NCT04737356

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

January 28, 2021

Last Update Submit

September 16, 2022

Conditions

Keywords

cognitive behavior therapy

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, after 7 weeks and follow-up at 12 months after treatment termination.

Secondary Outcomes (8)

  • Change in Brunnsviken Brief Quality of Life Questionnaire

    Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.

  • Change in Robson Self-concept Questionnaire

    Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.

  • Change in Self-Compassion Scale Short Format

    Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.

  • Change in Performance based self-esteem Scale

    Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.

  • Change in Patient Health Questionnaire

    Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.

  • +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 as well as self-determination therapy for low self-esteem among adolescents.

Cognitive Behavior Therapy

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

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)

Linköping University

Linköping, 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

January 28, 2021

First Posted

February 3, 2021

Study Start

February 15, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations