NCT07880028Toborzás még nem indult
Adapted Group Therapy Compared With Usual Care for Anxiety and Depression in Adults With an Autism Diagnosis
A Randomised, Unblinded Trial Evaluating a 12-week Autism-adapted Group Cognitive Behavioural Therapy Versus Treatment as Usual Adults (18+) With Autism Spectrum Diagnosis and Co-occurring Anxiety and/or Depressive Disorders.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 19.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to learn whether an adapted group therapy works to treat anxiety and depression in adults with an autism diagnosis. The therapy is a form of cognitive behavioral therapy (CBT). CBT is a talking therapy. It helps people work with their thoughts, feelings, and habits. This version is adapted for adults with an autism diagnosis. The room is quiet and calm. Each session follows the same plan. The group uses a workbook. The clinic already offers this therapy. No one has yet tested how well it works compared to usual care. The main questions it aims to answer are: * Does the group therapy help participants feel better overall after 12 weeks? * Does it lower symptoms of anxiety and low mood more than usual care? * Do participants still feel better 3 months after the therapy ends? Researchers will compare the adapted group therapy with usual care. Usual care is the one-to-one follow-up that participants already get at the clinic. A computer places each participant in one of the two groups at random. This means chance decides, not the researchers and not the participant. Adults can take part if they: * Are 18 years or older * Have an autism diagnosis * Have anxiety or low mood * Already get care at the clinic Participants will: * Keep their own therapist and their usual care for the whole study * Start the group therapy now, or stay with usual care and get the same group offer later, about 6 to 7 months after the start * Meet in a group of 6 to 10 people for 1 hour a week for 12 weeks, if they start the group therapy now * Answer questionnaires on a phone or computer at the start, each week for 12 weeks, and again after 3 and 6 months * Choose whether to wear a heart rate band during group sessions. This is optional. Participants can take it off at any time. The study takes place at one outpatient clinic in Oslo, Norway.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 154 (tervezett)
- Első benyújtás
- 2026. okt. 11.
- Kezdés
- 2026. okt. 19.
- Elsődleges befejezés
- 2030. szept. 1.
- Fő szponzor
- Lovisenberg Diakonale Hospital
- Betegségek
- Autizmus spektrumzavar
- NCT-szám
- NCT07880028
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 154
- 2026. okt. 19. és az elsődleges befejezés (2030. szept. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Concurrent structured psychotherapy for anxiety or depression delivered by a provider outside the participating services, which would confound attribution of any change
Más betegség
- Severe underweight or a severe eating disorder requiring specialist treatment
Egyéb
- Acute psychosis, mania, or a severe depressive episode requiring intensive or inpatient care at enrollment
- Intellectual disability (ICD-10 F70 to F73)
- Circumstances in which the responsible clinician judges that participation in a group format would not be clinically appropriate at this time
Kiket keres a vizsgálat
- Aged 18 years or older
- A clinical autism spectrum diagnosis recorded in the patient record (ICD-10 F84.0, F84.1, F84.5, F84.8 or F84.9)
- Anxiety and/or depressive symptoms at a clinical level, evidenced either by a recorded diagnosis (ICD-10 F41.1 to F41.9, F32, F33 or F34.1) or by a description of such symptoms in the patient record
- Sufficient knowledge of Norwegian to take part in group discussion and to complete written exercises without an interpreter
- Verbal and cognitive capacity sufficient to take part in group discussion and written exercises
- An assigned responsible clinician at the hospital who will remain responsible for the participant's care throughout the study period
- Capacity to give informed consent, and written informed consent given
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.