Self EsteemNCT04737356
SIA - Internet-administered CBT for Adolescents With Low Self-esteem
A study testing Cognitive behavior therapy in people with Self Esteem, run by Linkoeping University at 1 site in Sweden.
Trial summary
The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Self Esteem
- What is being tested?
- Cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2021to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.
- Conditions
- Self Esteem
- Being tested
- Cognitive behavior therapy
- Keywords
- cognitive behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy | Experimental | Therapist-Guided Internet based Cognitive Behavior Therapy Receives: Behavioral: Cognitive behavior therapy |
| Wait-list control | No intervention | Wait-list control participants will receive the same treatment at the end of the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before treatment, after 3 weeks, after 7 weeks and follow-up at 12 months after treatment termination.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start15 Feb 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737356
- Sponsor's protocol ID
- SIA
- Status last verified
- Sep 2022
- First submitted
- 28 Jan 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIA - Internet-administered CBT for Adolescents With Low Self-esteem
- ClinicalTrials.gov ID
- NCT04737356
- Acronym / sponsor ID
- SIA
- Conditions
- Self Esteem
- Keywords
- cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy | Experimental | Behavioral: Cognitive behavior therapyTherapist-Guided Internet based Cognitive Behavior Therapy |
| Wait-list control | No intervention | –Wait-list control participants will receive the same treatment at the end of the study period. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapyInternet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents. | Behavioural | Cognitive Behavior Therapy |
Primary outcome
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.
8 secondary outcomes
Change in Brunnsviken Brief Quality of Life Questionnaire
Time frame: 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.
Change in Self-Compassion Scale Short Format
Time frame: 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.
Change in Patient Health Questionnaire
Time frame: 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.
Change in Alcohol Use Disorder Identification Test
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy in people with Self Esteem, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.