Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder

NCT02806271 | Completed

• 1 other identifier: 2016 - 143
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Worry Postponement; Stimulus Control

Outcome Measures

Primary Outcomes (1)

• Change in worry as measures by the Penn State Worry Questionnaire - Past Week

  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 (14)

• Change in mindfulness the Cognitive and Affective Mindfulness Scale-Revised

  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)

• Change in mindfulness as measured by the Southampton Mindfulness Questionnaire

  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)

• Change in problem solving as measured by Social Problem Solving Inventory - Revised

  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)

• Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire

  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)

• Change in attentional control as measured by the Random Interval Generation Task

  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)

Study Arms (3)

Worry Postponement

EXPERIMENTAL

Two weeks of daily worry postponement

Behavioral: Worry Postponement; Behavioral: Worry Monitoring

Worry Monitoring

ACTIVE COMPARATOR

Two weeks of daily worry monitoring

Behavioral: Worry Monitoring

Assessment Only Control

NO INTERVENTION

No intervention, participants will complete three assessment time points

Interventions

Worry Postponement BEHAVIORAL

In worry postponement, participants are instructed to learn to notice naturally occurring episodes of worry. When they notice they are worrying they are instructed to disengage from their worry and postpone it to a designated 30 minute "worry period" to be carried out at the same time and place daily during the two week intervention. Participants are to use their worry time to worry about problems that have come up during the day and to problem solve where appropriate.

Also known as: Stimulus Control for Worry

Worry Postponement

Worry Monitoring BEHAVIORAL

For two weeks participants are instructed to monitor their worry using a smartphone based application. Participants are instructed to make a record each time they have a worry episode by briefly describing the content of their worry. Participants also complete two brief daily questionnaires about the duration of their worry, the intensity of their worry, their ability to disengage from their worry, and the occurrence of nighttime episodes of worry.

Worry Monitoring; Worry Postponement

Eligibility Criteria

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

You may qualify if:

• 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
• If a comorbid diagnosis is present, its associated CSR is at least 1 point lower than that of their GAD diagnosis.

You may not qualify if:

• 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
• Report clinically significant suicidal ideation, intent, or plan
• 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
• 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.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (4)

• 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.

  PMID: 6615390 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22977265 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Lab website

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Kathleen Tallon, MA

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 20, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)