Online Writing Intervention for Major Depressive Disorder

NCT06699719 | Completed

• 1 other identifier: 100/2018
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to examine the feasibility of administering an online writing intervention to patients diagnosed with Major Depressive Disorder, and whether this intervention impacts symptoms of depression. It also examines the impact of the intervention on symptoms of anxiety, personal functioning, and perceived problem complexity, and how participants experience the intervention. The main questions the trial aims to answer are: Will participants randomized to the online writing intervention complete at least three sessions? Is the writing intervention associated with a reduction in symptoms of depression and anxiety, perceived problem complexity, and/or an improvement in personal functioning? What are participants' perceptions of the online writing intervention, including both positive and negative experiences? Participants will: Complete four sessions of an online writing intervention or no writing intervention over the course of one week Complete questionnaires before and after the intervention, and at a one-month follow-up Complete qualitative interviews probing into their experiences with the intervention

Conditions

Major Depression; Generalized Anxiety Disorder (GAD)

Keywords

Expressive writing; Major Depression; Online intervention; Digital mental health

Outcome Measures

Primary Outcomes (2)

• Feasibility of completing EW

  Feasibility is defined as 70% of EW participants completing at least three 20-minute sessions of EW.

  Feasibility is determined immediately following the completion of the third writing session, which is at minimum after 3 days or one week, on average.

• Depressive symptoms

  Severity of depressive symptoms, as assessed via the Patient Health Questionnaire (PHQ-9); values range from 0-27 with higher scores indicating greater symptom severity (or worse outcome).

  On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups

Secondary Outcomes (3)

• Anxiety symptoms

  On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups

• Impaired functioning

  On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups

• Problem Complexity

  On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups

Study Arms (2)

Control

NO INTERVENTION

Participants are not asked to complete the online writing intervention

Expressive writing

EXPERIMENTAL

Participants are asked to complete four 20-minute sessions of an online writing task on consecutive days.

Behavioral: Expressive writing

Interventions

Expressive writing BEHAVIORAL

Participants are asked to complete four 20-minute sessions of a writing task on consecutive days, which is sent to their email address via an online link. Participants are instructed "for the next 20 minutes to please use the provided box to write their very deepest thoughts and feelings about a negative issue or personal problem that they are currently being affected by. In their writing, they are encouraged to let go and explore their emotions and thoughts regarding this issue or problem, and to not worry about spelling or grammar. They are asked to consider setting a timer or have a clock handy to make sure they write for 20 minutes." Instructions are accompanied by a text box, which allows participants to write freely for the allotted time.

Also known as: EW, online writing intervention

Expressive writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18 or older
• assessed by a psychiatrist and received a diagnosis of MDD with or without another co-morbid condition
• access to the internet and an email address

You may not qualify if:

• \- no ability to understand, speak, or write in English

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1R8, Canada

Location

Related Publications (10)

• Gratzer D, Goldbloom D. Making Evidence-Based Psychotherapy More Accessible in Canada. Can J Psychiatry. 2016 Oct;61(10):618-23. doi: 10.1177/0706743716642416. Epub 2016 Apr 5. No abstract available.

  PMID: 27310234 BACKGROUND

• Hayes AM, Feldman GC, Beevers CG, Laurenceau JP, Cardaciotto L, Lewis-Smith J. Discontinuities and cognitive changes in an exposure-based cognitive therapy for depression. J Consult Clin Psychol. 2007 Jun;75(3):409-421. doi: 10.1037/0022-006X.75.3.409.

  PMID: 17563158 BACKGROUND

• Sbarra DA, Boals A, Mason AE, Larson GM, Mehl MR. Expressive Writing Can Impede Emotional Recovery Following Marital Separation. Clin Psychol Sci. 2013 Mar 18;1(2):120-134. doi: 10.1177/2167702612469801.

  PMID: 25606351 BACKGROUND

• Kovac SH, Range LM. Does writing about suicidal thoughts and feelings reduce them? Suicide Life Threat Behav. 2002 Winter;32(4):428-40. doi: 10.1521/suli.32.4.428.22335.

  PMID: 12501967 BACKGROUND

• Sloan DM, Marx BP, Epstein EM, Lexington JM. Does altering the writing instructions influence outcome associated with written disclosure? Behav Ther. 2007 Jun;38(2):155-68. doi: 10.1016/j.beth.2006.06.005. Epub 2007 Jan 18.

  PMID: 17499082 BACKGROUND

• Gortner EM, Rude SS, Pennebaker JW. Benefits of expressive writing in lowering rumination and depressive symptoms. Behav Ther. 2006 Sep;37(3):292-303. doi: 10.1016/j.beth.2006.01.004. Epub 2006 May 30.

  PMID: 16942980 BACKGROUND

• Krpan KM, Kross E, Berman MG, Deldin PJ, Askren MK, Jonides J. An everyday activity as a treatment for depression: the benefits of expressive writing for people diagnosed with major depressive disorder. J Affect Disord. 2013 Sep 25;150(3):1148-51. doi: 10.1016/j.jad.2013.05.065. Epub 2013 Jun 18.

  PMID: 23790815 BACKGROUND

• Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.

  PMID: 17073523 BACKGROUND

• Chiu M, Lebenbaum M, Cheng J, de Oliveira C, Kurdyak P. The direct healthcare costs associated with psychological distress and major depression: A population-based cohort study in Ontario, Canada. PLoS One. 2017 Sep 5;12(9):e0184268. doi: 10.1371/journal.pone.0184268. eCollection 2017.

  PMID: 28873469 BACKGROUND

• Baikie KA, Geerligs L, Wilhelm K. Expressive writing and positive writing for participants with mood disorders: an online randomized controlled trial. J Affect Disord. 2012 Feb;136(3):310-9. doi: 10.1016/j.jad.2011.11.032. Epub 2011 Dec 30.

  PMID: 22209127 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders

Study Officials

• Benoit H Mulsant, MD, MS, FRCPC, DLFAPA

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Only one intervention arm is available to study participants (i.e., an online EW intervention), and participants are randomized to one of two arms: 1) the intervention, which is to complete four sessions of writing online or 2) no intervention (i.e., control).

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 21, 2024
• Study Start: March 27, 2019
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)