NCT07880028Not yet recruiting
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.
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 11 Oct 2026
- Start date
- 19 Oct 2026
- Primary completion date
- 1 Sept 2030
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Diseases
- Autism
- NCT number
- NCT07880028
What you commit to
- Study type: Interventional
- Planned participants: 154
- From 19 Oct 2026 to the primary completion date, 1 Sept 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent structured psychotherapy for anxiety or depression delivered by a provider outside the participating services, which would confound attribution of any change
Other illness
- Severe underweight or a severe eating disorder requiring specialist treatment
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.