DepressionNCT03987477
Online Intervention to Modify Interpretation Biases in Depression
A study testing Interpretation bias modification program and Waiting list in people with Depression and Cognitive Change, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Cognitive biases have been found to be possible causal and vulnerability factors for depression. There is empirical evidence on the presence of negative emotional biases in interpretation in people with depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Cognitive Change
- What is being tested?
- Interpretation bias modification program and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2019to 1 Mar 2021
- 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
- Present (PHQ-9) or past (DID) episode of depression.
- Access to Internet
- Fluent in Spanish language
Who cannot join
- Being under any psychological treatment
- Having a psychotic condition
- Having any cognitive impairment or condition that do not allow to follow the program
- Serious auditory or visual impairments
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Psychology, Complutense University of Madrid
Madrid, 28223
About this study
Official title: Brief Online Intervention to Modify Interpretation Biases in Depression: An Experimental Approach
Cognitive biases have been found to be possible causal and vulnerability factors for depression. There is empirical evidence on the presence of negative emotional biases in interpretation in people with depressive symptoms. A whole new area of research, called Cognitive Bias Modification (CBM), is focused on targeting negative cognitive emotional biases to investigate its impact on clinical symptoms. A recent meta-analysis has shown that this type of programs are effective in reducing cognitive biases but there is still controversy on their clinical value to reduce symptoms. The purpose of the study is to create a brief online intervention aimed to reduce negative emotional cognitive biases present in depression and to analyze its impact on clinical symptoms and well-being.
Read the detailed description
More specifically, the intervention is framed within the area of CBM but it is rooted on techniques and change procedures used in cognitive-behavioral therapies. While original CBM studies train participants to change cognitive biases in an automatic manner, by forcing individuals to find positive outcomes to ambiguous scenarios, this new intervention focuses on teaching participants the meaning of emotional cognitive biases and how to modify them by using an effortful type of processing (i.e., looking for adaptive alternative interpretations to ambiguous stories).
The study has been design to overcome some of the limitations that have been pointed out in this emerging research area. Firstly, although there are recent efforts to understand how interpretation, attention and memory cognitive biases may be related, it is still not clear how they interact with each other. For this purpose, some authors have pointed out the need to use longitudinal data to see how one process may affect each other over time. Secondly, different systematic reviews and meta-analyses have investigated the moderating role of variables that may be affecting the heterogeneity of results found in CBM interventions. Mental imagery has been found to be a useful tool to help participants in their changing process, while there is no preferred number of sessions for these interventions. This study will help shed some light into this factors by using mental imagery during four sessions online.
- Conditions
- Depression, Cognitive Change
- Being tested
- Interpretation bias modification program, Waiting list
- Keywords
- Cognitive Biases, Cognitive Bias Modification, Depression, Online intervention, Cognitive Bias Interpretation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation bias modification programBehavioural
Also called Cognitive bias modification, Online cognitive bias intervention, Online interpretation bias intervention
Brief online program aimed at the modification of negative interpretation biases.
Waiting listBehavioural
Waiting list procedure for the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will be exposed to a brief online program aimed at the modification of negative emotional cognitive biases. The program consists of an introduction and four 1-hour sessions, in video format. In each session, participants are required to complete some open questions and scales about the type of cognitive bias addressed in each session. All sessions are structured in four parts: 1) description and examples of some specific cognitive biases; 2) information about negative consequences of each bias; 3) explanation of adaptive strategies to modify cognitive biases (i.e., the four-questions approach used in standard Cognitive behavioral therapy); and 4) use of some practices to familiarize participants with the use of those strategies. Receives: Behavioral: Interpretation bias modification program |
| Waiting list group | Other | The control group will be composed of individuals waiting for the treatment. Participants will not be exposed to the experimental program or any other between the pre-evaluation and the post-evaluation sessions. Participants in this group will have access to the potential benefits of the intervention after the post-evaluation of both groups. Receives: Behavioral: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of pleasantness ratings given to the ambiguous scenarios presented in the Ambiguous Scenarios Test for Depression-II, (AST-D-II) to measure interpretation bias.
Participants are asked to rate how pleasant they perceive 15 ambiguous scenarios in a scale from -5 (very unpleasant) to 5 (very pleasant).
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).
Total score of each of the three subscales of the Depression, Anxiety and Stress Scale-21 (DASS) questionnaire.
Three subscales, with 7 items each, measuring symptoms of depression, anxiety and stress. Scores multiplied by 2 and summed up for each scale.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).
Total score on general, eudaimonic, hedonic, and social well-being as measured by the Pemberton Happiness Index (PHI)
Scale of 11 items measuring emotional well-being at different levels.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).
Secondary outcomes (6)
Ratio of the number of negative unscrambled sentences by the number of emotional unscrambled sentences in the Scrambled Sentence Test (SST) with cognitive load.
The task presents 20 scrambled sentences with 6 words each. Participants are asked to construct a sentence using 5 of the 6 words. In addition, participants are shown a number, at the beginning of the task, to report it at the end (cognitive load). The resulting ratio of correctly negative unscrambled sentences between correctly emotional unscrambled sentences is an index of automatic interpretation bias.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Proportion of time fixating the mouse cursor on negative over positive words to uncover them during the SST.
During the SST, words are covered so that participants can only see them when placing the mouse cursor over them. The time spent on negative words is a measure of negative attention bias.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Ratio of recalled negative unscrambled sentences and recalled emotional unscrambled sentences during the SST.
Participants are asked to remember, during 5 minutes, the sentences they construct during the SST. The ratio of negative and emotional unscrambled sentences that participants recall is a measure of memory bias.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Number of items viewed before reaching a decision in the Computerized Beads Task.
The task presents two jars with beads containing positive or negative adjectives. Each jar has a different ratio of positive and negative words. Participants are told that one of the jars is going to be selected and one bead is going to be taken out and returned to it in each trial. Participants have to decide which jar is being used based on the number of positive and negative adjectives that are taken in each trial. The number of beads viewed before reaching a decision is an index of jumping to conclusion bias.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Total score on the Dysfunctional Attitudes Scale (DAS)
Scale of 40 sentences which participants have to rate from 1 (totally agree) to 7 (totally disagree). The sum of the scores given to each sentence is an index of dysfunctional cognitive schemas.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Total score on the Brooding subscale of the Ruminative Responses Scale (RRS)
Subscale of 5 items which participants have to rate from 1 (totally disagree) to 5 (totally agree). The total score, ranging from 5 to 25, is an index of brooding.
Measured: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start30 Sep 2019
- Primary completion30 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmelo Vázquez, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987477
- Sponsor's protocol ID
- CT17/17-CT18/17 UCM
- Status last verified
- Apr 2022
- First submitted
- 7 Jun 2019
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The authors have not decided yet on IPD sharing.
Publications
Becker, E. S., & Vrijsen, J. N. Cognitive processes in CBT. In The science of cognitive behavioral therapy (pp. 77-106). Academic Press, 2017
Everaert J, Koster EH, Derakshan N. The combined cognitive bias hypothesis in depression. Clin Psychol Rev. 2012 Jul;32(5):413-24. doi: 10.1016/j.cpr.2012.04.003. Epub 2012 Apr 21.
PubMed 22681914Gotlib IH, Joormann J. Cognition and depression: current status and future directions. Annu Rev Clin Psychol. 2010;6:285-312. doi: 10.1146/annurev.clinpsy.121208.131305.
PubMed 20192795Jones EB, Sharpe L. Cognitive bias modification: A review of meta-analyses. J Affect Disord. 2017 Dec 1;223:175-183. doi: 10.1016/j.jad.2017.07.034. Epub 2017 Jul 18.
PubMed 28759865Sanchez, A., Duque, A., Romero, N., & Vazquez, C. Disentangling the interplay among cognitive biases: Evidence of combined effects of attention, interpretation and autobiographical memory in depression. Cognitive Therapy and Research 41(6): 829-841, 2017.
Everaert J, Duyck W, Koster EH. Attention, interpretation, and memory biases in subclinical depression: a proof-of-principle test of the combined cognitive biases hypothesis. Emotion. 2014 Apr;14(2):331-40. doi: 10.1037/a0035250. Epub 2014 Feb 10.
PubMed 24512247Duque, A., López-Gómez, I., Blanco, I., & Vázquez, C. Modificación de Sesgos Cognitivos (MSC) en depresión: Una revisión crítica de nuevos procedimientos para el cambio de sesgos cognitivos. Terapia Psicológica 33(2): 103-116, 2015
Menne-Lothmann C, Viechtbauer W, Hohn P, Kasanova Z, Haller SP, Drukker M, van Os J, Wichers M, Lau JY. How to boost positive interpretations? A meta-analysis of the effectiveness of cognitive bias modification for interpretation. PLoS One. 2014 Jun 26;9(6):e100925. doi: 10.1371/journal.pone.0100925. eCollection 2014.
PubMed 24968234Cristea IA, Kok RN, Cuijpers P. Efficacy of cognitive bias modification interventions in anxiety and depression: meta-analysis. Br J Psychiatry. 2015 Jan;206(1):7-16. doi: 10.1192/bjp.bp.114.146761.
PubMed 25561486Nieto I, Vazquez C. Disentangling the mediating role of modifying interpretation bias on emotional distress using a novel cognitive bias modification program. J Anxiety Disord. 2021 Oct;83:102459. doi: 10.1016/j.janxdis.2021.102459. Epub 2021 Jul 29.
PubMed 34358756Nieto I, Vazquez C. 'Relearning how to think': A brief online intervention to modify biased interpretations in emotional disorders-study protocol for a randomised controlled trial. Trials. 2021 Jul 31;22(1):510. doi: 10.1186/s13063-021-05459-3.
PubMed 34332616
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Online Intervention to Modify Interpretation Biases in Depression: An Experimental Approach
- ClinicalTrials.gov ID
- NCT03987477
- Acronym / sponsor ID
- CT17/17-CT18/17 UCM
- Conditions
- Depression, Cognitive Change
- Keywords
- Cognitive Biases, Cognitive Bias Modification, Depression, Online intervention, Cognitive Bias Interpretation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 17 Jun 2019 (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.
Cognitive biases have been found to be possible causal and vulnerability factors for depression. There is empirical evidence on the presence of negative emotional biases in interpretation in people with depressive symptoms. A whole new area of research, called Cognitive Bias Modification (CBM), is focused on targeting negative cognitive emotional biases to investigate its impact on clinical symptoms. A recent meta-analysis has shown that this type of programs are effective in reducing cognitive biases but there is still controversy on their clinical value to reduce symptoms. The purpose of the study is to create a brief online intervention aimed to reduce negative emotional cognitive biases present in depression and to analyze its impact on clinical symptoms and well-being.
Detailed description
More specifically, the intervention is framed within the area of CBM but it is rooted on techniques and change procedures used in cognitive-behavioral therapies. While original CBM studies train participants to change cognitive biases in an automatic manner, by forcing individuals to find positive outcomes to ambiguous scenarios, this new intervention focuses on teaching participants the meaning of emotional cognitive biases and how to modify them by using an effortful type of processing (i.e., looking for adaptive alternative interpretations to ambiguous stories).
The study has been design to overcome some of the limitations that have been pointed out in this emerging research area. Firstly, although there are recent efforts to understand how interpretation, attention and memory cognitive biases may be related, it is still not clear how they interact with each other. For this purpose, some authors have pointed out the need to use longitudinal data to see how one process may affect each other over time. Secondly, different systematic reviews and meta-analyses have investigated the moderating role of variables that may be affecting the heterogeneity of results found in CBM interventions. Mental imagery has been found to be a useful tool to help participants in their changing process, while there is no preferred number of sessions for these interventions. This study will help shed some light into this factors by using mental imagery during four sessions online.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Interpretation bias modification programThe experimental group will be exposed to a brief online program aimed at the modification of negative emotional cognitive biases. The program consists of an introduction and four 1-hour sessions, in video format. In each session, participants are required to complete some open questions and scales about the type of cognitive bias addressed in each session. All sessions are structured in four parts: 1) description and examples of some specific cognitive biases; 2) information about negative consequences of each bias; 3) explanation of adaptive strategies to modify cognitive biases (i.e., the four-questions approach used in standard Cognitive behavioral therapy); and 4) use of some practices to familiarize participants with the use of those strategies. |
| Waiting list group | Other | Behavioral: Waiting listThe control group will be composed of individuals waiting for the treatment. Participants will not be exposed to the experimental program or any other between the pre-evaluation and the post-evaluation sessions. Participants in this group will have access to the potential benefits of the intervention after the post-evaluation of both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present (PHQ-9) or past (DID) episode of depression.
- Access to Internet
- Fluent in Spanish language
Key exclusion criteria (4 listed)
- Being under any psychological treatment
- Having a psychotic condition
- Having any cognitive impairment or condition that do not allow to follow the program
- Serious auditory or visual impairments
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 |
|---|---|---|
| Interpretation bias modification programAlso: Cognitive bias modification, Online cognitive bias intervention, Online interpretation bias interventionBrief online program aimed at the modification of negative interpretation biases. | Behavioural | Experimental group |
| Waiting listWaiting list procedure for the control group. | Behavioural | Waiting list group |
Primary outcome
Total score of pleasantness ratings given to the ambiguous scenarios presented in the Ambiguous Scenarios Test for Depression-II, (AST-D-II) to measure interpretation bias.
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).
Participants are asked to rate how pleasant they perceive 15 ambiguous scenarios in a scale from -5 (very unpleasant) to 5 (very pleasant).
Total score of each of the three subscales of the Depression, Anxiety and Stress Scale-21 (DASS) questionnaire.
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).
Three subscales, with 7 items each, measuring symptoms of depression, anxiety and stress. Scores multiplied by 2 and summed up for each scale.
Total score on general, eudaimonic, hedonic, and social well-being as measured by the Pemberton Happiness Index (PHI)
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).
Scale of 11 items measuring emotional well-being at different levels.
6 secondary outcomes
Ratio of the number of negative unscrambled sentences by the number of emotional unscrambled sentences in the Scrambled Sentence Test (SST) with cognitive load.
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Proportion of time fixating the mouse cursor on negative over positive words to uncover them during the SST.
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Ratio of recalled negative unscrambled sentences and recalled emotional unscrambled sentences during the SST.
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Number of items viewed before reaching a decision in the Computerized Beads Task.
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Total score on the Dysfunctional Attitudes Scale (DAS)
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
Total score on the Brooding subscale of the Ruminative Responses Scale (RRS)
Time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention).
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 2 May 2022.
- BackgroundBecker, E. S., & Vrijsen, J. N. Cognitive processes in CBT. In The science of cognitive behavioral therapy (pp. 77-106). Academic Press, 2017
- Background: PubMed 22681914Everaert J, Koster EH, Derakshan N. The combined cognitive bias hypothesis in depression. Clin Psychol Rev. 2012 Jul;32(5):413-24. doi: 10.1016/j.cpr.2012.04.003. Epub 2012 Apr 21.
- Background: PubMed 20192795Gotlib IH, Joormann J. Cognition and depression: current status and future directions. Annu Rev Clin Psychol. 2010;6:285-312. doi: 10.1146/annurev.clinpsy.121208.131305.
- Background: PubMed 28759865Jones EB, Sharpe L. Cognitive bias modification: A review of meta-analyses. J Affect Disord. 2017 Dec 1;223:175-183. doi: 10.1016/j.jad.2017.07.034. Epub 2017 Jul 18.
- BackgroundSanchez, A., Duque, A., Romero, N., & Vazquez, C. Disentangling the interplay among cognitive biases: Evidence of combined effects of attention, interpretation and autobiographical memory in depression. Cognitive Therapy and Research 41(6): 829-841, 2017.
- Background: PubMed 24512247Everaert J, Duyck W, Koster EH. Attention, interpretation, and memory biases in subclinical depression: a proof-of-principle test of the combined cognitive biases hypothesis. Emotion. 2014 Apr;14(2):331-40. doi: 10.1037/a0035250. Epub 2014 Feb 10.
- BackgroundDuque, A., López-Gómez, I., Blanco, I., & Vázquez, C. Modificación de Sesgos Cognitivos (MSC) en depresión: Una revisión crítica de nuevos procedimientos para el cambio de sesgos cognitivos. Terapia Psicológica 33(2): 103-116, 2015
- Background: PubMed 24968234Menne-Lothmann C, Viechtbauer W, Hohn P, Kasanova Z, Haller SP, Drukker M, van Os J, Wichers M, Lau JY. How to boost positive interpretations? A meta-analysis of the effectiveness of cognitive bias modification for interpretation. PLoS One. 2014 Jun 26;9(6):e100925. doi: 10.1371/journal.pone.0100925. eCollection 2014.
- Background: PubMed 25561486Cristea IA, Kok RN, Cuijpers P. Efficacy of cognitive bias modification interventions in anxiety and depression: meta-analysis. Br J Psychiatry. 2015 Jan;206(1):7-16. doi: 10.1192/bjp.bp.114.146761.
- Derived from this study: PubMed 34358756Nieto I, Vazquez C. Disentangling the mediating role of modifying interpretation bias on emotional distress using a novel cognitive bias modification program. J Anxiety Disord. 2021 Oct;83:102459. doi: 10.1016/j.janxdis.2021.102459. Epub 2021 Jul 29.
- Derived from this study: PubMed 34332616Nieto I, Vazquez C. 'Relearning how to think': A brief online intervention to modify biased interpretations in emotional disorders-study protocol for a randomised controlled trial. Trials. 2021 Jul 31;22(1):510. doi: 10.1186/s13063-021-05459-3.
- Individual participant dataSharing planned: Undecided. The authors have not decided yet on IPD sharing.
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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.
Carmelo Vázquez, PhD study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation bias modification program and Waiting list in people with Depression and Cognitive Change, run by Universidad Complutense de Madrid at 1 site in Spain.
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 3 inclusion and 4 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 2 May 2022. 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 Spain. 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?
Total score of pleasantness ratings given to the ambiguous scenarios presented in the Ambiguous Scenarios Test for Depression-II, (AST-D-II) to measure interpretation bias. (time frame: Change from the first assesment (the day before starting the intervention) to the second assessment (the day after completing the intervention) and the follow-up assessments (2 weeks and 3 months after completing the intervention).). 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?
On the ClinicalTrials.gov record for NCT03987477, which also lists 11 linked publications.
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 2 May 2022.