NCT07617467

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Dec 2028

Study Start

First participant enrolled

March 9, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

May 22, 2026

Last Update Submit

May 22, 2026

Conditions

Depression - Major Depressive DisorderDepression Anxiety DisorderAnxietyAnxiety Depression

Keywords

depressionAcceptance and Commitment Therapyanxietyanxiety depressionadolescents

Outcome Measures

Primary Outcomes (3)

  • Depression, Anxiety, Stress Scale

    Measures depression, anxiety and stress

    From enrollment to 1 year

  • Hamilton Rating Scale Depression HDRS

    Measures level of depression

    From enrollment to 1 year

  • The Psychological Flexibility Questionnaire PSY-Flex

    Questionnaire measuring Psychological Flexibility

    From enrollment to 1 year

Secondary Outcomes (17)

  • The Structural Clinical Interview for DSM-5 Clinician Version (SCID-5-CV

    Enrollemnt of study and after 12 months

  • Clinical Outcomes in Routine Evaluation (CORE-OM)

    From enrollment to 1 year

  • The PTSD Checklist for DSM-5 PCL-5

    From enrollment to 1 year

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

    From enrollment to 1 year

  • The Mental Health Continuum short form MHC-SF

    From enrollment to 1 year

  • +12 more secondary outcomes

Study Arms (2)

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.

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.

Other: TAU

Interventions

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.

Group based Acceptance and Commitment Therapy
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.

Treatment as usual TAU

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Score on DASS-21 depression scale ≤ 14

You may not qualify if:

  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sørlandet Hospital

Arendal, Agder, 4824, Norway

RECRUITING

Sorlandet hospital

Kristiansand, Agder, 4624, Norway

RECRUITING

Related Publications (9)

  • 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.

    PMID: 32292369BACKGROUND

  • 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.

    PMID: 31555180BACKGROUND

  • 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.

    PMID: 21151705BACKGROUND

  • 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.

    PMID: 16300724BACKGROUND

  • 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.

    PMID: 18690535BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 29867064BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Vegard Øksendal Haaland, PhD

CONTACT

40454145vegard.oksendal.haaland@sshf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 1, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)