Affect-focused group therapy for complex and long-lasting psychiatric conditions - a pilot study

ISRCTN ISRCTN12656480
DOI https://doi.org/10.1186/ISRCTN12656480
Sponsor Region Stockholm
Funders Region Stockholm, Stockholms Universitet
Submission date
10/02/2026
Registration date
10/02/2026
Last edited
10/02/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Many adults in psychiatric care have long-lasting and complex mental health problems, such as severe anxiety, trauma-related difficulties, and personality problems. These individuals often do not benefit sufficiently from standard treatments and may have limited access to structured psychological therapy. This pilot study aims to evaluate whether a structured, affect-focused group psychotherapy (ISTDP-G) is feasible, acceptable, and safe for adults with complex and treatment-resistant psychiatric conditions in public psychiatric care.

Who can participate?
Adults aged 18 years or older who are currently receiving care within specialist adult psychiatric services and who have long-term, complex, and/or treatment-resistant psychiatric problems may be invited to participate. All participants must be assessed as suitable and motivated for group-based psychotherapy.

What does the study involve?
Participants will take part in a structured group psychotherapy programme consisting of 25 weekly sessions, each lasting 90 minutes. The treatment focuses on understanding emotions and anxiety and developing healthier ways of managing emotional distress. Participants will complete questionnaires before, during, and after treatment, as well as at a 6-month follow-up.

What are the possible benefits and risks of participating?
Participants may experience improvements in emotional regulation, psychological symptoms, and quality of life. As with any psychotherapy, discussing emotions may cause temporary discomfort. Therapists actively monitor safety throughout the treatment.

Where is the study run from?
The study is run from Stockholm University in collaboration with specialist psychiatric clinics in Stockholm, Sweden.

When is the study starting and how long is it expected to run for?
May 2022 to December 2024

Who is funding the study?
1. Region Stockholm (Sweden)
2. Stockholms Universitet (Sweden)

Who is the main contact?
Prof. Björn Philips, bjorn.philips@psychology.su.se

Contact information

Prof Björn Philips
Principal investigator, Public, Scientific

Department of Psychology
Stockholm University
Stockholm
10691
Sweden

ORCiD logoORCID ID 0000-0003-4313-1011
Phone +46 (0)8 162010
Email bjorn.philips@psychology.su.se

Study information

Primary study designInterventional
AllocationN/A: single arm study
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentSingle
PurposeTreatment
Scientific titleIntensive short term dynamic group therapy for complex or therapy-resistant psychiatric disorders - a pilot study
Study objectivesThe primary objective of this pilot study is to evaluate the feasibility, acceptability, and safety of an affect-focused group psychotherapy (ISTDP-G) for adults with complex and/or treatment-resistant psychiatric conditions within public adult psychiatric care.

Specific objectives are to assess treatment completion rates, session attendance, patient-perceived helpfulness, data completeness, and the occurrence of serious adverse events. Secondary, exploratory objectives are to examine changes in emotion regulation, anxiety, depression, quality of life, dissociative symptoms, personality functioning, and self-harm, from pre- to post-treatment and follow-up.
Ethics approval(s)

Approved 20/04/2022, Swedish Ethics Review Authority (Box 2110, Uppsala, 75002, Sweden; +46 (0)10 4750800; registrator@etikprovning.se), ref: 2022-01875-01

Health condition(s) or problem(s) studiedComplex and/or therapy-resistant psychiatric disorders
InterventionThe intervention is a structured affect-focused group psychotherapy based on Intensive Short-Term Dynamic Psychotherapy (ISTDP), referred to as ISTDP-G. The treatment focuses on the relationship between emotions, anxiety, and maladaptive emotion-regulation strategies, with the aim of increasing patients’ capacity to regulate anxiety and reduce dysfunctional patterns that maintain psychological distress. The intervention is designed for adults with chronic, severe, and complex psychiatric problems, often characterised by high comorbidity, treatment resistance, impulsivity, and/or self-harm behaviours.

ISTDP-G is delivered in a highly structured group format and consists of three sequential phases: (1) psychoeducation about anxiety and emotion regulation, including practical exercises; (2) therapist-guided individual work within the group, focusing on anxiety regulation and barriers to emotional processing; and (3) continued individual work in the group, with emphasis on the links between emotions, anxiety, and learned automatic coping strategies. Therapists take an active role throughout to minimise negative group processes and ensure safety.

The treatment comprises 25 weekly sessions of 90 minutes. Each group includes up to six participants and is led by trained psychotherapists.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Emotion regulation measured using the Difficulties in Emotion Regulation Scale–16 at weekly during treatment and at follow-up
Key secondary outcome measure(s)
  1. Anxiety measured using the Generalized Anxiety Disorder 7-item scale at pre-treatment, post-treatment, and 6-month follow-up
  2. Depression measured using Patient Health Questionnaire-9 at pre-treatment, post-treatment, and 6-month follow-up
  3. Quality of life measured using the Brunnsviken Brief Quality of Life Scale at pre-treatment, post-treatment, and 6-month follow-up
  4. Dissociation measured using the Brief Dissociative Experiences Scale Modified at pre-treatment, post-treatment, and 6-month follow-up
  5. Personality functioning measured using the Levels of Personality Functioning Scale – Brief Form 2.0 at pre-treatment, post-treatment, and 6-month follow-up
  6. Self-harm measured using the Deliberate Self-Harm Inventory: Nine-Item Version at pre-treatment, post-treatment, and 6-month follow-up
Completion date15/12/2024

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration24
Total final enrolment24
Key inclusion criteriaMeet at least one of the following criteria whilst also expressing motivation for group treatment:
1. Having two or more personality disorder diagnoses
2. Having a personality disorder together with another psychiatric diagnosis
3. Having a psychiatric diagnosis and at least one year of contact with adult psychiatric services without being able to conclude treatment because of persistent functional impairment
4. Having autism in combination with another psychiatric diagnosis
5. Having undergone two or more treatment attempts without satisfactory effect
6. Having a psychiatric diagnosis together with active self-harm behavior
Key exclusion criteria1. A primary diagnosis of substance dependency (note that a diagnosis of substance dependency that was considered secondary to another psychiatric diagnosis did not lead to exclusion)
2. Psychiatric problems that were not considered as complex (i.e., a single anxiety/mood disorder, having been treated with positive outcome, etc)
3. Therapy-disrupting antisocial behavior
4. PTSD with acute symptoms such as easily triggered flashbacks (note that PTSD without acute flashbacks and trauma in general was not reason for exclusion)
5. Ongoing psychotic illness
6. Intellectual disability with a documented IQ of 70 or below
7. The need for an interpreter in order to communicate in Swedish
Date of first enrolment01/05/2022
Date of final enrolment15/11/2023

Locations

Countries of recruitment

  • Sweden

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

10/02/2026: Study's existence confirmed by the Swedish Ethics Review Authority.