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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05180084
Other study ID # SIYA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2022
Est. completion date June 13, 2022

Study information

Verified date March 2024
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The study will test an adapted guided internet-delivered self-help program (Self-Esteem in Young Adults -SIYA) which lasts for seven weeks. Following recruitment via social media and a telephone interview, included participants will be randomized to active treatment or control. The control group will receive the intervention later.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date June 13, 2022
Est. primary completion date June 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: Low self-esteem, as indicated by rating of < 20 the Rosenberg Self-Esteem Scale. Age between 18 and 25 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, self-determination theory and self-compassion therapy for low self-esteem among young adults.

Locations

Country Name City State
Sweden Department of Behavioral Sciences and Learning, Linköping University Linköping Östergötland

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 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 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 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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