Depressive SymptomsNCT05566691
Strategies for Coping With Negative Thoughts
A study testing Positive thinking, Positive thinking + Mood induction and Thought reevaluation in people with Depressive Symptoms and Anxiety, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Negative Thinking
- What is being tested?
- Positive thinking, Positive thinking + Mood induction and Thought reevaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older.
Who cannot join
- A level of visual impairment that would prevent them from being able to answer questions on an electronic screen.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depressive Symptoms, Anxiety, Negative Thinking
- Being tested
- Positive thinking, Positive thinking + Mood induction, Thought reevaluation, Thought reevaluation + Mood induction
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive thinkingOther
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 inductionOther
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 reevaluationOther
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 inductionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Thought reevaluation + Mood induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline, each day for 6 days, and one week post-baseline.
Secondary outcomes (2)
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.
Measured: Assessed at baseline and one week post-baseline.
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.
Measured: Assessed at baseline and one week post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start29 Aug 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566691
- Sponsor's protocol ID
- 2022B0242
- Status last verified
- Jan 2023
- First submitted
- 2 Sep 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Coping With Negative Thoughts
- ClinicalTrials.gov ID
- NCT05566691
- Acronym / sponsor ID
- 2022B0242
- Conditions
- Depressive Symptoms, Anxiety, Negative Thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive thinking | Active comparator | Other: Positive thinkingVideos 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. |
| Positive thinking plus mood induction | Active comparator | Other: Positive thinking + Mood inductionThe 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. |
| Thought reevaluation | Active comparator | Other: Thought reevaluationVideos 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. |
| Thought reevaluation plus mood induction | Active comparator | Other: Thought reevaluation + Mood inductionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old or older.
Key exclusion criteria (1 listed)
- A level of visual impairment that would prevent them from being able to answer questions on an electronic screen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive thinkingParticipants 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. | Other | Positive thinking |
| Positive thinking + Mood inductionParticipants 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. | Other | Positive thinking plus mood induction |
| Thought reevaluationParticipants 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. | Other | Thought reevaluation |
| Thought reevaluation + Mood inductionParticipants 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. | Other | Thought reevaluation plus mood induction |
Primary outcome
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.
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.
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.
2 secondary outcomes
Change in positive thinking and cognitive restructuring skills
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive thinking, Positive thinking + Mood induction and Thought reevaluation in people with Depressive Symptoms and Anxiety, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Affect Schedule (time frame: Assessed at baseline, each day for 6 days, and one week post-baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.