Study design and participants
A 3-group, parallel, randomised controlled trial.
Sample
Patients admitted with first ever or recurrent stroke (diagnosed on clinical history and signs, supplemented by CT brain scan when ordered by clinician) to hospitals in Leeds and Bradford. We were notified of stroke admissions in the two Leeds trusts by the Leeds Stroke Database. In Bradford we contacted admitting wards each week.
Inclusion criteria
Adults admitted to hospital with first ever or recurrent stroke (other than subarachnoid haemorrhage) within the past month; who were local residents and able to give written consent.
Exclusion criteria
Patients who were: too ill to interview within 1 month of stroke; unable to participate through impaired speech, cognition or use of English; living in a residential home; had a serious concurrent illness, which was likely to dominate the pattern of care or were participating in another rehabilitation trial.
Randomisation and masking
The trial had three arms: problem-solving therapy from a psychiatric nurse, non-specific support given by volunteers or treatment-as-usual. We screened all notifications of stroke admissions, and after obtaining verbal consent for the initial assessment we undertook a baseline interview and a Mini-Mental State Examination (MMSE) [11]. Randomisation was third party, after a telephone call from a research interviewer to a remote trials office. Random allocation was generated by computer in the trials office in blocks of 15, stratified by admitting NHS trusts. Eligible patients were then asked to give written consent to the treatment to which they had been randomised, and to be followed up at 6 and 12 months. If the patient refused the intervention we asked them to consent to follow-up. Patients were sent a letter confirming their participation and giving the name of their volunteer or nurse, as appropriate, and the planned follow-up dates. In this way, patients were not aware that their treatment was being randomly allocated, and did not know that other patients were receiving a different treatment. This design, which is a variant of Zelen’s procedure [12], was approved by the three local research ethics committees that reviewed the study.
Patients were not masked to their allocation as this is clearly impossible to achieve with this type of intervention. However, as a result of the randomisation procedure patients were unaware of other treatment allocations.
Interventions and comparators
Problem-solving therapy
This short-term therapy was delivered in the patient’s home, after discharge, by one of two Community Psychiatric Nurses employed specifically for the study. The aim was to improve the patient’s problem solving skills, so that the patient feels he or she is taking control of coping. Improved coping skills should result in reduced psychological distress and rates of depression. The therapist followed a manual in helping the patient to identify and prioritise problems, set goals and identify solutions to the problems, choose and try a plausible solution and then re-assess in the light of the results. The therapy had six sessions: identifying stroke related problems including gaps in knowledge about stroke; identifying non-stroke problems; identifying available external resources; identifying personal coping resources; looking at the problem-solving process, and summarising the process. The therapy has been described in more detail elsewhere [13]. The six sessions were planned to be given in 6 h, about a fortnight apart, with the patient doing ‘homework’ between each meeting. One benefit of a manual-based therapy is that the therapist can give more or less time to each session by monitoring the patient’s progress. The therapy was adaptable to be used with or without a carer present. The therapists received training and regular clinical supervision from a specialist liaison psychiatrist (AH). The therapy was not given if the patient was discharged to residential care or remained in hospital 6 months after stroke.
Non-specific support
One of 47 volunteers recruited to the study was assigned to provide talking (non-specific) support. The volunteers attended a training meeting that focussed on the consequences of stroke. More than half the volunteers had personal or family experience of stroke. We asked the volunteer to visit the patient 6–8 times and paid travel expenses. For practical reasons the volunteers began their visits to the patient soon after randomisation, sometimes before the patient was discharged.
Treatment as usual
No additional effort was made, during the course of the trial, to enhance routine psychiatric care in stroke services. At the time of the trial, no stroke service in Leeds or Bradford had dedicated clinical psychology or psychiatry time available for the treatment of mood disorders associated with stroke, although referral was possible from all services for mental health assessment and treatment of cases identified by stroke staff as requiring specialist care.
Outcome assessment
A trained interviewer obtained personal and social details, and undertook the following assessments during the initial interview:
The Mini-Mental State Examination (MMSE) [11], a brief screen for cognitive dysfunction. It is scored 0–30 with higher scores indicating better function.
The Barthel index [14], which assesses activities of daily living skills. It is scored 0–20, with higher scores indicating greater abilities. The patient’s self-reported pre-stroke and post-stroke abilities were assessed.
The Frenchay Activities Index [15] is a measure of social function, scored 0–45, with higher scores indicating greater function. It is broader in scope than the Barthel index, including items to assess frequency of shopping, travel, hobbies, etc. The patient’s self-reported pre-stroke activities were assessed.
The Present State Examination: short form (PSE) [10] is a semi-structured, standardised psychiatric interview from which is derived an index of definition. The index has a range 1–7, with a score of > 5 indicating probable psychiatric disorder; we gave each of these cases a psychiatric diagnosis according to the research criteria of ICD-10.
The General Health Questionnaire (GHQ-28) [9] is a measure of psychological distress scored 0–28, with higher scores indicating greater distress. Scores on the GHQ can be used to identify probable psychiatric disorder: for neurological in-patients the threshold is > 12 and among outpatients the threshold is > 9 and above.
The patients also completed an adapted version of a scale to assess satisfaction with aspects of care given in hospital and after discharge [16].
Follow up assessments took place in the patient’s home with an interviewer who was not informed of the treatment allocation of the patient. Patients who received problem-solving were asked by the therapist not to reveal their allocation. To test the extent of unmasking of outcome assessors, we asked the interviewer to guess the allocation of 127 patients seen at 12 months.
Primary assessments were PSE and GHQ-28 at 12 months. Secondary assessments were: the Barthel index, the Frenchay Activities Index, patient satisfaction, medication use, and contacts with health and social services at 12 months, and all the above at 6 months.
Sample size calculation
The sample size of 450 was calculated to give 80% power to detect a 2-point difference in GHQ score, including an estimate of 20% lost to follow-up, through death and refusals, randomly distributed between the groups. We based the sample size calculation for the study on producing a 2-point change because no minimally clinically important difference has been defined for the GHQ since it is designed primarily as a screening tool.
Statistical analysis
Prior to starting the study we planned to undertake two forms of analysis: in the first (Phase 1) we planned to compare the outcome data for all three groups at 6 & 12 months to test variation between them. In the second (Phase 2) we planned to compare problem-solving therapy with the other 2 groups to test its benefit.
Our methods of analysis included the Kruskal-Wallis (non-parametric) analysis of variance to examine ordinal scales in Phase 1. Other measures were dichotomised and analysed using logistic regression in Phase 2 of our plan. We used therapy as the ‘baseline’ group, since we planned the trial to compare it with both treatment-as-usual and non-specific support, similar to that provided in previous studies [17].