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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04737356
Other study ID # SIA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date February 15, 2022

Study information

Verified date September 2022
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 15, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 19 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive behavior therapy
Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.

Locations

Country Name City State
Sweden Linköping University Linköping

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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