SIA - Internet-administered CBT for Adolescents With Low Self-esteem

Study Overview
=================
Brief Summary
-----------------
The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.

Official Title
-----------------
SIA - Internet-administered CBT for Adolescents With Low Self-esteem

Conditions
-----------------
Self Esteem

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low self-esteem, as indicated by rating of < 20 the Rosenberg Self-Esteem Scale. Age between 15 and 19 years old. Access to a computer, smartphone, or tablet with internet access. Write and speak Swedish. In case of use of psychotropical medication, a stable dose for the past three months prior to registration and no planned changes during the treatment. Exclusion Criteria: Other ongoing psychological treatment that affects the treatment received in the study. No comorbid severe depressive symptoms and no suicidal plans. Ongoing alcohol use disorder, as indicated by Alcohol Use Disorders Identification Test (AUDIT). Severe psychiatric comorbidities (e.g. psychosis, anorexia nervosa) that requires specialist care within the regular psychiatric care.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavior Therapy<br>Therapist-Guided Internet based Cognitive Behavior Therapy | Behavioral: Cognitive behavior therapy<br>* Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.<br>|
| No Intervention: Wait-list control<br>Wait-list control participants will receive the same treatment at the end of the study period. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rosenberg Self-Esteem Scale | A 10-item measure of self-esteem. Sum scores range between 0-30. A higher score indicates a higher self-esteem. | Before treatment, after 3 weeks, after 7 weeks and follow-up at 12 months after treatment termination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brunnsviken Brief Quality of Life Questionnaire | Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Robson Self-concept Questionnaire | A 30-item measure of self-esteem. Sum scores range between 0-210. A higher score indicates a higher self-esteem. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Self-Compassion Scale Short Format | A 12-item measure of self-compassion. Sum scores range between 1-5. A higher score indicates higher self-compassion. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Performance based self-esteem Scale | A 4-item measure of performance based self-esteem. Sum scores range between 4-20. A higher score indicates a higher performance based self-esteem. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Patient Health Questionnaire | A 9 item measure of depressive symptoms. Sum scores range from 0-27. A higher score indicates more depressive symptoms. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Generalised Anxiety Disorder 7-item scale | Seven item measure of generalized anxiety disorder. Sum score range from 0 to 21, with higher scores indicating more generalized anxiety. Cut-offs for interpretation: 0-5 minimal anxiety, 6-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Alcohol Use Disorder Identification Test | A 10 item measure of alcohol use disorders. Sum scores range from 0-40. A higher score indicates higher alcohol use. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 
| Change in Rathus assertiveness schedule - 6 | Six item measure of assertiveness. Sum score range from -18 to 18. A higher score indicates higher assertiveness. | Before treatment, after 7 weeks and follow-up at 12 months after treatment termination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive behavior therapy