Psychiatric Disorder
Conditions
Keywords
Young adults, transitional psychiatry, group psychotherapy, feasibility study, psychoeducation, suicidality, media/internet/gaming addiction, communication skills, self-efficacy
Brief summary
This prospective, non-randomised, pre-post feasibility study evaluates CHANGE, a novel 8-session modularized cognitive behavioral group psychotherapy for young adults (18-25 years) with psychiatric disorders receiving inpatient or day-care treatment. All eligible participants (planned n=30) receive the intervention in addition to treatment-as-usual; there is no control arm. The primary aim is to assess feasibility, acceptability and appropriateness of the intervention (SMI (a German scale for feasibility), SAI (a German scale for acceptability), AIS (a German scale for appropriateness) scales; recruitment, retention, adherence and dropout rates). Secondary outcomes include perceived competence, self-efficacy (SWE), motivation (FEVER), satisfaction, quality of life (WHOQOL-BREF) and level of functioning (GAF), assessed before (T0) and after (T1) the intervention.
Detailed description
Mental disorders frequently begin before age 25, during the 'transition' phase between adolescent and adult psychiatric care, a period of ongoing biopsychosocial development that is often insufficiently addressed by conventional, age-segregated care systems. CHANGE (Create Health in Adolescence for New and Genuine Experiences) was developed to address this gap with four thematic modules delivered over 8 weekly 75-minute group sessions (max. 12 participants/group): (1) transition-specific psychoeducation, (2) suicidality, (3) media/internet/gaming addiction, and (4) communication. Sessions are led by a psychiatrist/psychotherapist in training under supervision, using a standardized therapist and patient manual. Participants are recruited from inpatient and day-care units at the Max Planck Institute of Psychiatry; screening, informed consent and baseline assessment (T0) precede the intervention, with a post-intervention assessment (T1) at completion. Analyses follow the CONSORT/TIDieR extension for pilot and feasibility trials (non-randomised items excluded), using descriptive statistics for feasibility/acceptability/appropriateness metrics and linear mixed-effects models for pre-post change in secondary outcomes.
Interventions
OTHERCHANGE - modularized group psychotherapy
8-session (weekly, 75 min/session), modularized group psychotherapy comprising 4 modules: (1) transition-specific psychoeducation, (2) suicidality, (3) media/internet/gaming addiction, (4) communication. Delivered in groups of max. 12 participants by a psychiatrist/psychotherapist in training under supervision, in addition to treatment-as-usual.
Sponsors
Max-Planck-Institute of Psychiatry
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible participants receive the modularized CHANGE group psychotherapy in addition to treatment-as-usual; there is no control or comparator arm. Outcomes are assessed before (T0) and after (T1) the 8-session intervention (single-arm, pre-post design).
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years and \< 26 years 2. Ability to provide written informed consent
Exclusion criteria
1. Age \< 18 years, age \>= 26 years 2. Lack of ability to provide written informed consent 3. Severe concomitant neurological or internal medical diseases 4. Severe cognitive impairment (IQ \< 80, severe learning disability, brain damage or pervasive developmental disorder) 5. Lack of eligibility for psychotherapy (e.g., insufficient language proficiency, hostile or uncooperative behavior) 6. Acute risk of self-harm or harm to others, including acute psychosis, acute mania, or acute suicidal behavior 7. Acute substance-based addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017) | T1 (8 weeks after baseline) | Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree), item 5 was added. |
| Acceptability of CHANGE group therapy programme, measured by SAI (a German version of AIM (Acceptability of intervention) questionnaire, Weiner et al. 2017) | T1 (8 weeks after baseline) | Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree), item 5 was added. |
| Appropriateness of CHANGE group therapy programme, measured by AIS (a German version of IAM (Appropriateness of intervention) questionnaire, Weiner et al. 2017) | T1 (8 weeks after baseline) | Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree). |
| Recruitment rate | T1 (8 weeks after baseline) | number of consented participants / number of eligible patients |
| Retention rate | T1 (8 weeks after baseline) | number of participants completed post-assessment / number of consented participants |
| Adherence rate | T1 (8 weeks after baseline) | number of attended sessions / total number of sessions |
| Dropout rate | T1 (8 weeks after baseline) | number of dropouts / total number of enrolled participants |
| Dropout reasons | T1 (8 weeks after baseline) | structured categories and free text |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003) | T0 (baseline), T1 (8 weeks after baseline) | Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true) |
| Change in adapted motivation, measured by adapted FEVER (German version of URICA (University of Rhode Island Change Assessment), Hasler et al. 2003). | T0 (baseline), T1 (8 weeks after baseline) | Questionnaire consisting of 24 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), item 11 was adapted. |
| Change in Quality of Life, measured by adapted WHOQOL-BREF (World Health Organization Quality of Life - Brief Version, German, Angermeyer et al. 2000) | T0 (baseline), T1 (8 weeks after baseline) | Questionnaire consisting of 26 items rated on a 5-point Likert scale with response formats varying by item (intensity, capacity, frequency, or satisfaction), item 10 was adapted. |
| Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996) | T0 (baseline), T1 (8 weeks after baseline) | Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree) |
| Change in Knowledge concerning therapy content, measured by a self-constructed Multiple Choice Questionnaire | T0 (baseline), T1 (8 weeks after baseline) | 16 multiple choice questions (4 per module), each offering 4 response options with one correct answer |
| Satisfaction, measured by Group Therapy Satisfaction scale (adapted from Westermann et al. 1996) | T1 (8 weeks after baseline) | Questionnaire consisting of 14 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (completely true). 2 model specific items were added per therapy module (8 added in total). |
Countries
Germany
Contacts
CONTACTNatan Yusupov, MD, PhD
PRINCIPAL_INVESTIGATORNatan Yusupov, MD, PhD
Max-Planck-Institute of Psychiatry
PRINCIPAL_INVESTIGATORAngelika Erhardt, MD, Prof.
Max-Planck-Institute of Psychiatry
PRINCIPAL_INVESTIGATORPeter Falkai, MD, Prof.
Max-Planck-Institute of Psychiatry
Outcome results
None listed