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

NCT03807193 | Completed

• 1 other identifier: worry factorial
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Keywords

Worry

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Penn State Worry Questionnaire (PSWQ)

  Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms

  Baseline, 8 weeks, 24 months and 36 months after treatment

Secondary Outcomes (8)

• Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)

  Baseline, 8 weeks, 24 months and 36 months after treatment

• Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

  baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment

• Change from baseline in Beck Anxiety Inventory (BAI)

  Baseline, 8 weeks, 24 months and 36 months after treatment

• Change from baseline in Patient Health Questionnaire (PHQ-9)

  baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment

• Beck Depression II Inventory (BDI-II)

  Baseline, 8 weeks, 24 months and 36 months after treatment

Study Arms (4)

Fixed treatment, weekly support

EXPERIMENTAL

Receives a predetermined treatment program and have weekly support.

Behavioral: Predetermined treatment; Behavioral: Weekly support

Fixed treatment, support on demand

EXPERIMENTAL

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

Behavioral: Predetermined treatment; Behavioral: Support on demand

Selected treatment, weekly support

EXPERIMENTAL

Select their own treatment material and have weekly support.

Behavioral: Self-selected treatment; Behavioral: Weekly support

Selected treatment, support on demand

EXPERIMENTAL

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

Behavioral: Self-selected treatment; Behavioral: Support on demand

Interventions

Self-selected treatment 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.

Selected treatment, support on demand; Selected treatment, weekly support

Predetermined treatment 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.

Fixed treatment, support on demand; Fixed treatment, weekly support

Weekly support 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, weekly support; Selected treatment, weekly support

Support on demand 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.

Fixed treatment, support on demand; Selected treatment, support on demand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköpings universitet

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gerhard Andersson, Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 16, 2019
• Study Start: February 12, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

SE (1)