Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support

NCT ID: NCT03807193

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-12

Study Completion Date

2020-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates two types of internet-based treatments for generalized anxiety disorder and two types of support. The treatments are a predetermined program for generalized anxiety disorder and a self-selected treatment. The different types of support are either a weekly contact trough a secure message system or support on demand.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Generalized anxiety disorder (GAD) is characterize by and excessive and uncontrollable worry that is present more days than not. The disorder is best described as a chronic condition with periods with more or less symptoms. The disorder is highly disabling with low quality of life for the individual and is associated with and high costs for society. Previous studies on internet-based cognitive behavior therapy for GAD has shown positive effects but there are still room for improvement.

The aim of this study is to evaluate two different internet-based treatments as well as two types of support through the use of a factorial design. The participants will be recruited trough advertising. After registration on the study's website the potential participants will be asked to answer screening questionnaires and demographic data for an initial screening. Those meeting inclusion criteria will be contacted for a diagnostic interview based Mini-International Neuropsychiatric Interview (M.I.N.I.). If meeting the study's inclusion criteria and not the exclusion criteria the participant will be included in the study and randomized to one of the four arms. The four arms are: Predetermined treatment program with weekly support, Predetermined treatment program with support on demand, Self-selected treatment with weekly support, Self-selected treatment with support on demand.

The predetermined treatment program is designed for treatment of worry and generalized anxiety disorder. It is based on newer forms of cognitive behavior therapy and includes mindfulness and acceptance. In the self-selected treatment the participants will select treatment interventions with the help of a manual and encouraged to choose interventions that they feel address their specific problems. The interventions that will be available are all based on standard cognitive behavior therapy techniques. The weekly support will be scheduled and delivered by clinical psychology students under supervision. This contact will be based on reports from the participants on the weeks work with the program and exercises. The support on demand will be also be delivered by clinical psychology students under supervision. This support takes place if and when the participant ask for support. Treatment will be 8 weeks long and both treatments will be delivered through the same platform. Contact with the participants will be trough written messages on a secure platform.

After the eight weeks of treatment the participants will be asked to answer the same measures as before the treatment as well as questions regarding how they experience the treatment. Follow up data will be collected at later points.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A factorial design with four cells:

Cell one: Predetermined treatment program with weekly support Cell two: Predetermined treatment program with support on demand Cell three: Self-selected treatment program with weekly support Cell four: Self-selected treatment program with support on demand
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fixed treatment, weekly support

Receives a predetermined treatment program and have weekly support.

Group Type EXPERIMENTAL

Predetermined treatment

Intervention Type BEHAVIORAL

The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.

Weekly support

Intervention Type BEHAVIORAL

The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.

Fixed treatment, support on demand

Receives a predetermined treatment program and have access to support on demand.

Group Type EXPERIMENTAL

Predetermined treatment

Intervention Type BEHAVIORAL

The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.

Support on demand

Intervention Type BEHAVIORAL

The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.

Selected treatment, weekly support

Select their own treatment material and have weekly support.

Group Type EXPERIMENTAL

Self-selected treatment

Intervention Type BEHAVIORAL

The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.

Weekly support

Intervention Type BEHAVIORAL

The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.

Selected treatment, support on demand

Select their own treatment material and have access to support on demand.

Group Type EXPERIMENTAL

Self-selected treatment

Intervention Type BEHAVIORAL

The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.

Support on demand

Intervention Type BEHAVIORAL

The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-selected treatment

The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.

Intervention Type BEHAVIORAL

Predetermined treatment

The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.

Intervention Type BEHAVIORAL

Weekly support

The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.

Intervention Type BEHAVIORAL

Support on demand

The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 18 years old
* fulfilling criteria for generalized anxiety syndrome
* 45 points or more on PSWQ
* Able to read and write in Swedish
* Have daily access to a computer and internet

Exclusion Criteria

* Alcohol or substance abuse
* Acute suicidal
* Ongoing psychological treatment
* Ongoing medication for anxiety or depression that is planned to be adjusted during the time of the treatment given in the study
* Complex psychiatric illness that highly disabling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gerhard Andersson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerhard Andersson, Professor

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Linköpings universitet

Linköping, Östergötland County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

worry factorial

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.