- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566691
Strategies for Coping With Negative Thoughts
January 6, 2023 updated by: Ohio State University
The primary objective of this study is to assess the impact of two strategies for coping with negative automatic thoughts (positive thinking and cognitive restructuring) on one's belief in negative thoughts and one's affect.
Another main objective is to assess whether participating in a positive mood induction (versus no mood induction) prior to using one of the two coping strategies impacts belief in negative thoughts and affect.
We will also explore the interaction between strategy condition and mood induction condition.
As secondary outcomes, we will evaluate whether there are changes in positive thinking skills and cognitive restructuring skills and depressive symptoms after one week of using the strategy.
Study Overview
Status
Completed
Conditions
Detailed Description
Participants will be randomized to learn about positive thinking or cognitive restructuring, which will involve watching brief videos, being presented with examples of how one might apply the strategy when experiencing negative thoughts, and practicing with a personal example using a worksheet.
Participants will also be randomized to positive mood induction, which is comprised of an autobiographical recall exercise in which participants are asked to recall a pleasant memory before filling out the worksheet.
Participants will be asked to use the strategy and complete a worksheet online once per day for six days.
Participants will respond to questionnaires at baseline and after 6 days of strategy use.
Study Type
Interventional
Enrollment (Actual)
301
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years old or older.
Exclusion Criteria:
- A level of visual impairment that would prevent them from being able to answer questions on an electronic screen.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Positive thinking
Videos will describe negative automatic thoughts and then describe positive thinking, its benefits, and how to use it to cope with negative thoughts.
A worksheet will then walk participants through applying the strategy to a recent negative thought of their own.
Daily surveys will involve a shortened version of this worksheet.
|
Participants will be provided with information about how to cope with negative thoughts using positive thinking and asked to complete a worksheet walking them through the steps of positively reevaluating negative thoughts.
|
Active Comparator: Positive thinking plus mood induction
The same videos will be used to describe negative automatic thoughts and then describe positive thinking, its benefits, and how to use it to cope with negative thoughts.
Participants will then undergo a positive mood induction in which they are asked to recall a pleasant memory and try to re-experience those feelings.
A worksheet will then walk participants through applying the strategy to a recent negative thought of their own.
Daily surveys will involve the same mood induction and a shortened version of this worksheet.
|
Participants will be provided with information about how to cope with negative thoughts using positive thinking and asked to complete a worksheet walking them through the steps of positively reevaluating negative thoughts.
They will be assigned to a positive mood induction before completion of the worksheet.
|
Active Comparator: Thought reevaluation
Videos will describe negative automatic thoughts and then describe reevaluating thoughts, its benefits, and how to use it to cope with negative thoughts.
A worksheet will then walk participants through applying the strategy to a recent negative thought of their own.
Daily surveys will involve a shortened version of this worksheet.
|
Participants will be provided with information about how to cope with negative thoughts using thought reevaluation and asked to complete a worksheet walking them through the steps of reevaluating negative thoughts.
|
Active Comparator: Thought reevaluation plus mood induction
The same videos will be used to describe negative automatic thoughts and then describe reevaluating thoughts, its benefits, and how to use it to cope with negative thoughts.
Participants will then undergo a positive mood induction in which they are asked to recall a pleasant memory and try to re-experience those feelings.
A worksheet will then walk participants through applying the strategy to a recent negative thought of their own.
Daily surveys will involve the same mood induction and a shortened version of this worksheet.
|
Participants will be provided with information about how to cope with negative thoughts using thought reevaluation and asked to complete a worksheet walking them through the steps of reevaluating negative thoughts.
They will be assigned to a positive mood induction before completion of the worksheet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Positive and Negative Affect Schedule
Time Frame: Assessed at baseline, each day for 6 days, and one week post-baseline.
|
The PANAS is a 20-item self report scale that measures positive affect (10 items) and negative affect (10 items).
Each item is rated on a Likert scale from 1 to 5, with higher scores indicating a higher endorsement of each affective descriptor.
|
Assessed at baseline, each day for 6 days, and one week post-baseline.
|
Change in belief in negative thought
Time Frame: Assessed at baseline, each day for 6 days, and one week post-baseline.
|
Participants will be asked how much they believed in a negative thought (0-100%) they recently experienced before completing a worksheet.
After using a positive thinking or cognitive restructuring worksheet, participants will rate how much they currently believe their initial negative thought.
|
Assessed at baseline, each day for 6 days, and one week post-baseline.
|
Change in mood
Time Frame: Assessed at baseline, each day for 6 days, and one week post-baseline.
|
Participants will be asked to rate their mood on a scale of 0 (very negative) to 100 (very positive) before and after the positive mood induction.
|
Assessed at baseline, each day for 6 days, and one week post-baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in positive thinking and cognitive restructuring skills
Time Frame: Assessed at baseline and one week post-baseline.
|
Cognitive restructuring skills will be assessed by the Competencies of Cognitive Therapy Scale-10, which is a 10-item self-report measure assessing the use of cognitive strategies to cope with negative mood.
Positive thinking skills will be measured by the 10-item Positive Thinking Skills Scale, which assesses the use of positive thinking strategies to cope with negative mood.
|
Assessed at baseline and one week post-baseline.
|
Change in Quick Inventory of Depressive Symptoms Self-Report
Time Frame: Assessed at baseline and one week post-baseline.
|
The QIDS-SR is a 16-item self-report measure of depressive symptoms.
Scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
|
Assessed at baseline and one week post-baseline.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2022
Primary Completion (Actual)
December 2, 2022
Study Completion (Actual)
December 2, 2022
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Estimate)
January 9, 2023
Last Update Submitted That Met QC Criteria
January 6, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022B0242
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Consciousness and Healing InitiativeNot yet recruitingAnxiety | Anxiety State | Mental Health Issue | Anxiety Generalized
-
University of MichiganBrain & Behavior Research FoundationRecruitingGeneralized Anxiety Disorder | Anxiety | Social Anxiety Disorder | Panic DisorderUnited States
Clinical Trials on Positive thinking
-
University of Kansas Medical CenterNational Institute on Aging (NIA)RecruitingAging | Exercise TrainingUnited States
-
Southern Methodist UniversityNational Cancer Institute (NCI); University of Kansas Medical Center; University...RecruitingPhysical InactivityUnited States
-
International Centre for Diarrhoeal Disease Research...Institute of Child Health; Bangor UniversityCompletedMaternal Depressive Symptom and Child Development
-
Virginia Polytechnic Institute and State UniversityNational Institute of Nursing Research (NINR); Carilion Clinic; University at...CompletedType 2 DiabetesUnited States
-
University of VermontNot yet recruitingTobacco Smoking
-
State University of New York at BuffaloEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Virginia Polytechnic Institute and State UniversityCarilion Clinic; University at BuffaloRecruitingType 2 Diabetes | Overweight and ObesityUnited States
-
Henry Ford Health SystemMichigan State University; University of Kansas; University of Maryland, College...Recruiting
-
Henry Ford Health SystemUniversity of Kansas; University of Maryland, College ParkEnrolling by invitation
-
Virginia Polytechnic Institute and State UniversityCarilion ClinicCompletedHormone Receptor Positive Malignant Neoplasm of BreastUnited States