Action Tendencies and Prognosis in Major Depressive Disorder

NCT04593537 | Completed

• 1 other identifier: VR_depression_study
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Predicting the prognosis and treatment responses in individuals with major depressive disorder (MDD) is currently based on trial and error, because some treatments work for some individuals, but not others. Novel predictors of prognosis and treatment response in MDD can add value to the development of targeted treatments and the stratified approaches to improve long-term outcomes of individuals with MDD. This study uses a novel virtual-reality-based measure of blame-related action tendencies and combines this with established predictors of treatment response and prognosis in individuals with MDD.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Self-rated Quick Inventory of Depressive Symptomatology -16

  Depressive symptoms assessed by the self-rated Quick Inventory of Depressive Symptomatology sum score. The score ranges from 0 to 27, with a higher score indicating more severe depressive symptoms.

  Four months

Secondary Outcomes (2)

• General Anxiety Disorder-7

  Four months

• Maudsley-Modified Patient Health Questionniare -9

  Four months

Study Arms (2)

MDD group

Participants with current major depressive disorder (MDD)

Other: No intervention

Control group

Participants without a family and personal history of a mood disorder, schizophrenia or substance/alcohol abuse but other disorders often co-morbid with MDD are allowed such as anxiety disorders

Other: No intervention

Interventions

No intervention OTHER

This is an observational study, no intervention is involved

Control group; MDD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified via online advertisements on Facebook, Google, Twitter, Instagram, self-help web groups, as well as by the IoPPN recruitment circular. Some of participants may also take part in other studies carried out by the same research team (Antidepressant Advisor studies 2 and 3) which recruit patients via online advertisements.

You may qualify if:

• Age≥18
• At least moderately severe major depressive syndrome on PHQ-9 (score≥15) at pre-screening despite having tried a serotonergic antidepressant medication
• Resident in the UK
• Able to complete self-report scales orally or in writing.
• Age≥18
• PHQ scores \< 10 at pre-screening
• Resident in the UK
• Able to complete self-report scales orally or in writing

You may not qualify if:

• Inability to consent to the study
• Unstable medical condition
• Currently being treated by mental health specialist
• Past diagnosis or family history of schizophrenia or schizo-affective disorder
• Current or family history of psychotic symptoms or bipolar disorder.
• Drug or alcohol abuse over the last 6 months, suspected central neurological condition (e.g. dementia, stroke)
• (planned)Pregnancy
• Breastfeeding or within 6 months of giving birth
• Inability to consent to the study
• Past history of MDD
• First-degree family history of MDD
• Unstable medical condition
• Currently being treated by mental health specialist
• Past diagnosis or family history of schizophrenia or schizo-affective disorder
• Current or family history of psychotic symptoms or bipolar disorder.

Sponsors & Collaborators

• King's College London: lead
• Scients Institute, USA: collaborator

Study Sites (1)

King's College London, IoPPN

London, SE5 8AF, United Kingdom

Location

Related Publications (8)

• Abramson LY, Seligman ME, Teasdale JD. Learned helplessness in humans: critique and reformulation. J Abnorm Psychol. 1978 Feb;87(1):49-74. No abstract available.

  PMID: 649856 BACKGROUND

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• Chekroud AM, Zotti RJ, Shehzad Z, Gueorguieva R, Johnson MK, Trivedi MH, Cannon TD, Krystal JH, Corlett PR. Cross-trial prediction of treatment outcome in depression: a machine learning approach. Lancet Psychiatry. 2016 Mar;3(3):243-50. doi: 10.1016/S2215-0366(15)00471-X. Epub 2016 Jan 21.

  PMID: 26803397 BACKGROUND

• Green S, Lambon Ralph MA, Moll J, Deakin JF, Zahn R. Guilt-selective functional disconnection of anterior temporal and subgenual cortices in major depressive disorder. Arch Gen Psychiatry. 2012 Oct;69(10):1014-21. doi: 10.1001/archgenpsychiatry.2012.135.

  PMID: 22638494 BACKGROUND

• Green S, Moll J, Deakin JF, Hulleman J, Zahn R. Proneness to decreased negative emotions in major depressive disorder when blaming others rather than oneself. Psychopathology. 2013;46(1):34-44. doi: 10.1159/000338632. Epub 2012 Aug 7.

  PMID: 22890331 BACKGROUND

• Pulcu E, Zahn R, Elliott R. The role of self-blaming moral emotions in major depression and their impact on social-economical decision making. Front Psychol. 2013 Jun 3;4:310. doi: 10.3389/fpsyg.2013.00310. eCollection 2013.

  PMID: 23750148 BACKGROUND

• Tangney JP, Stuewig J, Mashek DJ. Moral emotions and moral behavior. Annu Rev Psychol. 2007;58:345-72. doi: 10.1146/annurev.psych.56.091103.070145.

  PMID: 16953797 BACKGROUND

• Zahn R, Lythe KE, Gethin JA, Green S, Deakin JF, Workman C, Moll J. Negative emotions towards others are diminished in remitted major depression. Eur Psychiatry. 2015 Jun;30(4):448-53. doi: 10.1016/j.eurpsy.2015.02.005. Epub 2015 Mar 6.

  PMID: 25752724 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 28, 2022

Record last verified: 2020-09

Locations

GB (1)