An interventional study of Autism-adapted group cognitive behavioral therapy in Autism Spectrum Disorder (ASD), Anxiety and Depression, sponsored by Lovisenberg Diakonale Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Lovisenberg Diakonale Hospital · Not applicable, Interventional, and Treatment
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:
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:
Participants will:
The study takes place at one outpatient clinic in Oslo, Norway.
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.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's planned enrollment of 154 is above the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
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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.
Behavioral: Autism-adapted group cognitive behavioral therapy
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.
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.
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.
Time frame: Baseline and week 12 (end of the 12-week intervention period)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months after baseline
Association Between In-Session Heart Rate Variability and Change in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score to Week 12
Heart rate variability is recorded continuously during group sessions using a chest-worn heart rate sensor, and summarized as the root mean square of successive differences (RMSSD) and the standard deviation of normal-to-normal intervals (SDNN), both in milliseconds. Higher values indicate greater vagally mediated autonomic regulation. Recording is available in the intervention arm only, because sensors are worn during group sessions, and supports no between-arm comparison. Use of a sensor is voluntary and is decided by the participant session by session, so the subsample may under-represent the most sensory-sensitive participants. Within the intervention arm, the association between early change in heart rate variability and change in CORE-OM total score to week 12 is estimated and reported with an effect size and a 95 percent confidence interval. This analysis is exploratory and hypothesis-generating.
Time frame: During each of the 12 weekly group sessions, and CORE-OM at baseline and week 12
Baseline Self-Reported Irritability as a Moderator of Change in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score to Week 12
Irritability is measured with two self-report items on affective reactivity, each scored 0 (not true), 1 (somewhat true) or 2 (certainly true), giving a score from 0 to 4. Higher scores indicate greater irritability. The baseline score is entered as a moderator of change in CORE-OM total score from baseline to week 12, across both arms, through an interaction term in a linear mixed-effects model. The measure is repeated at week 12 for descriptive purposes only; no change over the intervention period is hypothesized. Results are reported with an effect size and a 95 percent confidence interval. This analysis is exploratory and hypothesis-generating.
Time frame: Baseline, with change in CORE-OM measured from baseline to week 12
Baseline Self-Reported Autistic Traits (Autism-Spectrum Quotient) as a Moderator of Change in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score to Week 12
The Autism-Spectrum Quotient is a 50-item self-report measure of autistic traits in adults of typical intellectual ability. Each item is scored 0 or 1 under standard scoring, giving a total from 0 to 50, with higher scores indicating more self-reported autistic traits. The measure is administered once, at baseline, and is retrieved from the patient record where the participant has completed it previously. The baseline score is entered as a moderator of change in CORE-OM total score from baseline to week 12 through an interaction term in a linear mixed-effects model, and reported with an effect size and a 95 percent confidence interval. This analysis is exploratory and hypothesis-generating.
Time frame: Baseline, with change in CORE-OM measured from baseline to week 12
Participant-Reported Experience of the Group Program, Assessed by Weekly Free-Text Responses
Participants in the intervention arm answer five open-ended questions after each group session, covering what they learned, what they found helpful, and anything they did not like or would have wanted different. Responses are short and structured by the question. They are summarized descriptively and reported by session number, so that it is apparent which components of the program participants found usable and what they would change. No interpretative coding framework is applied, because the material is too brief to support one. Responses are de-identified before analysis. This outcome characterizes acceptability and experience and is not used to support claims about treatment effect.
Time frame: Weekly during weeks 1 through 12
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Plan to share: 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.
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Lovisenberg Diakonale Hospital