Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety
Primary Purpose
Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Waitlist
Tailored Internet-delivered CBT
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Have anxiety symptoms
Exclusion Criteria:
- Suicidal ideation
- Alcohol addiction
- Other major primary psychiatric disorder
- Ongoing psychological treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored Internet-delivered CBT
Waitlist
Arm Description
Tailored Internet-delivered CBT during 8 weeks.
Weekly check-up.
Outcomes
Primary Outcome Measures
Beck Anxiety Inventory (BAI)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Secondary Outcome Measures
Patient Health Questionnaire (PHQ)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
The Generalized Anxiety Disorder 7-item Scale (GAD-7)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Quality of Life Inventory (QOLI)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Cognitive Failures Questionnaire (CFQ)
Wisconsin Card Sorting Test-64 (WCST-64)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02403557
Brief Title
Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety
Official Title
Individually-tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Older Adults With Anxiety and Depression: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and comorbid depressive symptoms in older adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Internet-delivered CBT
Arm Type
Experimental
Arm Description
Tailored Internet-delivered CBT during 8 weeks.
Arm Title
Waitlist
Arm Type
Active Comparator
Arm Description
Weekly check-up.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
Weekly check up.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Internet-delivered CBT
Intervention Description
Tailored Internet-delivered CBT during 8 weeks.
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Description
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ)
Description
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Title
The Generalized Anxiety Disorder 7-item Scale (GAD-7)
Description
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Title
Quality of Life Inventory (QOLI)
Description
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Title
Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S)
Description
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Title
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Description
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Title
Cognitive Failures Questionnaire (CFQ)
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
Title
Wisconsin Card Sorting Test-64 (WCST-64)
Time Frame
Two weeks pre treatment, two weeks post treatment and 12 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have anxiety symptoms
Exclusion Criteria:
Suicidal ideation
Alcohol addiction
Other major primary psychiatric disorder
Ongoing psychological treatment
12. IPD Sharing Statement
Learn more about this trial
Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety
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