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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Positive thinking
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.
Other: Positive thinking + Mood induction
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.
Other: Thought reevaluation
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.
Other: Thought reevaluation + Mood induction
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings