TABLE 2.
Study Characteristics and Outcome Data of Included Studies
| Author (year) | Study Type | Quality of Evidence | Study Population | Dropout | Experimental Conditions | Instrument | Methods | Follow-Up | Results |
|---|---|---|---|---|---|---|---|---|---|
| Bennebroek Evertsz et al 2017 19 | RCT | ⊕⊕⊕⊝ | n = 59 intervention group; n = 59 control group |
25.4%; 30.5% |
IBD patients with poor mental QoL | IBDQ, SF-36 | Eight 1-hr wkly sessions of IBD-specific CBT vs WLC | 1 and 3.5 mo | Significantly greater improvement in IBDQ and SF-36 mental score after 3.5 mo compared with control group (P < 0.01) |
| Berding et al 2017 41 | RCT | ⊕⊕⊕⊝ | n = 105 intervention group; n = 102 control group |
20%; 6.9% |
IBD patients | SF-12 | 2 d group sessions of self-management patient education program with medical information and coping and self-management skills vs WLC | 3 mo | No significant difference between both groups regarding physical (P = 0.54) or mental (P = 0.18) HRQoL |
| Boye et al 2011 18 | RCT | ⊕⊕⊕⊝ | n = 57 intervention group; n = 57 control group |
21.1%; 19.3% |
IBD patients with high chronic distress (PSQ ≥ 60) | IBDQ | Three 3 h group sessions psychoeducation in combination with CBT and 6-9 individual wkly CBT sessions with booster sessions at follow-up, at-home assignments of relaxation training and behavioral adjustments vs TAU | 6, 12, 18 mo | QoL improved from baseline to 18 mo in intervention group (P = 0.009). Significant differences only found in UC group, not in CD group. |
| Hunt et al 2019 36 | Parallel RCT | ⊕⊕⊕⊝ | n = 70 intervention group; n = 70 control group |
41.4%; 51.4% |
IBD patients | sIBDQ | Self-help IBD-specified CBT workbook vs psychoeducational workbook | Wk 6, 3 mo | Significant improvement in sIBDQ score in intervention group from baseline to wk 6 (P < 0.01) and 3 mo (P < 0.05) and significant compared with control group at wk 6 (P < 0.05). QoL remained significantly improved compared with control group during flare. |
| Jedel et al 2014 21 | RCT | ⊕⊕⊕⊝ | n = 27 intervention group; n = 28 control group |
3.7%; 3.6% |
UC patients in remission | IBDQ | MBSR program, 8 wkly 2.5 h group sessions, 6 d/week 45 min computer sessions vs. same time/attention mind-body medicine | Wk 8, 6 and 12 mo | No significant difference between intervention and control groups in 12 mo total IBDQ score (P = 0.07). Significantly better IBDQ total scores in intervention group with flare compared to control flare patients at 12 mo (P = 0.001). |
| Keefer et al 2013 22 | RCT | ⊕⊕⊕⊝ | n = 26 intervention group; n = 29 control group |
11.5%; 3.4% |
UC patients in remission | IBDQ + SF-12 version 2 | 7 wkly 40 min gut-directed hypnotherapy sessions, home practice via audio hypnosis 5 times/wk vs education about mind-body connection | 8, 20, 36, 52 wk | Nonsignificant improvement in IBDQ scores in intervention group at 1 y compared to baseline and compared to attention control (control group that receives the same attention but no other elements of intervention)(P < 0.05). |
| Vogelaar et al 2014 23 | RCT | ⊕⊕⊕⊝ | n = 49 intervention group; n = 49 control group |
2.04%; 0% |
IBD patients in remission with severe fatigue (CIS-fatigue ≥ 35) | IBDQ + SF-36 + EQ-5D | Six 1.5 h SFT plus psychoeducation sessions in first 3 mo, 1 booster session at 6 mo vs TAU | 3, 6, 9 mo | SFT was associated with significantly higher mean IBDQ total score compared with control group at 3 mo (P = 0.02), but effect declined at 6 (P = 0.241) and 9 months (P = 0.635). SF-36 scores not significantly improved. |
| Wynne et al 2019 45 | RCT | ⊕⊕⊕⊝ | n = 61 intervention group; n = 61 control group |
39.3%; 31.1% |
IBD patients with psychosocial dysfunction plus inactive/stable mild disease | SHS | Eight 90 min wkly group sessions of ACT vs TAU | 8, 20 wk | No total scores reported. In PP only general well-being increased compared with control group, but not in ITT, and no evidential increase in other domains. |
| Berill et al 2014 28 | RCT | ⊕⊕⊝⊝ | n = 33 intervention group; n = 33 control group |
45.5%; 51.5% |
IBD patients in remission with IBS symptoms or high stress levels | IBDQ | Six 40 min face-to-face multiconvergent mindfulness-based therapy vs TAU | 4, 8, 12 mo | PP analysis significant at 4 mo only (P = 0.038). No significant difference in improvement in IBDQ scores between groups at follow-up (all P > 0.05). IBS-type subgroup had higher IBDQ scores at 4 mo compared to control subgroup (P = 0.038). |
| Deter et al 2007 42 | RCT | ⊕⊕⊝⊝ | n = 71 intervention group; n = 37 control group |
39.4%; 29.7% |
CD | HRQL | 20 h psychodynamic psychotherapy plus 10 autogenic training session relaxation treatment program, maximum of 1 year vs TAU | 12, 18, 24 mo | No significant changes in HRQoL between intervention and control groups. |
| Diaz-Sibaja et al 2009 39 | RCT | ⊕⊕⊝⊝ | n = 33 intervention group; n = 24 control group |
45.5%; 41.7% |
IBD patients in remission | Spanish IBDQ | 10 wkly 2 h group sessions focused on coping, problem-solving, relaxation, and cognitive restructuring techniques vs. WLC | 10 wk; 3, 6, 12 mo | IBDQ scores of intervention group significantly improved at wk 10 and 3 mo (P < 0.01) but not at 6 mo (P = 0.20) and 12 mo (P = 0.06). No significant difference between mean scores of both groups pre- and posttreatment. |
| Keller et al 2004 43 | RCT | ⊕⊕⊝⊝ | n = 71 intervention group n = 37 control group |
26.8%; 21.6% |
CD patients | QL | ≥10 individual/group verbal psychodynamic psychotherapy sessions (50-100 min) and ≥10 relaxation sessions (maximum 1 y) vs TAU | 12 mo, 24 mo | No evidential differences in QoL between or in-between groups found. |
| Langhorst et al 2007 24 | RCT | ⊕⊕⊝⊝ | n = 30 intervention group; n = 30 control group |
0% 13.3% |
UC patients | IBDQ plus SF-36 | 60 h lifestyle modification program over 10 wk consisting of exercise, relaxation techniques, CBT, psychoeducation group therapy, and Mediterranean-type diet vs TAU | 3, 12 mo | No significant effect at 3 and 12 mo for IBDQ scales. At 3 mo only physical function scale had significantly improved (P = 0.0175), but after 12 mo no significant differences between groups. |
| McCombie et al 2016 25 | RCT | ⊕⊕⊝⊝ | n = 131 intervention group n = 100 control group |
59.5%; 34.0% |
IBD patients | IBDQ plus SF-12 | 8 wk computerized CBT, 8 sessions vs TAU | 12 wk, 6 mo | ITT analysis showed no increase in IBDQ scores at 12 wk (P = 0.44) and 6 mo (P = 0.50); no increase in SF-12 mental and physical scores all P > 0.05. PP analysis showed greater increase in mean IBDQ score than in control patients (P = 0.01). Improvement in SF-12 mental scores significant at wk 12 (P = 0.03) but not SF-12 physical scores (P = 0.20). |
| Mikocka-Walus et al 2015 40 ; Mikocka-Walus et al 2017 49 | RCT | ⊕⊕⊝⊝ | n = 92 intervention group; n = 84 control group |
65.2%; 46.4%; (at 24 months) |
IBD patients in remission or with mild disease | SF-36 | 10 wkly 2 h group sessions CBT (either face-to-face or online CBT) vs TAU | 6, 12, 24 mo | Significant improvement in mental QoL over 12 mo in CBT group in univariate analysis (P = 0.013) but at multivariate level no significant effect at 12 and 24 mo (P > 0.5). |
| Oxelmark et al 2007 32 | RCT | ⊕⊕⊝⊝ | n = 24 intervention group; n = 20 control group |
25%; 25% |
IBD patients in remission or with mild disease | IBDQ | Nine wkly 1.5 h group psychotherapy sessions focused on coping, stress management, diet, and lectures about IBD vs TAU | 6, 12 mo | No significant difference in IBDQ scores at 6 and 12 mo compared to baseline and between both groups. |
| Elsenbruch et al 2005 30 | Partial RCT | ⊕⊝⊝⊝ | n = 15 intervention group; n = 15 control group |
6.7%; 0% |
UC patients in remission or with low disease activity | IBDQ + SF-36 | 10 wkly 6 h program mind-body therapy (stress management, diet, exercise, cognitive-behavioral techniques) vs WLC | 10 wk | No significant difference in improvement between groups for IBDQ total scores. The intervention group showed greater improvements in SF-36 Psychological Health Sum score (P < 0.05). |
| Gerbarg et al 2015 31 | RCT | ⊕⊝⊝⊝ | n = 16 intervention group; n = 13 control group |
12.5%; 15.4% |
IBD patients | IBDQ | 2 d 9 h total breath, body, and mind workshop, daily 20 min breathing exercises with follow-up session vs 9 h educational seminar and educational lectures | 6, 26 wk | Significant improvement in IBDQ mean scores at wk 6 and 26 (both P = 0.01), significant improvement compared with control group at week 26 (P = 0.04). |
| Haapamäki et al 2018 46 | Prospective observational study | ⊕⊝⊝⊝ | n = 142 intervention | 37.3% | IBD patients | 15D questionnaire | 10-12 d of group adaptation courses (lectures, exercise, relaxation, social, individual consult) divided into 2 periods separated by 4-6 mo | 12 d, 6, 12 mo | Significant increase in HRQoL at all time points (all P < 0.001). |
| Hou et al 2017 35 | Prospective observational study | ⊕⊝⊝⊝ | n = 21 | 14.3% | IBD patients with co-occurring anxiety or depression | sIBDQ | 1 d (5 h) ACT plus IBD education group workshop | 3 mo | No significant improvement in sIBDQ scores (P = 0.08). |
| Jordan et al 2019 37 | Prospective observational study | ⊕⊝⊝⊝ | n = 28 | 3.6% | IBD patients in remission or with mild disease with moderate to severe symptoms of anxiety and/or low mood | sIBDQ | 4-10 (mode 6) wkly 50 min sessions of CBT | 4-10 wk | Significant increase in sIBDQ scores compared to baseline (P < 0.001). |
| Keefer et al 2012 34 | Pilot RCT | ⊕⊝⊝⊝ | n = 16 intervention group; n = 12 control group |
7.1% | CD patients in remission | IBDQ | 6 wkly 60 min sessions of “project management” based on cognitive-behavioral principles of health behavior change and social learning theory vs TAU |
6 wk | PP analysis showed more improvement in intervention group on IBDQ total score (P = 0.001). |
| Larsson et al 2003 20 | RCT | ⊕⊝⊝⊝ | n = 49 intervention group; n = 17 control group |
46.9% | IBD patients with anxiety and depression (scored by HADS) | SF-36 + IBDQ | 8 sessions group-based patient education with information about IBD, nutrition, diet, stress management, adaptation, and coping strategies vs WLC |
6 mo | No significant difference in PP within-group analysis at follow-up for both questionnaires. |
| Lores et al 2019 10 | Prospective observational study | ⊕⊝⊝⊝ | n = 91 | 22.0% | IBD patients with mental health issues (scored by HADS) | AQoL-8D | In-service or external CBT and ACT vs decliners (patients who scored above clinical cut-off scores on the mental health questionnaires but who declined psychological treatment) | 12 mo | Significant increase in HRQoL in intervention group from baseline (P < 0.001) and compared with decliners (P < 0.05). |
| Maunder and Esplen 2001 29 | Prospective observational study | ⊕⊝⊝⊝ | n = 30 | 36.7% | IBD patients | IBDQ | 20 wkly 90 min supportive-expressive group therapy sessions | 20 weeks | PP analysis showed nonsignificant improvement in IBDQ score (P = 0.35). |
| Miller and Whorwell 2008 47 | Prospective observational study | ⊕⊝⊝⊝ | n = 15 | 0% | IBD patients with refractory disease | Multiple choice question | 12 sessions of gut-focused hypnosis plus audio practice at home | 2 to 16 years (mean = 5.4 years) | At baseline 6.67% good/excellent QoL, after hypnotherapy 80% (calculated P = 0.003). |
| Mizrahi et al 2012 26 | RCT | ⊕⊝⊝⊝ | n = 28 intervention group; n = 28 control group |
35.7%; 25.0% |
IBD patients with active disease | IBDQ | 5 wk individual 50 min relaxation training with guided imagery at 2 wk intervals, daily 15 min relaxation exercises at home vs WLC |
5 weeks | PP analysis showed significant difference in effect of intervention over time (P = 0.014) and within-patient improvements (P = 0.002) on general IBDQ scores. |
| Neilson et al 2016 44 | Non-RCT | ⊕⊝⊝⊝ | n = 33 intervention group; n = 27 control group |
15.2%; 11.1% |
IBD patients | WHOQoL-BREF | 8 wkly 2.5 h and one 7 h mindfulness group session, 45 min daily home exercises vs TAU | 8 weeks, 32 weeks |
At wk 8, significantly greater improvements in intervention group compared with control group but only in psychological health (P < 0.01) and physical health (P < 0.01). At wk 32, no significant differences. |
| O’Connor et al 2019 38 | Pilot RCT | ⊕⊝⊝⊝ | n = 10 intervention group; n = 13 control group |
0% | IBD patients in remission who reported fatigue | SF-36 + sIBDQ | 3 small-group 1 h psychoeducational sessions focusing on fatigue every 8 wk for 6 mon vs TAU | 6 months | SF-general health and SIBDQ greater improvement in intervention arm (no P stated). |
| Schoultz et al 2015 27 | Pilot RCT | ⊕⊝⊝⊝ | n = 22 intervention group; n = 22 control group |
40.9%; 45.5% |
IBD patients | (adapted) IBDQ | 8 wkly 2 h group sessions on mindfulness-based cognitive therapy and 45 min home practice 6 d/wk vs IBD leaflet | 8 weeks, 6 months | No significant interaction between mindfulness-based cognitive therapy group and time on QoL scores (P = 0.437). |
| Vogelaar et al 2011 33 | Pilot RCT | ⊕⊝⊝⊝ | n = 9 PST group; n = 8 SFT group; n = 12 control group |
44.4%; 12.5%; 8.3% |
CD patients with high fatigue scores (CIS-fatigue > 35) but no depression (HADS < 10) | IBDQ + EQ-5D | 10 sessions PST in 3 mo vs 5 sessions SFT in 3 mo vs TAU | 6 months | No significant differences in EQ-5D and IBDQ total scores between intervention group and control group. |
ACT indicates acceptance and commitment therapy; CIS, checklist individual strength; EQ-5D, EuroQol Five Dimensions Health Questionnaire; HADS, Hospital Anxiety and Depression Scale; IBS, irritable bowel syndrome; ITT, intention to treat; MBSR, mindfulness-based stress reduction; n, population number; PP, per protocol; PSQ, perceived stress questionnaire; PST, problem-solving therapy; QL, German Quality-of-Life questionnaire; SFT, solution-focused therapy; SHS, Short Health Scale; sIBDQ, short Inflammatory Bowel Disease Questionnaire; SIBDQ: Spanish Inflammatory Bowel Disease Questionnaire; TAU, treatment as usual; WHOQoL-BREF, World Health Organization Quality of Life-BREF; WLC, waitlist control patient.
+/–: corresponds with level of evidence.