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. 2019 May 1;2019(5):CD004780. doi: 10.1002/14651858.CD004780.pub4

Dare 2001.

Methods RCT
Participants Country: UK
Diagnostic tool: DSM‐IV
No. screened: No detail
No. randomised: Total : 84: Psychoanalytic psychotherapy: 21; Family therapy: 22; Cognitive analytic therapy: 22; Routine treatment: 19
No. started trial: No detail
No. dropped out during intervention: Total : 30: Psychoanalytic psychotherapy: 9; Family therapy: 6; Cognitive analytic therapy: 9; Routine treatment: 6; “4 failed to attend the first treatment session. 6 dropped out within the first two months and a further 19 dropped out during the later stages of treatment” (pg. 218). This adds up to 29 ‐ but they stated 54 completed from 84 randomised ‐ these numbers do not match with the numbers for each group.
Number dropped out during follow‐up: No detail
Number analysed (LOCF): Total : 84; Psychoanalytic psychotherapy: 21; Family therapy: 22; Cognitive analytic therapy: 22; Routine treatment: 19
Number analysed (observed case): Total : 54; Psychoanalytic psychotherapy: 12; Family therapy: 16; Cognitive analytic therapy: 13; Routine treatment: 13
Mean age (SD) in years: Total : 26.3 (6.7); Psychoanalytic psychotherapy: 26.7(6.4); Family therapy: 26.6 (7.6); Cognitive analytic therapy: 27.2 (7.6); Routine treatment: 24.3 (4.5)
Age range: No detail
Gender %: Total: 2% male (all in the family therapy group): 98% female
Subtype: No detail
Age of onset in years: Total : 19.0 (5.3); Psychoanalytic psychotherapy: 18.8 (4.2); Family therapy: 20.5 (7.5); Cognitive analytic therapy: 19.9 (4.1); Routine treatment: 16.6 (4.1)
Duration of illness in years: Total : 6.3 years (5.9); 79% had received previous treatment (43% of these as inpatients and 19% requiring multiple admissions); Psychoanalytic psychotherapy: 6.7 (5.9) (71% had received previous treatment ‐ 24% as inpatient); Family therapy: 5.8 (4.9) (82% had received previous treatment ‐ 55% as inpatient); Cognitive analytic therapy: 6.7 (7.6) (77% received previous treatment ‐ 36% as inpatient); Routine treatment: 6.1 (5.0) (84% had received previous treatment ‐ 58% as inpatient)
Baseline weight in kgs:Total: 41.1 (5.1) ‐ mean average body weight for height (74.3%); Psychoanalytic psychotherapy: 40.8 (4.6) mean average body weight for height (72.8%); Family therapy: 41.0 (6.2) mean average body weight for height (72.8%); Cognitive analytic therapy: 41.9 (4.6) mean average body weight for height (77.3%); Routine treatment: 40.6 (5.2) mean average body weight for height (73.9%)
Baseline BMI: Total : 15.4 (1.6); Psychoanalytic psychotherapy: 15.0 (1.6); Family therapy: 15.2 (1.5); Cognitive analytic therapy: 16.0 (1.7); Routine treatment: 15.3 (1.6)
Baseline eating disorder scale score (MRS):Total: 5.5 (1.4)
Baseline purging % (vomiting daily or at least weekly):Total : 36% Daily only 13%; Psychoanalytic psychotherapy: 15% Daily only 19%; Family therapy: 14% Daily only 9%; Cognitive analytic therapy: 28% Daily only 27%; Routine treatment: 37% Daily only 11%
Comorbidity: No detail
Details on living arrangements (lived with their parents or another family member): Total : 50%; Psychoanalytic psychotherapy: 52%; Family therapy:59%; Cognitive analytic therapy: 41%; Routine treatment: 47%
Details on living arrangements : 24% lived with a marital or common law partner and 26% alone; Psychoanalytic psychotherapy: 14% cohabiting; 33% alone; Family therapy: 27% cohabiting; 14% alone; Cognitive analytic therapy: 32% cohabiting; 27% alone; Routine treatment: 21% cohabiting; 32% alone
Family education/employment/income: No detail
Recruitment strategy: Sequential referrals to the outpatient eating‐disorder service
Exclusion criteria:
  1. Mental or physical state was considered so dangerous as to require urgent admission to hospital e.g. suicidal risk

  2. Extremely low body weight

Interventions Setting of care: Outpatient
 Training/qualification of care provider(s): Yes: A psychologist, doctor and a social worker with training in family therapy
 Treatment manual: No
 Supervision of treatment: Yes: Bi‐weekly 90 minute group format  
 Adherence to treatment: No detail
 
 Intervention group 1Description: Family‐based therapy
 Described as 'Family Therapy' in report. Phase 1 focused on the family control of refeeding but participants took an active role to oppose the anorexic eating habits
 Length: Mean of 13.6 sessions of 1 hour to 1 hour 15 minutes sessions between once a week and once every 3 weeks
 
 Intervention group 2Description: Focal psychoanalytic psychotherapy
 Non‐directive with no advice given about AN or symptom management but addresses: a) conscious and unconscious meanings of the symptom in terms of the participants' history and their experience with their family, b) the effects of the symptom and its influence on the participants current relationship, and c) the manifestation of those influences in the relationship with the therapist
 Length: Planned once a week for a year but mean of 24.9 sessions of 50 minute duration
 
 Intervention group 3Description: Cognitive analytic therapy
 Participants are helped to evolve a formal mapped‐out structure of the place of the anorexia in their experience of themselves and their early and current relationships
 Length: Planned weekly sessions for 20 weeks then monthly for 3 months but mean number of 12.9 sessions of 50 minute duration
 
 Intervention group 4Description: Routine treatment
 Included low contact, outpatient management with provision of information and encouragement
 Length: Planned to be a low‐contact intervention with mean 10.9 sessions of 30 minute duration over approximately 1 year
Outcomes Eating psychopathology
 Morgan Russell Assessment Schedule (Morgan 1988)
 Behavioural indices
 BMI
 Recovered: weight > 85% ABW; menstruation returned, no bulimic symptoms
 Significantly improved: weight > 85% of ABW but amenorrhoea persists and/or occasional bulimic symptoms (< weekly)
 Improved: weight > 75% ABW and 10% weight gain and/or regular bulimic symptoms (weekly)
 Poor: weight < 75% ABW or weight gain < 10% or frequent bulimic symptoms (daily)
Notes Included in family therapy vs standard care/treatment as usual
 Family therapy categorised as family‐based therapy
 Also included in family therapy vs individual psychological intervention
 Family therapy categorised as family‐based therapy
 Personal communication stated that the cause of death of the participant who died in the routine group was not available in research files
 Funded by: Leverhulme Foundation and the Mental Health Research Fund
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “a stratified randomisation procedure...the minimization method (Pocock 1982) was used to control for age of onset and the duration of the illness.” Pg. 216
Personal communication stated that stratified randomisation with minimisation was used to control for age of onset, duration of illness, marital status, and presence of symptoms. If minimisation resulted in a tie, a random sequence had been generated by computer and was used.
Allocation concealment (selection bias) Low risk Quote: "sealed envelopes"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Therapists and participants cannot be blinded in trials of family‐based therapy
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: “the follow‐up research clinician was not blind to treatment” pg. 216
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk
  1. Dropouts and their timing are described, but numbers who completed the final assessment not stated clearly. Some discrepancy in numbers, i.e. did 30 or 29 dropout? Reasons for dropout described only for 13 who experienced serious adverse outcomes (including 1 participant who died). ITT analysis done.

  2. States that ITT analysis done using data obtained from last session with therapist or by a combination of telephone interview with GP or a parent

  3. Personal communication states that an attempt to follow up all participants was undertaken, regardless of how much therapy they received

Selective reporting (reporting bias) Unclear risk
  1. Abstract describes specific interventions as superior, but the results suggest this was only for weight, not for any measures of psychopathology

  2. We obtained group totals for eating disorder psychopathology and weight via  personal communication

Other bias Unclear risk
  1. Uneven treatment dosages and duration

  2. Expertise differed in treatment‐group therapists