Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression

Depressive Disorder Clinical Trial

Official title:

Effects of Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061653
• Other study ID #: IIT2023496
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Manli Huang, M.D
• Phone: 13957162975
• Email: huangmanli[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Depression is among the most prevalent psychiatric disorders, with an upward trend in its manifestation in younger individuals. In contrast to adult depression, adolescent depression often presents with longer attack durations, higher recurrence rates, chronicity, and elevated disability rates. At present, treatment options for adolescent depression encompass pharmacological, physical, and psychological therapies. However, current evidence suggests that no antidepressant medication is entirely safe for youths, with only fluoxetine and escitalopram being FDA-approved for treating adolescent depression.

Given the weight of interpersonal stressors faced by teenagers, the NICE guidelines recommend interpersonal therapy(IPT) as a first-line treatment. A 2020 meta-analysis in the Journal of the American Academy of Child and Adolescent Psychiatry reported that interpersonal therapy exhibited significantly greater improvements in depression symptoms than cognitive behavioral therapy(CBT), although psychotherapeutic effects were modest, achieving a remission rate of 60%. These results underscore the need for further research to enhance interpersonal therapy's effectiveness in treating adolescent depression.

High-Definition Transcranial Direct Current Stimulation (HD-tDCS）is a highly secure non-invasive brain stimulation technique that produces sustained effects even after stimulation has discontinued, rendering it particularly valuable for therapeutic interventions. The proposed study aims to augment a single IPT treatment with HD-tDCS stimulation for adolescent depression. By enhancing the excitability of the cerebral cortex, HD-tDCS could potentially enhance IPT's therapeutic efficacy in treating adolescent depression while facilitating further investigation of its underlying neural circuit mechanisms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Sign a written informed consent form, willing to participate in the study and accept treatment (patients under 18 years of age need to obtain the consent of their parents or legal guardians);

2. Age between 12 and 18 years;

3. Right-handed;

4. Han ethnicity;

5. Meet the DSM-5 diagnostic criteria for depression;

6. HAMD-24=20;

7. Understand written language and able to complete questionnaires;

8. First-episode depression patients who have never received any treatment or relapse depression patients, have not taken any psychotropic drugs in the past 2 weeks, have not received systematic psychological or physical therapy.

Exclusion Criteria:

1. Exclusion criteria for tDCS: (1) Patients with metal implants in the body; those with metal implants such as titanium or magnetic devices (including aneurysm clips); (2) Patients with implanted devices such as cardiac pacemakers, deep brain stimulators (DBS); (3) Patients with intracranial hypertension, skull defects, or tumors; (4) Patients with unstable vital signs such as severe cardiac or somatic diseases; (5) Patients in the acute phase of cerebrovascular diseases; (6) Patients with adverse reactions to electrical stimulation; (7) Patients with pain sensitivity, injury, or inflammation in the stimulation area.

2. Exclusion criteria for MRI;

3. Patients with severe neurological, cardiac, liver, kidney, endocrine, and blood system diseases, or any other condition that may interfere with the study evaluation;

4. Patients with organic mental disorders and mental retardation;

5. Patients with alcohol or drug dependence;

6. Patients with a high risk of suicide.

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

Combination Product:
• IPT plus HD-tDCS
psychotherapy plus device
• IPT plus sham HD-tDCS
psychotherapy plus sham device

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-item Hamilton Depression Rating Scale	Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.	Baseline
Primary	24-item Hamilton Depression Rating Scale	Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.	1-month
Primary	24-item Hamilton Depression Rating Scale	Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.	2-month
Primary	24-item Hamilton Depression Rating Scale	Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.	3-month
Primary	Child Depression Rating Scale-Revised	Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.	Baseline
Primary	Child Depression Rating Scale-Revised	Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.	1-month
Primary	Child Depression Rating Scale-Revised	Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.	2-month
Primary	Child Depression Rating Scale-Revised	Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.	3-month
Secondary	17-item Hamilton Anxiety Rating Scale	Score<7:No anxiety; Score=7:Possibly anxious; Score=14:Definitely anxious; Score=21:Definitely significantly anxious; Score=29:Possibly severely anxious.	Baseline
Secondary	17-item Hamilton Anxiety Rating Scale	Score<7:No anxiety; Score=7:Possibly anxious; Score=14:Definitely anxious; Score=21:Definitely significantly anxious; Score=29:Possibly severely anxious.	1-month
Secondary	17-item Hamilton Anxiety Rating Scale	Score<7:No anxiety; Score=7:Possibly anxious; Score=14:Definitely anxious; Score=21:Definitely significantly anxious; Score=29:Possibly severely anxious.	2-month
Secondary	17-item Hamilton Anxiety Rating Scale	Score<7:No anxiety; Score=7:Possibly anxious; Score=14:Definitely anxious; Score=21:Definitely significantly anxious; Score=29:Possibly severely anxious.	3-month
Secondary	Beck Scale for Suicide Ideation	Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.	Baseline
Secondary	Beck Scale for Suicide Ideation	Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.	1-month
Secondary	Beck Scale for Suicide Ideation	Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.	2-month
Secondary	Beck Scale for Suicide Ideation	Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.	3-month
Secondary	the Chinese version of the Snaith-Hamilton Pleasure Scale	A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit	Baseline
Secondary	the Chinese version of the Snaith-Hamilton Pleasure Scale	A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit	1-month
Secondary	the Chinese version of the Snaith-Hamilton Pleasure Scale	A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit	2-month
Secondary	the Chinese version of the Snaith-Hamilton Pleasure Scale	A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit	3-month
Secondary	Interpersonal Relationship Scale	A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.	Baseline
Secondary	Interpersonal Relationship Scale	A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.	1-month
Secondary	Interpersonal Relationship Scale	A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.	2-month
Secondary	Interpersonal Relationship Scale	A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.	3-month
Secondary	Emotion Regulation Questionnaire	A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.	Baseline
Secondary	Emotion Regulation Questionnaire	A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.	1-month
Secondary	Emotion Regulation Questionnaire	A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.	2-month
Secondary	Emotion Regulation Questionnaire	A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.	3-month
Secondary	Toronto Alexithymia Scale-20	It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.	Baseline
Secondary	Toronto Alexithymia Scale-20	It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.	1-month
Secondary	Toronto Alexithymia Scale-20	It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.	2-month
Secondary	Toronto Alexithymia Scale-20	It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.	3-month
Secondary	The Reflective Function Questionnaire for Youths	Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.	Baseline
Secondary	The Reflective Function Questionnaire for Youths	Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.	1-month
Secondary	The Reflective Function Questionnaire for Youths	Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.	2-month
Secondary	The Reflective Function Questionnaire for Youths	Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.	3-month
Secondary	Comfort Rating Questionnaire	Evaluating adverse reactions of tdcs.	Baseline
Secondary	Comfort Rating Questionnaire	Evaluating adverse reactions of tdcs.	1-month
Secondary	Comfort Rating Questionnaire	Evaluating adverse reactions of tdcs.	2-month
Secondary	Comfort Rating Questionnaire	Evaluating adverse reactions of tdcs.	3-month
Secondary	IL-6 level	Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.	Baseline
Secondary	IL-6 level	Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.	2-month
Secondary	MRI data	Reflecting brain structure and function	Baseline
Secondary	MRI data	Reflecting brain structure and function	2-month
Secondary	EEG data	Reflecting brain function. It will be used for analysing Left-right asymmetry of forehead Alpha wave energy,mapping the brainnetworks.	Baseline
Secondary	EEG data	Reflecting brain function. It will be used for analysing Left-right asymmetry of forehead Alpha wave energy,mapping the brainnetworks.	2-month
Secondary	TMS-evoked potentials(TEPs)	Reflecting cortical excitability. N15, P30, N45, P55, N100, P180 and N280 components were evoked during single-pulse TMS stimulation of motor cortex (M1). Early components of TEPs (N15-P30) reflect cortical excitatory activity, while other components (N45-N100) are associated with cortical inhibitory activity.	Baseline
Secondary	TMS-evoked potentials(TEPs)	Reflecting cortical excitability. N15, P30, N45, P55, N100, P180 and N280 components were evoked during single-pulse TMS stimulation of motor cortex (M1). Early components of TEPs (N15-P30) reflect cortical excitatory activity, while other components (N45-N100) are associated with cortical inhibitory activity.	2-month
Secondary	Thinc-integrated Tools(THINC-it)	THINC-it(https://progress.im/en/)is the first tool to assess cognitive functioning in MDD using both subjective and objective tests and is available as a free download for use on tablets, smartphones or computers. The tool's four objective test sections use recognized cognitive paradigms to assess subjects' performance in the key cognitive domains of attention, working memory, and executive function. The Choice Reaction Time (CRT) focuses on attention and executive function, the 1-Back Memory Task (1-Back) examines memory, attention/concentration, and executive function, the Digit Symbol Substitution Test (DSST) examines processing speed, attention, and executive function, and the Test of Connectivity B (TMT-B) assesses executive function. The 5-item Cognitive Impairment Questionnaire (PDQ?5?D) is the subjective component of the instrument and can be used to assess patients' performance in attention/concentration, planning/organization, retrospection, and prospective memory.	Baseline
Secondary	Thinc-integrated Tools(THINC-it)	THINC-it(https://progress.im/en/)is the first tool to assess cognitive functioning in MDD using both subjective and objective tests and is available as a free download for use on tablets, smartphones or computers. The tool's four objective test sections use recognized cognitive paradigms to assess subjects' performance in the key cognitive domains of attention, working memory, and executive function. The Choice Reaction Time (CRT) focuses on attention and executive function, the 1-Back Memory Task (1-Back) examines memory, attention/concentration, and executive function, the Digit Symbol Substitution Test (DSST) examines processing speed, attention, and executive function, and the Test of Connectivity B (TMT-B) assesses executive function. The 5-item Cognitive Impairment Questionnaire (PDQ?5?D) is the subjective component of the instrument and can be used to assess patients' performance in attention/concentration, planning/organization, retrospection, and prospective memory.	2-month
Secondary	Perceptual judgment test	Assess subjects' perception of interpersonal information.	Baseline
Secondary	Perceptual judgment test	Assess subjects' perception of interpersonal information.	2-month
Secondary	Distance memory test	Assessment of Working memory.	Baseline
Secondary	Distance memory test	Assessment of Working memory.	2-month
Secondary	ERP experiment	The participants are instructed to watch the animations,while EEG data is recorded. Event-related Mu-wave will be used for evaluating social interaction ability.	Baseline
Secondary	ERP experiment	The participants are instructed to watch the animations,while EEG data is recorded. Event-related Mu-wave will be used for evaluating social interaction ability.	2-month