NCT07314515

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

December 3, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

voice hearing

Outcome Measures

Primary Outcomes (3)

  • Interpretation and relationship with the voices

    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).

    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.

  • Severity and phenomenological characteristics of voice hearing

    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)

    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

    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)

    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.

Secondary Outcomes (5)

  • Social Cognition

    Social cognition is tested 3 months before treatment and right after

  • Subjective experience of feeling safe, accepted, and soothed in social relationships.

    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

  • Compassion towards self.

    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

  • Subjective sense of interpersonal closeness and belonging

    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 availability and adequacy of social support

    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

Other Outcomes (2)

  • Primary caregivers

    Before treatment

  • Additional questions

    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

Study Arms (1)

10 sessions manualized CFT treatment for young voice heares

EXPERIMENTAL

60 voice hearing patients age 13-18 years old 20 patients with first-episode schizophrenia age 18-21

Behavioral: ECHO Manualized CFT treatment for young voice heares

Interventions

A manualized 10 session, intervention inspired by compassion focused therapy. A primary caretaker paticipates in 5 sessions.

Also known as: 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
10 sessions manualized CFT treatment for young voice heares

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatriatric Children and Youth Hospital

Esbjerg, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 37578215BACKGROUND
  • 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.

  • 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.

  • 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.

  • Gilbert, P., Introducing compassion-focused therapy. Advances in psychiatric treatment, 2009. 15(3): p. 199-208.

    RESULT
  • 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

    RESULT
  • 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.

MeSH Terms

Conditions

Hallucinations

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charlie Heriot-Maitland, Dr.

    Balanced Minds

    STUDY CHAIR

Central Study Contacts

Maja K Musaeus, Psychologist

CONTACT

Vibeke F Bliksted, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

January 2, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations