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.
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
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Anxiety Disorder, Anxiety
- 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.
Norway2 sites, 2 recruiting
- 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
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:
- Group-based Acceptance and Commitment Therapy (ACT)
- 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.
- Conditions
- Depression - Major Depressive Disorder, Depression Anxiety Disorder, Anxiety, Anxiety Depression
- 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 group | Role | What they receive |
|---|---|---|
| Group based Acceptance and Commitment Therapy | Experimental | Participants 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 TAU | Active comparator | Participants 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.
Depression, Anxiety, Stress Scale
Measures depression, anxiety and stress
Measured: From enrollment to 1 year
Hamilton Rating Scale Depression HDRS
Measures level of depression
Measured: From enrollment to 1 year
The Psychological Flexibility Questionnaire PSY-Flex
Questionnaire measuring Psychological Flexibility
Measured: From enrollment to 1 year
Secondary outcomes (17)
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
Clinical Outcomes in Routine Evaluation (CORE-OM)
Self report about psychological symptoms
Measured: From enrollment to 1 year
The PTSD Checklist for DSM-5 PCL-5
PCL-5 questionnaire, symptoms of PTSD
Measured: From enrollment to 1 year
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
The Mental Health Continuum short form MHC-SF
questionnaire that measure positive mental health and well-being
Measured: From enrollment to 1 year
Alcohol Use Disorder Identification Test, AUDIT
Questionnaire screening for alcohol harmful use and dependence
Measured: From enrollment to 1 year
The drug use disorders identification test DUDIT
Questionnaire screening for harmful use and dependence of drugs
Measured: From enrollment to 1 year
Difficulties in Emotion Regulation Scale short form DERS SF
Questionnaire measuring problems with emotion regulations
Measured: From enrollment to 1 year
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
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
The Process-Based Assessment Tool PBAT
Questionnaire measuring processes and clinical interventions in therapy
Measured: From enrollment to 1 year
The Five Facet Mindfulness Questionnaire FFMQ
Questionnaire measuring components and structure of mindfulness
Measured: From enrollment to 1 year
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
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
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
The Bergen Insomnia Scale, BIS
Questionnaire for measuring insomnia
Measured: From enrollment to 1 year
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.
- First posted1 Jun 2026
- Study start9 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- University of Oslo, Helse Sor-Ost, Karolinska Institutet, Australian Catholic University
- Responsible party
- Sponsor
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 32292369Ostergaard 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 31555180Kashdan 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 21151705Hayes 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 16300724Biglan 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 18690535Hayes, 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based ACT for Psychological Distress of Young People
- ClinicalTrials.gov ID
- NCT07617467
- Acronym / sponsor ID
- ACT-YOUNG / 162090
- Conditions
- Depression - Major Depressive Disorder, Depression Anxiety Disorder, Anxiety, Anxiety Depression
- Keywords
- depression, Acceptance and Commitment Therapy, anxiety, anxiety depression, adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- University of Oslo, Helse Sor-Ost, Karolinska Institutet, Australian Catholic University
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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:
- Group-based Acceptance and Commitment Therapy (ACT)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Group based Acceptance and Commitment Therapy | Experimental | Other: Group-based Acceptance and Commitment TherapyParticipants assigned to this arm will receive a structured, manualized group-based Acceptance and Commitment Therapy (ACT) intervention delivered by trained clinicians. |
| Treatment as usual TAU | Active comparator | Other: TAUParticipants 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Score on DASS-21 depression scale ≤ 14
Key exclusion criteria (1 listed)
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based Acceptance and Commitment TherapyGroup-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. | Other | Group based Acceptance and Commitment Therapy |
| TAUTreatment 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. | Other | Treatment as usual TAU |
Primary outcome
Depression, Anxiety, Stress Scale
Time frame: From enrollment to 1 year
Measures depression, anxiety and stress
Hamilton Rating Scale Depression HDRS
Time frame: From enrollment to 1 year
Measures level of depression
The Psychological Flexibility Questionnaire PSY-Flex
Time frame: From enrollment to 1 year
Questionnaire measuring Psychological Flexibility
17 secondary outcomes
The Structural Clinical Interview for DSM-5 Clinician Version (SCID-5-CV
Time frame: Enrollemnt of study and after 12 months
Clinical Outcomes in Routine Evaluation (CORE-OM)
Time frame: From enrollment to 1 year
The PTSD Checklist for DSM-5 PCL-5
Time frame: From enrollment to 1 year
The Level of Personality Functioning Scale brief, LPFS-BF2.0
Time frame: From enrollment to 1 year
The Mental Health Continuum short form MHC-SF
Time frame: From enrollment to 1 year
Alcohol Use Disorder Identification Test, AUDIT
Time frame: From enrollment to 1 year
The drug use disorders identification test DUDIT
Time frame: From enrollment to 1 year
Difficulties in Emotion Regulation Scale short form DERS SF
Time frame: From enrollment to 1 year
The Cognitive Fusion Questionnaire CFQ
Time frame: From enrollment to 1 year
The Bulls Eyes Values Survey scale BEVS
Time frame: From enrollment to 1 year
The Process-Based Assessment Tool PBAT
Time frame: From enrollment to 1 year
The Five Facet Mindfulness Questionnaire FFMQ
Time frame: From enrollment to 1 year
The Self Compassion Scale short form SCS SF
Time frame: From enrollment to 1 year
EQ-5D-5L
Time frame: From enrollment to 1 year
The Work and Social Adjustment Scale, WSAS
Time frame: From enrollment to 1 year
The Bergen Insomnia Scale, BIS
Time frame: From enrollment to 1 year
The metacognitions questionnaire, MCQ-30
Time frame: From enrollment to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 32292369Ostergaard 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.
- Background: PubMed 31555180Ostergaard 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.
- Background: PubMed 21151705Kashdan 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.
- Background: PubMed 16300724Hayes 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.
- Background: PubMed 18690535Biglan 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.
- BackgroundHayes, 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.
- BackgroundHayes, 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.
- BackgroundHalliburton, 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.
- Background: PubMed 29867064Baddam 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.
- State of the ACT EvidenceLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Depression - Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.