title: An evaluation of treatment integrity in a randomized trial of behavioural therapy for low mood in stroke patients with aphasia.
abstract: OBJECTIVE
  To assess the treatment integrity of behavioural therapy for low mood in stroke patients with aphasia.
  
  
  METHODS
  Participants were recruited to a multicentre randomized controlled trial (Communication and Low Mood; CALM trial) comparing behavioural therapy with a usual care control group.
  
  
  METHODS
  Of the 51 participants randomly allocated to receive behavioural therapy, 44 participants completed treatment.
  
  
  METHODS
  Participants were assessed on measures of disability, language and mood. The number and length of therapy sessions, and therapist was recorded. Allocation of time to therapy components was compared across three phases of therapy. Associations between levels of disability, aphasia, mood and the therapy patients received were determined. Therapy content was compared between centres and at the beginning and end of the trial.
  
  
  RESULTS
  The mean number of therapy sessions was 9.1 (range 3-18, SD 2.6) and the mean duration of sessions was 58 minutes (range 30-89 minutes, SD 10.7). Allocation of time to each therapy component significantly differed across the three phases of therapy (P < 0.05). There were no significant associations (P > 0.05) between the length and number of sessions and patients' aphasia, mood or disability, suggesting similar levels of therapy were provided regardless of patients' characteristics. The content of therapy showed some differences between centres (P < 0.01) and there was programme drift in some components of therapy.
  
  
  CONCLUSIONS
  The results support the ability of the therapists to deliver behavioural therapy according to the treatment manual. However there were differences between centres and over time in some components of therapy.
authors.affiliation: 1Institute of Work, Health and Organisations, University of Nottingham, UK.
authors.forename: Shirley A
authors.initials: SA
authors.lastname: Thomas
authors.forename: Claire
authors.initials: C
authors.lastname: Russell
authors.forename: Ruth
authors.initials: R
authors.lastname: Seed
authors.forename: Esme
authors.initials: E
authors.lastname: Worthington
authors.forename: Marion F
authors.initials: MF
authors.lastname: Walker
authors.forename: Jamie A
authors.initials: JA
authors.lastname: Macniven
authors.forename: Nadina B
authors.initials: NB
authors.lastname: Lincoln
mesh_terms: D000704:Analysis of Variance; D001037:Aphasia / Q000209:etiology / Q000523:psychology / Q000534:rehabilitation*; D002983:Clinical Competence; D015928:Cognitive Behavioral Therapy / Q000379:methods / Q000592:standards*; D004739:England; D019983:Guideline Adherence; D006801:Humans; D019964:Mood Disorders / Q000209:etiology / Q000628:therapy*; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D020521:Stroke / Q000150:complications / Q000523:psychology; D000071939:Stroke Rehabilitation; D013997:Time Factors
keywords: Stroke; aphasia; behavioural therapy; depression; process evaluation