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NCT Number: NCT07314515

The ECHO Study: Compassion-focused Therapy for Young Voice Hearers and Their Caregivers

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.

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Key information

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatriatric Children and Youth Hospital

Esbjerg, Denmark

Location contact

Maja K Musaeus, Psychologist

CONTACT

[email protected]

91543221

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECHO Manualized CFT treatment for young voice heares

Behavioral

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

Other names: 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

Primary outcomes

  1. 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.

    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).

  2. 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.

    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)

  3. 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.

    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)

Secondary outcomes

  1. Social Cognition

    Time frame: Social cognition is tested 3 months before treatment and right after

    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)

  2. 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).

  3. 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

    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).

  4. 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

    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).

  5. 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

    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).

Other outcomes

  1. Primary caregivers

    Time frame: Before treatment

    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

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maja K Musaeus, Psychologist

CONTACT

[email protected]

+4591543221

Vibeke F Bliksted, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Region Syddanmark

Registry information

Acronym: ECHO

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 2, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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