Connection to Environment With Cognitive Therapy (CONNECT): Exploring Trauma, Voices and Dissociation Through Targeted Psychological Intervention. A Single-Case Experimental Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Changes in Dissociation
研究概览
简要总结
Connection to Environment with Cognitive Therapy (CONNECT): A Single-Case Experimental Design Exploring Dissociative Experiences and Voices
Emerging empirical evidence has suggested that dissociation is a robust determinant of voice-hearing in psychosis, and that dissociation mediates the link between trauma and voices. Despite the emerging evidence-base, targeted therapeutic interventions focusing on dissociation remain largely untested.
The aim of the current study is to investigate whether targeting dissociation leads to improvements in distressing voices in people with a history of trauma. This will be done by delivering an eight session intervention called 'CONNECT' to six individuals within the Glasgow Psychological Trauma Service (GPTS) who hear voices, have experienced trauma and are dissociating. The intervention will focus on learning strategies to manage dissociation. It is hypothesised that reduced levels of dissociation will be associated with reduction in the frequency and distress associated with hearing voices.
This study will use a randomized multiple baseline single-case experimental design, meaning that participants will be randomly allocated to a baseline of two, three or four weeks and then will begin eight weeks of Connection to Environment Cognitive Therapy (CONNECT). As well as daily measures during baseline and intervention phases, there will be four assessment points (baseline, pre-intervention, post-intervention and follow-up). The study will take approximately three months plus follow-up one month after therapy ends. Individual levels of dissociation and voices will be compared during baseline and intervention periods using visual analysis and Tau-U.
This study will contribute to the evidence-based for dissociation interventions targeting distressing voices among this population. It serves to investigate the proposed mechanism in a clinical population using a therapeutic intervention. It will therefore inform clinicians of the effectiveness and feasibility of using such strategies in clinical practice and may have good generalizability to practice.
详细描述
- Purpose and Design:
We will use a single case experimental design (SCED). This approach is common in early stage studies when exploring whether an intervention creates therapeutic change, typically by applying multiple measures to investigate the constructs of interest. A SCED also offers advantages for this type of exploratory research over a randomized controlled trial (RCT), because of the rich detail in the data and reduced research costs. Also, because individuals are compared against their own baseline scores, a smaller sample can be recruited and participants do not need to be matched by age, education or other variables to have a comparable control group, like in a RCT. For a targeted intervention, like CONNECT, which is predicted to lead to change in voices, even after therapy has stopped, a multiple- baseline design is the most appropriate form of SCED. We will randomize participants to baseline periods of either two, three, or four weeks before the intervention begins. This increases confidence that any therapeutic change is more likely to be because of the intervention, not just natural change over time. Equally, if therapeutic change is demonstrated across participants allocated to different baseline lengths, we can be confident that it is not the length of the baseline that is responsible for this effect.
Importantly, this study has been carefully designed in close partnership with the GPTS to ensure that it is in line with routine care. Open and close communication between the main researcher, the field supervisor and the wider team will be important to manage any ethical issues that may arise. 2. Aims and Hypotheses The aim of the current study is to investigate whether targeting dissociation through Connection to Environment Cognitive Therapy (CONNECT) is associated with improvements in distressing voices in people with a history of trauma. It is hypothesized that reductions in dissociation will lead to improvements in the frequency and distress associated with hearing voices.
Primary Hypotheses:
- Dissociation will significantly reduce following CONNECT therapy.
- Voice frequency and distress will significantly reduce following CONNECT therapy.
- Reductions in dissociation will precede reductions in voice frequency and distress
Secondary Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be randomized to 3 baseline periods of two, three or four weeks. Both therapist (who is also the main researcher) and participant will be aware of which baseline arm the participant has been randomised to upon beginning the baseline, however not before this.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voices: Hearing a voice/voices for a minimum of six months. Score ≥ 2 (i.e. "Voices occurring at least once a day") on the frequency item of the Psychotic Symptom Rating Scale (PSYRATS). Score ≥ 3 (i.e. "Voices are very distressing, although subject could feel worse") on the distress intensity rating of the PSYRATS.
- •Trauma: Score ≥ 1 on any of the items of the Brief Betrayal Trauma Survey-14 (BBTS-14) assessing lifetime exposure to interpersonal trauma.
- •Dissociation: Dissociative Experiences Scale Taxon (DES-T) score suggestive of clinical levels of dissociative symptoms, as indicated by a score >
- •Treatment motivation: Indicated that they consider voices and dissociation as a presenting difficulty, and that they would like to receive a psychological intervention specifically designed to address these difficulties. This will be assessed using four items integrated in the PSYRATS interview administered and the self-reported therapy goals generated through the initial assessment in the GPTS.
- •Capacity to provide informed consent.
- •Deemed to have sufficient English to engage in therapy or have access to an appropriate interpreter within the GPTS.
排除标准
- •Concurrently receiving another form of psychological intervention.
- •Cognitive impairment that may impact ability to consent and/or engage.
研究组 & 干预措施
Baseline Period of 2 weeks
2 participants will be randomly allocated to a baseline of 2 weeks before commencing CONNECT intervention.
干预措施: Connection to Environment with Cognitive Therapy (CONNECT) (Other)
Baseline Period of 3 weeks
2 participants will be randomly allocated to a baseline of 3 weeks before commencing CONNECT intervention.
干预措施: Connection to Environment with Cognitive Therapy (CONNECT) (Other)
Baseline Period of 4 weeks
2 participants will be randomly allocated to a baseline of 4 weeks before commencing CONNECT intervention.
干预措施: Connection to Environment with Cognitive Therapy (CONNECT) (Other)
结局指标
主要结局
Changes in Dissociation
时间窗: Changes in dissociation measured daily from beginning to end of baseline and beginning to end of therapy
Dissociation will also be measured using a daily self-report measure as used in previous studies (Varese et al., 2012). This consists of one question about dissociation "how much has dissociation been a problem today?" with answers ranging from 0% (never) to 100% (always).
Changes in Voices
时间窗: Changes in voices measured daily from beginning to end of baseline and beginning to end of therapy
Voices will also be measured using a daily self-report measure as used in previous studies (Varese et al., 2012). This consists of one question about voices "how much have the voices been a problem today?" with answers ranging from 0% (never) to 100% (always)
Changes in Voices
时间窗: Changes in voices measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up
Changes in voices will be measured using the Voice Hearing subscale of the Psychotic Symptom Rating Scale (PSYRATS; Haddock et al, 1999). This comprises of 12-items with responses ranging from 0 (absent) to 4 (severe).
Changes in Voices
时间窗: Changes in voices measured in each session from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up
Voices will also be measured using a session measure as used in previous studies (Varese et al., 2012). This is a 5-item scale with questions on voice frequency, distress and control. Responses range from a scale of 0% to 100%.
Changes in Dissociation
时间窗: Changes in dissociation measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up
Changes in Dissociation will be measured using The Revised Dissociative Experiences Scale (DES-II, Carlson \& Putnam, 1993). A 28-item, self-report measure of dissociative experiences in daily life with answers ranging from 0-100%.
Changes in Dissociation
时间窗: Changes in dissociation measured in each session from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up
Changes in dissociation will also be measured using a session measure as used in previous studies (Varese et al., 2012). This includes seven questions relating to dissociative experiences in the past week, with answers ranging from 0% (never) to 100% (always).
次要结局
- Changes in Perceived Movement Towards Goals(Changes in movement towards goals will be measured daily from beginning to end of baseline and beginning to end of therapy)
- Changes in Therapeutic Alliance(Changes in Therapeutic Alliance measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up)
- Changes in Psychological distress(Changes in distress measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up)