A self-guided Internet-based intervention for individuals with chronic pain and depressive symptoms: study protocol of a randomized controlled trial.
CBT
Chronic pain
Emotional problems
Internet-based self-help
Online-intervention
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Jul 2023
11 Jul 2023
Historique:
received:
24
03
2022
accepted:
08
06
2023
medline:
13
7
2023
pubmed:
12
7
2023
entrez:
11
7
2023
Statut:
epublish
Résumé
Despite the existence of evidence-based therapy options for the treatment of chronic pain and comorbid depressive symptoms (e.g., CBT), many individuals remain untreated. Treatment gaps result from a lack of specialists, patient fear of stigmatization, or patient immobility. Internet-based self-help interventions could serve as an anonymous and flexible alternative treatment option. In a pilot study, chronic pain patients with comorbid depressive symptoms who used a generic Internet-based depression program showed a significant reduction in depressive symptoms (but not pain symptoms) compared to a waitlist control group. Based on these findings, we developed the low-threshold, anonymous, and cost-free Internet-based self-help intervention Lenio that is tailored to the specific needs of chronic pain patients with comorbid depressive symptoms. Lenio is accompanied by the smartphone application (app) COGITO designed to increase therapeutic success. With Lenio and COGITO addressing both chronic pain and depressive symptoms, the trial aims to increase treatment effects of online interventions for chronic pain patients by reducing both depressive symptoms and pain. The effectiveness of the Internet-based self-help intervention and accompanying smartphone app will be evaluated in a randomized controlled trial (RCT). A total of 300 participants will be randomized into an intervention group (Lenio/COGITO), an active control group (depression-focused smartphone app), or a waitlist control group. Assessments will be done at baseline, after an 8-week intervention period (post), and after 16 weeks (follow-up). The primary outcome is the post-assessment reduction in "pain impairment" (mean value of impairment in daily life, free time, and work) as assessed by the DSF (German pain questionnaire). Secondary outcomes will include the reduction in depressive symptoms as well as in the severity of pain. Lenio is one of the first Internet-based interventions to reduce chronic pain and depression that will be empirically evaluated. Internet-based interventions could offer a promising alternative to conventional face-to-face psychotherapy in the treatment of chronic pain patients. The primary objective of the current study is to add essential insight into the feasibility, effectiveness, and acceptance of Internet-based interventions for people with chronic pain and depressive symptoms. DRKS-ID DRKS00026722, Registered on October 6th, 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Despite the existence of evidence-based therapy options for the treatment of chronic pain and comorbid depressive symptoms (e.g., CBT), many individuals remain untreated. Treatment gaps result from a lack of specialists, patient fear of stigmatization, or patient immobility. Internet-based self-help interventions could serve as an anonymous and flexible alternative treatment option. In a pilot study, chronic pain patients with comorbid depressive symptoms who used a generic Internet-based depression program showed a significant reduction in depressive symptoms (but not pain symptoms) compared to a waitlist control group. Based on these findings, we developed the low-threshold, anonymous, and cost-free Internet-based self-help intervention Lenio that is tailored to the specific needs of chronic pain patients with comorbid depressive symptoms. Lenio is accompanied by the smartphone application (app) COGITO designed to increase therapeutic success. With Lenio and COGITO addressing both chronic pain and depressive symptoms, the trial aims to increase treatment effects of online interventions for chronic pain patients by reducing both depressive symptoms and pain.
METHODS
METHODS
The effectiveness of the Internet-based self-help intervention and accompanying smartphone app will be evaluated in a randomized controlled trial (RCT). A total of 300 participants will be randomized into an intervention group (Lenio/COGITO), an active control group (depression-focused smartphone app), or a waitlist control group. Assessments will be done at baseline, after an 8-week intervention period (post), and after 16 weeks (follow-up). The primary outcome is the post-assessment reduction in "pain impairment" (mean value of impairment in daily life, free time, and work) as assessed by the DSF (German pain questionnaire). Secondary outcomes will include the reduction in depressive symptoms as well as in the severity of pain.
DISCUSSION
CONCLUSIONS
Lenio is one of the first Internet-based interventions to reduce chronic pain and depression that will be empirically evaluated. Internet-based interventions could offer a promising alternative to conventional face-to-face psychotherapy in the treatment of chronic pain patients. The primary objective of the current study is to add essential insight into the feasibility, effectiveness, and acceptance of Internet-based interventions for people with chronic pain and depressive symptoms.
TRIAL REGISTRATION
BACKGROUND
DRKS-ID DRKS00026722, Registered on October 6th, 2021.
Identifiants
pubmed: 37434163
doi: 10.1186/s13063-023-07440-8
pii: 10.1186/s13063-023-07440-8
pmc: PMC10334640
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
453Informations de copyright
© 2023. The Author(s).
Références
Cogn Behav Ther. 2016;45(1):5-31
pubmed: 26818413
Pain. 1992 Aug;50(2):133-149
pubmed: 1408309
J Pain Res. 2016 Jun 28;9:457-67
pubmed: 27418853
Psychol Med. 2015 Jan;45(1):11-27
pubmed: 24569086
Psychother Psychosom Med Psychol. 2018 Sep;68(9-10):391-398
pubmed: 29631298
Dtsch Arztebl Int. 2017 Oct 13;114(41):681-688
pubmed: 29082858
Clin Psychol Rev. 2012 Jun;32(4):329-42
pubmed: 22466510
JAMA Psychiatry. 2017 Apr 01;74(4):351-359
pubmed: 28241179
J Rehabil Med. 2014 Sep;46(8):798-805
pubmed: 24847727
J Med Internet Res. 2009 Jul 24;11(3):e19
pubmed: 19632977
Expert Rev Neurother. 2009 May;9(5):745-58
pubmed: 19402782
Pain. 1993 Feb;52(2):157-168
pubmed: 8455963
Medicina (Kaunas). 2019 Dec 04;55(12):
pubmed: 31817180
J Pain. 2018 Jul;19(7):741-753
pubmed: 29481976
Psychiatry Res. 2018 Nov;269:753-762
pubmed: 30273901
Eur Arch Psychiatry Clin Neurosci. 2019 Aug;269(5):577-586
pubmed: 30088072
Crit Care Med. 2018 Sep;46(9):e825-e873
pubmed: 30113379
Clin J Pain. 2006 Nov-Dec;22(9):790-8
pubmed: 17057561
Postgrad Med. 2019 Apr;131(3):185-198
pubmed: 30700198
Curr Psychiatry Rep. 2018 Mar 5;20(2):12
pubmed: 29504088
Lancet. 2017 Sep 16;390(10100):1211-1259
pubmed: 28919117
J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86
pubmed: 11132119
Pain Pract. 2009 May-Jun;9(3):173-80
pubmed: 19298363
Internet Interv. 2016 Jan 03;4:17-34
pubmed: 30135787
J Occup Rehabil. 2008 Sep;18(3):249-61
pubmed: 18536983
J Pain. 2020 May - Jun;21(5-6):529-545
pubmed: 31683020
Schmerz. 2002 Aug;16(4):263-70
pubmed: 12192435
Clin J Pain. 2017 Jun;33(6):552-568
pubmed: 27479642
JMIR Mhealth Uhealth. 2021 Jul 12;9(7):e26498
pubmed: 34255711
Schmerz. 2012 Apr;26(2):168-75
pubmed: 22527646
J Pain. 2019 Jan;20(1):47-59
pubmed: 30107241
JAMA Psychiatry. 2021 Apr 1;78(4):361-371
pubmed: 33471111
J Affect Disord. 2016 Mar 15;193:267-73
pubmed: 26774513
PLoS One. 2018 Jun 29;13(6):e0199750
pubmed: 29958268
Psychol Res Behav Manag. 2011;4:41-9
pubmed: 22114534
Behav Res Ther. 2004 Jun;42(6):711-29
pubmed: 15081886
Psychiatr Serv. 2014 Jan 1;65(1):24-32
pubmed: 24081188
Postgrad Med. 2019 Sep;131(7):438-444
pubmed: 31482756
PLoS One. 2013 Jul 03;8(7):e62873
pubmed: 23843932
Psychother Psychosom Med Psychol. 2003 Sep-Oct;53(9-10):406-11
pubmed: 14528410
Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55
pubmed: 2762479
Cogn Behav Ther. 2018 Jan;47(1):1-18
pubmed: 29215315
Science. 1965 Nov 19;150(3699):971-9
pubmed: 5320816
Spine (Phila Pa 1976). 2006 Jan 1;31(1):104-10
pubmed: 16395186