Strategies for Coping With Negative Thoughts

Anxiety Clinical Trial

Official title:

Strategies for Coping With Negative Thoughts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566691
• Other study ID #: 2022B0242
• Status: Completed
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: December 2, 2022

Study information

• Verified date: January 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Positive and Negative Affect Schedule	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.
Primary	Change in belief in negative thought	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.
Primary	Change in mood	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	Change in positive thinking and cognitive restructuring skills	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.
Secondary	Change in Quick Inventory of Depressive Symptoms Self-Report	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.