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Depression - Major Depressive DisorderACT-YOUNGNCT07617467

Group-based ACT for Psychological Distress of Young People

A study testing Group-based Acceptance and Commitment Therapy and TAU in people with Depression - Major Depressive Disorder and Depression Anxiety Disorder, run by Sorlandet Hospital HF at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical study investigates the effectiveness of two psychological treatment formats for young people aged 16-25 with symptoms of depression, anxiety, stress, or interpersonal difficulties. Read more about this study

Who is it for?
Ages 16 to 25 years
What is being tested?
Group-based Acceptance and Commitment Therapy and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
2 sitesNorway
Study dates
9 Mar 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Score on DASS-21 depression scale ≤ 14

Who cannot join

  • Psychosis

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vegard Øksendal Haaland, PhD contact

40454145 ext. +47

vegard.oksendal.haaland@sshf.no

Norway2 sites, 2 recruiting
  • Sørlandet Hospital

    Arendal, Agder, 4824

    Tom Østergaard, PhD, 47519722 ext. 47, tom.ostergaard@sshf.no

    Recruiting
  • Sorlandet hospital

    Kristiansand, Agder, 4624

    Kenneth Lindberget, PhD candidate, 38038585 ext. 47, kenneth.lindberget@sshf.no

    Recruiting

Other trials in Norway

About this study

This clinical study investigates the effectiveness of two psychological treatment formats for young people aged 16-25 with symptoms of depression, anxiety, stress, or interpersonal difficulties. The study compares group-based Acceptance and Commitment Therapy (ACT) with treatment as usual (TAU), most frequent that would be individual psychotherapy, both of which are established treatment approaches.

The study uses a randomized controlled design (RCT), in which participants are randomly assigned to one of the two treatment conditions. This allows for a systematic comparison of treatment outcomes between ACT delivered in a group format and standard individual therapy.

Read more

The ACT group intervention consists of a structured program in which participants meet regularly over a defined treatment period. The treatment focuses on processes such as psychological flexibility, acceptance of internal experiences, and engagement in actions aligned with personal values.

The individual therapy condition consists of one-to-one sessions with a clinician, following standard therapeutic practice. Treatment content and duration are tailored to the participant's clinical presentation and therapeutic needs.

Outcome measures include standardized assessments of mental health symptoms, functioning, and psychological processes. These assessments are conducted at baseline, during the treatment period, at post-treatment, and at follow-up time points. Data collected from these measures will be used to evaluate changes over time and differences between the two treatment conditions.

The primary aim of the study is to determine whether group-based ACT is as effective as, or more effective than, individual psychotherapy for young people receiving mental health services. The results are expected to contribute to improved knowledge about treatment options for this age group and inform future clinical practice.

Read the detailed description

Background and Rationale Mental health problems among adolescents and young adults represent a significant and increasing public health concern. A substantial proportion of young people experience symptoms of depression, anxiety, and related psychological distress during a developmental period characterized by major psychological, social, and biological transitions. These challenges may interfere with identity development, educational attainment, and social functioning, with potential long-term consequences for health and well-being .

At the same time, mental health services face increasing demand and limited capacity, resulting in prolonged waiting times and restricted access to timely care. Traditional outpatient treatment is primarily delivered as individual psychotherapy, which limits the number of patients that can be treated. There is therefore a need to evaluate alternative and potentially more scalable treatment formats that can maintain or improve clinical outcomes while increasing accessibility.

Acceptance and Commitment Therapy (ACT) is a transdiagnostic behavioral intervention that aims to improve psychological functioning by enhancing psychological flexibility. The ability to act in accordance with personal values while remaining in contact with difficult internal experiences. Rather than focusing solely on symptom reduction, ACT targets core processes such as acceptance, cognitive defusion, present-moment awareness, values clarification, and committed action.

Although ACT has a substantial evidence base in adult populations, research on its effectiveness for young people remains more limited, particularly in routine clinical settings and in comparison with standard care. Group-based formats may represent an efficient way of delivering ACT, while also offering therapeutic benefits such as peer support, normalization, and shared learning. The present study addresses important gaps in the literature by evaluating a structured group-based ACT intervention tailored for young people, compared with treatment as usual (TAU), within specialized mental health services.

Study Objectives The primary objective of the study is to evaluate the effectiveness of group-based ACT compared with treatment as usual in reducing symptoms of depression and anxiety among young people aged 16-25.

Secondary objectives include:

  • Evaluating the impact of the intervention on psychological well-being, quality of life, and functional outcomes
  • Assessing whether group-based ACT leads to comparable or improved remission rates relative to TAU
  • Investigating mechanisms of change, particularly the role of psychological flexibility related to the ACT processes
  • Exploring potential moderators of treatment outcome, including demographic and clinical characteristics

Study Design

This study is a randomized controlled trial (RCT) with two parallel treatment arms:

  1. Group-based Acceptance and Commitment Therapy (ACT)
  2. Treatment as usual (TAU), typically consisting of individual psychotherapy Participants meeting eligibility criteria will be randomly allocated to one of the two conditions. The study is conducted in routine clinical settings across child/adolescent (BUP) and adult (DPS) mental health services, as well as in collaboration with primary care services, to enhance ecological validity and generalizability .

The target sample size is 212 participants, accounting for expected attrition and ensuring adequate statistical power for both outcome and process analyses .

Participants

Inclusion criteria:

Age 16-25 years Moderate symptoms of depression, score of 14 and above in the DASS 21 questionnaire

Exclusion criteria:

Severe psychiatric conditions requiring alternative treatment (e.g., psychosis, bipolar disorder) Active substance dependence Acute suicidal ideation or behavior Eating disorders or developmental disorders requiring specialized interventions Participants with specific disorders for which established evidence-based treatments are indicated (e.g., OCD) will be offered those treatments outside the study.

Interventions:

Group-based ACT

The experimental intervention is a structured group program based on Acceptance and Commitment Therapy, adapted for young people using the DNA-V framework. The intervention focuses on developing skills in:

  • Awareness of internal experiences
  • Acceptance and willingness
  • Cognitive defusion
  • Values clarification
  • Committed action The group format aims to promote experiential learning and peer interaction. The intervention consists of multiple sessions delivered over a defined treatment period, with each group including up to 10 participants and led by trained therapists. Sessions are manualized to ensure consistency and fidelity, and adherence will be monitored through supervision and video recordings .

Treatment as Usual (TAU) Participants allocated to TAU will receive standard care within mental health services. This typically involves individual psychotherapy delivered by a clinician. The content, frequency, and duration of treatment are determined by clinical needs and routine practice, reflecting real-world conditions.

Procedures and Assessments:

Participants will undergo a baseline assessment prior to randomization, including diagnostic evaluation using structured clinical interviews. Follow-up assessments will be conducted at multiple time points:

  • Baseline (pre-treatment)
  • During treatment (6 weeks)
  • Post-treatment (12 weeks)
  • 6-month follow-up
  • 12-month follow-up

Outcome data will be collected using a combination of clinician-administered interviews and validated self-report measures assessing:

  • Depression and anxiety symptoms
  • General psychological distress
  • Quality of life
  • Functional impairment
  • Psychological processes relevant to ACT (e.g., flexibility, mindfulness, values-based action) In addition to these scheduled assessments, ecological momentary assessment (EMA) will be conducted using a digital platform. Participants will complete brief daily measures during the treatment period and periodic follow-up assessments thereafter. This approach allows for detailed analysis of temporal changes and treatment processes in real-world contexts .

Outcomes

Primary outcomes:

  • Changes in symptoms of depression and anxiety

Secondary outcomes:

  • Psychological well-being
  • Quality of life
  • Functional impairment
  • Remission rates

Process outcomes:

  • Psychological flexibility
  • Emotional regulation
  • Mindfulness
  • Self-compassion
  • Values-consistent behavior

Statistical Analysis Data will be analyzed using appropriate statistical methods for longitudinal and randomized designs. Primary analyses will compare changes in outcome measures between treatment conditions over time.

Secondary analyses will examine:

  • Mediation effects to identify mechanisms of change
  • Moderation effects to identify subgroups for whom the treatment is particularly effective Missing data will be handled using established statistical techniques appropriate for repeated measures designs.

Ethical Considerations Participation in the study is voluntary, and all participants will provide informed consent prior to inclusion. Participants may withdraw at any time without consequences for their access to treatment.

The interventions evaluated in this study are based on established therapeutic approaches and are not expected to pose significant risk. However, participation in group-based treatment may be experienced as challenging for some individuals. Measures are in place to monitor and address adverse reactions, including the presence of trained therapists and access to follow-up support .

The study will be conducted in accordance with ethical guidelines and has been approved by the regional ethics committee.

Significance This study will contribute to the evidencebase for psychological treatments for young people by evaluating a scalable, group-based intervention within routine clinical practice. The findings may inform service development and improve access to effective mental health care for this population. Additionally, the study will provide insight into the mechanisms underlying therapeutic change, supporting further refinement of interventions based on ACT principles.

Being tested
Group-based Acceptance and Commitment Therapy, TAU
Keywords
depression, Acceptance and Commitment Therapy, anxiety, anxiety depression, adolescents
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group-based Acceptance and Commitment TherapyOther

    Group-Based Acceptance and Commitment Therapy (ACT) consists of a structured, manualized group intervention delivered according to established ACT principles and tailored for young people. The intervention is provided in a group format within specialized mental health services and focuses on enhancing psychological flexibility through core ACT processes. Treatment is delivered by trained clinicians, and the group format emphasizes experiential exercises, mindfulness practices, values-based work, and peer interaction. The frequency and duration of sessions follow the study protocol.

  • TAUOther

    Treatment as Usual (TAU) consists of standard mental health care provided according to routine clinical practice within hospital-based specialized mental health services, as well as through municipal health services and student health services when applicable. The type, format (e.g., individual or group-based), frequency, and duration of care are determined by clinical need and may vary between participants.

Study groups in NCT07617467
Study groupRoleWhat they receive
Group based Acceptance and Commitment TherapyExperimentalParticipants assigned to this arm will receive a structured, manualized group-based Acceptance and Commitment Therapy (ACT) intervention delivered by trained clinicians.
Receives: Other: Group-based Acceptance and Commitment Therapy
Treatment as usual TAUActive comparatorParticipants assigned to this arm will receive treatment as usual consisting of standard mental health care delivered according to routine clinical practice within hospital-based specialized mental health services and, when applicable, municipal health services or student health services. The type, format, frequency, and duration of care are determined by clinical need and may vary between participants.
Receives: Other: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression, Anxiety, Stress Scale

    Measures depression, anxiety and stress

    Measured: From enrollment to 1 year

  2. Hamilton Rating Scale Depression HDRS

    Measures level of depression

    Measured: From enrollment to 1 year

  3. The Psychological Flexibility Questionnaire PSY-Flex

    Questionnaire measuring Psychological Flexibility

    Measured: From enrollment to 1 year

Secondary outcomes (17)
  1. The Structural Clinical Interview for DSM-5 Clinician Version (SCID-5-CV

    Diagnostic interview SCID 5 CV

    Measured: Enrollemnt of study and after 12 months

  2. Clinical Outcomes in Routine Evaluation (CORE-OM)

    Self report about psychological symptoms

    Measured: From enrollment to 1 year

  3. The PTSD Checklist for DSM-5 PCL-5

    PCL-5 questionnaire, symptoms of PTSD

    Measured: From enrollment to 1 year

  4. The Level of Personality Functioning Scale brief, LPFS-BF2.0

    The Level of Personality Functioning Scale brief form, Alternative Model for Personality disorders DSM-5, section iii LPFS-BF2.0 questionnaire. Screening tool for personality disorders

    Measured: From enrollment to 1 year

  5. The Mental Health Continuum short form MHC-SF

    questionnaire that measure positive mental health and well-being

    Measured: From enrollment to 1 year

  6. Alcohol Use Disorder Identification Test, AUDIT

    Questionnaire screening for alcohol harmful use and dependence

    Measured: From enrollment to 1 year

  7. The drug use disorders identification test DUDIT

    Questionnaire screening for harmful use and dependence of drugs

    Measured: From enrollment to 1 year

  8. Difficulties in Emotion Regulation Scale short form DERS SF

    Questionnaire measuring problems with emotion regulations

    Measured: From enrollment to 1 year

  9. The Cognitive Fusion Questionnaire CFQ

    Questionnaire about cognitive fusion. Cognitive fusion refers to becoming so entangled with thoughts that they strongly dominate behavior, emotions, and perception.

    Measured: From enrollment to 1 year

  10. The Bulls Eyes Values Survey scale BEVS

    Questionnaire about value congruent behavior. Examening peoples values and how much they are satisfied with reaching those values

    Measured: From enrollment to 1 year

  11. The Process-Based Assessment Tool PBAT

    Questionnaire measuring processes and clinical interventions in therapy

    Measured: From enrollment to 1 year

  12. The Five Facet Mindfulness Questionnaire FFMQ

    Questionnaire measuring components and structure of mindfulness

    Measured: From enrollment to 1 year

  13. The Self Compassion Scale short form SCS SF

    Questionnaire measuring self compassion. Measures of how compassionately a person relates to themselves during periods of difficulty, failure, suffering, or inadequacy.

    Measured: From enrollment to 1 year

  14. EQ-5D-5L

    EQ EuroQol 5 D 5 Dimensions 5L 5 Levels. Questionnaire used to measure health-related quality of life (HRQoL).

    Measured: From enrollment to 1 year

  15. The Work and Social Adjustment Scale, WSAS

    Questionnaire that measures how much a person's mental or physical health problems are interfering with their ability to function in everyday life

    Measured: From enrollment to 1 year

  16. The Bergen Insomnia Scale, BIS

    Questionnaire for measuring insomnia

    Measured: From enrollment to 1 year

  17. The metacognitions questionnaire, MCQ-30

    Questionnaire about metacognitive beliefs. The beliefs people have about their own thinking

    Measured: From enrollment to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start9 Mar 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Model description
RCT
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617467
Sponsor's protocol ID
162090
Acronym
ACT-YOUNG
Status last verified
May 2026
First submitted
22 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ostergaard T, Lundgren T, Zettle RD, Landro NI, Haaland VO. Psychological Flexibility in Depression Relapse Prevention: Processes of Change and Positive Mental Health in Group-Based ACT for Residual Symptoms. Front Psychol. 2020 Mar 27;11:528. doi: 10.3389/fpsyg.2020.00528. eCollection 2020.

    PubMed 32292369
  • Ostergaard T, Lundgren T, Rosendahl I, Zettle RD, Jonassen R, Harmer CJ, Stiles TC, Landro NI, Haaland VO. Acceptance and Commitment Therapy Preceded by Attention Bias Modification on Residual Symptoms in Depression: A 12-Month Follow-Up. Front Psychol. 2019 Aug 29;10:1995. doi: 10.3389/fpsyg.2019.01995. eCollection 2019.

    PubMed 31555180
  • Kashdan TB, Rottenberg J. Psychological flexibility as a fundamental aspect of health. Clin Psychol Rev. 2010 Nov;30(7):865-78. doi: 10.1016/j.cpr.2010.03.001. Epub 2010 Mar 12.

    PubMed 21151705
  • Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

    PubMed 16300724
  • Biglan A, Hayes SC, Pistorello J. Acceptance and commitment: implications for prevention science. Prev Sci. 2008 Sep;9(3):139-52. doi: 10.1007/s11121-008-0099-4. Epub 2008 Aug 9.

    PubMed 18690535
  • Hayes, L.; Boyd, C.P.; Sewell, J. Acceptance and Commitment Therapy for the Treatment of Adolescent Depression: A Pilot Study in a Psychiatric Outpatient Setting. Mindfulness 2011, 2, 86-94.

  • Hayes, L. L., & Ciarrochi, J. V. (2015). The thriving adolescent: Using acceptance and commitment therapy and positive psychology to help teens manage emotions, achieve goals, and build connection. New Harbinger Publications.

  • Halliburton, A. E., & Cooper, L. D. (2015). Applications and adaptations of Acceptance and Commitment Therapy (ACT) for adolescents. Journal of Contextual Behavioral Science, 4(1), 1-11.

  • Baddam SKR, Canapari CA, van Noordt SJR, Crowley MJ. Sleep Disturbances in Child and Adolescent Mental Health Disorders: A Review of the Variability of Objective Sleep Markers. Med Sci (Basel). 2018 Jun 4;6(2):46. doi: 10.3390/medsci6020046.

    PubMed 29867064

Questions about this trial

What is this clinical trial studying?

A study testing Group-based Acceptance and Commitment Therapy and TAU in people with Depression - Major Depressive Disorder and Depression Anxiety Disorder, run by Sorlandet Hospital HF at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vegard Øksendal Haaland, PhD (40454145 ext. +47, vegard.oksendal.haaland@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression, Anxiety, Stress Scale (time frame: From enrollment to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07617467, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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