- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05180084
Internet-administered CBT for Young Adults With Low Self-esteem
Internet-administered Cognitive Behavioural Therapy for Young Adults With Low Self-esteem
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Östergötland
-
Linköping, Östergötland, Sweden, 58183
- Department of Behavioral Sciences and Learning, Linköping University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavior Therapy
Therapist-Guided Internet based 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.
|
No Intervention: Wait-list control
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
Time Frame: Before treatment, after 3 weeks, after 7 weeks and follow-up at 12 months after treatment termination
|
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
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
|
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
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
|
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
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
|
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 Patient Health Questionnaire
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
|
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 Alcohol Use Disorder Identification Test
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
|
A 10 item measure of alcohol use disorders.
Sum scores range from 0-40.
A higher score indicates higher alcohol use.
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Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
|
Change in Generalised Anxiety Disorder 7-item scale
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination
|
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 Performance based self-esteem Scale
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination
|
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 Rathus assertiveness schedule - 6
Time Frame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerhard Andersson, Linkoeping University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SIYA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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