- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314515
The ECHO Study: Compassion-focused Therapy for Young Voice Hearers and Their Caregivers (ECHO)
In this project, a 10-session treatment program was developed aimed at young people who experience voice hearing. The treatment has potential to easily be implemented in everyday clinical practice in Child and Adolescent Psychiatry, and eventually in Educational Psychological Counselling (PPR) and the newly established STIME services (low-threshold municipal treatment offers for children and young people).
As part of the treatment, the young person's caregivers are involved. This means a high degree of involvement from adults who know the young person well and are part of their daily life.
In addition to traditional Compassion-focuced therapy (CFT), the treatment is expanded with an intervention where an audio file is recorded with content corresponding to the adolescent's voice hearing. The parents are invited to listen to the audio file while participating in a therapy session. This will help improve the caregivers understanding of the young person's experiences and challenges.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maja K Musaeus, Psychologist
- Phone Number: +4591543221
- Email: maja@musaeus.eu
Study Contact Backup
- Name: Vibeke F Bliksted, Professor
- Email: vibeke.fuglsang.bliksted@rsyd.dk
Study Locations
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Esbjerg, Denmark
- Psychiatriatric Children and Youth Hospital
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Contact:
- Maja K Musaeus, Psychologist
- Phone Number: 91543221
- Email: maja@musaeus.eu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participants should have been referred to a child and adolescent psychiatric hospital in Denmark .
- The participants have heard voices within the last 2 weeks.
- The participant can hear the content of the voices. The content takes the form of spoken works.
- A caregiver who can participate in 5 sessions
Exclusion Criteria:
- Participants has an estimated IQ under 70
- Participants who don't speak and understand Danish,
- Current drug misuse / abuse (during sessions)
- Brain injury or neurological disorder e.g. severe epilepsy
- Impaired vision or hearing to a degree that makes participation in therapy under normal conditions impossible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 10 sessions manualized CFT treatment for young voice heares
60 voice hearing patients age 13-18 years old 20 patients with first-episode schizophrenia age 18-21
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A manualized 10 session, intervention inspired by compassion focused therapy.
A primary caretaker paticipates in 5 sessions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interpretation and relationship with the voices
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up.
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Psychotic symptoms are measured with: BAVQ-R (Beliefs about Voices Questionnaire - Revised) (Chadwick et al., 2000).(
35 items are rated (0-3) total minimum score 0, maximum score 105.
Some scores indicate higher distress, while other indicate lower distress).
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up.
|
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Severity and phenomenological characteristics of voice hearing
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up.
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PSYRATS AH (Psychotic Symptoms Rating Scale Auditory Hallucinations) (Haddock et al., 1999).
(11 items are rated (0-4) total minimum score 0, maximum score 44.
Higher score being more severe)
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up.
|
|
Perceived ability to control or influence the voices
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up.
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The Yale Control Over Perceptual Experiences (COPE) Scales measures voluntary control over voices such as being able to intentionally influence the timing, frequency, or intensity of voice hearing experiences (Mourgues et al., 2022).
(36 items are rated (1-7) total minimum score 36, maximum score 252.
Higher scores indicate stronger perceived control over voices)
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Social Cognition
Time Frame: Social cognition is tested 3 months before treatment and right after
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Social cognition is tested with TASIT 2A DK (The Awareness of Social Inference Test) (McDonald et al., 2003).
(60 items are rated, minimum total score 0, maximum score is 60.
Lower score being more severe)
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Social cognition is tested 3 months before treatment and right after
|
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Subjective experience of feeling safe, accepted, and soothed in social relationships.
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
|
SSPS (Social safeness and pleasure scale) (Gilbert et al., 2009).
(11 items are rated (1-5).
Total minimum 11, total maximum 55.
Lower score being more severe).
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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Compassion towards self.
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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SCS-SF (Self-Compassion Scale Short Form) (Raes et al., 2011; Neff et al., 2019) (12 items are rated (1-5) total minimum 12, total maximum 60.
Lower score being more severe).
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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Subjective sense of interpersonal closeness and belonging
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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The Social Connectedness Scale Revised (Lee et al., 1995; Sabitelli et al., 2005).
(8 items are rated (1-6).
Total minimum score 8, total maximum score 48.
Lower score being more severe).
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
|
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Perceived availability and adequacy of social support
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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MSPSS (The Multidimensional Scale of Perceived Social Support) (Zimet et al. 1988).(12
items are rated (1-7) total minimum 12, total maximum 84.
Lower score being more severe).
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary caregivers
Time Frame: Before treatment
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Factual information about the young person: Education, cohabiting or divorced parents, the young person's residence, family history of mental illness, diagnosis and medication of the young person
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Before treatment
|
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Additional questions
Time Frame: Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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Additionally, questions are asked about how well you feel your parents understand you (e.g., do they know what motivates you and what scares you?) (Likert scale 1-10).
Questions about daily stress, sleep, violence and abuse, well-being and quality of life, interaction with family and friends (from the "How are you?"
survey among youth in the Central Denmark Region).
Quality of life is measured with WHO-5.
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Data is collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Charlie Heriot-Maitland, Dr., Balanced Minds
Publications and helpful links
General Publications
- Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
- Heriot-Maitland C. Position paper - CFT for psychosis. Psychol Psychother. 2024 Mar;97(1):59-73. doi: 10.1111/papt.12490. Epub 2023 Aug 14.
- Neff KD, Toth-Kiraly I, Yarnell LM, Arimitsu K, Castilho P, Ghorbani N, Guo HX, Hirsch JK, Hupfeld J, Hutz CS, Kotsou I, Lee WK, Montero-Marin J, Sirois FM, de Souza LK, Svendsen JL, Wilkinson RB, Mantzios M. Examining the factor structure of the Self-Compassion Scale in 20 diverse samples: Support for use of a total score and six subscale scores. Psychol Assess. 2019 Jan;31(1):27-45. doi: 10.1037/pas0000629. Epub 2018 Aug 20.
- Gilbert, P., Introducing compassion-focused therapy. Advances in psychiatric treatment, 2009. 15(3): p. 199-208.
- Mourgues C, Hammer A, Fisher V, Kafadar E, Quagan B, Bien C, Jaeger H, Thomas R, Sibarium E, Negreira AM, Sarisik E, Polisetty V, Nur Eken H, Imtiaz A, Niles H, Sheldon AD, Powers AR. Measuring Voluntary Control Over Hallucinations: The Yale Control Over Perceptual Experiences (COPE) Scales. Schizophr Bull. 2022 May 7;48(3):673-683. doi: 10.1093/schbul/sbab144.
- Woods, S. W., Parker, S., Kerr, M. J., Walsh, B. C., Wijtenburg, S. A., Prunier, N., Nunez, A. R., Buccilli, K., Mourgues-Codern, C., Brummitt, K., Kinney, K. S., Trankler, C., Szacilo, J., Colton, B.-L., Ali, M., Haidar, A., Billah, T., Huynh, K., Ahmed, U., Adery, L. L., Marcy, P. J., Allott, K., Amminger, P., Arango, C., Broome, M. R., Cadenhead, K. S., Chen, E. Y. H., Choi, J., Conus, P., Cornblatt, B. A., Glenthøj, L. B., Horton, L. E., Kambeitz, J., Kapur, T., Keshavan, M. S., Koutsouleris, N., Langbein, K., Lavoie, S., Diaz-Caneja, C. M., Mathalon, D. H., Mittal, V. A., Nordentoft, M., Pasternak, O., Pearlson, G. D., Gaspar, P. A., Shah, J. L., Smesny, S., Stone, W. S., Strauss, G. P., Wang, J., Corcoran, C. M., Perkins, D. O., Schiffman, J., Perez, J., Mamah, D., Ellman, L. M., Powers, A. R. III, Coleman, M. J., Anticevic, A., Fusar-Poli, P., Kane, J. M., Kahn, R. S., McGorry, P. D., Bearden, C . E., Shenton, M. E., Nelson, B., Calkins, M. E., Hendricks, L., Bouix, S., Addington, J., McGlashan, T. H., Yung, A. R., & The Accelerating Medicines Partnership Schizophrenia (2024). Development of the PSYCHS: Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS. Early Intervention in Psychiatry, 18(4), 255-272. https://doi.org/10.1111/eip.13457
- Chandwick P, Lees S, Birchwood M. The revised Beliefs About Voices Questionnaire (BAVQ-R). Br J Psychiatry. 2000 Sep;177:229-32. doi: 10.1192/bjp.177.3.229.
- McDonald S, Flanagan S, Rollins J, Kinch J. TASIT: A new clinical tool for assessing social perception after traumatic brain injury. J Head Trauma Rehabil. 2003 May-Jun;18(3):219-38. doi: 10.1097/00001199-200305000-00001.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1852876
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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