Autism Spectrum Disorder (ASD)CoMindNCT07880028
Adapted Group Therapy Compared With Usual Care for Anxiety and Depression in Adults With an Autism Diagnosis
A study testing Autism-adapted group cognitive behavioral therapy in people with Autism Spectrum Disorder (ASD) and Anxiety, run by Lovisenberg Diakonale Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Anxiety, Depression
- What is being tested?
- Autism-adapted group cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 1 Sep 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute psychosis, mania, or a severe depressive episode requiring intensive or inpatient care at enrollment
- Intellectual disability (ICD-10 F70 to F73)
- Severe underweight or a severe eating disorder requiring specialist treatment
- Concurrent structured psychotherapy for anxiety or depression delivered by a provider outside the participating services, which would confound attribution of any change
- Circumstances in which the responsible clinician judges that participation in a group format would not be clinically appropriate at this time
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
Background: This multicentre, randomised, controlled trial investigates the clinical effectiveness of a 12-week autism-adapted group cognitive behavioural therapy (CBT) program compared to treatment as usual (TAU) for reducing psychological distress in adults with autism spectrum diagnosis (ASD) and co-occurring anxiety and/or depressive symptoms. The primary objective is to compare the change in the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) total score from baseline to the end of the 12-week intervention.
Design: A multicentre, unblinded, parallel-group randomised trial conducted in an adult psychiatric clinic (ages 18+). Clinician-referred patients (N=154) with a clinical autism diagnosis and clinically evaluated anxiety or depressive symptoms are randomised (1:1) to ASD-adapted group CBT or TAU. Randomisation is stratified by baseline symptom severity, biological sex, age, and co-occurring ADHD. The sample size provides 80% power (two-sided α = 0.05) to detect a moderate effect size (Cohen's d = 0.5) on the primary outcome, allowing for up to 15% attrition.
Interventions: The experimental arm consists of twelve weekly ASD-adapted group CBT sessions led by two licensed clinicians. The programme is already delivered at Lovisenberg Diakonale Sykehus in small scale, and is built from cognitive behavioural therapy for anxiety and depression and from published recommendations for autism-specific adaptation. The control arm consists of TAU (ongoing individual therapy), with session frequency, duration, modality, and content systematically logged.
Assessments: the between-arm difference in CORE-OM total score at week 12, adjusted for baseline. Secondary endpoints address depressive and anxiety symptoms, life satisfaction, and participant-reported common therapeutic factors, all at week 12. Assessments at 3 and 6 months are retained as routine clinical follow-up and are used to describe durability within each arm. Weekly free-text responses characterise acceptability and experience, and free-text responses at weeks 2 and 12 address the sensory and environmental adaptations specifically. Three exploratory measures address for whom, and by what pathway, the programme may work: heart rate variability (HRV) recorded during sessions, as a physiological index of autonomic regulation that does not rely on self-report; self-reported irritability, as a candidate moderator linking neurodevelopmental conditions to depression; and self-reported autistic traits, to characterise the sample in relation to outcome.
Analysis: Primary analysis will utilise intention-to-treat principles via linear mixed-effects models that accounts for the partially nested structure of the design (clustering within therapy groups in the intervention arm only) and adjusts for stratification factors and baseline score. Free-text responses are analysed using qualitative content analysis and reflexive thematic analysis. Exploratory analyses examine irritability, autistic traits, alliance and HRV, and are reported with effect sizes and 95% confidence intervals to inform future synthesis.
- Conditions
- Autism Spectrum Disorder (ASD), Anxiety, Depression
- Being tested
- Autism-adapted group cognitive behavioral therapy
- Keywords
- Autism Spectrum Disorder, Autism spectrum diagnosis, Anxiety Disorders, Depressive Disorder, Comorbidity, Cognitive Behavioral Therapy, Psychotherapy, Group, Autism-adapted cognitive behavioral therapy, Treatment as usual, Mental Health Services, Patient Reported Outcome Measures, Heart Rate, Heart rate variability
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism-adapted group cognitive behavioral therapyBehavioural
Twelve weekly 60-minute sessions of group cognitive behavioral therapy, adapted for adults with an autism diagnosis and delivered in sensory-adapted clinical rooms by two licensed clinicians to groups of 6 to 10 participants. Content across the twelve weeks covers mindfulness, education about anxiety and depression, identifying and managing stressors, sleep and routine, autistic burnout and sensory sensitivity, coping strategies, social interaction, accommodations and support systems, understanding emotions in oneself and others, cognitive behavioral tools for working with thoughts and behavior, and planning for demanding periods. Participants receive a workbook with slides, text and exercises, and are given an assignment between sessions each week. The program is delivered in addition to the individual outpatient follow-up participants already receive, and does not replace it.
| Study group | Role | What they receive |
|---|---|---|
| Adapted group cognitive-behavioral therapy | Experimental | Participants attend twelve weekly 60-minute sessions of group cognitive behavioral therapy adapted for adults with an autism diagnosis, in addition to the individual outpatient follow-up they already receive. Groups have 6 to 10 participants and two licensed clinicians. Each session follows a fixed structure: welcome, review of the previous week's assignment, new content with visual support, an in-session exercise, and a summary with an assignment. Adaptations cover the environment (reduced lighting and noise, fixed time, place and seating), the format (small groups, 60 minutes, an explicit agenda), the materials (visual summaries and a workbook rather than discussion alone), and the content (autism-specific psychoeducation, recognising emotions in oneself and others, attention to sensory sensitivity and autistic identity, and individualised coping plans). Participants keep their own responsible clinician throughout. Receives: Behavioral: Autism-adapted group cognitive behavioral therapy |
| Treatment as usual | No intervention | Participants continue the individual outpatient follow-up they already receive at the clinic, delivered by licensed clinicians without systematic autism-specific adaptations. Content, frequency, duration and mode of contact are decided case by case by the responsible clinician, and are recorded from the patient record. Participants receive no group intervention during the 12-week trial period. After the week-12 assessment they are offered a place in the clinic's group programme as ordinary clinical treatment, outside the research design. Because group cycles start three times a year, this is in practice about six to seven months after randomisation. No additional research data are collected on account of that treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score at Week 12
The CORE-OM is a 34-item self-report measure of psychological distress over the past week. Each item is scored from 0 (not at all) to 4 (most or all of the time). Items cover four domains: subjective well-being (4 items), problems and symptoms (12 items), life functioning (12 items), and risk to self or others (6 items). The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40. Higher scores indicate greater psychological distress, so a negative change from baseline indicates improvement. All 34 items are included in the primary total score. The between-arm difference in change from baseline to week 12 is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. Analysis follows the intention-to-treat principle and includes all randomized participants in the arm to which they were allocated.
Measured: Baseline and week 12 (end of the 12-week intervention period)
Secondary outcomes (7)
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Week 12
The PHQ-9 is a 9-item self-report measure of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score is the sum of the nine items and ranges from 0 to 27. Higher scores indicate more severe depressive symptoms, so a negative change from baseline indicates improvement. The between-arm difference in change from baseline to week 12 is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. No formal adjustment for multiplicity is applied across secondary outcomes; secondary findings are interpreted as supportive rather than confirmatory.
Measured: Baseline to week 12
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 12
The GAD-7 is a 7-item self-report measure of anxiety symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score is the sum of the seven items and ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms, so a negative change from baseline indicates improvement. The between-arm difference in change from baseline to week 12 is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. No formal adjustment for multiplicity is applied across secondary outcomes; secondary findings are interpreted as supportive rather than confirmatory.
Measured: Baseline to week 12
Trajectory of Weekly Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score Across the 12-Week Intervention Period
The CORE-OM is a 34-item self-report measure of psychological distress over the past week, scored from 0 (not at all) to 4 (most or all of the time) per item. The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40, with higher scores indicating greater distress. This outcome is the rate of change in total score across the twelve weekly measurements, rather than the change between two timepoints. Trajectories are analysed in a linear mixed-effects model with time modelled continuously and a random slope for participant, and compared between arms through the arm by time interaction. A steeper negative slope indicates faster improvement.
Measured: Baseline and weekly during weeks 1 through 12
Change From Baseline in Satisfaction With Life Scale (SWLS) Total Score at Week 12 and 3 Months
The SWLS is a 5-item self-report measure of global life satisfaction. Each item is scored from 1 (strongly disagree) to 7 (strongly agree). The total score is the sum of the five items and ranges from 5 to 35. Higher scores indicate greater life satisfaction, so a positive change from baseline indicates improvement. Note that the direction of improvement is the opposite of that for the CORE-OM, PHQ-9 and GAD-7. The between-arm difference in change from baseline is estimated at week 12 and at 3 months in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. Both timepoints are randomized comparisons, because no participant in the usual-care arm has started in a group by 3 months.
Measured: Baseline, week 12, and 3 months after baseline
Modum Process Outcome Questionnaire (M-POQ) Common Therapeutic Factors Score at Weeks 4, 8 and 12
The M-POQ common factors module is a 14-item self-report measure of outcome expectancy, treatment credibility and therapeutic alliance. Higher scores indicate more favourable ratings of the treatment and of the working relationship with the clinician. Participants in the intervention arm rate the two group leaders jointly; participants in the usual-care arm rate their responsible clinician. There is no baseline measurement, because participants are given time to get to know the clinicians before alliance is rated. Scores are compared between arms at each of the three timepoints in a linear mixed-effects model adjusted for the stratification factors.
Measured: Weeks 4, 8 and 12
Change From Baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score at 3 Months
The CORE-OM is a 34-item self-report measure of psychological distress over the past week, scored from 0 (not at all) to 4 (most or all of the time) per item. The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40, with higher scores indicating greater distress and a negative change indicating improvement. This outcome assesses whether any difference between arms is retained after the intervention period ends. The 3-month assessment is a randomized comparison: group cycles begin three times a year, so no participant allocated to usual care has started in a group by this timepoint, and the arms remain as randomized. The between-arm difference in change from baseline is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors.
Measured: Baseline and 3 months after baseline
Change From Baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score at 6 Months
The CORE-OM is a 34-item self-report measure of psychological distress over the past week, scored from 0 (not at all) to 4 (most or all of the time) per item. The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40, with higher scores indicating greater distress and a negative change indicating improvement. This outcome describes the durability of change within each arm. By 6 months a proportion of participants allocated to usual care have started in the group program as ordinary clinical treatment, outside the research design, so the arms are no longer as randomized. Change is therefore analysed within arm, and any between-arm contrast at this timepoint is reported descriptively together with the number and timing of usual-care participants who have started in a group. No hypothesis is specified at 6 months.
Measured: Baseline and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost
- Responsible party
- Principal investigator, Emilie Meyer Bull, Lovisenberg Diakonale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880028
- Sponsor's protocol ID
- 987850
- Other IDs
- Id 41170
- Acronym
- CoMind
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The data are health data from a small clinical sample at a single outpatient clinic. Participants have consented to the use of their data in this project only. Neither that consent nor the approval from the Regional Committee for Medical and Health Research Ethics covers sharing with other researchers, and the participant information states that the data are used only in this project, are not shared with others, and are not transferred out of Norway. Other materials are shared openly. The statistical analysis plan is deposited in a public repository before any outcome data are analyzed, and the analysis code is published; neither contains participant data. Any access by other researchers would require a new application to the committee and new consent from participants.