An Online Self-help Intervention for Prevention of Depression in Primary Care

NCT04139785 | Unknown

• 1 other identifier: 0001
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is a common condition and is the leading cause of disability worldwide. Preventing or delaying the onset of depression is an important way to reduce the burden of depression. Some research suggests online methods may be effective in preventing depression, but to date, few studies have looked at the application of these methods in the UK. This study aims to assess the effects of an online self-help intervention (Moodbuster) on preventing depression in a primary care population, who are experiencing mild-moderate symptoms of depression, but do not meet the threshold for diagnosis. A randomised control design with a six-month and nine-month follow up will be used to compare Moodbuster to a wait-listed control group. Then, a qualitative process evaluation will be used to understand the barriers and facilitators of implementing the intervention. Eligible participants in Greater Manchester (individuals with mild to moderate symptoms of depression, who do not have a diagnosis of major depressive disorder and have access to the internet) will take part in a 6-week online self-help programme, accompanied by three telephone calls with a trained researcher to support them in their use of the programme. Researchers will follow-up with participants six and nine months after starting the programme to measure depression, anxiety, quality of life, and use of services. The process evaluation will involve qualitative interviews with participants and focus groups with practitioners who referred individuals to the study. This study will assess the effects of Moodbuster on preventing depression and barriers and facilitators of implementing such an intervention in a UK primary care population. It is hypothesised that the intervention group will display reduced depression symptoms and incidence, reduced service use, and improved quality of life, and the intervention will be acceptable to a UK primary care population.

Conditions

Depression

Keywords

Depression; Anxiety; Prevention; Public Mental Health; Primary Care

Outcome Measures

Primary Outcomes (2)

• Depression Symptoms (Patient Health Questionnaire, 9-item)

  Difference in self-reported depression symptoms between intervention and control groups. The PHQ-9 is formed of nine items, each item is scored from 0-3 (0 = not at all; 3 = nearly every day) yielding a total score between 0 and 27. Higher scores are associated with decreased functional status and increased symptom-related difficulties.

  6 months

• Depression Symptoms (Patient Health Questionnaire, 9-item)

  Difference in self-reported depression symptoms between intervention and control groups. The PHQ-9 is formed of nine items, each item is scored from 0-3 (0 = not at all; 3 = nearly every day) yielding a total score between 0 and 27. Higher scores are associated with decreased functional status and increased symptom-related difficulties.

  9 months

Secondary Outcomes (9)

• Depression Onset (Beck Depression Inventory-II)

  9 months

• Anxiety Symptoms (Generalised Anxiety Disorder Assessment, 7-item)

  6 months

• Anxiety Symptoms (Generalised Anxiety Disorder Assessment, 7-item)

  9 months

• Quality of Life (EQ-5D-5L)

  6 months

• Quality of Life (EQ-5D-5L)

  9 months

Study Arms (2)

Intervention

EXPERIMENTAL

Guided Cognitive Behavioural Therapy based app

Other: Moodbuster

Care as usual

NO INTERVENTION

Care as usual

Interventions

Moodbuster OTHER

Moodbuster intervention comprises three elements: (1) a web-based interface providing the patients access to CBT therapies, (2) a web-based portal for the trial co-ordinator and researchers, where they can view participation, amend modules and send login codes, (3) a mobile phone component which enables daily EMA monitoring of mood state, cognitions, activities, social interaction, and sleep. The mobile application will be used to capture EMA data.

Intervention

Eligibility Criteria

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

You may qualify if:

• Aged 18 or above
• Willing and able to give informed consent for participation
• Have sub-threshold mild to moderate symptoms of depression (PHQ-9 scores of 5-9)
• Access to the internet
• In possession of a mobile smartphone (Android) and computer
• In possession of an e-mail address

You may not qualify if:

• Currently, or has ever, met DSM-IV criteria for major depression, bipolar disorder, substance dependence, or a psychotic disorder
• Has had a major depressive episode (meeting DSM-IV criteria) as measured by the BDI-II
• Is currently receiving psychotherapy, on a waiting list for psychotherapy, or received psychotherapy in the last six months for any mental health problem
• Is unable to speak, read, or write in English
• Has started a course of antidepressants within the last six weeks
• Endorsement of PHQ item 9 "thoughts you would be better off dead, or of hurting yourself in some way"

Sponsors & Collaborators

• Mental Health Foundation, London: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• VU University of Amsterdam: collaborator
• University of Manchester: collaborator

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

RECRUITING

Related Publications (15)

• Buntrock C, Ebert DD, Lehr D, Smit F, Riper H, Berking M, Cuijpers P. Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1854-63. doi: 10.1001/jama.2016.4326.

  PMID: 27139058 BACKGROUND

• Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up treatment of depression and anxiety: a global return on investment analysis. Lancet Psychiatry. 2016 May;3(5):415-24. doi: 10.1016/S2215-0366(16)30024-4. Epub 2016 Apr 12.

  PMID: 27083119 BACKGROUND

• Ustun TB, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJ. Global burden of depressive disorders in the year 2000. Br J Psychiatry. 2004 May;184:386-92. doi: 10.1192/bjp.184.5.386.

  PMID: 15123501 BACKGROUND

• Gun SY, Titov N, Andrews G. Acceptability of Internet treatment of anxiety and depression. Australas Psychiatry. 2011 Jun;19(3):259-64. doi: 10.3109/10398562.2011.562295.

  PMID: 21682626 BACKGROUND

• Gilbody S, Brabyn S, Lovell K, Kessler D, Devlin T, Smith L, Araya R, Barkham M, Bower P, Cooper C, Knowles S, Littlewood E, Richards DA, Tallon D, White D, Worthy G; REEACT collaborative. Telephone-supported computerised cognitive-behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. Br J Psychiatry. 2017 May;210(5):362-367. doi: 10.1192/bjp.bp.116.192435. Epub 2017 Mar 2.

  PMID: 28254959 BACKGROUND

• Deady M, Choi I, Calvo RA, Glozier N, Christensen H, Harvey SB. eHealth interventions for the prevention of depression and anxiety in the general population: a systematic review and meta-analysis. BMC Psychiatry. 2017 Aug 29;17(1):310. doi: 10.1186/s12888-017-1473-1.

  PMID: 28851342 BACKGROUND

• Christensen H, Batterham P, Mackinnon A, Griffiths KM, Kalia Hehir K, Kenardy J, Gosling J, Bennett K. Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial. J Med Internet Res. 2014 Sep 2;16(9):e199. doi: 10.2196/jmir.3507.

  PMID: 25270886 BACKGROUND

• Clarke G, Reid E, Eubanks D, O'Connor E, DeBar LL, Kelleher C, Lynch F, Nunley S. Overcoming depression on the Internet (ODIN): a randomized controlled trial of an Internet depression skills intervention program. J Med Internet Res. 2002 Dec;4(3):E14. doi: 10.2196/jmir.4.3.e14.

  PMID: 12554545 BACKGROUND

• Cukrowicz KC, Joiner TE. Computer-based intervention for anxious and depressive symptoms in a non-clinical population. Cognit Ther Res [Internet]. Springer US; 2007 [cited 2018 Aug 3];31:677-93. Available from: http://link.springer.com/10.1007/s10608-006-9094-x

  BACKGROUND

• Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533.

  PMID: 24313693 BACKGROUND

• Imamura K, Kawakami N, Furukawa TA, Matsuyama Y, Shimazu A, Umanodan R, Kawakami S, Kasai K. Effects of an Internet-based cognitive behavioral therapy (iCBT) program in Manga format on improving subthreshold depressive symptoms among healthy workers: a randomized controlled trial. PLoS One. 2014 May 20;9(5):e97167. doi: 10.1371/journal.pone.0097167. eCollection 2014.

  PMID: 24844530 BACKGROUND

• Lintvedt OK, Griffiths KM, Sorensen K, Ostvik AR, Wang CE, Eisemann M, Waterloo K. Evaluating the effectiveness and efficacy of unguided internet-based self-help intervention for the prevention of depression: a randomized controlled trial. Clin Psychol Psychother. 2013 Jan-Feb;20(1):10-27. doi: 10.1002/cpp.770. Epub 2011 Sep 2.

  PMID: 21887811 BACKGROUND

• Spek V, Cuijpers P, Nyklicek I, Smits N, Riper H, Keyzer J, Pop V. One-year follow-up results of a randomized controlled clinical trial on internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years. Psychol Med. 2008 May;38(5):635-9. doi: 10.1017/S0033291707002590. Epub 2008 Jan 21.

  PMID: 18205965 BACKGROUND

• Musiat P, Conrod P, Treasure J, Tylee A, Williams C, Schmidt U. Targeted prevention of common mental health disorders in university students: randomised controlled trial of a transdiagnostic trait-focused web-based intervention. PLoS One. 2014 Apr 15;9(4):e93621. doi: 10.1371/journal.pone.0093621. eCollection 2014.

  PMID: 24736388 BACKGROUND

• Morgan AJ, Jorm AF, Mackinnon AJ. Email-based promotion of self-help for subthreshold depression: Mood Memos randomised controlled trial. Br J Psychiatry. 2012 May;200(5):412-8. doi: 10.1192/bjp.bp.111.101394. Epub 2012 Mar 22.

  PMID: 22442102 BACKGROUND

Related Links

• World Health Organisation (2017)
• Mental Health and Well being in England Adult Psychiatric Morbidity Survey 2014

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Kathryn M Abel, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Antonis Kousoulis, MD

  Mental Health Foundation

  STUDY DIRECTOR

Central Study Contacts

Angela Parker

CONTACT

07855348127; angela.parker@nihr.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will follow a two-armed randomised controlled, single-blind, parallel group, wait-list control design. Individuals with mild-moderate symptoms of depression who do not have a diagnosis of depression are invited to participate

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: October 23, 2019
• Primary Completion: November 1, 2020
• Study Completion: April 1, 2021
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Six months through 10 years following publication.

Locations

GB (1)