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Dissociative SymptomsHYDRANCT07895875

Clinical Hypnosis Versus Guided Imagery for Dissociative Symptoms in Adults

A study testing Clinical Hypnosis and Non-Hypnotic Guided Imagery in people with Dissociative Symptoms, run by University of Rome Foro Italico at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized controlled trial aims to investigate whether a brief clinical hypnosis intervention can reduce dissociative symptoms more effectively than guided imagery in adults receiving psychiatric care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dissociative Symptoms
What is being tested?
Clinical Hypnosis and Non-Hypnotic Guided Imagery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteItaly
Study dates
Mar 2027to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A total score of 30 or higher on the Dissociative Experiences Scale-II (DES-II).
  • Clinically significant dissociative symptomatology confirmed by the Structured Clinical Interview for DSM-IV Dissociative Disorders-Revised (SCID-D-R), operationalized as at least moderate severity in one or more core dissociative symptom domains.
  • Sufficient clinical stabilization to provide informed consent and safely participate in the intervention, as determined by the treating clinician and study assessor.
  • Sufficient fluency in Italian to complete study procedures. -

Who cannot join

  • A current schizophrenia-spectrum or other psychotic disorder.
  • A current substance use disorder judged to interfere with safe or reliable participation in the study.
  • Acute suicidal ideation or intent requiring immediate clinical intervention.
  • A severe neurological or neurocognitive condition that could substantially interfere with informed consent, comprehension, or participation in study procedures.
  • Concurrent participation in another structured experimental intervention specifically targeting dissociative symptoms.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Celeste Chianese, MSc contact

+393392991298

celeste.chianese@aslroma3.it

Francesca Strappini, PhD contact

+393921514029

francesca.strappini@uniroma4.it

Italy1 site
  • ASL Roma 3 - Centro di Salute Mentale Fiumicino

    Fiumicino, Lazio, 00054

    Celeste Chianese, MSc, +393392991298, celeste.chianese@aslroma3.it

    Celeste Chianese, MSc

Other trials in Italy

About this study

Official title: Targeting Dissociation Through Volitional Hypnosis: Protocol for a Randomized Controlled Trial

This randomized controlled trial aims to investigate whether a brief clinical hypnosis intervention can reduce dissociative symptoms more effectively than guided imagery in adults receiving psychiatric care.

Dissociative symptoms may include feelings of detachment from oneself or the surrounding environment, difficulties with memory, changes in the sense of identity, and a reduced sense of control over one's experiences. These symptoms can interfere with everyday functioning and occur across different mental health conditions.

Read more

The study will enroll approximately 160 adults with clinically significant dissociative symptoms. Participants will be randomly assigned to one of two groups: clinical hypnosis or non-hypnotic guided imagery. Both interventions will consist of four individual, in-person sessions lasting approximately 50 minutes each, delivered over 4-6 weeks alongside usual psychiatric care.

The clinical hypnosis intervention is designed to help participants recognize changes in their mental and bodily experiences, maintain awareness during these changes, and practice intentionally regulating them. The guided imagery intervention focuses on relaxation, sensory awareness, grounding, and emotional stabilization without using hypnosis-specific techniques.

The main outcome will be the severity of dissociative symptoms, measured using the Dissociative Experiences Scale-II (DES-II) approximately one week after the final session. Additional assessments will examine quality of life, psychological symptoms, and the safety and tolerability of both interventions. Follow-up evaluations at 3 and 6 months will assess whether any changes in dissociative symptoms are maintained.

The study will also explore whether participants' sense of control over their experiences may help explain treatment-related changes in dissociative symptoms.

Read the detailed description

Scientific Background and Rationale

Clinically significant dissociation involves disruptions in the integration of consciousness, memory, identity, perception, and the perceived control over mental states and behavior. Dissociative symptoms occur across a range of psychiatric conditions and are associated with considerable psychological distress and functional impairment. Despite their clinical relevance, evidence supporting specific psychological interventions targeting dissociative symptoms remains limited, particularly from adequately controlled randomized trials.

Clinical hypnosis is of particular interest because hypnosis and dissociation share certain phenomenological characteristics, including absorption, alterations in self-experience, and changes in perceived agency. However, these phenomena are conceptually distinct, and their relationship does not necessarily imply a shared underlying mechanism.

The HYDRA trial is informed by the clinical hypothesis that some spontaneous dissociative experiences may be understood as dysregulated self-hypnotic processes. This hypothesis is used as a therapeutic framework rather than an established explanation of dissociation. Accordingly, the intervention investigates whether structured practice in intentionally regulating hypnotic and absorption-like experiences may help individuals develop greater awareness of and control over experiences that are ordinarily perceived as involuntary.

Conceptual Framework: Volitional Hypnosis

For the purposes of this study, *volitional hypnosis* is defined as a study-specific operational construct referring to the capacity to intentionally initiate, observe, modulate, and terminate hypnotic or absorption-like experiential states while maintaining reflective awareness.

The clinical hypnosis intervention is informed by Ericksonian principles of individualized therapeutic communication, utilization, indirect suggestion, metaphor, and experiential learning. Within a structured and manualized framework, participants progressively practice recognizing early changes in experiential states, maintaining reflective awareness during these changes, and deliberately returning to a grounded, present-oriented state.

The intervention is conceived as an adjunctive self-regulation and skill-acquisition module rather than a comprehensive psychotherapy. It does not require the retrieval or processing of traumatic memories, and procedures intended to recover allegedly inaccessible memories are excluded.

Rationale for the Active Comparator

Non-hypnotic guided imagery was selected as an active comparator to provide a credible stabilization-oriented intervention while controlling for several nonspecific therapeutic factors, including therapist attention, treatment expectancy, focused attention, relaxation, mental imagery, and grounding.

The comparator incorporates structured imaginative and attentional exercises but excludes formal hypnotic induction, trance-deepening procedures, and suggestions explicitly aimed at intentionally entering, modifying, or terminating hypnotic states.

Because guided imagery may itself support emotional regulation and experiential engagement, it is not considered an inert control condition. This comparison is intended to provide a rigorous test of whether the explicit hypnotic framework and systematic training of volitional state regulation offer additional therapeutic benefits beyond those associated with a credible non-hypnotic psychological intervention.

Hypothesized Processes of Change

The primary clinical hypothesis is that clinical hypnosis will produce greater reductions in dissociative symptom severity than guided imagery.

An additional exploratory hypothesis concerns sense of agency, defined as the subjective experience of control over one's actions and experiences. The study will investigate whether changes in sense of agency during treatment are associated with subsequent changes in dissociative symptoms.

Baseline individual differences in hypnotic suggestibility, interoceptive awareness, and alexithymia will also be explored as potential moderators or prognostic factors of treatment response. These analyses are exploratory and are not intended to establish causal mechanisms.

Safety and Clinical Considerations

Given the potential vulnerability of individuals experiencing clinically significant dissociation, both interventions incorporate standardized procedures for monitoring distress, dissociative destabilization, orientation, and perceived control. Procedures for grounding, reorientation, temporary suspension, and clinical reassessment are prespecified and applied consistently across treatment conditions.

Adverse events and treatment tolerability will be systematically monitored. Independent clinical safety oversight is planned throughout the study.

By comparing clinical hypnosis with an active psychological intervention, the HYDRA trial aims to clarify the potential clinical utility, safety, and specific contribution of volitional hypnotic training in the management of dissociative symptoms.

Being tested
Clinical Hypnosis, Non-Hypnotic Guided Imagery
Keywords
Clinical Hypnosis, Dissociation, Volitional Control, Sense of Agency, Ericksonian Hypnosis, Guided Imagery, Randomized Controlled Trial
Medical subject headings
Dissociative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical HypnosisBehavioural

    Also called Volitional Hypnosis

    A manualized, four-session Ericksonian clinical hypnosis intervention designed to develop intentional regulation of dissociative and absorption-like experiences. Sessions incorporate permissive hypnotic induction, therapeutic metaphors, indirect suggestions, dual-awareness training, and structured practice in recognizing, modulating, and terminating hypnotic states. Each individual session lasts approximately 50 minutes and is delivered in person every 10-12 days. The intervention is provided alongside usual psychiatric care.

  • Non-Hypnotic Guided ImageryBehavioural

    A manualized, four-session non-hypnotic guided imagery intervention focusing on sensory grounding, voluntary mental imagery, attentional flexibility, and emotional stabilization. Sessions involve structured imagery exercises, present-moment sensory awareness, and attention-shifting practices, without formal hypnotic induction or trance-deepening procedures. Each individual session lasts approximately 50 minutes and is delivered in person every 10-12 days. The intervention is provided alongside usual psychiatric care.

Study groups in NCT07895875
Study groupRoleWhat they receive
Clinical HypnosisExperimentalParticipants assigned to this arm will receive four individual, in-person sessions of manualized Ericksonian clinical hypnosis, delivered approximately every 10-12 days. Each session will last approximately 50 minutes (±5 minutes). The intervention is designed to develop the ability to recognize, observe, and intentionally regulate dissociative or absorption-like experiential states while maintaining reflective awareness. Treatment progressively focuses on stabilization and recognition of experiential changes, dual awareness, voluntary modulation of hypnotic states, and consolidation of self-regulation skills. Sessions incorporate permissive hypnotic induction, individualized therapeutic metaphors, indirect suggestions, structured experiential exercises, and standardized grounding and reorientation procedures. The intervention does not involve trauma-memory retrieval or processing. Clinical hypnosis will be delivered as an adjunct to usual psychiatric care, which participants will
Receives: Behavioral: Clinical Hypnosis
Non-Hypnotic Guided ImageryActive comparatorParticipants allocated to this arm will receive four individual, in-person sessions of manualized non-hypnotic guided imagery, delivered approximately every 10-12 days. Each session will last 50 minutes (±5 minutes), matching the experimental condition in duration, frequency, and therapist contact. The intervention focuses on sensory grounding, voluntary mental imagery, attentional flexibility, and emotional stabilization. Participants will progressively practice constructing calming mental images, maintaining awareness of their physical surroundings, shifting attention between imagined and external sensory experiences, and independently applying these strategies in daily life. The intervention will exclude formal hypnotic induction, trance-deepening procedures, post-hypnotic suggestions, and techniques explicitly aimed at intentionally entering, modifying, or terminating hypnotic states. Participants will continue to receive their usual psychiatric care throughout the trial.
Receives: Behavioral: Non-Hypnotic Guided Imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dissociative Symptom Severity (DES-II Total Score) Copia

    Dissociative symptom severity will be assessed using the Dissociative Experiences Scale-II (DES-II), a 28-item self-report questionnaire measuring the frequency of dissociative experiences. The total score is calculated as the mean of the 28 item scores and ranges from 0 to 100, with higher scores indicating greater dissociative symptom severity.

    The primary endpoint is the DES-II total score at post-treatment. The primary treatment effect will be estimated as the adjusted between-group difference in post-treatment DES-II scores, controlling for baseline DES-II.

    Measured: 7 ± 3 days after the fourth intervention session (post-treatment).

Secondary outcomes (7)
  1. Dissociative Symptom Severity at 3-Month Follow-up (DES-II)

    Dissociative symptom severity will be assessed using the Dissociative Experiences Scale-II (DES-II), a 28-item self-report measure. The total score ranges from 0 to 100, with higher scores indicating greater dissociative symptom severity. This secondary endpoint will evaluate maintenance of treatment effects at 3-month follow-up.

    Measured: 3 months after Session 4 (±14 days)

  2. Dissociative Symptom Severity at 6-Month Follow-up (DES-II)

    Dissociative symptom severity will be assessed using the Dissociative Experiences Scale-II (DES-II), a 28-item self-report measure. The total score ranges from 0 to 100, with higher scores indicating greater dissociative symptom severity. This secondary endpoint will evaluate maintenance of treatment effects at 6-month follow-up.

    Measured: 6 months after Session 4 (±14 days).

  3. Global Psychological Distress (SCL-90-R Global Severity Index)

    Global psychological distress will be assessed using the Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R). The GSI summarizes overall psychological symptom distress, with higher scores indicating greater severity. Post-treatment scores will be compared between groups, adjusting for baseline values.

    Measured: Baseline and 7 ± 3 days after Session 4 (post-treatment).

  4. PTSD Symptom Severity (CAPS-5 Total Score)

    PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), restricted to participants meeting DSM-5 Criterion A for traumatic exposure at baseline. The total symptom severity score is calculated by summing the severity ratings of the 20 DSM-5 PTSD symptoms, ranging from 0 to 80, with higher scores indicating greater symptom severity. The same index traumatic event will be used at baseline and post-treatment.

    Measured: Baseline and 7 ± 3 days after Session 4 (post-treatment).

  5. Anxiety Symptom Severity (GAD-7 Total Score)

    Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a seven-item self-report questionnaire measuring symptoms over the preceding two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Post-treatment scores will be compared between groups, adjusting for baseline values.

    Measured: Baseline and 7 ± 3 days after Session 4 (post-treatment).

  6. Depressive Symptom Severity (PHQ-9 Total Score)

    Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a nine-item self-report questionnaire measuring depressive symptoms over the preceding two weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Post-treatment scores will be compared between groups, adjusting for baseline values.

    Measured: Baseline and 7 ± 3 days after Session 4 (post-treatment).

  7. Quality of Life (WHOQOL-BREF)

    Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), a 26-item self-report questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment. Domain scores will be calculated according to standard WHO scoring procedures, with higher scores indicating better quality of life. The four domain scores will be analyzed separately, without calculating an overall total score. Post-treatment scores will be compared between treatment groups, adjusting for the corresponding baseline values.

    Measured: Baseline and 7 ± 3 days after Session 4 (post-treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study startMar 2027 (estimated)
  3. Primary completionMay 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895875
Sponsor's protocol ID
HYDRA-RCT-2026-01
Acronym
HYDRA
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data (IPD) will not be made openly available due to the clinical sensitivity of the study population and the potential risk of participant re-identification. De-identified and data-minimized participant-level datasets may be shared with qualified researchers upon reasonable request, subject to participant consent, Ethics Committee approval, applicable GDPR requirements, and an appropriate data-use agreement. Data elements presenting an unacceptable risk of re-identification will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Hypnosis and Non-Hypnotic Guided Imagery in people with Dissociative Symptoms, run by University of Rome Foro Italico at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Celeste Chianese, MSc (+393392991298, celeste.chianese@aslroma3.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dissociative Symptom Severity (DES-II Total Score) Copia (time frame: 7 ± 3 days after the fourth intervention session (post-treatment).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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