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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
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

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

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

    First Posted
    March 26, 2015
    Last Updated
    March 1, 2016
    Sponsor
    Linkoeping University
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    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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