Back to results

Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents With Depression (IDA)

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Behavioral activation (BA)

Regular care within primary or secondary mental health care for children

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

13-17 years of age,
A principal diagnosis of mild or moderate MDD
Willing to be randomized to either of the three treatment arms,
Basic proficiency in Swedish, both adolescent, and a participating caregiver
Regular access to a desktop, laptop computer connected to the internet, as well as a mobile phone,
If using medication with antidepressants, central stimulants, and neuroleptics it has to be unchanged at least 6 weeks prior to inclusion,
A minimum of one caregiver that is able to co-participate in the treatment

Exclusion Criteria:

Immediate risk to self or others, requiring urgent medical attention, such as suicidality, or repeated self-injurious behavior.
Other psychiatric disorders or social problems requiring other actions at first hand (e.g., diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, or alcohol/substance dependence; ongoing bullying in school, abuse and/or neglect in the family; high and prolonged absence from school).
Previous psychological treatment for MDD for a minimum of at least 3 sessions within the last 12 months prior to assessment.
Current use of benzodiazepines.
Ongoing psychological treatment for any other psychiatric disorder.

Sites / Locations

BUP Internetbehandling, BUP Forsknings- och utvecklingscentrum i StockholmRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Guided ICBT

Self-guided ICBT

Treatment as usual (TAU)

Arm Description

Participants in guided ICBT will receive internet-delivered CBT with therapist support. The treatment consists of 8 online modules with interactive features such as videos and illustrations, delivered over a maximum of 10 weeks. The main treatment focus is behavioral activation. The adolescent and the caregiver are provided with their own separate programs and login to the treatment platform. The caregiver's program also consists of 8 chapters, including psychoeducation about depression and how to support their adolescent in treatment. The adolescents and caregivers have regular contact with a personal assigned therapist via written text messages in the platform. Participants are typically in contact with their therapist several times a week. The adolescent and caregiver can continue to access all treatment modules for the whole follow-up period (3 months), but without therapist-support.

The self-guided arm is identical to the guided arm, however without the therapist support. To ensure patient safety, there will be clear instructions to the patients and primary caregivers on how to get in contact with the study team in case of acute problems, and there will be clinical routines to detect and manage deterioration or suicidal tendencies.

Participants randomized to TAU, will be referred to the local CAMH's or primary care unit for children and youths and will be free to receive any treatment, either psychosocial, medical, or a combination of both. The content of TAU and the treatment techniques used will be monitored.

Outcomes

Primary Outcome Measures

Change from baseline in clinician-rated depressive scores on Children's Depression Rating Scale - Revised (CDRS-R)

CDRS-R is a semi-structured clinician interview, assessing level of depressive symptomatology. Total range is 17-113, with higher values representing a worse outcome.

Secondary Outcome Measures

Clinical Global Impression Scale - Severity (CGI-S)

CGI-S was developed to assess how mentally ill a specific patient compared to a particular patient population (e.g. with major depressive disorder) at a certain time. It consists of a single item rated on a seven-point scale ranging from 1="no symptoms" to 7="extreme symptoms".

Clinical Global Impression - Improvement (CGI-I)

CGI-I is developed to assess improvement of psychiatric symptoms for a specific patient compared to baseline. It consists of a single item rated on a seven-point scale ranging from 1="very much improved" to 7="very much worse".

Children's global assessment scale (CGAS)

The CGAS is a single item 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent a better outcome.

Internet Intervention Patient Adherence Scale (iiPAS)

The iiPAS is a clinician-rated measure of patient adherence to internet-delivered behavioral interventions (38) with 5 items rated on a 0 to 4 Likert scale with total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. The scale covers client's work pace, engagement, communication with the therapist, motivation for change, and login frequency. The iiPAS has demonstrated excellent internal consistency and good construct validity as well as a strong association with objective measures of patient activity in ICBT(38). For participants in the self-guided group, we will use an adapted version excluding item 3 since communication with therapist is not applicable, and a research assistant will make the rating at post-treatment.

Anhedonia Scale for Adolescents (ASA)

The ASA is an adolescent specific measure of anhedonia with 14 items with a four graded-scale from 0 (never) to 3 (always), ranging from 0 to 42 points. A higher score indicates more anhedonia. The ASA has high test-retest reliability and good convergent validity with standardized measures of depression.

Affective Reactivity Index (ARI)

The ARI is a measure of irritability, consisting of six items with a three graded scale and one item on impairment due to irritability, ranging from 0 to 12 points with higher scores indicating a worse outcome. The ARI has demonstrated an excellent internal consistency and differentiates cases from controls in a clinic a community sample.

Behavioral activation of Depression Scale - short form (BADS-S)

The BADS-S is designed to track changes in proposed mediators of behavioral activation, e.g. activation and avoidance. Total range is from 0-54 with higher values indicating higher degree of activation and lower degree of avoidance. Changes during treatment in proposed mediators of behavioral activation on the BADS-S will be reported for the ICBT interventions.

Concomitant interventions

To assess if the adolescent has received other psychological treatments during the trial period, the adolescents answer questions about other potential psychological treatments they have received apart from the interventions included in the trial.

The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version

The CSQ-8 is an 8-item self-rated 4-point scale, measuring different aspects of satisfaction with treatment, e.g. perception of quality of treatment, if the treatment adequately addressed their needs and overall satisfaction. Total range is 8 to 32, with higher values indicating higher satisfaction. Mean in total satisfaction scores on the CSQ-8 for each treatment group at end of treatment and at follow-up will be reported.

Insomnia Severity Index (ISI)

ISI, a brief screening measure of insomnia, a seven-item scale ranging from 0 to 28 points, with higher values representing a worse outcome.

Kidscreen-10 Index - adolescent and parent version

Kidscreen-10 assess the adolescents' general health-related quality of life. Total range from 10-50, with higher values indicating better health-related quality of life.

Need for further treatment - adolescent and parent version

Investigate whether the participant considers her/himself in need of further treatment for her/his depression. The scale ranges from 0 (no need for more treatment) to 4 (great need for more treatment) where higher scores indicate a worse outcome.

Negative Effects Questionnaire (NEQ-20) - adolescent and parent version

NEQ-20 investigates participants' negative effects of psychological treatments. Total range is 0-80, with higher values representing a worse outcome.

The Revised Children's Anxiety and Depression Scale, short (RCADS-S) -adolescent and parent version

The RCADS-S, a shortened version of the Spence Child Anxiety Scale, is a child and parent self-report measure of anxiety- and depression-related psychopathology. Only the anxiety subscales are administered in this study since depressive symptoms are measured thoroughly by other measures. Total range is 0-45, with higher values representing a worse outcome.

Quick Inventory of Depressive Symptomatology 17 items (QIDS-17) - adolescent and parent version

The QIDS-17 covers the nine symptoms defined in the Diagnostic Statistical Manual of Mental Disorders (DSM-5) of depression rated in a scale from 0 (none) to 3 (highest) with a sum-range of 0-27. A total score of 6-10 indicates mild depression, 11-15 moderate, 16-20 severe and 21 and above very severe. Response is defined as a reduction by half of the initial score on QIDS-17. Remission is defined as below 6 points on QIDS-17. The QIDS-17 is a very reliable measure and most discriminating at moderate levels of depression.

Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent version

WSAS-Y is a parent- and adolescent-rated scale of impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. The scale generates a global score ranging from 0 to 40, with higher scores indicating greater impairment.

The Expressed Emotion Adjective Checklist (EEAC)

The EEAC is a validated self-rated questionnaire of the caregiver's positive and negative emotions directed towards the adolescent. The EEAC include 20 adjectives (each scored 1-8 where 1 indicates never and 8 always).

Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)

The TiC-P assess healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. In the present study no health economic evaluations will be conducted. Rather this instrument is included to gain feasibility data in preparation of a planned larger randomized controlled study. Therefore, no data on TiC-P will be reported in this trial. The TiC-P assess healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss.

Treatment credibility and expectancy scale - adolescent and parent version

Four qualitative questions about treatment credibility will be administered at week 3, asking how well the treatment suits adolescents with depression, how much they believe this treatment will help him/her, if and to what extent they would recommend this treatment to a friend with depression and how much improvement they expect from the treatment. Each item is scored on a 5-point Likert scale, from 1 to 5. The scale ranges from 4 to 20 points, where a higher score indicates a better outcome.

Full Information

NCT ID

NCT04977856

First Posted

July 13, 2021

Last Updated

November 7, 2022

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT04977856

Brief Title

Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents With Depression

Acronym

IDA

Official Title

Efficacy and Cost-effectiveness of Internet-delivered Cognitive Behavior Therapy for Adolescents With Mild to Moderate Depression: A Randomized Controlled Trial of Guided and Self-guided ICBT vs. Treatment as Usual

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 10, 2021 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Adolescent depression is a prevalent and impairing condition that can be effectively treated with Cognitive Behavior Therapy (CBT). However, a majority of adolescents do not have access to CBT. Internet-delivered CBT (ICBT) has been suggested as a way to increase availability to effective psychological treatments. Yet, the research on ICBT for adolescents has been lagging behind significantly. The overall aim of this research project is to increase the availability of evidence-based psychological treatments for adolescents with depression by developing and evaluating internet-delivered Cognitive Behavior Therapy (ICBT) for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of the guided and self-guided ICBT for adolescents with mild to moderate depression in a randomized controlled trial (RCT) with three-arms; guided ICBT (with therapist-support) and self-guided ICBT (without therapist-support) vs treatment as usual (TAU).

Detailed Description

Primary and secondary objectives Primary objective: 1. To determine the clinical efficacy of Guided and Self-guided ICBT for depression for reducing depressive symptom severity (as measured by the CDRS-R (27) in adolescents with mild and moderate major depressive disorder (MDD), compared with an active control intervention (treatment as usual within primary or secondary child and adolescent mental health care). The primary endpoint is the follow-up 3 months post-treatment. Secondary objectives: To establish the 12-month durability of the treatment effects. To conduct a health-economic evaluation of guided ICBT for depression and self-guided ICBT for depression, compared with TAU, from multiple perspectives, both in the short term (primary endpoint) and the long term (12-month follow-up). Research questions: Is guided and self-guided ICBT more efficacious than TAU in regard to the reduction of depressive symptoms? Is guided and self-guided ICBT more cost-effective than TAU? Is self-guided ICBT more cost-effective than guided ICBT? Are the therapeutic gains of ICBT maintained long term (i.e., 1 year after the intervention)?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single-blind parallel-group randomised controlled trial

Masking

Outcomes Assessor

Masking Description

Assessors conducting post- and follow-up assessments will be blind to treatment allocation, for the full duration of the trial. The outcome measures are identical for both groups, ensuring that the assessors remain blind. At each follow-up assessment, participants will be reminded by their assessor to not reveal their arm allocation. To measure blinding integrity, all assessors will record whether the participating families inadvertently reveal their group allocation, and subsequently guess each participant's treatment allocation at each assessment point and motivate their choice. The blinding will be broken after the trial's final participant has finished his/her 3-month follow-up assessment (primary endpoint). The trial will end when the trial's final participant has finished his/her 3-month follow-up assessment.

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Guided ICBT

Arm Type

Experimental

Arm Description

Arm Title

Self-guided ICBT

Arm Type

Experimental

Arm Description

Arm Title

Treatment as usual (TAU)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral activation (BA)

Intervention Description

The main goal of the BA is to increase engagement in values-based activities and decrease avoidant behaviors that serve to maintain depression. The adolescent will learn about depression, how behavioral activations works, monitor their own activities, plan and do more values-based activities and deal with obstacles to getting in touch with positive reinforcement, such as avoidance behaviors.

Intervention Type

Other

Intervention Name(s)

Regular care within primary or secondary mental health care for children

Intervention Description

Regular care (supportive therapy, waitlist, psychological treatments, drugs, or a combination of different interventions)

Primary Outcome Measure Information:

Title

Change from baseline in clinician-rated depressive scores on Children's Depression Rating Scale - Revised (CDRS-R)

Description

CDRS-R is a semi-structured clinician interview, assessing level of depressive symptomatology. Total range is 17-113, with higher values representing a worse outcome.

Time Frame

week 0, week 10, at 3 and 12 months follow-up

Secondary Outcome Measure Information:

Title

Clinical Global Impression Scale - Severity (CGI-S)

Description

Time Frame

week 0, week 10, at 3 and 12 months follow-up

Title

Clinical Global Impression - Improvement (CGI-I)

Description

Time Frame

week 10, at 3- and 12 months follow-up

Title

Children's global assessment scale (CGAS)

Description

The CGAS is a single item 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent a better outcome.

Time Frame

week 0, week 10, at 3 and 12 months follow-up

Title

Internet Intervention Patient Adherence Scale (iiPAS)

Description

Time Frame

Week 10

Title

Anhedonia Scale for Adolescents (ASA)

Description

Time Frame

week 0, week 10, at 3 and 12 months follow-up

Title

Affective Reactivity Index (ARI)

Description

Time Frame

week 0, week 10, at 3 and 12 months follow-up

Title

Behavioral activation of Depression Scale - short form (BADS-S)

Description

Time Frame

week 0, weekly during treatment (week 1 to week 10), at 3- and 12 months follow-up

Title

Concomitant interventions

Description

Time Frame

Week 10 and 3- and 12-months follow-up assessments.

Title

The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version

Description

Time Frame

week 10

Title

Insomnia Severity Index (ISI)

Description

ISI, a brief screening measure of insomnia, a seven-item scale ranging from 0 to 28 points, with higher values representing a worse outcome.

Time Frame

week 0, week 10, and at 3- and 12 months follow-up

Title

Kidscreen-10 Index - adolescent and parent version

Description

Kidscreen-10 assess the adolescents' general health-related quality of life. Total range from 10-50, with higher values indicating better health-related quality of life.

Time Frame

week 0, week 10, at 3- and 12-months follow-up

Title

Need for further treatment - adolescent and parent version

Description

Time Frame

at 3 months follow-up

Title

Negative Effects Questionnaire (NEQ-20) - adolescent and parent version

Description

NEQ-20 investigates participants' negative effects of psychological treatments. Total range is 0-80, with higher values representing a worse outcome.

Time Frame

Week 10 and 3 months follow-up

Title

The Revised Children's Anxiety and Depression Scale, short (RCADS-S) -adolescent and parent version

Description

Time Frame

week 0, week 10, 3- and 12 months follow-up

Title

Quick Inventory of Depressive Symptomatology 17 items (QIDS-17) - adolescent and parent version

Description

Time Frame

week 0, weekly from week 1 to week 10, at 3- and 12 months follow-up

Title

Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent version

Description

Time Frame

week 0, week 10, 3- and 12 months follow-up

Title

The Expressed Emotion Adjective Checklist (EEAC)

Description

Time Frame

week 0, week 10, 3- and 12 months follow-up

Title

Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)

Description

Time Frame

week 0, week 10, at 3- and 12 months follow-up

Title

Treatment credibility and expectancy scale - adolescent and parent version

Description

Time Frame

week 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 13-17 years of age, A principal diagnosis of mild or moderate MDD Willing to be randomized to either of the three treatment arms, Basic proficiency in Swedish, both adolescent, and a participating caregiver Regular access to a desktop, laptop computer connected to the internet, as well as a mobile phone, If using medication with antidepressants, central stimulants, and neuroleptics it has to be unchanged at least 6 weeks prior to inclusion, A minimum of one caregiver that is able to co-participate in the treatment Exclusion Criteria: Immediate risk to self or others, requiring urgent medical attention, such as suicidality, or repeated self-injurious behavior. Other psychiatric disorders or social problems requiring other actions at first hand (e.g., diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, or alcohol/substance dependence; ongoing bullying in school, abuse and/or neglect in the family; high and prolonged absence from school). Previous psychological treatment for MDD for a minimum of at least 3 sessions within the last 12 months prior to assessment. Current use of benzodiazepines. Ongoing psychological treatment for any other psychiatric disorder.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eva Serlachius, PhD

Phone

+467070155232

eva.serlachius@ki.se

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca Grudin, PhD student

Phone

+46 70-261 59 68

rebecca.grudin@ki.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Serlachius, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

BUP Internetbehandling, BUP Forsknings- och utvecklingscentrum i Stockholm

City

Stockholm

State/Province

Stockholms Län

ZIP/Postal Code

11364

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grudin Rebecca, PhD-student

Phone

+46 702615968

rebecca.grudin@ki.se

First Name & Middle Initial & Last Name & Degree

Serlachius Eva, Professor

Phone

+46707155232

eva.serlachius@ki.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents With Depression

We'll reach out to this number within 24 hrs