DepressionNCT05800119
An Intervention to Correct Dualistic Reasoning About the Effectiveness of Psychotherapy for Biologically Caused Mental Disorders
A study testing Brain-level condition and Mind-level condition in people with Depression, run by Yale University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test in three samples, including sample 1: lay people without reported depression symptoms, sample 2: lay people with reported depression symptoms and sample 3: mental health clinicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Brain-level condition and Mind-level condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,243 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 2 Apr 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
- Participation was open to individuals in the US
- For sample 1, lay people without reported depression symptoms, there was no specific inclusion criteria
- For sample 2, lay people with reported depression symptoms, participants were included if they indicated via Amazon Mechanical Turk Toolkit that they experienced symptoms of depression
- For sample 3, mental health clinicians, participants were included if they indicated that they were a practicing mental health clinician in the United States
Who cannot join
- For lay people without reported depression symptoms, the only exclusion criteria was age (i.e., no participants under 18 years of age)
- For lay people with reported depression symptoms, participants were excluded if they scored < 14 on the Beck Depression Inventory-II (BDI-II), indicating no depression symptoms
- For mental health clinicians, participants were excluded if they indicated that they were not currently licensed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exemption: Perception of Mental Disorders
The goal of this clinical trial is to test in three samples, including sample 1: lay people without reported depression symptoms, sample 2: lay people with reported depression symptoms and sample 3: mental health clinicians. The main questions it aims to answer are: 1) do each of these populations show a bias against psychotherapy wherein they judge psychotherapy to be less effective, relative to baseline ratings, when a mental illness (i.e., depression) is attributed to biological factors, 2) whether an intervention emphasizing the neurobiological effects of psychotherapy can remove this bias against psychotherapy for biologically-caused mental disorders, and 3) whether this intervention is more effective compared to an active control intervention that emphasizes the effectiveness of psychotherapy, but not its neurobiological effects. Participants will
- rate the effectiveness of psychotherapy for depression before and after learning about the biological causes of depression
- be assigned to one of three conditions: 1) an intervention condition where participants will receive a brief reading passage (approximately 126 words in length) providing psychoeducation about how psychotherapy changes the brain of an individual with depression, or 2) an active control condition where participants will receive a reading passage (approximately 115 words) emphasizing the effectiveness of psychotherapy, or 3) a control condition where they will receive no additional materials
- as a secondary outcome, participants will also rate the effectiveness of medication for depression, before and after learning about the biological causes of depression
Read the detailed description
Overview: Previous studies showed that biological explanations for mental disorders, which are popularizing, cause laypeople and clinicians to judge that psychotherapy is less effective. This could be clinically detrimental, as the combination of pharmacotherapy and psychotherapy is often optimal. Objective: This study tests a "de-biasing" intervention developed to counteract the flawed dualistic belief that activities perceived as occurring in the mind (e.g., psychotherapy) do not necessarily affect the brain. Design, Setting, Participants: This survey was conducted between September 10, 2020 and April 2, 2022 through Qualtrics.com over laypeople with and without symptoms of depression, and licensed clinicians in the U.S. Participants were randomly assigned to either an intervention condition explaining how psychotherapy results in brain-level changes, an active control condition explaining the effectiveness of psychotherapy but not its biological mechanisms, or a control condition with no intervention. Main Outcome Measures: Participants rated the efficacy of psychotherapy for biologically caused depression before and after being assigned to one of the three conditions. It was hypothesized that the dualism intervention would increase ratings of the effectiveness of psychotherapy, even after participants learned about the biological causes of depression. It was also expected that this intervention would increase psychotherapy ratings more than the active control materials that also emphasized the effectiveness of psychotherapy.
- Conditions
- Depression
- Being tested
- Brain-level condition, Mind-level condition
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-level conditionBehavioural
Participants will receive a brief reading passage about the neurobiological effects of psychotherapy.
Mind-level conditionOther
Participants will receive an active control consisting of a brief reading passage about the effectiveness of psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Brain-level condition | Experimental | Participants assigned to this condition received a brief reading passage (126 words) that provided psychoeducation about how psychotherapy can change the brain of those with depression, and specifically how psychotherapy can change the functioning of the prefrontal cortex and the amygdala, and affect neurotransmitters. Receives: Behavioral: Brain-level condition |
| Mind-level condition | Active comparator | Participants assigned to this condition received a brief reading passage (115 words) that provided psychoeducation about the effectiveness of psychotherapy for depression, and specifically how psychotherapy can improve maladaptive thought processes and teach people with depression how to regulate negative emotions. Receives: Other: Mind-level condition |
| Control condition | No intervention | Participants assigned to this condition received no additional materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beliefs about the effectiveness of psychotherapy from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test
This outcome is measured with two questions, both on a 1-7 rating scale. The questions measure participants' beliefs about the effectiveness of psychotherapy. These two questions were asked on an online survey where participants completed the questions at pretest (before participants learned about the biological causes of depression, and were assigned to one of the three conditions) and at post-test. The questions were as follows: 1) "how effective would psychotherapy treatment be at addressing what might be the causes of depression? From 1 "not at all effective" to 7 "extremely effective" and 2) "how likely is it that symptoms will improve with psychotherapy treatment? From 1 "no improvement" to 7 "full recovery with no remaining symptoms." These questions were averaged to create a composite pretest and post-test psychotherapy effectiveness score. The change in mean scores from pretest to post-test will be the outcome of interest.
Measured: Pretest and post-test, both measures completed during an approximately 10-minute survey
Secondary outcomes (1)
Change in beliefs about the effectiveness of medication from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test
This outcome is measured with two questions, both on a 1-7 rating scale. The questions measure participants' beliefs about the effectiveness of medication. These two questions were asked on an online survey where participants completed the questions at pretest (before participants learned about the biological causes of depression, and were assigned to one of the three conditions) and at post-test. The questions were as follows: 1) "how effective would medication treatment be at addressing what might be the causes of depression? From 1 "not at all effective" to 7 "extremely effective" and 2) "how likely is it that symptoms will improve with medication treatment? From 1 "no improvement" to 7 "full recovery with no remaining symptoms." These questions were averaged to create a composite pretest and post-test medication effectiveness score. The change in mean scores from pretest to post-test will be the secondary outcome of interest.
Measured: Pretest and post-test, both measures completed during an approximately 10-minute survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start18 Sep 2020
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800119
- Sponsor's protocol ID
- 2000025071
- Other IDs
- 2000029423
- Status last verified
- May 2023
- First submitted
- 22 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exemption: Perception of Mental Disorders
- ClinicalTrials.gov ID
- NCT05800119
- Acronym / sponsor ID
- 2000025071
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,243 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 5 Apr 2023 (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 goal of this clinical trial is to test in three samples, including sample 1: lay people without reported depression symptoms, sample 2: lay people with reported depression symptoms and sample 3: mental health clinicians. The main questions it aims to answer are: 1) do each of these populations show a bias against psychotherapy wherein they judge psychotherapy to be less effective, relative to baseline ratings, when a mental illness (i.e., depression) is attributed to biological factors, 2) whether an intervention emphasizing the neurobiological effects of psychotherapy can remove this bias against psychotherapy for biologically-caused mental disorders, and 3) whether this intervention is more effective compared to an active control intervention that emphasizes the effectiveness of psychotherapy, but not its neurobiological effects. Participants will
- rate the effectiveness of psychotherapy for depression before and after learning about the biological causes of depression
- be assigned to one of three conditions: 1) an intervention condition where participants will receive a brief reading passage (approximately 126 words in length) providing psychoeducation about how psychotherapy changes the brain of an individual with depression, or 2) an active control condition where participants will receive a reading passage (approximately 115 words) emphasizing the effectiveness of psychotherapy, or 3) a control condition where they will receive no additional materials
- as a secondary outcome, participants will also rate the effectiveness of medication for depression, before and after learning about the biological causes of depression
Detailed description
Overview: Previous studies showed that biological explanations for mental disorders, which are popularizing, cause laypeople and clinicians to judge that psychotherapy is less effective. This could be clinically detrimental, as the combination of pharmacotherapy and psychotherapy is often optimal. Objective: This study tests a "de-biasing" intervention developed to counteract the flawed dualistic belief that activities perceived as occurring in the mind (e.g., psychotherapy) do not necessarily affect the brain. Design, Setting, Participants: This survey was conducted between September 10, 2020 and April 2, 2022 through Qualtrics.com over laypeople with and without symptoms of depression, and licensed clinicians in the U.S. Participants were randomly assigned to either an intervention condition explaining how psychotherapy results in brain-level changes, an active control condition explaining the effectiveness of psychotherapy but not its biological mechanisms, or a control condition with no intervention. Main Outcome Measures: Participants rated the efficacy of psychotherapy for biologically caused depression before and after being assigned to one of the three conditions. It was hypothesized that the dualism intervention would increase ratings of the effectiveness of psychotherapy, even after participants learned about the biological causes of depression. It was also expected that this intervention would increase psychotherapy ratings more than the active control materials that also emphasized the effectiveness of psychotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain-level condition | Experimental | Behavioral: Brain-level conditionParticipants assigned to this condition received a brief reading passage (126 words) that provided psychoeducation about how psychotherapy can change the brain of those with depression, and specifically how psychotherapy can change the functioning of the prefrontal cortex and the amygdala, and affect neurotransmitters. |
| Mind-level condition | Active comparator | Other: Mind-level conditionParticipants assigned to this condition received a brief reading passage (115 words) that provided psychoeducation about the effectiveness of psychotherapy for depression, and specifically how psychotherapy can improve maladaptive thought processes and teach people with depression how to regulate negative emotions. |
| Control condition | No intervention | –Participants assigned to this condition received no additional materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participation was open to individuals in the US
- For sample 1, lay people without reported depression symptoms, there was no specific inclusion criteria
- For sample 2, lay people with reported depression symptoms, participants were included if they indicated via Amazon Mechanical Turk Toolkit that they experienced symptoms of depression
- For sample 3, mental health clinicians, participants were included if they indicated that they were a practicing mental health clinician in the United States
Key exclusion criteria (3 listed)
- For lay people without reported depression symptoms, the only exclusion criteria was age (i.e., no participants under 18 years of age)
- For lay people with reported depression symptoms, participants were excluded if they scored < 14 on the Beck Depression Inventory-II (BDI-II), indicating no depression symptoms
- For mental health clinicians, participants were excluded if they indicated that they were not currently licensed
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 |
|---|---|---|
| Brain-level conditionParticipants will receive a brief reading passage about the neurobiological effects of psychotherapy. | Behavioural | Brain-level condition |
| Mind-level conditionParticipants will receive an active control consisting of a brief reading passage about the effectiveness of psychotherapy. | Other | Mind-level condition |
Primary outcome
Change in beliefs about the effectiveness of psychotherapy from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test
Time frame: Pretest and post-test, both measures completed during an approximately 10-minute survey
This outcome is measured with two questions, both on a 1-7 rating scale. The questions measure participants' beliefs about the effectiveness of psychotherapy. These two questions were asked on an online survey where participants completed the questions at pretest (before participants learned about the biological causes of depression, and were assigned to one of the three conditions) and at post-test. The questions were as follows: 1) "how effective would psychotherapy treatment be at addressing what might be the causes of depression? From 1 "not at all effective" to 7 "extremely effective" and 2) "how likely is it that symptoms will improve with psychotherapy treatment? From 1 "no improvement" to 7 "full recovery with no remaining symptoms." These questions were averaged to create a composite pretest and post-test psychotherapy effectiveness score. The change in mean scores from pretest to post-test will be the outcome of interest.
1 secondary outcome
Change in beliefs about the effectiveness of medication from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test
Time frame: Pretest and post-test, both measures completed during an approximately 10-minute survey
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 6 May 2023.
- Individual participant dataSharing planned: No
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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 Brain-level condition and Mind-level condition in people with Depression, run by Yale 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 4 inclusion and 3 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 6 May 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 beliefs about the effectiveness of psychotherapy from baseline to after learning about the biological causes of depression, as measured by two survey questions taken at pretest and at post-test (time frame: Pretest and post-test, both measures completed during an approximately 10-minute survey). 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 6 May 2023.