Garcia‐Vega 2004.

Study characteristics
Methods	RCT Setting: Spain, single centre, Inflammatory Intestinal Disease Unit of Asturias Central Hospital Study period: NS
Participants	Inclusion criteria: non‐active stage of the illness (HBI) and receiving pharmacological treatment with sulfasalazine (5‐ASA compounds), no dietary restrictions Exclusion criteria: dietary restrictions, as variability of these was considered to be a potential cause of error in the results Age (mean ± SD): IG: SM: 28.7 +/‐ 6.4 (19 to 52) IG: SDSM: 31 +/‐ 5.7 (22 to 40) CG: 35.3 +/‐ 9.1 (20 to 52) Sex (M/F): IG: SM: 5/10, SDSM: 5/10 CG: 6/9 Site of disease: NS Use of concurrent medication: NS Disease activity: non‐active. All participants had been diagnosed and treated in the Inflammatory Intestinal Disease Unit of Asturias Central Hospital (Spain). The evaluation was done by a physician on the basis of clinical history, physical examination, and radiological and laboratory tests. Disease duration: IG: SM: 5.6 +/‐ 6 (1 to 26 years) (text says 1 to 32 years range) CG: 8.2 +/‐ 5.7 (1 to 21 years) Number randomised: IG: SM: 15, SDSM: 15 CG: 15 Number reaching end of study: IG: SM: 13, SDSM: 14 CG: 13 Number analysed: IG: SM: 15, SDSM: 15 (2 groups) CG: 15 Postrandomisation exclusion: not clear 5 (2 SM, 1 SDSM, 2 CG)
Interventions	IG 1: SM: Stress management group. The aim of this treatment was to provide the participant with effective techniques to mitigate the physiological effects of stress and tension, and to modify or improve his/her coping skills. IG 2: SDSM: Self‐directed stress management group. This condition was similar to stress management, but the participant was his/her own therapist. Participants followed a self‐directed stress management programme according to a written guide on stress management procedures. Treatment of participants in the 2 experimental groups consisted of 8‐week individual sessions led by the same psychologist. The first 2 sessions were dedicated to the psychological evaluation of each participant in all 3 groups, establishment of the baseline symptomatology, and providing the participant basic information about gastrointestinal function. The remaining 6 sessions depended on the treatment group to which the participants had been allocated. It is unclear whether IG group 1 and 2 received conventional therapy as per the control group. There is no mention of any concurrent therapies or what the standard care protocol was. We wrote to the authors for clarity on this matter but received no response. CG: Participants in the control group received conventional medical treatment and did not receive any other special therapy. As mentioned above, participants attended the first and second visit to the therapist, at which they completed the semi‐structured interview and the symptoms self‐monitored in this period were recorded.
Outcomes	Length of intervention: 8 weeks of intervention and follow‐up again at 6 and 12 months Primary outcomes: Pain intensity: average intensity symptom (AIS) = sum of the daily symptom intensities/number of symptomatic days Secondary outcomes: None reported
Notes	Funding source: NS Conflict of interest: NS Author contact details: elenagv@correo.uniovi.es
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The authors mention that sequence generation was random but do not explain how this was done. We contacted the author for this information but received no response.
Allocation concealment (selection bias)	Unclear risk	Not mentioned. We contacted the author but received no response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible for this type of intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"All patients were assessed and treated by the same gastroenterologist and the same psychologist", "The 6 month check‐up was carried out by a gastroenterologist who did not know to which experimental group the patient belonged", "The 12 month check‐up was carried out by the gastroenterologist and the psychologist"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The data presented are not for all randomised participants; the number of dropouts can be inferred, but more details are needed. We contacted the author for this information but received no response.
Selective reporting (reporting bias)	Unclear risk	The statistical analysis methods are presented in the results section; indices are presented instead of raw data; and there are no pain intensity results, no protocol, and methods are unclear. We contacted the author for clarification but received no response.
Other bias	High risk	There is a considerable baseline difference between the SM and SDSM groups for abdominal pain frequency.