NCT03441490

Brief Summary

The purpose of this study is to evaluate the effects of learning support and chat on treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for adolescents with anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable anxiety

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

Study Start

First participant enrolled

February 8, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

February 14, 2018

Last Update Submit

August 8, 2018

Conditions

Keywords

Learning SupportChatAdolescents

Outcome Measures

Primary Outcomes (2)

  • Beck Anxiety Inventory (BAI)

    Measures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

    Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  • Beck Depression Inventory - II (BDI-II)

    Measures clinical depression. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

    Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

Secondary Outcomes (8)

  • Penn State Worry Questionnaire for Children (PSWQ - C)

    Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  • Generalised Anxiety Disorder (GAD-7)

    First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.

  • Mini-Social Phobia Inventory (MINI-SPIN)

    Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  • Agoraphobic Cognitions Questionnaire (ACQ)

    Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  • Satisfaction With Life Scale (SWLS)

    Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  • +3 more secondary outcomes

Study Arms (4)

ICBT standard

ACTIVE COMPARATOR

Internet-based cognitive behavioural therapy with therapeutic guidance through mail

Behavioral: Guided-ICBT for adolescents with anxiety

ICBT chat

EXPERIMENTAL

Internet-based cognitive behavioural therapy with therapeutic guidance through chat

Behavioral: Guided-ICBT with chat

ICBT learning support

EXPERIMENTAL

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail

Behavioral: Guided-ICBT with learning support

ICBT with learning support and chat

EXPERIMENTAL

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat

Behavioral: Guided-ICBT with learning support and chat

Interventions

Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.

ICBT standard

Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.

ICBT chat

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.

ICBT learning support

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.

ICBT with learning support and chat

Eligibility Criteria

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

You may qualify if:

  • Be between the ages of 15-19 years old
  • Have symptoms of anxiety, anxiety disorder

You may not qualify if:

  • Suicidal ideation
  • Alcohol addiction
  • other major primary psychiatric disorder
  • Ongoing psychological treatment
  • recent (during last 4 weeks) change in psychiatric medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Choline O-Acetyltransferase

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

AcetyltransferasesAcyltransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Gerhard Andersson, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Design is a two-by-two factorial randomized trial with four intervention groups: 1, ICBT with therapeutic guidance through mail. 2, ICBT with therapeutic guidance through chat. 3, ICBT with learning support and terapeutic guidance through mail. 4. ICBT with learning support and terapeutic guidance through chat.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor Gerhard Andersson

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 22, 2018

Study Start

February 8, 2018

Primary Completion

May 20, 2018

Study Completion

June 20, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations