility criteria: Inclusion Criteria:

* Patients with mood disorders (such as depression, bipolar disorder) diagnosed by a psychiatrist.
* Patient Health Questionnaire-9 items (PHQ-9) score 5-19 points (indicating mild depression to moderate to severe depression)
* Agree to participate in logotherapy
* Able to participate in logotherapy

Exclusion Criteria:

* Patients with severe emotional disorders who cannot participate in logotherapy.
* Those who have severe psychopathological phenomena and cannot judge reality or those who are mentally deficient.
* Those who have serious suicidal ideation or clear suicide plan are not suitable for interview

Primary outcomes:
measure: Purpose in life Test-1
timeFrame: pre-test (before intervention)
measure: Purpose in life Test-2
timeFrame: post-test 1 (the week after the intervention)
measure: Purpose in life Test-3
timeFrame: post-test 2 (three months after the intervention)
measure: Purpose in life Test-4
timeFrame: post-test 3 (nine months after the intervention)
measure: Beck Depression Inventory II-1
timeFrame: pre-test (before intervention)
measure: Beck Depression Inventory II-2
timeFrame: post-test 1 (the week after the intervention)
measure: Beck Depression Inventory II-3
timeFrame: post-test 2 (three months after the intervention)
measure: Beck Depression Inventory II-4
timeFrame: post-test 3 (nine months after the intervention)
measure: Beck Anxiety Inventory-1
timeFrame: pre-test (before intervention)
measure: Beck Anxiety Inventory-2
timeFrame: post-test 1 (the week after the intervention)
measure: Beck Anxiety Inventory-3
timeFrame: post-test 2 (three months after the intervention)
measure: Beck Anxiety Inventory-4
timeFrame: post-test 3 (nine months after the intervention)
measure: Beck Scale for Suicide Ideation-1
timeFrame: pre-test (before intervention)
measure: Beck Scale for Suicide Ideation-2
timeFrame: post-test 1 (the week after the intervention)
measure: Beck Scale for Suicide Ideation-3
timeFrame: post-test 2 (three months after the intervention)
measure: Beck Scale for Suicide Ideation-4
timeFrame: post-test 3 (nine months after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Niaosong District
Study officials:
affiliation: Second Degree Bachelor of Science in nursing, National Taiwan University
name: Fan-Ko Sun, PhD
role: STUDY_CHAIR
References: