NEST: A Group Intervention for Parents With Complex PTSD

NCT07766265 | Not Yet Recruiting

• 2 other identifiers: 2026-01379222855
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Parenting can be especially challenging for people with this condition, and few treatment programs currently address this specific need. The main questions it aims to answer are:

• Is the NEST group intervention feasible to deliver and acceptable to parents with Complex PTSD?
• Do parents' trauma-related symptoms and their experience of the parenting role change from before to after the intervention? Participants will:
• Complete online questionnaires about trauma-related symptoms and parenting before the group therapy, after it ends, and again three months later
• Take part in nine weekly 90-minute group therapy sessions, co-led by a member of the study team and a mental health professional from the treatment site
• Some participants will additionally be invited to a short interview about their experience with the group therapy

Conditions

Complex Post-Traumatic Stress Disorder

Keywords

Complex Post-Traumatic Stress Disorder; CPTSD; ICD-11; Trauma-Informed Intervention; Parents; Parenting Intervention; Group Therapy

Outcome Measures

Primary Outcomes (6)

• Feasibility - Enrollment/ Recruitment Rate

  Feasibility will be assessed descriptively by the number of participants enrolled and the time required to reach the planned sample size.

  From day one of recruitment to baseline measurement T0

• Feasibility - Retention Rate

  Retention will be assessed as the proportion of participants completing the post-intervention assessment (T1). A retention rate ≥70% at T1 is defined a priori as the benchmark for implementation-readiness.

  From enrollment through T1 (approximately 9-10 weeks after enrollment)

• Feasibility - Intervention Adherence (Session Attendance)

  Adherence will be assessed as the proportion of participants attending at least 7 of 9 group sessions. A rate of ≥70% of participants attending at least 7 of 9 sessions is defined a priori as the benchmark for implementation-readiness.

  From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)

• Feasibility - Protocol Deviations

  Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.

  From enrollment through T1 (approximately 9-10 weeks after enrollment)

• Acceptability - TFA Questionnaire

  Acceptability will be assessed using the generic Theoretical Framework of Acceptability questionnaire (TFA; Sekhon et al., 2022), translated into German and adapted to the group therapy context. The TFA covers seven constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy) plus a general acceptability item. Acceptability is considered sufficient if ratings indicate an overall positive evaluation.

  Post-intervention (T1, approximately 9-10 weeks after enrollment)

• Acceptability - Qualitative Interviews

  A subset of participants will additionally complete a semi-structured qualitative interview (approximately 40-50 minutes) exploring their experience of the intervention. Acceptability is considered sufficient if no substantial recurring concerns regarding safety, burden, or contextual fit emerge in qualitative findings.

  Post-intervention (T1, approximately 9-10 weeks after enrollment)

Secondary Outcomes (6)

• ICD-11 PTSD and Complex PTSD Symptom Severity

  Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)

• Parental Stress (PSS)

  Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)

• Parental Self-Efficacy

  Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)

• Parenting Practices

  Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)

• Parental Reflective Functioning

  Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)

Study Arms (1)

NEST Group Intervention

EXPERIMENTAL

Participants receive the NEST group intervention, a manualized, trauma-informed program comprising nine weekly 90-minute group sessions co-led by a member of the study team and a mental health professional from the treatment site. Sessions address parenting-related challenges associated with Complex PTSD, including self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, and age-appropriate communication with children about the parent's diagnosis. All participants complete self-report questionnaires at three time points (T0, T1, T2) and a subset also completes a semi-structured qualitative interview at T1.

Behavioral: Trauma-Informed Parenting Group Intervention

Interventions

Trauma-Informed Parenting Group Intervention BEHAVIORAL

The NEST group intervention is a manualized, trauma-informed program consisting of nine weekly 90-minute group sessions, co-led by a member of the study team and a mental health professional from the treatment site. Groups are closed and comprise 6-8 parents. Sessions address parenting-related challenges associated with Complex PTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories are not processed within the group.

Also known as: NEST - Nurturing Emotional Safety in Trauma-Affected Parenting

NEST Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CPTSD according to ICD-11, confirmed by the treating psychotherapist or psychiatrist
• Caregiver of at least one child aged 0-18 years (including biological, adoptive, step-, or foster parents and other primary caregivers)
• Currently receiving individual psychotherapeutic treatment (outpatient or inpatient setting)
• Age 18 years or older
• Sufficient German language proficiency to participate in group sessions and complete study questionnaires
• Ability to provide written informed consent

You may not qualify if:

• Current acute psychosis or severe psychiatric instability requiring immediate intensive treatment
• Severe cognitive impairment or inability to participate adequately in group-based procedures
• No current contact with the child
• Insufficient German language proficiency

Sponsors & Collaborators

• St.Gallen University of Applied Sciences: lead
• Swiss National Science Foundation: collaborator

Study Sites (3)

Psychiatrische Dienste Aargau (PDAG)

Windisch, Canton of Aargau, 5210, Switzerland

Location

Eastern Switzerland University of Applied Sciences (OST)

Sankt Gallen, Canton of St. Gallen, 9001, Switzerland

Location

Integrierte Psychiatrie Winterthur (ipw)

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Study Officials

• Rahel Bachem, PhD

  Eastern Switzerland University of Applied Sciences

  STUDY CHAIR

• Joelle Schenkel, MSc

  Eastern Switzerland University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joelle Schenkel, MSc

CONTACT

+41 58 257 32 99; joelle.schenkel@ost.ch

Rahel Bachem, PhD

CONTACT

+41 58 257 35 26; rahel.bachem@ost.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

CH (3)