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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Max-Planck-Institute of Psychiatry
Munich, Germany
Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
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.
Time frame: T1 (8 weeks after baseline)
Acceptability of CHANGE group therapy programme, measured by SAI (a German version of AIM (Acceptability of intervention) questionnaire, Weiner et al. 2017)
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.
Time frame: T1 (8 weeks after baseline)
Appropriateness of CHANGE group therapy programme, measured by AIS (a German version of IAM (Appropriateness of intervention) questionnaire, Weiner et al. 2017)
Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree).
Time frame: T1 (8 weeks after baseline)
Recruitment rate
number of consented participants / number of eligible patients
Time frame: T1 (8 weeks after baseline)
Retention rate
number of participants completed post-assessment / number of consented participants
Time frame: T1 (8 weeks after baseline)
Adherence rate
number of attended sessions / total number of sessions
Time frame: T1 (8 weeks after baseline)
Dropout rate
number of dropouts / total number of enrolled participants
Time frame: T1 (8 weeks after baseline)
Dropout reasons
structured categories and free text
Time frame: T1 (8 weeks after baseline)
Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true)
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in adapted motivation, measured by adapted FEVER (German version of URICA (University of Rhode Island Change Assessment), Hasler et al. 2003).
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.
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in Quality of Life, measured by adapted WHOQOL-BREF (World Health Organization Quality of Life - Brief Version, German, Angermeyer et al. 2000)
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.
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996)
Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in Knowledge concerning therapy content, measured by a self-constructed Multiple Choice Questionnaire
16 multiple choice questions (4 per module), each offering 4 response options with one correct answer
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Satisfaction, measured by Group Therapy Satisfaction scale (adapted from Westermann et al. 1996)
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).
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Time frame: T1 (8 weeks after baseline)