Clinical trial NCT02806271: Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder
Official title: Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Worry Postponement
Stimulus Control
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-06-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Worry postponement is a commonly recommended treatment component in cognitive behavioral therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally occurring instances of worry to a designated 30 minute "worry period" later in the day. Despite being commonly recommended, there is little known about the efficacy and mechanisms of worry postponement. The purpose of this study is to determine the efficacy and mechanisms of change of a two-week worry postponement intervention in people with Generalized Anxiety Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only control condition. Changes in worry or associated features will be examined at post intervention and at a 2-week follow up.

Detailed description: Generalized Anxiety Disorder (GAD) is a disorder characterized by excessive and uncontrollable worry. People with GAD report that worry significantly interferes with their ability to enjoy their life and function effectively in their roles. Worry postponement is a treatment technique developed by Borkovec and colleagues (1983) to reduce excessive worry. In worry postponement, people are instructed to notice naturally occurring episodes of worry and to then disengage from their worry and postpone it to a designated 30 minute "worry period" later in the day. People are instructed to confine their worry to this 30 minute period and to use that period to problem solve concerns they have been having. Worry postponement is a widely recommended technique for treating excessive worry in people with GAD and is often combined with other cognitive-behavioural interventions. Despite being commonly recommended, there are very few studies demonstrating worry postponement's efficacy for reducing worry, and no studies have looked at the effect of this intervention in people with GAD. The present study aims to extend the literature by comparing a two-week worry postponement intervention to worry monitoring alone and to an assessment only control condition. Participants will complete baseline self-report measures of worry and associated symptoms and cognitive processes. They will complete three computer tasks measuring attention control. They will then be randomized to one of three conditions (worry postponement, worry monitoring, assessment only control). Participants will follow instructions corresponding to their condition daily for two weeks. In the worry postponement and worry monitoring conditions this will involve completing brief daily worry questionnaires at home for the two weeks of the intervention. In the assessment only condition participants will not complete any measures during the two weeks after the first session. Subsequent to this, all participants will return to the lab to repeat baseline measures, and will return again two weeks later to complete measures. The entire study will require three lab visits, spanning over four weeks. This study aims to determine what the effects of worry postponement are, relative to worry monitoring and assessment only, on worry, GAD and associated symptoms, and cognitive processes related to worry. A secondary aim of this study is to examine which mechanisms predict change in worry in a worry postponement study. This will be the first study to our knowledge, to examine these questions in a sample of people with GAD. This study will provide important information for optimizing the treatment of worry in people with GAD.

Eligibility criteria: Inclusion Criteria:

1. Endorse symptoms consistent with a primary diagnosis of Generalized Anxiety Disorder (GAD) as defined by DSM-5 (APA, 2013), with a clinician severity rating (CSR) ≥ 4
2. If a comorbid diagnosis is present, its associated CSR is at least 1 point lower than that of their GAD diagnosis.

Exclusion Criteria:

1. Have a current or past history of psychosis or mania, or endorse symptoms consistent with a diagnosis of a substance use disorder in the past 12 months
2. Report clinically significant suicidal ideation, intent, or plan
3. Participants will be excluded if they are currently receiving psychological treatment or counseling (e.g., cognitive behaviour therapy, supportive counseling, etc.), unless this treatment is infrequent (meeting once monthly or less) or the participant has been receiving consistent weekly treatment for 12 weeks and still meets all other eligibility criteria
4. Are taking psychotropic medications and have had a change in dose in the past 12 weeks. If they have recently discontinued a psychotropic medication, they will be included if it has been at least 1 month since discontinuation, or 3 months if they had been taking fluoxetine/Prozac. If a participant is taking psychotropic medication on an as needed basis (e.g., benzodiazepines), they will be included and their use of this medication will be noted in order to assess whether it has a moderating effect on intervention outcome.

Primary outcomes:
measure: Change in worry as measures by the Penn State Worry Questionnaire - Past Week
timeFrame: This measure will be administered four times over the course of the four week study; changes will be examined in scores from baseline, at 1 week (mid-intervention), at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Secondary outcomes:
measure: Change in mindfulness the Cognitive and Affective Mindfulness Scale-Revised
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in mindfulness as measured by the Southampton Mindfulness Questionnaire
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in problem solving as measured by Social Problem Solving Inventory - Revised
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in attentional control as measured by the Random Interval Generation Task
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in attentional control as measured by the N-back task
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in worry frequency as measured by daily worry diaries
timeFrame: Worry measures completed daily during two week intervention period
measure: Change in meta cognitive beliefs about worry as measured by the Metacognitions Questionnaire-30
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in attentional control over worry as measured by the Breathing Focus Task
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in symptoms of depression as measured by the Depression, Anxiety, and Stress Scales - 21
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in symptoms of anxiety as measured by the Depression, Anxiety, and Stress Scales - 21
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in symptoms of insomnia as measured by the Insomnia Severity Index
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in health complaints as measured by the Subjective Health Complaints Questionnaire
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
measure: Change in rumination as measured by the Ruminative Response Scales
timeFrame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Kathleen Tallon, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borkovec TD, Wilkinson L, Folensbee R, Lerman C. Stimulus control applications to the treatment of worry. Behav Res Ther. 1983;21(3):247-51. doi: 10.1016/0005-7967(83)90206-1. No abstract available.
citation: Brosschot JF, Van Der Doef M. Daily worrying and somatic health complaints: Testing the effectiveness of a simple worry reduction intervention. Psychol Health. 2006; 21: 19-31. doi:10.1080/14768320500105346
citation: McGowan SK, Behar E. A preliminary investigation of stimulus control training for worry: effects on anxiety and insomnia. Behav Modif. 2013 Jan;37(1):90-112. doi: 10.1177/0145445512455661. Epub 2012 Sep 12.
citation: Newman MG, Borkovec TD. Cognitive behavioral therapy for worry and generalized anxiety disorder. In: Simos G, editor. Cognitive behaviour therapy: A guide for the practising clinician. New York; Taylor & Francis; 2002. P 150-172.