NCT05180084

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

June 17, 2025

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

December 17, 2021

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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, and after 7 weeks (post-treatment assesment).

Secondary Outcomes (8)

  • Change in Brunnsviken Brief Quality of Life Questionnaire

    Before treatment and after 7 weeks (post-treatment assessment)

  • Change in Robson Self-concept Questionnaire

    Before treatment and after 7 weeks (post-treatment assessment)

  • Change in Self-Compassion Scale Short Format

    Before treatment and after 7 weeks (post-treatment assessment)

  • Change in Patient Health Questionnaire

    Before treatment and after 7 weeks (post-treatment assessment)

  • Change in Generalised Anxiety Disorder 7-item scale

    Before treatment and after 7 weeks (post-treatment assessment)

  • +3 more secondary outcomes

Study Arms (2)

Cognitive Behavior Therapy

EXPERIMENTAL

Therapist-Guided Internet based Cognitive Behavior Therapy

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.

Interventions

Internet-based CBT intervention based on CBT theory, self-determination theory and self-compassion therapy for low self-esteem among young adults.

Cognitive Behavior Therapy

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gerhard Andersson

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 6, 2022

Study Start

February 7, 2022

Primary Completion

June 13, 2022

Study Completion

June 13, 2022

Last Updated

June 17, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations