Group-based ACT for Psychological Distress of Young People

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-25
SponsorSorlandet Hospital HF

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Score on DASS-21 depression scale ≤ 14

Disqualifiers

Psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group-based Acceptance and Commitment Therapy

    Other intervention

    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.

  • TAU

    Other intervention

    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 groups

212 Participants
are divided into 2 treatment groups
Group A: Group based Acceptance and Commitment TherapyExperimental treatment 1 intervention
Group B: Treatment as usual TAUActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Depression, Anxiety, Stress Scale

Measures depression, anxiety and stress

Time frame
From enrollment to 1 year
2

Hamilton Rating Scale Depression HDRS

Measures level of depression

Time frame
From enrollment to 1 year
3

The Psychological Flexibility Questionnaire PSY-Flex

Questionnaire measuring Psychological Flexibility

Time frame
From enrollment to 1 year

Secondary outcomes

1

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

Diagnostic interview SCID 5 CV

Time frame
Enrollemnt of study and after 12 months
2

Clinical Outcomes in Routine Evaluation (CORE-OM)

Self report about psychological symptoms

Time frame
From enrollment to 1 year
3

The PTSD Checklist for DSM-5 PCL-5

PCL-5 questionnaire, symptoms of PTSD

Time frame
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

Time frame
From enrollment to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sorlandet Hospital HF

Lead sponsor

University of Oslo

Collaborator

Helse Sor-Ost

Collaborator

Karolinska Institutet

Collaborator

Australian Catholic University

Collaborator