search
Back to results

The Effects of Logotherapy in Adolescents With Mood Disorders

Primary Purpose

Mood Disorder of Depressed Type

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
logotherapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mood Disorder of Depressed Type focused on measuring logotherapy, depression, anxiety, suicidal ideation, adolescent

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Logotherapy

    Routine psychiatric outpatient treatment

    Arm Description

    3 months of logotherapy intervention by interviewing with the participant, once every two weeks, about 1-2 hours each time, a total of 6 times of logotherapy.

    Will not provide any logotherapy. Just routine psychiatric outpatient treatment.

    Outcomes

    Primary Outcome Measures

    Purpose in life Test-1
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Purpose in life Test-2
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Purpose in life Test-3
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Purpose in life Test-4
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Beck Depression Inventory II-1
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Beck Depression Inventory II-2
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Beck Depression Inventory II-3
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Beck Depression Inventory II-4
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Beck Anxiety Inventory-1
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Beck Anxiety Inventory-2
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Beck Anxiety Inventory-3
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Beck Anxiety Inventory-4
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Beck Scale for Suicide Ideation-1
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Beck Scale for Suicide Ideation-2
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Beck Scale for Suicide Ideation-3
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Beck Scale for Suicide Ideation-4
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    April 2, 2023
    Sponsor
    National Taiwan University Hospital
    Collaborators
    Kaoshiung Chang Gung Memorial Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05797428
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    Kaoshiung Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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. 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. 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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mood Disorder of Depressed Type
    Keywords
    logotherapy, depression, anxiety, suicidal ideation, adolescent

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Logotherapy
    Arm Type
    Experimental
    Arm Description
    3 months of logotherapy intervention by interviewing with the participant, once every two weeks, about 1-2 hours each time, a total of 6 times of logotherapy.
    Arm Title
    Routine psychiatric outpatient treatment
    Arm Type
    No Intervention
    Arm Description
    Will not provide any logotherapy. Just routine psychiatric outpatient treatment.
    Intervention Type
    Other
    Intervention Name(s)
    logotherapy
    Intervention Description
    The logotherapy is carried out in an individual way in this study. The full-time assistant will give the experimental group 3 months of logotherapy intervention by interviewing with the participant, once every two weeks, about 1-2 hours each time, a total of 6 times of logotherapy to guide the participant to find the meaning of his life and value.The location is mainly in the hospital when the participant has to return for consultation, or at the participant's home.
    Primary Outcome Measure Information:
    Title
    Purpose in life Test-1
    Description
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Time Frame
    pre-test (before intervention)
    Title
    Purpose in life Test-2
    Description
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Time Frame
    post-test 1 (the week after the intervention)
    Title
    Purpose in life Test-3
    Description
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Time Frame
    post-test 2 (three months after the intervention)
    Title
    Purpose in life Test-4
    Description
    There are 20 items in this scale, which are divided into four dimensions: quality of life, value of life, purpose of life, and freedom of life. Each question is scored on a scale of 1-5, and the total score ranges from 20-100, with higher scores representing a higher sense of meaning in life.
    Time Frame
    post-test 3 (nine months after the intervention)
    Title
    Beck Depression Inventory II-1
    Description
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Time Frame
    pre-test (before intervention)
    Title
    Beck Depression Inventory II-2
    Description
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Time Frame
    post-test 1 (the week after the intervention)
    Title
    Beck Depression Inventory II-3
    Description
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Time Frame
    post-test 2 (three months after the intervention)
    Title
    Beck Depression Inventory II-4
    Description
    This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
    Time Frame
    post-test 3 (nine months after the intervention)
    Title
    Beck Anxiety Inventory-1
    Description
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Time Frame
    pre-test (before intervention)
    Title
    Beck Anxiety Inventory-2
    Description
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Time Frame
    post-test 1 (the week after the intervention)
    Title
    Beck Anxiety Inventory-3
    Description
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Time Frame
    post-test 2 (three months after the intervention)
    Title
    Beck Anxiety Inventory-4
    Description
    This scale contains 21 items and each item is scored from 0-3 points. The total score ranges from 0-63 points. The higher the score, the higher the degree of anxiety.
    Time Frame
    post-test 3 (nine months after the intervention)
    Title
    Beck Scale for Suicide Ideation-1
    Description
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Time Frame
    pre-test (before intervention)
    Title
    Beck Scale for Suicide Ideation-2
    Description
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Time Frame
    post-test 1 (the week after the intervention)
    Title
    Beck Scale for Suicide Ideation-3
    Description
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Time Frame
    post-test 2 (three months after the intervention)
    Title
    Beck Scale for Suicide Ideation-4
    Description
    This scale contains 21 items. The first 19 items mainly measure the severity of the individual's attitudes, behaviors, and plans for suicide in the past week. Each question is calculated on a scale of 0-2, and the total score ranges from 0-38, with higher scores indicating stronger suicidal ideation. The last two questions, which are not counted, ask about the number of previous suicide attempts and the severity of the intention of the last suicide attempt.
    Time Frame
    post-test 3 (nine months after the intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fan-Ko Sun, PhD
    Phone
    +886-2-33669702
    Email
    sunfanko@ntu.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chun-Ying Chiang, PhD
    Phone
    +886-7-6151100
    Ext
    7724
    Email
    chunying@isu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fan-Ko Sun, PhD
    Organizational Affiliation
    Second Degree Bachelor of Science in nursing, National Taiwan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effects of Logotherapy in Adolescents With Mood Disorders

    We'll reach out to this number within 24 hrs