A variety of data were collected to achieve the aims of the study (see ‘Specific aims’ section, page 71). Data relating to feasibility of implementing and evaluating the intervention were collected for the primary outcomes of the study, in order to inform development of the intervention and future definitive evaluation. Detail of the feasibility data recorded can be found in the ‘Analysis plan’ section, presented later in this chapter (page 111). The secondary outcome of the study was to gather clinical outcome data relating to effect and data on adverse events. Clinical outcomes were collected in the current study to acquire preliminary evidence of the direction of any treatment effect and to estimate completion rates of the chosen clinical outcomes (Lancaster et al., 2004; Thabane et al., 2010). The remainder of this section describes and justifies the chosen clinical outcomes proposed for future trials.
Clinical outcome data collected for this feasibility study included questionnaires, readmission data and data on adverse events. All questionnaires were collected at baseline, post-treatment and 6-month follow-up (see Table 8). They were primarily collected in person where possible. Alternatively, participants were contacted by telephone, by post or via their clinical psychiatric nurse (CPN). All other data (readmission and adverse events data) were extracted from NHS Lothian electronic medical records.
Table 8
Timeline of clinical outcome data collection
Baseline measures Post-treatment Measures 6-month follow-up Measures MHCS CORE 10 BSI-18 MHCS CORE 10 BSI-18 CTQ-SF LOS MHCS CORE 10 BSI-18 Readmission data Adverse events data Brief Symptom Inventory Scale-18 (BSI-18), Clinical Outcome of Routine Evaluatio-10 (CORE-10), Childhood Trauma Questionnaire-Short Form (CTQ-SF), length of stay (LOS), Mental Health Confidence Scale (MHCS).
4.7.1 Clinical outcomes
Proposed primary outcomes for main trial
The proportion of readmissions at 6-months following discharge of the index admission is the proposed primary outcome measure for a future trial. The number of readmissions, or ‘revolving door patients’ is a significant problem for acute inpatient services in the UK (Cogan et al., 2012) and worldwide (Loch, 2014). Readmissions are expensive for services (Personal Social Services Research Unit [PSSRU], 2010) and may have a negative effect on patient outcome, i.e. a predictor of readmissions is the number of previous admissions (Information Services Division Scotland, 2009). One aim of the psychological intervention is to use acute admissions as a turning point for patients, which involves identify problems resulting in the current admission and teaching patients’ new ways of coping in future (Clarke & Wilson, 2009). Consequently, patients are supported to take responsibility for maintaining their mental health which may have implications for future service use, specifically readmission. Understanding whether this cross- diagnostic psychological intervention can reduce the risk of readmissions is valuable to both patients and services, however is currently unknown.
Although informative, there are also limitations associated with recording only the proportion of readmissions (Fischer et al., 2014). For example, individuals who have not been discharged at follow-up may not be considered readmitted. Additionally, the proportion of individuals discharged from the index admission may influence the proportion of people readmitted during the follow-up period. Additional information would need to be gathered to address this in a full trial. To address these limitations in the current study, the number of days admitted to an acute inpatient ward within 6-months of the index discharge was also recorded for each participant to further inform service use following discharge.
Although the proportion of readmissions at 12-months was pre-specified, the proportion of readmissions was recorded at 6-months instead (see ‘Protocol amendments’ section, page 110). The length of follow-up was reduced due to slow recruitment and time restrictions, therefore 6 months was the longest follow-up possible. Previous research of psychological intervention in acute inpatient settings has used between three- and 24-
2005; Gaudiano & Herbert, 2006; Schramm et al., 2007; Tarrier et al., 2004), therefore six months was considered acceptable for the current feasibility trial.
Proposed secondary outcomes for main trial
Three other clinical outcomes measures were pre-specified and collected. These included two self-report measures of emotional/psychological distress and one self-report measure of self-efficacy in relation to coping with metal health (see Appendix 11). Self-report measures have previously been rated as more acceptable measures, than clinician rated measures, to those with lived experiences of psychosis and affective disorder (Crawford et al., 2011), therefore only self-report questionnaires were used in this feasibility trial.
Questionnaires
Psychological/emotional distress
In line with the aims of the intervention, psychological (or emotional) distress was considered an important outcome to include in evaluating the psychological intervention. The influential and maintaining role of emotional/psychological distress in severe mental illnesses (SMI) and acute exacerbation of symptoms has been recognised (Birchwood & Trower, 2006; Clarke, 2015; Linehan, 1993). Additionally, results from the meta-analysis reported in Chapter three suggest that brief psychological therapy delivered during an acute psychiatric admission may reduce inpatients emotional distress (i.e. depression and anxiety) at post-intervention. Two measures of psychological distress were collected, one of which has been used in previous evaluation of the Woodhaven approach, therefore allowing for easy comparison. The second measure of psychological distress was included because it specifically measures physical symptoms of psychological distress (somatization). Details of these measures are described below.
The Clinical Outcomes in Routine Evaluation (CORE) 10 (Connell & Barkham, 2007) was one questionnaire used to measure psychological distress. It is a 10-item questionnaire measuring total psychological distress and three domains of distress: ‘problems’ largely relating to anxiety and depression (6 items), general and social ‘functioning’ (3 items) and ‘risk’ to self (1 item). Each item is measured on a 5-point scale ranging from 0 (not at all) to 4 (most or all of the time) with a higher score indicating higher severity. The 10 items have been taken from the 34-item CORE-OM. Although the CORE-OM is recommended where possible, the CORE 10 lends itself better to an
acute inpatient environment as it requires less time to complete. The CORE 10 has shown to have good internal reliability (.90) (Barkham et al., 2013), good internal consistency (0.82) in a primary care clinical sample (Connell & Barkham, 2007). Furthermore, it has previously been used by Clarke and colleagues to evaluate the Woodhaven Approach (Durrant & Tolland, 2009) (see Chapter 2).
According to the theory underpinning the psychological intervention (see intervention section), high states of arousal are associated with emotional distress experienced by acute inpatients (Clarke, 1999; Teasdale, 1993). The intervention, therefore, predominantly focuses on teaching or improving skills to cope with and tolerate such arousal (see intervention section and introduction). Consequently, reduced arousal was considered an important outcome of treatment. The Brief Symptom Inventory Scale (BSI- 18) (Derogatis, 2001) was chosen to capture this. The BSI-18 is a shortened version (18 items) of the BSI (Derogatis & Melisaratos, 1983) which is a 57-item self-report measure of psychological distress with nine dimensions. (Derogatis, 2001). Each item is scored on a 5 point Likert scale (0='not at all' to 4='extremely') with a higher score indicating higher severity. The BSI-18 was developed to include the most prevalent psychiatric symptoms of psychological distress: somatisation (6 items), depression (6 items) and anxiety (6 items), therefore the questionnaire was considered suitable to measure psychological distress in a cross-diagnostic population. Specifically, questions within the somatization subscale, such as ‘how much were you distressed by pains in your heart or chest, trouble getting your breath, spells of terror or panic, etc.’, were thought appropriate to capture changes in physical arousal targeted by the intervention. Furthermore, the BSI-18 is quick to administer, therefore suiting an acute inpatient population. The BSI-18 has shown good reliability for the global symptom index (GSI), somatization, depression and anxiety (.90, .68, .84, and .79 respectively) and good internal consistency (.89, .74, .84, and .79, respectively) (Derogatis, 2001).
Self-efficacy
There is strong support for the notion that self‐efficacy mediates the relationship between coping, and positive and negative outcomes (Salanova, Grau, & Martinez, 2006). In line with the person-centred approach, an aim of treatment was to increase patients’ feeling of control in terms of their symptoms, as opposed to just reducing presentation of symptoms. According to Clarke and colleagues (Durrant & Tolland, 2009),
that incorporate a coping strategy (e.g. attention control, self-compassion, distress tolerance and emotion regulation). Self-efficacy should therefore indicate intervention effectiveness. The Mental Health Confidence Scale (MHCS) was used to measure self- efficacy (Carpinello, Knight, Markowitz, & Pease, 2000). This measure was developed by a group involving mental health researchers, recipients of mental health services and individuals who have recovered from mental illness (Carpinello et al., 2000). It can therefore be considered a patient important outcome. The MHCS has also been identified as a recovery-related measure, therefore is in keeping with the recovery approach (Ralph, Kidder, Edmund, & Phillips, 2000). This measure was thought to be acceptable to participants as it contains ‘positive’ items which is an important feature of outcome measures identified by service user (Crawford et al., 2011). The MHCS measures self- efficacy in relation to mental health using 16 items that are rated on a six point Likert scale that ranges from 1 (very non-confident) to 6 (very confident) with a higher score indicating higher levels of self-efficacy. The 16 items include three domains: optimism, coping and advocacy. A total score is made up of the total of all items. Construct validity of this scale is high and error variance is low, therefore the measure is considered by the authors to be reliable (Carpinello et al., 2000).
Adverse events
Trials of psychological intervention have been criticized for failing to measure adverse events (Duggan et al., 2014). Therefore, as recommended, adverse events are reported in the current study (Duggan et al., 2014). The number of people who made contact with intensive home treatment teams (IHTT), the number of people who made contact with A&E services (in relation to mental health), the number of deaths related to mental health (e.g. suicide) and the number of participants not discharged at follow-up were recorded.
Proposed predictor of treatment outcome for main trial
Theoretically, the role of childhood adversity has been highlighted as a contributing factor of adulthood mental health problems (Clarke, 2002; Teasdale & Barnard, 1995); and in the last decade, supporting evidence has emerged. For example, a meta-analysis of 18 case controls, 10 prospective and quasi-experimental studies and 8 population based cross-sectional studies suggests childhood trauma is strongly associated with increased risk of developing psychosis in later life (Varese et al., 2012). Furthermore, a recent study, including 251 participants, has shown a positive correlation between the number of
experienced adverse childhood events and number of psychotic symptoms (Longden, Sampson, & Read, 2016). A recent meta-analysis has also suggested that childhood adversity is strongly associated with bipolar disorder compared to non-clinical controls (Palmier-Claus, Berry, Bucci, Mansell, & Varese, 2016). Given that acute psychiatric inpatient services commonly provide care for people with the diagnoses previously mentioned, it is possible that trauma may be a predicting factor of treatment outcome of psychological interventions delivered in acute inpatient settings. However, whether this is the case is currently unknown. To investigate this issue in a future definitive trial, an outcome of childhood trauma may be collected. However, some patients may find completing outcomes which measures childhood trauma unacceptable, given the sensitive nature of the questions. In order to determine the feasibility of exploring childhood trauma as a predictor of outcome of acute inpatient psychological intervention, a measure of childhood trauma was collected during the current study. The aim was to determine the feasibility of collecting a measure of childhood trauma as a predictor of treatment outcome in future definitive trials, based on the completion rate.
The Childhood Trauma Questionnaire Short Form (CTQ-SF) (Bernstein et al., 2003) is a retrospective self-report measure of childhood abuse and neglect. It consists of 28 items that focus on constructs of adverse childhood experiences such as emotional abuse, physical abuse, neglect and sexual abuse. Each item is rated on a 5-point scale from ‘Never true’ to ‘Very often true’, where a higher score indicates higher constructs of trauma. This measure includes five types of maltreatment: emotion abuse, physical abuse, sexual abuse, emotional neglect and physical neglect. It also includes a denial scale to detect false negative trauma. The scale is a valid measure in both clinical and non-clinical samples and has good criterion-related validity (Bernstein et al., 2003).