Psychosis Clinical Trial
— CONNECTOfficial title:
Connection to Environment With Cognitive Therapy (CONNECT): Exploring Trauma, Voices and Dissociation Through Targeted Psychological Intervention. A Single-Case Experimental Design
Verified date | October 2020 |
Source | NHS Greater Glasgow and Clyde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 21, 2020 |
Est. primary completion date | September 21, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. Trauma: Score = 1 on any of the items of the Brief Betrayal Trauma Survey-14 (BBTS-14) assessing lifetime exposure to interpersonal trauma. 3. Dissociation: Dissociative Experiences Scale Taxon (DES-T) score suggestive of clinical levels of dissociative symptoms, as indicated by a score > 20. 4. 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. 5. Capacity to provide informed consent. 6. Deemed to have sufficient English to engage in therapy or have access to an appropriate interpreter within the GPTS. Exclusion Criteria: 1. Concurrently receiving another form of psychological intervention. 2. Cognitive impairment that may impact ability to consent and/or engage. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS GG&C Glasgow Psychological Trauma Service (The Anchor) | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participant experience: | Will be measured using Satisfaction with Therapy Questionnaire (STQ) (Lawlor et al., 2017). A 22-item self-report to assess satisfaction with CBTp. Items are scored on a scale ranging from 1 to 5, with higher scores corresponding to higher satisfaction | This will be administered at 1-month follow up only | |
Other | Trauma History | Brief Betrayal Trauma Survey (BBTS; Goldberg & Freyd, 2006) is a 14-item self-report measure of frequency of traumatic experiences with responses ranging from 'never', 'one or two times' or 'more than that'. | This will be administered at screening only | |
Primary | Changes in Voices | 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 measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up | |
Primary | Changes in Voices | 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 voices measured in each session from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up | |
Primary | Changes in Voices | 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 measured daily from beginning to end of baseline and beginning to end of therapy | |
Primary | Changes in Dissociation | 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 measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up | |
Primary | Changes in Dissociation | 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). | Changes in dissociation measured in each session from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up | |
Primary | Changes in Dissociation | 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 dissociation measured daily from beginning to end of baseline and beginning to end of therapy | |
Secondary | Changes in Psychological distress | Measured using the CORE-10 (Barkham et al, 2013). A 10-item scale of psychological distress, with four-point likert-responses. Will be administered at screening, beginning of baseline, beginning of therapy, end of therapy, 1 month follow-up | Changes in distress measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up | |
Secondary | Changes in Therapeutic Alliance | Will be measured using the Working Alliance Inventory - Short Revised (Hatcher & Gillaspy, 2006). The WAI-SR is a self-report scale consisting of 12 items rated on a five-point likert scale. The WAI-SR has good reliability and validity with moderate correlation to clinical outcomes (r=0.24; Martin et al., 2000). | Changes in Therapeutic Alliance measured from beginning to end of baseline; beginning to end of therapy and at 1 month follow-up | |
Secondary | Changes in Perceived Movement Towards Goals | Changes in perceived movement towards personalized goals will be measured through the daily measure question "to what extent do you feel that you have moved towards your goal of X today?". Answers will range from 0% (not at all) to 100% (extremely) | Changes in movement towards goals will be measured daily from beginning to end of baseline and beginning to end of therapy |
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