NCT05566691

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2022

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

September 2, 2022

Last Update Submit

January 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (2)

  • Change in positive thinking and cognitive restructuring skills

    Assessed at baseline and one week post-baseline.

  • Change in Quick Inventory of Depressive Symptoms Self-Report

    Assessed at baseline and one week post-baseline.

Study Arms (4)

Positive thinking

ACTIVE COMPARATOR

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

Positive thinking plus mood induction

ACTIVE COMPARATOR

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

Thought reevaluation

ACTIVE COMPARATOR

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

Thought reevaluation plus mood induction

ACTIVE COMPARATOR

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

Interventions

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

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.

Positive thinking plus 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.

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. They will be assigned to a positive mood induction before completion of the worksheet.

Thought reevaluation plus mood induction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older.

You may not qualify if:

  • A level of visual impairment that would prevent them from being able to answer questions on an electronic screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

October 4, 2022

Study Start

August 29, 2022

Primary Completion

December 2, 2022

Study Completion

December 2, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations