| Literature DB >> 34911469 |
Jie Chen1,2, Xuejie Chen2, Yuhao Sun1, Ying Xie1, Xiaoyan Wang3, Ran Li4, Therese Hesketh5,6.
Abstract
OBJECTIVE: Cognitive behavioral therapy (CBT) is now included in the treatment of patients with inflammatory bowel disease (IBD) in many settings. However, different clinical trials report different outcomes without consensus. This study aims to evaluate the impact of CBT on the mental state, quality of life and disease activity of patients with IBD.Entities:
Keywords: Cognitive behavior therapy; Crohn's disease; Depression; Inflammatory bowel disease; Quality of life; Ulcerative colitis
Mesh:
Year: 2021 PMID: 34911469 PMCID: PMC8672154 DOI: 10.1186/s12876-021-02003-0
Source DB: PubMed Journal: BMC Gastroenterol ISSN: 1471-230X Impact factor: 3.067
Fig. 1.A flow chat diagram of screening and selection processes
Characteristics of including studies
| References | Region | Design | Duration | Participants (age, sex) | Sample size | Interventions (types, duration) | Control |
|---|---|---|---|---|---|---|---|
| McCombie et al. [ | New Zealand | RCT | October 29, 2012, until October 2, 2013 | Aged 18–65 years; average age: 38.86; male: 71; female: 128; | Total (n = 199) CD(n = 137) UC (n = 54) IBD-U (n = 8) | 8-weeks self-administered CCBT: involved 8 sessions with 62 resources | TAU |
| Mikocka-Walus et al. [ | Australia | RCT | 21/10/2009 and 14/04/2016 | Aged 18 years or over; male: 94; female: 80 | Total (n = 174) CD (n = 107) UC (n = 67) | 10-weeks CBT (in F2F and CBT group): met weekly at a tertiary hospital for 2 h sessions | SC |
| Mikocka-Walus et al. [ | Australia | RCT | 21/10/2009 and 14/04/2016 | Aged 18 years or over; male: 94; female: 80 | Total (n = 174) CD (n = 107) UC (n = 67) | 10-weeks CBT (in F2F and CBT group): met weekly at a tertiary hospital for 2 h sessions sessions; 10 W | SC |
| Wynne et al. [ | Ireland | RCT | March 2015 and January 2017 | Aged between 18 and 65 years; male: 36; female: 43 | Total (n = 79) CD (n = 38) UC (n = 41) | 8-weeks ACT: consisted of 8 90-min weekly sessions; Each group consisted of 14–16 particles | |
| Szigethy et al. [ | America | RCT | September 2002 and August 2007 | Aged between 11 and 17 years; male: 20; female: 21 | Total (n = 41) CD (n = 29) UC (n = 12) | 12-weeks PASCET-PI: consisted of nine modules delivered over 9–11 sixty-minute sessions | TAU |
| Berrill et al. [ | England | RCT | January 2011 and May 2013 | Aged 18–65 years; average age:44.9; male: 15; female: 51 | Total (n = 66) CD (n = 21) UC (n = 45) | 16-weeks multi-convergent therapy course plus standard medical therapy (MCT) | Standard medical therapy |
| Stapersma et al. [ | Netherlands | RCT | September 2014 and October 1, 2016 | Aged 10–25 years; male: 22; female: 48 | Total (n = 70) (CD:36; UC: 26; IBD-U:8) | 12-weeks PASCET-PI; 10 weekly individual sessions | CAU |
| Stapersma et al. [ | Netherlands | RCT | September 2014 and October 1, 2016 | Aged 10–25 years; male: 22; female: 48 | Total (n = 70) CD (n = 36) UC (n = 26) IBD-U (n = 8) | 12-weeks PASCET-PI; 10 weekly individual sessions | CAU |
| Hunt et al. [ | America | RCT | average age(M(SD)):35.64 (13.18); male: 48; female: 92 | Total (n = 140) CD (n = 67) UC (n = 47) IBD-U (n = 24) | 8-weeks self-help CBT: consisted of a self-help book based on skills and principles used in CBT | Psychoeducational workbook | |
| Levy et al. [ | America | RCT | September 2007 and March 2014 | Aged 8 to 17 years; average age:13.5(SD = 2.7); male: 18; female: 167 | Total (n = 185) CD (n = 127) UC (n = 58) | 18.6-days social learning and cognitive behavioural therapy condition (SLCBT) | ES |
| Thompson et al. [ | America | RCT | Aged 11–17; male: 20; female: 21 | Total (n = 41) CD (n = 29) UC (n = 12) | PASCET-PI treatment arm participated in 9–11 individual CBT sessions(supplemented by three parent sessions) | TAU |
TAU treatment as usual, SC standard care alone, CAU care-as-usual, ES educational support condition, MCT multiconvergent therapy, MBSR mindfulness-based stress reduction, PASCET-PI primary and secondary control enhancement therapy-physical illness
Risk of bias assessment. Methodological quality: review author's judgment about each methodological quality item for each included study
| References | Random sequence generation (selection bias) | Allocation concealment (selection bias) | Blinding of participants and personnel (performance bias) | Blinding of outcome assessment (detection bias) | Incomplete outcome data (attrition bias)† | Selective reporting (reporting bias)‡ | Validated assessment instruments of outcome used§ |
|---|---|---|---|---|---|---|---|
| McCombie et al. [ | + | −a | −b | ?c | + | ?q | + |
| Mikocka-Walus et al. [ | + | −d | −e | ? | + | + | + |
| Mikocka-Walus et al. [ | + | −d | +e | ? | + | + | + |
| Wynne et al. [ | + | −f | ? | ? | + | + | + |
| EVA Szigethy et al. [ | ? | ? | ? | + | + | + | + |
| Berrill et al. [ | + | −g | ? | ? | + | + | + |
| Stapersma et al. [ | + | ? | ?j | +k | +l | + | + |
| Stapersma et al. [ | + | ? | +m | ? | +l | + | + |
| Hunt et al. [ | + | +n | ? | ? | + | ?q | + |
| Levy et al. [ | + | +o | ? | +p | + | + | + |
| Thompson et al. [ | ? | ? | ? | ? | + | + | + |
+Low risk of bias
−High risk of bias
?Unclear risk of bias
†The processing methods of attrition data are reported
‡The outcome that stated in advance has been reported
§Validated assessment tools were used for the assessment
aParticipants were present when they were randomized
bWithout blinding; all patients in the TAU group were aware of the CCBT patients receiving CCBT
cThe author considered that blinding would not have improved the results in favor of the CCBT
dParticipants are aware they may be offered an intervention or the placebo
eGiven impossibility of blinding the intervention, we decided to withdraw the information regarding the intervention from the controls. Thus, the controls had been informed they participated in an observational study on mental health in IBD
fThe author considered that it was not possible to blind participants to their allocated group. To minimize bias, an investigator not involved in recruitment or screening performed randomization, and participants completed all study questionnaires alone
gParticipants were not blinded as to their allocation following randomization and there was no placebo therapy used in the control group
hParticipants were not randomly assigned to groups
iParticipant selection
jOnly describes the independent curriculum and does not describe the implementation of the blind method in detail
kV30% was rated on adherence by at least one rater, and of that 30%, half was evaluated by at least two raters (i.e. 15% of all sessions). Audiotapes were randomly selected to be rated by two of the raters; interrater agreement was globally calculated using Pearson’s correlation between two data columns with (1) all first ratings and (2) all second ratings for all patients and sessions combined
lVery low attrition (< 3%)
mThe interviewer and treating physicians had no access to the files in which the randomization result was described; the youth and their parents not to reveal the trial arm assignment to the interviewer and treating physicians; web-based questionnaires, to be completed at home
nParticipants were allocated upon receipt of their consent and confirmation of eligibility by a research assistant, who assigned sequential participants based on the results of the coin toss. Thus, allocation was not predetermined and was concealed until assignment
oParticipants were blind to their group assignment
pTThis scale was then mailed back to the study office in a sealed stamped envelope and thus not seen by the therapist
qOutcomes reported for completers only