García‐Vega 2004.

Methods	RCT, not blinded
Participants	Crohn’s disease, in remission (HBI < 5). All receiving sulfasalazine or 5 ASA Exclusion criteria: dietary restrictions A total of 45 participants were randomised to one of three treatment groups, two intervention groups (guided stress management n = 15 and self‐directed stress management n = 15) and a control group (conventional medical treatment n = 15) Age [Mean(SD) years]: guided stress management group 28.7 (6.4); self‐directed stress management group 31.0 (5.7); control group 35.3 (9.1) Gender: guided stress management group (5 males, 10 females); self‐directed stress management group (5 males, 10 females); control group (6 males, 9 females) Disease duration [Mean(SD) years]: guided stress management group 5.6 (6.0); self‐directed stress management group 5.7 (4.8); control group 8.2 (5.7) Loss to follow‐up: No loss to follow‐up (author information)
Interventions	Stress management programme: a) guided stress management (relaxation practice, problem‐solving, coping in everyday life) b) self‐directed stress management (personal planning skills, autogenic training) Mode of delivery: a) face to face; delivered by psychotherapist, b) introduction by psychotherapist, written guide and audiotape Duration: a) 2 sessions, followed by weekly sessions over 6 weeks, daily practice, b) 2 sessions, daily practice for 8 weeks Setting of trial: Single centre in Spain, gastroenterology department Setting of intervention: Participants home Comparision treatment: none (standard medical therapy ‐ salicylates [author information]) Co‐interventions: 5 ‐ ASA compounds
Outcomes	Fatigue was assessed using a self‐reported daily diary (recorded between evening dinner and retiring). Tiredness (a subjective feeling of tiredness) was one of the 10 Crohn's disease symptoms assessed for presence or absence and rated for severity (according to the scale: 1 = mild, 2 = moderate and 3 = severe). Quality of life and adverse events were not assessed, however, the author reported that there were no adverse events. Other outcomes: "Symptom reduction score" for individual symptoms assessed in those afflicted only Assessment time points: Baseline, post‐intervention, month 6, month 12
Notes	3‐arm trial (2 experimental, 1 control) No evidence of power calculation statistical analysis Non‐validated fatigue measure Additional information was supplied by the author.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table was used (author information).
Allocation concealment (selection bias)	High risk	Allocation was performed by therapist (author information) ‐ open allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the psychosocial nature of this intervention, participants and personnel could not be blinded to the intervention receiving/delivering.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Subjective outcome and participants were not blinded. A gastroenterologist performed the blind evaluation (authors information).
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants included in the analysis (author information)
Selective reporting (reporting bias)	Low risk	All information on outcomes were transparent and outcomes assessed were reported.
Other bias	High risk	Some diversity in baseline characteristics of groups Tiredness was assessed using a single item of a Crohn's disease symptom outcome assessment. The validity of the outcome measure not reported