Psychological Therapy for Dissociation, Trauma and Voices: A Single Case Experimental Design

NCT04127526 | Completed

• 1 other identifier: GN19MH346
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dissociation; Auditory Hallucination; Trauma, Psychological; Psychosis

Keywords

Dissociation; Psychosis; Trauma; Hallucinations; Psychological Therapies

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• 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

• 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 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

Other Outcomes (2)

• Participant experience:

  This will be administered at 1-month follow up only

• Trauma History

  This will be administered at screening only

Study Arms (3)

Baseline Period of 2 weeks

ACTIVE COMPARATOR

2 participants will be randomly allocated to a baseline of 2 weeks before commencing CONNECT intervention.

Other: Connection to Environment with Cognitive Therapy (CONNECT)

Baseline Period of 3 weeks

ACTIVE COMPARATOR

2 participants will be randomly allocated to a baseline of 3 weeks before commencing CONNECT intervention.

Other: Connection to Environment with Cognitive Therapy (CONNECT)

Baseline Period of 4 weeks

ACTIVE COMPARATOR

2 participants will be randomly allocated to a baseline of 4 weeks before commencing CONNECT intervention.

Other: Connection to Environment with Cognitive Therapy (CONNECT)

Interventions

Connection to Environment with Cognitive Therapy (CONNECT) OTHER

8 sessions of strategies to reduce dissociation. Flexible, toolbox approach including but not limited to grounding strategies using objects, therapy oils and naming objects in the room.

Baseline Period of 2 weeks; Baseline Period of 3 weeks; Baseline Period of 4 weeks

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \> 20.
• 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.

You may not qualify if:

• Concurrently receiving another form of psychological intervention.
• Cognitive impairment that may impact ability to consent and/or engage.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS GG&C Glasgow Psychological Trauma Service (The Anchor)

Glasgow, Scotland, G51 1DH, United Kingdom

Location

MeSH Terms

Conditions

Dissociative Disorders; Hallucinations; Psychological Trauma; Psychotic Disorders; Wounds and Injuries

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrew Gumley

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Case Experimental Design. All participants will receive treatment and outcomes during treatment period will be compared to a randomized baseline period of two, three or four weeks (2 participant in each baseline arm).

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 15, 2019
• Study Start: September 11, 2019
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)