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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Self-selected treatment
Predetermined treatment
Weekly support
Support on demand
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Worry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linköpings universitet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Fixed treatment, weekly support

Fixed treatment, support on demand

Selected treatment, weekly support

Selected treatment, support on demand

Arm Description

Receives a predetermined treatment program and have weekly support.

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

Select their own treatment material and have weekly support.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Designed to capture the criteria for generalized anxiety disorder according to diagnostic and statistical manual of mental disorders (DSM), 9 items with score range 0-12. Higher scores indicate greater symptom severity
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity
Change from baseline in Beck Anxiety Inventory (BAI)
Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Change from baseline in Patient Health Questionnaire (PHQ-9)
Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity
Beck Depression II Inventory (BDI-II)
Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Acceptance and Action Questionnaire II (AAQ-II)
Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility
Brunnsviken Brief Quality of life scale (BBQ)
12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life
General self-efficacy scale
Measure of percieved self-efficay. 10 items rated on a four-point Likert scale. Score range 10-40 with a higher score indicating a higher percieved self-efficacy.

Full Information

First Posted
January 8, 2019
Last Updated
February 18, 2021
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT03807193
Brief Title
Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support
Official Title
Self-selected or Predetermined Internet-based Cognitive Behavior Therapy for Generalized Anxiety Disorder With Weekly Support or Support on Demand: A Factorial Treatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Worry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed treatment, weekly support
Arm Type
Experimental
Arm Description
Receives a predetermined treatment program and have weekly support.
Arm Title
Fixed treatment, support on demand
Arm Type
Experimental
Arm Description
Receives a predetermined treatment program and have access to support on demand.
Arm Title
Selected treatment, weekly support
Arm Type
Experimental
Arm Description
Select their own treatment material and have weekly support.
Arm Title
Selected treatment, support on demand
Arm Type
Experimental
Arm Description
Select their own treatment material and have access to support on demand.
Intervention Type
Behavioral
Intervention Name(s)
Self-selected treatment
Intervention Description
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
Intervention Name(s)
Predetermined treatment
Intervention Description
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
Intervention Name(s)
Weekly support
Intervention Description
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
Intervention Name(s)
Support on demand
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Description
Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment
Secondary Outcome Measure Information:
Title
Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Description
Designed to capture the criteria for generalized anxiety disorder according to diagnostic and statistical manual of mental disorders (DSM), 9 items with score range 0-12. Higher scores indicate greater symptom severity
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity
Time Frame
baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity
Time Frame
baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Title
Beck Depression II Inventory (BDI-II)
Description
Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment
Title
Acceptance and Action Questionnaire II (AAQ-II)
Description
Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment
Title
Brunnsviken Brief Quality of life scale (BBQ)
Description
12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment
Title
General self-efficacy scale
Description
Measure of percieved self-efficay. 10 items rated on a four-point Likert scale. Score range 10-40 with a higher score indicating a higher percieved self-efficacy.
Time Frame
Baseline, 8 weeks, 24 months and 36 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköpings universitet
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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